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Condoms [MH] AND Randomized Controlled Trial [PT] and hasabstract


1: J Acquir Immune Defic Syndr 2002 May 1;30(1):69-72

Reduced HIV risk-taking and low HIV incidence after enrollment and
risk-reduction counseling in a sexually transmitted disease prevention trial in
Nairobi, Kenya.

Kaul R, Kimani J, Nagelkerke NJ, Fonck K, Keli F, MacDonald KS, Ronald AR,
Plummer FA, Bwayo JJ, Ngugi EN, Temmerman M, Moses S.

Department of Medical Microbiology, University of Nairobi, Kenya.
rupertkaul@hotmail.com

There is an urgent need in sub-Saharan Africa to develop more effective methods
of HIV prevention, including improved strategies of sexually transmitted
infection (STI) prevention or an HIV vaccine. The efficacy of these strategies
may be tested through clinical trials within cohorts at high risk for STI and
HIV, such as female commercial sex workers. For ethical reasons, standard HIV
prevention services, including access to free condoms, risk-reduction
counseling, and STI therapy, will generally be offered to all study subjects.
Because study subjects would often not otherwise have access to these prevention
services, it is possible that enrollment in such clinical trials will itself
reduce incidence rates of STI and HIV below expected levels, reducing the power
to test the efficacy of the randomized intervention. We show that the provision
of standard HIV prevention services as part of a randomized STI/HIV prevention
trial is temporally associated with a dramatic reduction in sexual risk-taking,
and that this reduction is directly associated with reduced STI incidence. This
finding should be considered in the design of clinical trials with an endpoint
of HIV incidence, in particular HIV preventive vaccine trials.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 12048365 [PubMed - indexed for MEDLINE]

2: AIDS Care 2002 Apr;14(2):147-61

A gender-specific HIV/STD risk reduction intervention for women in a health care
setting: short- and long-term results of a randomized clinical trial.

Ehrhardt AA, Exner TM, Hoffman S, Silberman I, Leu CS, Miller S, Levin B.

HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric
Institute, NY 10032, USA. ehrharda@child.cpmc.columbia.edu

This study assessed the short- and long-term effect of a gender-specific group
intervention for women on unsafe sexual encounters and strategies for protection
against HIV/STD infection. Family planning clients (N = 360) from a high HIV
seroprevalence area in New York City were randomized to an eight-session, a
four-session or a control condition and followed at one, six and 12 months
post-intervention. Using an intention-to-treat analysis, women who were assigned
to the eight-session group had about twice the odds of reporting decreased or no
unprotected vaginal and anal intercourse compared to controls at one month (OR =
1.93, 95% confidence interval [CI] = 1.07, 3.48, p = 0.03) and at 12-month
follow-up (OR = 1.65, 95% CI = 0.94, 2.90, p = 0.08). Relative to controls,
women assigned to the eight-session condition reported during the previous month
approximately three-and-a-half (p = 0.09) and five (p < 0.01) fewer unprotected
sex occasions at one- and 12-month follow-up, respectively. Women in the
eight-session group also reduced the number of sex occasions at both follow-ups,
and had a greater odds of first time use of an alternative protective strategy
(refusal, outercourse, mutual testing) at one-month follow-up. Results for the
four-session group were in the expected direction but overall were inconclusive.
Thus, gender-specific interventions of sufficient intensity can promote short-
and long-term sexual risk reduction among women in a family planning setting.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 11940275 [PubMed - indexed for MEDLINE]

3: Public Health Rep 2001;116 Suppl 1:103-19

Long-term effectiveness of a peer-based intervention to promote condom and
contraceptive use among HIV-positive and at-risk women.

Fogarty LA, Heilig CM, Armstrong K, Cabral R, Galavotti C, Gielen AC, Green BM.

Department of Health Policy and Management, Johns Hopkins University Bloomberg
School of Public Health, Baltimore, MD 21205, USA. lfogarty@jhsph.edu

OBJECTIVE: The authors used data from a larger study to evaluate the long-term
effects of a peer advocate intervention on condom and contraceptive use among
HIV-infected women and women at high risk for HIV infection. METHODS:
HIV-infected women in one study and women at high risk for HIV infection in a
second study were selected from the Women and Infants Demonstration Project and
assigned to a standard or an enhanced HIV prevention treatment group. The
enhanced intervention included support groups and one-on-one contacts with peer
advocates tailored to clients' needs. The authors interviewed women at baseline
and at 6-, 12- and 18-months, and measured changes in consistency of condom and
contraceptive use and in self-efficacy and perceived advantages and
disadvantages of condom and contraceptive use. RESULTS: Of HIV-infected women,
the enhanced group had improved consistency in condom use, increased perceived
advantages of condom use, and increased level of self-efficacy compared with the
standard group. Of women at risk, the enhanced intervention group at six months
maintained consistent condom use with a main partner and perceived more benefit
of condom use compared with the standard group. These differences diminished at
12 months. CONCLUSIONS: The enhanced intervention was generally effective in the
HIV+ study. In the at-risk study, however, intervention effects were minimal and
short-lived. Factors related to the theory, intervention design, and sample
characteristics help explain these differences.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 11889279 [PubMed - indexed for MEDLINE]

4: Public Health Rep 2001;116 Suppl 1:82-93

Safer choices: reducing teen pregnancy, HIV, and STDs.

Coyle K, Basen-Engquist K, Kirby D, Parcel G, Banspach S, Collins J, Baumler E,
Carvajal S, Harrist R.

ETR Associates, Scotts Valley, California, USA. karinc@etr.org

OBJECTIVES: This study evaluated the long-term effectiveness of Safer Choices, a
theory-based, multi-component educational program designed to reduce sexual risk
behaviors and increase protective behaviors in preventing HIV, other STDs, and
pregnancy among high school students. METHODS: The study used a randomized
controlled trial involving 20 high schools in California and Texas. A cohort of
3869 ninth-grade students was tracked for 31 months from fall semester 1993
(baseline) to spring semester 1996 (31-month follow-up). Data were collected
using self-report surveys administered by trained data collectors. Response rate
at 31-month follow-up was 79%. RESULTS: Safer Choices had its greatest effect on
measures involving condom use. The program reduced the frequency of intercourse
without a condom during the three months prior to the survey, reduced the number
of sexual partners with whom students had intercourse without a condom, and
increased use of condoms and other protection against pregnancy at last
intercourse. Safer Choices also improved 7 of 13 psychosocial variables, many
related to condom use, but did not have a significant effect upon rates of
sexual initiation. CONCLUSIONS: The Safer Choices program was effective in
reducing important risk behaviors for HIV, other STDs, and pregnancy and in
enhancing most psychosocial determinants of such behavior.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 11889277 [PubMed - indexed for MEDLINE]

5: JAMA 2002 Mar 6;287(9):1117-22

Comment in:
JAMA. 2002 Mar 6;287(9):1171-2.

Effect of nonoxynol-9 gel on urogenital gonorrhea and chlamydial infection: a
randomized controlled trial.

Roddy RE, Zekeng L, Ryan KA, Tamoufe U, Tweedy KG.

Family Health International, PO Box 13950, Research Triangle Park, NC 27709,
USA. rroddy@fhi.org

CONTEXT: Nonoxynol-9 has been suggested as a vaginal microbicide to protect
against common sexually transmitted infections. OBJECTIVE: To compare
nonoxynol-9 gel and condom use (gel group) vs condom use alone (condom group)
for the prevention of male-to-female transmission of urogenital gonococcal and
chlamydial infection. DESIGN AND SETTING: Randomized controlled trial conducted
at 10 community clinics and 10 pharmacies in Yaounde, Cameroon, between October
1998 and September 2000, with 6 months of follow-up. PARTICIPANTS: High-risk
population of 1251 women (excluding sex workers) being treated for or who had
symptoms of sexually transmitted infections. Three were excluded from the gel
group (0.5%) and 7 from the condom group (1%) because of no follow-up data.
INTERVENTIONS: Nonoxynol-9 gel (100 mg) and condoms or condoms only. MAIN
OUTCOME MEASURE: A positive test result for gonococcal or chlamydial infection
by the ligase chain reaction assay; secondary outcome measure was a positive
test result for human immunodeficiency virus (HIV). RESULTS: The rate ratio (RR)
for new urogenital infections was 1.2 for the gel group vs condom group (95%
confidence interval [CI], 0.9-1.6; P =.21). The gel group had 116 diagnosed
gonococcal infections, chlamydial infections, or both for a rate of 43.6 per 100
person-years, and the condom group had 100 infections for a rate of 36.6 per 100
person-years. The RR for gonococcal infection in the gel group vs the condom
group was 1.5 (95% CI, 1.0-2.3) and for chlamydial infection was 1.0 (95% CI,
0.7-1.4). There were 5 new cases of HIV infections in the gel group and 4 in the
condom group. Three women in each group became pregnant during the study.
CONCLUSION: Nonoxynol-9 gel did not protect against urogenital gonococcal or
chlamydial infection.

Publication Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial

PMID: 11879108 [PubMed - indexed for MEDLINE]

6: Am J Community Psychol 2001 Dec;29(6):937-64

Community-based interventions to reduce low income, African American women's
risk of sexually transmitted diseases: a randomized controlled trial of three
theoretical models.

St Lawrence JS, Wilson TE, Eldridge GD, Brasfield TL, O'Bannon RE 3rd.

Jackson State University, USA. nzs4@cdc.gov

A community-based sample of disadvantaged African American women (n = 445) was
recruited to participate in 1 of 3 theoretically driven experimental
interventions based on either the theory of gender and power, social learning
theory, or cognitive behavioral theory. Intervention outcomes were compared with
a waiting list control condition. From baseline to postintervention, women in
the experimental interventions showed differential change on cognitive indices
(knowledge and attitudes) and skill acquisition (partner negotiation skills,
correct condom application, lubricant selection, and information-provision to
social networks) whereas control participants were unchanged. Women in the 3
experimental interventions also completed follow-up assessments for 1 year
following the interventions. In all 3 experimental conditions, condom use
increased relative to the control group and there were no differences between
the experimental interventions. Women who participated in one of the
theoretically grounded interventions continued to increase condom use over the
following year. Women entering new relationships reported significantly more
condom use than did women who remained in ongoing relationships. The findings
suggest that intervention models that have proven effective for women who engage
in high-risk behavior may be less effective for women in established
relationships for whom risk is primarily derived from the extrarelationship
behavior of their partners.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 11800513 [PubMed - indexed for MEDLINE]

7: Pediatrics 2001 Nov;108(5):E85

A prospective study of psychological distress and sexual risk behavior among
black adolescent females.

DiClemente RJ, Wingood GM, Crosby RA, Sionean C, Brown LK, Rothbaum B, Zimand E,
Cobb BK, Harrington K, Davies S.

Emory University, Rollins School of Public Health, Department of Behavioral
Sciences and Health Education, Atlanta, Georgia 30322, USA.
rdiclem@sph.emory.edu

OBJECTIVE: The purpose of the study was to examine the association between
adolescents' psychological distress and their sexually transmitted disease/human
immunodeficiency virus (STD/HIV)-associated sexual behaviors and attitudes.
METHOD: Sexually active black adolescent females (N = 522) completed, at
baseline and again 6 months later, a self-administered questionnaire that
assessed sexual health attitudes and emotional distress symptoms (using
standardized measures, alpha =.84), a structured interview that assessed
STD/HIV-associated sexual risk behaviors, and a urine screen for pregnancy.
RESULTS: In multivariate analyses, controlling for observed covariates,
adolescents with significant distress at baseline were more likely than their
peers, after 6 months, to be pregnant (adjusted odds ratio [AOR]: = 2.0), have
had unprotected vaginal sex (AOR = 2.1), have nonmonogamous sex partners (AOR =
1.7), and not use any form of contraception (AOR = 1.5). Additionally, they were
also more likely to: perceive barriers to condom use (AOR = 2.2), be fearful of
the adverse consequences of negotiating condom use (AOR = 2.0), perceive less
control in their relationship (AOR = 2.0), have experienced dating violence (AOR
= 2.4), feel less efficacious in negotiating condom use with a new sex partner
(AOR = 1.6), and have norms nonsupportive of a healthy sexual relationship (AOR
= 1.7). DISCUSSION: The findings suggest that psychological distress is
predictive over a 6-month period of a spectrum of STD/HIV-associated sexual
behaviors and high-risk attitudes. Brief screening to detect distress or
depressive symptoms among adolescent females can alert the clinician to the need
to conduct a sexual health history, initiate STD/HIV-preventive counseling, and
refer for comprehensive psychological assessment and appropriate treatment.
Among adolescents receiving STD treatment, those with even moderate emotional
distress may be at heightened risk for further unhealthy outcomes. STD/HIV
interventions should also consider psychological distress as one potential risk
factor that may impact program efficacy.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 11694669 [PubMed - indexed for MEDLINE]

8: AIDS 2001 Nov 9;15(16):2171-9

HIV incidence and sexually transmitted disease prevalence associated with condom
use: a population study in Rakai, Uganda.

Ahmed S, Lutalo T, Wawer M, Serwadda D, Sewankambo NK, Nalugoda F, Makumbi F,
Wabwire-Mangen F, Kiwanuka N, Kigozi G, Kiddugavu M, Gray R.

Johns Hopkins University School of Public Health, Baltimore, Maryland 21205,
USA.

OBJECTIVE: Evidence of condom effectiveness for HIV and sexually transmitted
disease (STD) prevention is based primarily on high-risk populations. We
examined condom effectiveness in a general population with high HIV prevalence
in rural Africa. METHODS: Data were from a randomized community trial in Rakai,
Uganda. Condom usage information was obtained prospectively from 17,264 sexually
active individuals aged 15-59 years over a period of 30 months. HIV incidence
and STD prevalence was determined for consistent and irregular condom users,
compared to non-users. Adjusted rate ratios (RR) of HIV acquisition were
estimated by Poisson multivariate regression, and odds ratios of STDs estimated
by logistic regression. RESULTS: Only 4.4% reported consistent condom use and
16.5% reported inconsistent use during the prior year. Condom use was higher
among males, and younger, unmarried and better educated individuals, and those
reporting multiple sex partners or extramarital relationships. Consistent condom
use significantly reduced HIV incidence [RR, 0.37; 95% confidence interval (CI),
0.15-0.88], syphilis [odds ratio (OR), 0.71; 95% CI, 0.53-0.94] and
gonorrhea/Chlamydia (OR, 0.50; 95% CI, 0.25-0.97) after adjustment for
socio-demographic and behavioral characteristics. Irregular condom use was not
protective against HIV or STD and was associated with increased
gonorrhea/Chlamydia risk (OR, 1.44; 95% CI, 1.06-1.99). The population
attributable fraction of consistent use for prevention of HIV was -4.5% (95% CI,
-8.3 to 0.0), due to the low prevalence of consistent use in the population.
CONCLUSIONS: Consistent condom use provides protection from HIV and STDs,
whereas inconsistent use is not protective. Programs must emphasize consistent
condom use for HIV and STD prevention.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 11684937 [PubMed - indexed for MEDLINE]

9: Obstet Gynecol 2001 Oct;98(4):570-5

Emergency contraception: randomized comparison of advance provision and
information only.

Ellertson C, Ambardekar S, Hedley A, Coyaji K, Trussell J, Blanchard K.

Population Council, Mexico City, Mexico. cellertson@popcouncil.org.mx

OBJECTIVE: To determine whether multiple courses of emergency contraceptive
therapy supplied in advance of need would tempt women using barrier methods to
take risks with their more effective ongoing contraceptive methods. METHODS: We
randomly assigned 411 condom users attending an urban family planning clinic in
Pune, India, to receive either information about emergency contraception along
with three courses of therapy to keep in case of need, or to receive only
information, including that about the locations where they could obtain
emergency contraception if needed. For up to 1 year, women returned quarterly
for follow-up, answering questions about unprotected intercourse, emergency
contraceptive use, pregnancies, sexually transmitted infections, and
acceptability. RESULTS: Women given advance supplies reported unprotected
intercourse at rates nearly identical to those among women given only
information (0.012 versus 0.016 acts per month). Among those who did have
unprotected intercourse, however, supply recipients were nearly twice as likely
(79% versus 44%) to have taken emergency contraception, although numbers were
too small to permit statistically significant inferences. No women used
emergency contraception more than once during the study, even though everyone in
the advance-supplies group had extra doses available. All women found knowing
about emergency contraception useful, and all those receiving only information
wished they had received supplies as well. CONCLUSION: Multiple emergency
contraception doses supplied in advance did not tempt condom users to risk
unprotected intercourse. After unprotected intercourse, however, those with
pills on hand used them more often. Women found advance provision useful.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 11576569 [PubMed - indexed for MEDLINE]

10: Health Psychol 2001 Sep;20(5):369-76

Social-cognitive theory mediators of behavior change in the National Institute
of Mental Health Multisite HIV Prevention Trial.

The National Institute of Mental Health Multisite HIV Prevention Trial was a
trial of an intervention to reduce sexual HIV risk behaviors among 3,706
low-income at-risk men and women at 7 U.S. research sites. The intervention,
based on social-cognitive theory and designed to influence behavior change by
improving expected outcomes of condom use and increasing knowledge, skills, and
self-efficacy to execute safer sex behaviors, was effective relative to a
control condition in reducing sexual risk behavior. At 3 months after completion
of the intervention, measures of these potential mediators were higher in the
intervention than in the control condition. Although the effect of the
intervention on sexual risk behavior was significantly reduced when the
variables were controlled statistically, supporting the hypothesis of their
mediation of the intervention effect, most of the effect remained unexplained,
indicating the influence of unmeasured factors on outcome.

Publication Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial

PMID: 11570651 [PubMed - indexed for MEDLINE]

11: JAMA 2001 Jun 27;285(24):3100-6

Comment in:
JAMA. 2001 Nov 7;286(17):2095; discussion 2096.
JAMA. 2001 Nov 7;286(17):2095; discussion 2096.
JAMA. 2001 Nov 7;286(17):2096.

Effect of condoms on reducing the transmission of herpes simplex virus type 2
from men to women.

Wald A, Langenberg AG, Link K, Izu AE, Ashley R, Warren T, Tyring S, Douglas JM
Jr, Corey L.

University of Washington, Virology Research Clinic, 1001 Broadway, Suite 320,
Seattle, WA 98122, USA. annawald@u.washington.edu

CONTEXT: Herpes simplex virus type 2 (HSV-2) is one of the most common sexually
transmitted infections in the United States. No prospective study has shown the
ability of condoms to reduce transmission of HSV-2. OBJECTIVE: To evaluate risk
factors for HSV-2 acquisition and efficacy of condoms in prevention of HSV-2
transmission. DESIGN: Analysis of data from a randomized, double-blind,
placebo-controlled trial conducted December 13, 1993, to June 28, 1996, of an
ineffective candidate HSV-2 vaccine with 18 months of follow-up. SETTING:
Eighteen clinical trial centers in the United States. PARTICIPANTS: A total of
528 monogamous couples discordant for HSV-2 infection, including an
HSV-2-susceptible population of 261 men and 267 women. MAIN OUTCOME MEASURE:
Acquisition of HSV-2 infection by susceptible partners, compared with those
remaining free of HSV-2 with regard to demographic characteristics, sexual
activity, and condom use. RESULTS: Twenty-six women (9.7%) vs 5 men (1.9%)
acquired HSV-2, for a rate per 10 000 sex acts (episodes of sexual intercourse)
of 8.9 vs 1.5, respectively (P<.001). In multivariable analysis, younger age
(adjusted hazard ratio [HR] per 5 years, 1.57; 95% confidence interval [CI],
1.22-2.04), seropositivity for HSV-1 and HSV-2 vs HSV-2 alone in the source
partner (adjusted HR, 2.34; 95% CI, 1.14-4.82), and more frequent sexual
activity (adjusted HR per additional sex act per week, 1.10; 95% CI, 1.01-1.19)
were associated with higher risk of HSV-2 acquisition. Condom use during more
than 25% of sex acts was associated with protection against HSV-2 acquisition
for women (adjusted HR, 0.085; 95% CI, 0.01-0.67) but not for men (adjusted HR,
2.02; 95% CI, 0.32-12.50). Risk of HSV-2 transmission declined from 8.5 per 100
person-years in the initial 150-day interval to 0.9 per 100 person-years in the
final 150-day interval (P =.002 for trend), concurrent with a decrease in sexual
activity and proportion of sex acts occurring when the source partner had
genital lesions. CONCLUSIONS: Condom use offers significant protection against
HSV-2 infection in susceptible women. Changes in sexual behavior, correlated
with counseling about avoiding sex when a partner has lesions, were associated
with reduction in HSV-2 acquisition over time. These data suggest that
identification of discordant couples can reduce transmission of HSV-2,
especially for heterosexual couples in which the male partner has HSV-2
infection.

Publication Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial

PMID: 11427138 [PubMed - indexed for MEDLINE]

12: Eur J Public Health 2001 Jun;11(2):153-9

Effects of peer-led AIDS education aimed at Turkish and Moroccan male immigrants
in The Netherlands. A randomised controlled evaluation study.

Kocken P, Voorham T, Brandsma J, Swart W.

Municipal Health Service of Rotterdam area, Department of Health Promotion, P.O.
Box 70032, 3000 LP Rotterdam, The Netherlands. kockenp@ggd.rotterdam.nl

BACKGROUND: An evaluation study was conducted in The Netherlands into acquired
immune deficiency syndrome (AIDS) education for immigrants given in their native
language by peers. Turkish and Moroccan men were trained to educate people from
their own ethnic group. The effect of peer education on the perceived threat of
AIDS and beliefs about condom use were studied. METHODS: Places where male
immigrants met, i.e. coffee houses, mosques and bars, were matched and randomly
assigned to experimental and control groups. The experimental group filled out a
short questionnaire at the end of the education session (post-test), whereas the
control group was pre-tested and had the opportunity of following the AIDS
education after participation in the questionnaire. RESULTS: Using multilevel
logistic regression analysis, an effect could be established on
misunderstandings regarding human immunodeficiency virus (HIV) transmission (OR
= 5.9 and 95% CI: 2.3-15.3) and risk appraisal for HIV infection (OR = 2.9 and
95% CI: 1.3-6.3). The perceived benefits of the protective effect of condom use
were affected in men 30 years and older, the perceived barrier of diminished
satisfaction if using condoms was changed among unmarried men, condom
self-efficacy was affected in men who valued peer education as important and an
effect on intention to use condoms was found among Moroccans. CONCLUSION:
Continuation of peer-led AIDS education for immigrants and adaption of the
message to the needs of specific target groups is recommended.

Publication Types:
Clinical Trial
Evaluation Studies
Randomized Controlled Trial

PMID: 11420801 [PubMed - indexed for MEDLINE]

13: Int J STD AIDS 2001 Jul;12(7):469-74

Condom use during a community intervention trial in Kenya.

Welsh MJ, Feldblum PJ, Kuyoh MA, Mwarogo P, Kungu D.

Family Health International, PO Box 38835, Nairobi, Kenya.

We conducted a cluster-randomized community intervention trial at Kenyan
agricultural sites to measure the impact of female condom introduction on
sexually transmitted infection (STI) prevalence. We present male and female
condom use data here. Six Intervention sites received a community risk-reduction
campaign and distribution of female condoms and male condoms, while 6 Control
sites received the same campaign with male condoms only. Male and female condom
distribution increased throughout follow-up. Self-reported male condom use
increased substantially during follow-up to over 60% of the participants. The
proportion of consistent male condom users at Control sites was higher than at
Intervention sites, 23% vs 14% at 6 months and 24% vs 22% at 12 months. At
Intervention sites, 11% and 7% of women used the female condoms all the time at
6 and 12 months, respectively, while the percentage of female condom non-users
grew. Male and female condom use was hindered by male partner objections;
suspicion of the study and the devices among residents; and bias against condoms
by clinic service providers. A large proportion of coital acts remained
unprotected during the trial. Our female condom intervention did not reduce STI
prevalence, compared with male condom promotion only.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 11394984 [PubMed - indexed for MEDLINE]

14: Contraception 2001 Mar;63(3):159-66

A comparison of three daily coital diary designs and a phone-in regimen.

Hays MA, Irsula B, McMullen SL, Feldblum PJ.

Biostatistics Division and Clinical Research Department, Family Health
International, Research Triangle Park, NC 27709, USA. mhays@fhi.org

Barrier contraceptive trials and disease intervention studies often utilize
coital diaries to measure sexual exposures: dates and frequency of intercourse,
product use, additional or alternative contraceptive use, and menstrual
bleeding. The validity of these self-reported data is a matter of debate, but if
used, better diary designs are sought. We studied 3 different coital diaries,
plus a phone-in regimen (none or weekly) in a 3 x 2 factorial design to compare
participant ratings and promptness of recording. Our underlying presumption was
that ease of and satisfaction with use, and promptness of data collection, are
associated with greater accuracy. A self-completed questionnaire at the end of
the study collected comparative retrospective data. Diary 1 captured information
about a single day on one page and had three columns, for up to three possible
acts of intercourse. Diary 2 had the same question format as the first diary,
but contained 7 days per page. Diary 3 had 7 days on a page, but instead of a
column for each act, participants enumerated the number of acts, the types of
contraception used, and condom use details. Half of the women in each diary
group phoned in their data weekly. Phone-in improved participants' satisfaction
with the diary design as reflected by higher ratings of diary features. Phone-in
did not improve recall of data at the end of the study for any of the diaries.
There were no differences in the promptness of diary completion. Diaries 1 and 2
showed good concordance with recalled data, and participants expressed a
preference for the layout of Diary 2. Women assigned to Diary 3 expressed
dissatisfaction with the design and were worse at recalling data at the end of
the study, probably due to the complexity of that diary design.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 11368990 [PubMed - indexed for MEDLINE]

15: Zhonghua Fu Chan Ke Za Zhi 1999 Jan;34(1):33-5

[Contraceptive efficacy of Sino-female condom: comparison with condom]

[Article in Chinese]

Xu J, Wu Y, Cao Q.

Shanghai Municipal Family Planning Commission, Shanghai 200002.

OBJECTIVE: To compare the contraceptive efficacy of Sino-female condom with
condom. METHODS: 603 volunteer couples were randomly divided into two groups:
304 couples using female condom for contraception, and 299 using condom. Using
lifetable method and log rank test, we compared the pregnancy rates and other
discontinuation rates after follow-up for 6 months in two groups. RESULTS: No
abnormal findings of cervical and vaginal smears were detected before and after
this clinical trial in all 603 women. The follow-up rates at 6 months were
99.01% and 99.67% in the female condom group and condom group, respectively. The
6-month gross cumulative pregnancy rates were 1.06 and 1.69 per 100 women and
the discontinuation rates due to allergy were 1.39 and 0.34, respectively. No
difference was statistically significant (P > 0.05). However, the
discontinuation rate for other causes in the female condom group was
significantly higher than that in the condom group (P < 0.01). The main cause
was that more than half of subjects were used to applying condom before this
study. CONCLUSION: The contraceptive efficacy of Sino-female condom is as same
as that of condom, and its clinical use is quite safe.

Publication Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial

PMID: 11263171 [PubMed - indexed for MEDLINE]

16: Contraception 2001 Jan;63(1):25-31

Randomized crossover trial comparing the eZ.on plastic condom and a latex
condom.

Cook L, Nanda K, Taylor D.

Family Health International, Research Triangle Park, NC, USA.

This randomized crossover trial compared the breakage and slippage rates,
safety, and acceptability of the recently developed polyurethane bi-directional
eZ.on condom with a marketed latex condom. Three hundred sixty couples were
asked to use 4 eZ.on condoms and 4 latex condoms. Like several other non-latex
condoms tested to date, the eZ.on condom had a higher clinical breakage rate
than its latex comparator, while the slippage rates were similar. The clinical
breakage rate for the eZ.on condom was 5.6%, compared with 0.9% for the latex
condom (difference = 4.76%, with upper 95% confidence bound on the difference =
6.26%). Thus, based on an a priori definition of a 2% clinically acceptable
difference, the study failed to conclude equivalence relative to clinical
breakage. The complete slippage rate for eZ.on was 1.6%; compared to 0.7% for
latex (difference = 0.87%, with upper 95% confidence bound = 1.55%). Thus, based
on an a priori definition of a 2% difference we concluded equivalence relative
to complete slippage. The safety profile of the eZ.on condom was good and
similar to the latex condom. The eZ.on was also found to be easier to don and
remove than the latex condom. Although no overall preference existed for either
condom, nearly 30%women and men strongly preferred the eZ.on condom to the latex
condom. The eZ.on condom may be an acceptable alternative for couples unable or
unwilling to use latex condoms.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 11257245 [PubMed - indexed for MEDLINE]

17: AIDS Care 2000 Oct;12(5):581-8

Use of female controlled microbicidal products for HIV risk reduction.

Malow RM, Ziskind D, Jones DL.

University of Miami, School of Medicine/JMH Mental Health/Hospital Centers,
Department of Psychiatry and Behavioral Sciences, Health Promotion Programs,
1695 N.W. 9 Avenue, Suite 3208, Miami, Florida 33136, USA. RMALOW@Bellsouth.net

Many over-the-counter microbicidal contraceptive methods reduce the risk of
acquiring sexually transmitted diseases. This pilot project compared the use of
female controlled barrier methods in an extremely high-risk population of
low-income drug abusing women following an intervention designed to promote HIV
risk reduction and barrier use. An HIV transmission risk reduction interactive
intervention emphasizing self-esteem, assertiveness and sexual negotiation was
offered to 41 drug dependent women. Participants were randomly assigned to one
of two conditions, a male and female condom condition or a male and female
condom plus N-9 products (vaginal suppositories, film, gel) condition. Results
from the three-month follow-up period suggest that there may be a synergistic
effect of availability of multiple protective methods on the overall rate of
protective behaviours. The use of the male condom for penile/vaginal sex
increased from 19% at study entry to 27% during the three-month follow-up
period. The total protected sexual episode rate, calculated to include use of
the other protective barriers distributed, was 60%. Thus, the condom use rate
was not found to decrease because of the availability of alternative methods of
protection. Future research should address the use of microbicidal products to
empower women to prevent STD/HIV transmission.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 11218544 [PubMed - indexed for MEDLINE]

18: AIDS 2001 Jan 26;15(2):245-50

Comment in:
AIDS. 2001 Jan 26;15(2):267-9.

An evaluation of a thicker versus a standard condom with gay men.

Golombok S, Harding R, Sheldon J.

Family and Child Psychology Research Centre, City University, London, UK.

OBJECTIVES: Although thicker (stronger) condoms are advocated in western Europe
for anal intercourse between men, empirical evidence supporting their greater
efficacy is lacking. The present study aimed to determine whether a thicker
condom is less likely to fail (break or slip off) than a standard (regular
thickness) condom, and to establish factors associated with condom failure among
gay men. DESIGN: A total of 283 homosexual couples participated in a
double-blind, randomized, controlled trial of a standard and a thicker condom.
METHODS: Each couple was allocated nine of either condom type. Data were
collected on user characteristics, and a questionnaire completed immediately
after the use of each condom. The thicker and the standard condoms were used by
142 and 141 couples, respectively. RESULTS: No significant differences were
found between the two condom types with respect to either clinical or
non-clinical definitions of failure (breakage and slippage). With instances of
inappropriate use removed, failure rates for the standard and the thicker condom
were low at 2.5 and 2.3%, respectively. User characteristics associated with
breakage were lower educational achievement, lack of confidence in condom use,
and a history of condom breakage. Behaviours associated with breakage were
unrolling the condom before fitting to the penis, longer penis length, absence
of additional lubricant, the use of inappropriate lubricant, and longer duration
of intercourse. CONCLUSION: Breakage and slippage rates were low for both condom
types. There is no evidence from the present investigation to support the use of
stronger (thicker) condoms over standard strength condoms among gay men. The
appropriate use of additional lubricant should be encouraged.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 11216934 [PubMed - indexed for MEDLINE]

19: Arch Pediatr Adolesc Med 2001 Jan;155(1):73-9

Randomized controlled trial of a safer sex intervention for high-risk adolescent
girls.

Shrier LA, Ancheta R, Goodman E, Chiou VM, Lyden MR, Emans SJ.

Division of Adolescent/Young Adult Medicine, Children's Hospital, 300 Longwood
Ave, Boston, MA 02115, USA. shrier@a1.tch.harvard.edu

OBJECTIVE: To determine the effect of an individualized safer sex intervention
on condom use and recurrent sexually transmitted disease (STD) among female
adolescents diagnosed as having an STD. DESIGN: Randomized controlled trial.
SETTING: Urban children's hospital adolescent clinic and inpatient service.
PARTICIPANTS: One hundred twenty-three adolescents with cervicitis or pelvic
inflammatory disease. INTERVENTION: Participants completed a questionnaire and
then were randomized to receive standard STD education or to watch a videotape
and have an individualized intervention session. Follow-up questionnaires were
completed at 1, 3, 6, and 12 months. Intervention participants met with an
educator at 1, 3, and 6 months to discuss interim sexual history and review the
intervention. MAIN OUTCOME MEASURES: Change in self-reported condom use and
recurrence of STD. Other self-reported behaviors, sexual risk knowledge,
attitudes toward condoms, and condom use negotiation skills were also assessed.
RESULTS: At 1 month, compared with control participants, intervention
participants had increased sexual risk knowledge and more positive attitudes
toward condoms and tended to use condoms more with a nonmain partner. At 6
months, fewer intervention participants than controls had sex with a nonmain
sexual partner in the previous 6 months. At 12 months, intervention participants
were less likely to have a current main partner and had a lower rate of
recurrent STD than controls, but these differences were not significant.
CONCLUSIONS: This individualized safer sex intervention may improve condom use
and decrease the number of partners among adolescent girls who have had an STD.
Studies with larger samples are needed to determine definitive intervention
effects on recurrent STD in this high-risk population.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 11177066 [PubMed - indexed for MEDLINE]

20: AIDS 2000 Dec 1;14(17):2769-79

Syndrome packets and health worker training improve sexually transmitted disease
case management in rural South Africa: randomized controlled trial.

Harrison A, Karim SA, Floyd K, Lombard C, Lurie M, Ntuli N, Wilkinson D.

South African Medical Research Council (Division of HIV Prevention and Vaccine
Research) 1, Mtubatuba. harrisoa@mrc.ac.za

BACKGROUND: Sexually transmitted diseases (STD) are important co-factors in HIV
transmission. We studied the impact of health worker training and STD syndrome
packets (containing recommended drugs, condoms, partner notification cards and
information leaflets) on the quality of STD case management in primary care
clinics in rural South Africa. METHODS: A randomized controlled trial of five
matched pairs of clinics compared the intervention with routine syndromic
management. Outcomes were measured by simulated patients using standardized
scripts, and included the proportion given recommended drugs; correctly case
managed (given recommended drugs plus condoms and partner cards); adequately
counselled; reporting good staff attitude; and consulted in privacy. RESULTS: At
baseline, the quality of STD case management was similarly poor in both groups.
Only 36 and 46% of simulated patients visiting intervention and control clinics,
respectively, were given recommended drugs. After the intervention, intervention
clinics provided better case management than controls: 88 versus 50% (P < 0.01)
received recommended drugs; 83 versus 12% (P < 0.005) were correctly case
managed; 68 versus 46% (P = 0.06) were adequately counselled; 84 versus 58%
experienced good staff attitude (P = 0.07); and 92 versus 86% (P = 0.4) were
consulted privately. A syndrome packet cost US$1.50; the incremental cost was
US$6.80. The total intervention cost equalled 0.3% of annual district health
expenditure. INTERPRETATION: A simple and affordable health service intervention
achieved substantial improvements in STD case management. Although this is a
critical component of STD control and can reduce HIV transmission,
community-level interventions to influence health-seeking behaviour are also
needed.

Publication Types:
Clinical Trial
Evaluation Studies
Randomized Controlled Trial

PMID: 11125896 [PubMed - indexed for MEDLINE]

21: Arch Pediatr Adolesc Med 2000 Oct;154(10):1017-24

Economic evaluation of Safer Choices: a school-based human immunodeficiency
virus, other sexually transmitted diseases, and pregnancy prevention program.

Wang LY, Davis M, Robin L, Collins J, Coyle K, Baumler E.

Surveillance and Evaluation Research Branch, Division of Adolescent and School
Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.
lgw0@cdc.gov.

OBJECTIVE: To evaluate the cost-effectiveness and cost benefit of Safer Choices,
a school-based human immunodeficiency virus, other sexually transmitted
diseases, and unintended pregnancy prevention intervention for high school
students. METHODS: The baseline cost-effectiveness and cost benefit were derived
in 4 steps: (1) estimation of intervention costs; (2) adaptation of the
Bernoulli model to translate increases in condom use into cases of human
immunodeficiency virus and other sexually transmitted diseases averted, and
development of a model to translate increases in contraceptive use into cases of
pregnancy averted; (3) translation of cases averted into medical costs and
social costs averted; and (4) calculation of the net benefit of the program.
Multivariable sensitivity analysis was performed to determine the robustness of
the base-case results. RESULTS: Under base-case assumptions, at an intervention
cost of $105,243, Safer Choices achieved a 15% increase in condom use and an 11%
increase in contraceptive use within 1 year among 345 sexually active students.
An estimated 0.12 cases of human immunodeficiency virus, 24.37 cases of
chlamydia, 2.77 cases of gonorrhea, 5.86 cases of pelvic inflammatory disease,
and 18.5 pregnancies were prevented. For every dollar invested in the program,
$2.65 in total medical and social costs were saved. Results of most of the
scenarios remained cost saving under a wide range of model variable estimates.
CONCLUSIONS: The Safer Choices program is cost-effective and cost saving in most
scenarios considered. School-based prevention programs of this type warrant
careful consideration by policy makers and program planners. Program cost data
should be routinely collected in evaluations of adolescent prevention programs.

Publication Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial

PMID: 11030854 [PubMed - indexed for MEDLINE]

22: Health Psychol 2000 Sep;19(5):458-68

Structure of outcome beliefs in condom use. The Project RESPECT Study Group.

Albarracin D, Ho RM, McNatt PS, Williams WR, Rhodes F, Malotte CK, Hoxworth T,
Bolan GA, Zenilman J, Iatesta M.

Department of Psychology, University of Florida, Gainesville 32611, USA.
albarrac@psych.ufl.edu

To study the structure of beliefs about condom use outcomes, the authors derived
and tested 4 psychosocial hypothetical models: (a) a 2-factor model of the
personal and social outcomes of condom use; (b) a 2-factor model of the pros and
cons of the behavior; (c) a 3-factor model (i.e., physical, self-evaluative, and
social) of outcome expectancies; and (d) a thematic 4-factor model of the
protection, self-concept, pleasure, and interaction implications of the
behavior. All 4 models were studied with a confirmatory factor analysis approach
in a multisite study of 4,638 participants, and the thematic solution was
consistently the most plausible. Self-concept and pleasure were most strongly
associated with attitudes toward using condoms, intentions to use condoms, and
actual condom use, whereas protection and interaction generally had little
influence.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 11007154 [PubMed - indexed for MEDLINE]

23: Sex Transm Dis 2000 Sep;27(8):446-51

Comment in:
Sex Transm Dis. 2000 Sep;27(8):452-5.
Sex Transm Dis. 2000 Sep;27(8):456-7.

Does measured behavior reflect STD risk? An analysis of data from a randomized
controlled behavioral intervention study. Project RESPECT Study Group.

Peterman TA, Lin LS, Newman DR, Kamb ML, Bolan G, Zenilman J, Douglas JM Jr,
Rogers J, Malotte CK.

National Center for STD, HIV, and TB Prevention, Centers for Disease Control and
Prevention, Atlanta, Georgia 30333, USA. tap1@cdc.gov

BACKGROUND: Many studies measure sex behavior to determine the efficacy of
sexually transmitted disease (STD)/HIV prevention interventions. GOAL: To
determine how well measured behavior reflects STD incidence. STUDY DESIGN: Data
from a trial (Project RESPECT) were analyzed to compare behavior and incidence
of STD (gonorrhea, chlamydia, syphilis, HIV) during two 6-month intervals.
RESULTS: A total of 2879 persons had 5062 six-monthly STD exams and interviews;
8.9% had a new STD in 6 months. Incidence was associated with demographic
factors but only slightly associated with number of partners and number of
unprotected sex acts with occasional partners. Many behaviors had paradoxical
associations with STD incidence. After combining behavior variables to compare
persons with highest and lowest risk behaviors, the STD incidence ratio was only
1.7. CONCLUSION: Behavioral interventions have prevented STD. We found people
tend to have safe sex with risky partners and risky sex with safe partners.
Therefore, it is difficult to extrapolate the disease prevention efficacy of an
intervention from a measured effect on behavior alone.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 10987449 [PubMed - indexed for MEDLINE]

24: Contraception 2000 Jun;61(6):369-77

Acceptability evaluation of a natural rubber latex, a polyurethane, and a new
non-latex condom.

Frezieres RG, Walsh TL.

Research Division, California Family Health Council, Los Angeles, California
90010, USA. frezieresr@cfnc.org

After more than a century of reliance on latex condoms, male condoms fabricated
from new materials are finally becoming commercially available to consumers.
This study was an open label acceptability study that compared three lubricated
condom products during vaginal intercourse: a natural rubber latex condom, a
polyurethane condom, and a new non-latex (styrene ethylene butylene styrene,
SEBS) condom. Fifty-four couples who were using condoms for birth control were
enrolled in this three-way crossover study. Each couple tested three condoms of
each type in a randomized sequence. Couples reported condom performance after
each use and rated condom acceptability after use of three condoms of each type.
At the completion of the study, participants selected their preferred condom
type for overall acceptability, sensitivity, ease of use, appearance, and
comfort. All three condom types had low clinical breakage and slippage rates
(</= 3.3%) although the polyurethane condom did not perform as well in other
measures of performance including unrolling, discomfort, stretching, bunching,
and sliding along the penis during intercourse. None of the condom types were
statistically preferred overall [males: natural rubber latex 37%, polyurethane
24%, new non-latex (SEBS) 37%, no preference 2%; females: natural rubber latex
33%, polyurethane 27%, new non-latex 37%, no preference 2%]. A statistically
higher proportion of couples preferred both the natural rubber latex condom and
the new non-latex condom above the polyurethane condom for ease of unrolling,
and the natural rubber latex condom above the other condom types for perceived
safety. Approximately two-thirds of both male and female participants preferred
one of the two condoms made of synthetic materials suggesting that consumers
will appreciate the availability of these products.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 10958880 [PubMed - indexed for MEDLINE]

25: Eval Health Prof 2000 Jun;23(2):123-48

Modeling intervention efficacy for high-risk women. The WINGS Project.

Greenberg J, Hennessy M, MacGowan R, Celentano D, Gonzales V, Van Devanter N,
Lifshay J.

University of Pennsylvania, USA.

This study evaluates the effectiveness of two strategies--communication and
condom skills training--for increasing condom-protected sex in a sample of 510
high-risk women ages 17 to 61. Baseline and 3- and 6-month postintervention
interview data were gathered in three cities participating in a randomized trial
of a six-session, group skill-building intervention. This analysis was conducted
for the entire sample and for six subgroups categorized by age, single or
multiple partners, and history of childhood sexual abuse. The dependent variable
was the odds ratio of protected sex acts at each follow-up. Structural equation
modeling was used to estimate effects for two intervention pathways. The pathway
through condom skills increased the odds of protected sex for the intervention
group (chi 2 difference = 35, df = 2, p < .05) as well as for all subgroups. The
pathways through communication were significant for the intervention group (chi
2 difference = 23, df = 3, p < .05) but fully effective only for participants
under 30 and participants who reported childhood sexual abuse. The effectiveness
of both pathways diminished at 6 months. WINGS demonstrates that condom skills
training can increase protected sex for a heterogeneous group of women. Further
research needs to examine how such skill training translates into use of condoms
by male partners. To increase the duration of intervention effects, booster
sessions may need to be incorporated.

Publication Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial

PMID: 10947521 [PubMed - indexed for MEDLINE]

26: AIDS Care 2000 Jun;12(3):357-64

Stage of change versus an integrated psychosocial theory as a basis for
developing effective behaviour change interventions. The Project RESPECT Study
Group.

Malotte CK, Jarvis B, Fishbein M, Kamb M, Iatesta M, Hoxworth T, Zenilman J,
Bolan G.

Health Science Department,California State University, Long Beach 90815, USA.

According to the Stages of Change (SOC) model, behavioural change involves a
process of movement from precontemplation (no intention to change), to
contemplation (some intention to change, but no behaviour), to preparation
(intention to change and early inconsistent behavioural attempts to change), to
action (consistent behavioural performance for less than six months) and
finally, to maintenance (consistent behavioural performance for six months or
more). Moreover, it is argued that cognitive (e.g. attitude change) and action
oriented (e.g. changing self-efficacy) strategies are differentially effective
at different stages. In contrast, most other behavioural prediction and change
models suggest that both cognitive and action oriented approaches are necessary
to move people from precontemplation to contemplation (i.e. to develop
intentions). This paper tests this and other differences between these two
theoretical approaches. Among other findings, our data indicate that a
combination of cognitive and action strategies may be the most effective way to
target individuals who have no intention to change their behaviour.

Publication Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial

PMID: 10928213 [PubMed - indexed for MEDLINE]

27: AIDS Care 2000 Jun;12(3):267-72

AIDS education for gay men: towards a more cognitive approach.

Gold RS.

School of Psychology, Deakin University, Victoria, Australia.
rongold@deakin.edu.au

An approach to AIDS education is presented that focuses on the thinking
processes which accompany gay men's decisions to engage in high-risk sex. It is
proposed that: (1) at the time they are deciding to have high-risk sex, gay men
generally engage in an 'internal dialogue' that justifies this decision to
themselves; (2) the AIDS-related thinking underpinning such self-justifications
can differ appreciably from the AIDS-related thinking that takes place outside
the sexual context; and (3) AIDS education can profitably exploit this
difference between 'heat of the moment' and 'cold light of day' thinking.
Evidence supporting these proposals is drawn from studies in which gay men who
had engaged in unprotected anal intercourse recalled the occasion concerned in
detail, including any self-justifications they had used; and from controlled
intervention studies, in which gay men who had engaged in unprotected anal
intercourse were confronted with the thinking they had employed in the heat of
the moment.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 10928202 [PubMed - indexed for MEDLINE]

28: Lancet 2000 Jun 17;355(9221):2101-5

Comment in:
Lancet. 2000 Aug 12;356(9229):600.

Promotion of condom use in a high-risk setting in Nicaragua: a randomised
controlled trial.

Egger M, Pauw J, Lopatatzidis A, Medrano D, Paccaud F, Smith GD.

Department of Social Medicine, University of Bristol, UK. m.egger@bristol.ac.uk

BACKGROUND: In Latin America, motels rent rooms for commercial and
non-commercial sex. We investigated the impact of providing health-education
material and condoms on condom use in Managua, Nicaragua. METHODS: In a
randomised controlled trial, in 19 motels, we gave condoms on request, made them
available in rooms, or gave condoms directly to couples, with and without the
presence of health-education material in the rooms. In a factorial design we
assessed condom use directly by searching the rooms after couples had left.
FINDINGS: 11 motels were used mainly by sex workers and their clients and eight
mainly for non-commercial sex. 6463 couples attended the motels in 24 days. On
3106 (48.0%) occasions, at least one used condom was retrieved. Condom use was
more frequent for commercial sex than for non-commercial sex (60.5 vs 20.2%).
The presence of health-education material lowered the frequency of condom use
for commercial sex (odds ratio 0.89 [95% CI 0.84-0.94]) and had no effect on use
for non-commercial sex (1.03 [0.97-1.08]). Condom use increased for commercial
(1.31 [1.09-1.75]) and non-commercial sex (1.81 (1.14-2.81) if condoms were
available in rooms. Directly handing condoms to couples was similarly effective
for commercial sex but less effective for non-commercial sex (1.32 [1.03-1.61]
vs 1.52 [1.01-2.38]). INTERPRETATION: In Latin America, motels are key locations
for promoting the use of condoms. Making condoms available in rooms is the most
effective strategy to increase condom use, whereas use of health-education
material was ineffective. These findings have important implications for
HIV-prevention policies.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 10902623 [PubMed - indexed for MEDLINE]

29: AIDS 2000 Jun 16;14(9):1249-55

A randomized trial of hierarchical counseling in a short, clinic-based
intervention to reduce the risk of sexually transmitted diseases in women.

Gollub EL, French P, Loundou A, Latka M, Rogers C, Stein Z.

University of Pennsylvania Center for Addiction Studies, Philadelphia 19104,
USA.

INTRODUCTION: Effective public health interventions to reduce the incidence of
sexually transmitted disease (STD), including HIV, among women are urgently
needed. METHODS: A randomized trial among STD clinic patients of two types of
counseling regarding methods to reduce disease transmission: a 'hierarchical'
message (HP), with counseling on male condoms, female condoms, diaphragms,
cervical caps, and spermicides (three formulations) and a single method message
(SM) covering male condoms only or female condoms only. For this analysis, 1591
subjects received one of three educational messages at the central public STD
clinic in Philadelphia. Disease incidence data for up to 6 months following the
index visit were extracted from the clinic's electronic database. The primary
outcome was STD reinfection: laboratory-confirmed trichomonas infection and/or
clinical diagnoses of at least one of four STD. Rates were based on the full
sample of randomized women (full sample) and on the subset who spontaneously
returned between 22 days and 183 days following their initial visit (returners).
RESULTS: Rates of trichomonas infection (SM 2.5% full sample and 12.9% returners
versus HP 2.4% full sample and 11.5% returners) and clinical diagnoses (SM 6.3%
full sample and 39.7% returners versus HP 6.9% full sample and 41.2% returners)
did not differ across the two arms of the randomized trial, both as a straight
percentage and in survival analysis (P = .81). CONCLUSION: At least in this
single-session intervention trial, increasing choices in protection for women
did not produce a change in disease risk compared with single-method approaches.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 10894290 [PubMed - indexed for MEDLINE]

30: Contraception 2000 Mar;61(3):217-23

Safety and acceptability of a baggy latex condom.

Macaluso M, Blackwell R, Carr B, Meinzen-Derr J, Montgomery M, Roark M, Lynch M,
Stringer EM.

Department of Epidemiology and International Health, School of Public Health,
University of Alabama at Birmingham, Birmingham, Alabama 35294-2010, USA.

A total of 104 couples participated in a randomized crossover trial to compare a
new baggy condom with a straight-shaft condom produced by the same manufacturer.
Participants completed a coital log after using each condom. All couples used
five condoms of each type. Among 102 couples who did not report major deviations
from the protocol, the breakage rate was eight of 510 (1.6%) for the baggy
condom, and six of 510 (1.2%) for the standard condom (rate difference, RD = 0.
4%, 95% confidence interval of the RD, CI = -1.0%; +1.8%). Slippage was reported
in 50 baggy condom logs and in 58 standard condom logs; the slippage rate was 50
of 510 (9.8%) for the baggy condom, and 58 of 510 (11.4%) for the standard
condom (RD = -1.6%, 95% CI = -5.4%; +2.2%). Slippage was most often partial (<1
inch) and may not indicate condom failure. Severe slippage rates were 11 of 510
(2.2%) for the baggy condom, and 18 of 510 (3.5%) for the standard condom (RD =
-1.4%, 95% CI = -3.4%; +0.7%). The findings support the conclusion that the two
condoms are equivalent with respect to breakage and slippage. The participants
appeared to prefer the baggy condom, suggesting that the new product may be more
acceptable to the public than the traditional straight-shaft condoms, and may be
easier to use consistently over long time periods.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 10827336 [PubMed - indexed for MEDLINE]

31: Contraception 2000 Mar;61(3):205-15

Comparative evaluation of three Tactylon(TM) condoms and a latex condom during
vaginal intercourse: breakage and slippage.

Callahan M, Mauck C, Taylor D, Frezieres R, Walsh T, Martens M.

Contraceptive Research and Development (CONRAD) Program, Eastern Virginia
Medical School, Arlington, Virginia, USA. info@conrad.org

This study compared breakage and slippage rates of three male condom styles made
of Tactylon(TM), a synthetic elastomer, to those of a marketed latex condom
during vaginal intercourse. Safety and acceptability outcomes were also
assessed. This two-center, prospective, crossover study enrolled 443 couples.
Each couple was randomly assigned to use three condoms of each type in one of 24
use sequences. Couples completed questionnaires after using each condom, all of
one condom type, and all four condom types. The percentage and standard error
(SE, in parentheses) of latex condoms with clinical breakage was 0.86% (0.295).
Percentages for Tactylon condoms were not equivalent to the latex study condom,
ranging from 3.50% to 4.17%. The percentage and SE of latex condoms with
complete slippage was 1.11% (0.328). Percentages for Tactylon condoms were
equivalent to those for latex, ranging from 0.70% to 1.31%. The Low-Modulus
Tactylon condom was the most preferred. Fewer medical events were reported with
the Tactylon condoms than with the latex condom. It was concluded that Tactylon
condoms were equivalent to the latex condom in terms of slippage but not
breakage. However, safety and acceptability seemed to be better for Tactylon
condoms. This may improve consistency of use and may attract new users.

Publication Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial

PMID: 10827335 [PubMed - indexed for MEDLINE]

32: Health Educ Res 2000 Feb;15(1):25-38

From psycho-social theory to sustainable classroom practice: developing a
research-based teacher-delivered sex education programme.

Wight D, Abraham C.

School of Social Sciences, University of Sussex, Brighton, UK.

This paper describes the development of a theoretically based sex education
programme currently undergoing a randomized controlled trial in the UK. It
considers some of the practical difficulties involved in translating
research-based conclusions into acceptable, replicable and potentially effective
classroom lessons. The discussion acknowledges that the implications of social
psychological research and the requirements of rigorous evaluation may conflict
with accepted principles inherent in current sex education practice. It also
emphasizes that theoretical ideas must be carefully embedded in lessons which
are informed by an awareness of classroom culture, and the needs and skills of
teachers. For example, the use of same-sex student groups to reflect on the
gendered construction of sexuality may be problematic. Materials must be
tailored to recipients' circumstances, which may require substituting for
limited experience with the use of detailed scripts and scenarios. Furthermore,
role-play techniques for sexual negotiation that work elsewhere may not be
effective in the UK. The use of trigger video sessions and other techniques are
recommended. Finally, the problems involved in promoting condom-related skills
are discussed. The paper concludes that, if an intervention is to be sustainable
beyond the research stage, it must be designed to overcome such problems while
remaining theoretically informed.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 10788199 [PubMed - indexed for MEDLINE]

33: Clin Infect Dis 2000 Apr;30(4):730-5

Reducing risk of sexually transmitted disease (STD) and human immunodeficiency
virus infection in a military STD clinic: evaluation of a randomized preventive
intervention trial.

Jenkins PR, Jenkins RA, Nannis ED, McKee KT Jr, Temoshok LR.

Care Clinic, Fayetteville, NC 28305-3438, USA.

Three single-session preventive interventions for reducing sexually transmitted
disease (STD) and human immunodeficiency virus infection risk behaviors were
evaluated with a sample of 400 men who attended a large military STD clinic. A
quasi-experimental, pre-evaluation/postevaluation design was used, comparing
standard clinic care alone versus standard care combined with 1 of 3
experimental interventions: health-risk appraisal, interactive video, and
targeted situational behaviors. Questionnaire data were collected at baseline
and during follow-up visits at 2 weeks and 2 months. Findings indicated that the
health-risk appraisal and interactive video increased adherence with clinic
recommendations to abstain from sex (chi(2)3199=19.67; P<.001) and increased
readiness to change "risky" partner-selection behavior (chi(2)2194=6.42; P<.04).
Follow-up data suggested that STD-related risk behavior was particularly
resistant to change but that the single-session intervention had some impact,
which could be viewed as a "priming" effect that enhances multisession
interventions.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 10770736 [PubMed - indexed for MEDLINE]

34: Contraception 1999 Nov;60(5):289-98

Evaluation of prostate-specific antigen as a quantifiable indicator of condom
failure in clinical trials.

Walsh TL, Frezieres RG, Nelson AL, Wraxall BG, Clark VA.

Research Division, California Family Health Council, Los Angeles 90010, USA.

The ability of condoms to retain all elements of semen during intercourse has
been assessed by postcoital visual inspection and in vitro permeability studies.
Yet, these observations may not be sufficiently precise or realistic. This pilot
study evaluated prostate-specific antigen (PSA) as a semen marker of inapparent
failure of the condom barrier under conditions of actual use. Twelve couples
collected samples from the vagina and surfaces of the condom using sterile
cotton swabs. We obtained precoital and postcoital samples for 24 acts of
unprotected intercourse, 54 acts of intercourse using intact condoms, and 40
acts of intercourse using condoms that had been deliberately punctured. We used
electrophoresis to determine the amount of PSA present in the samples. PSA was
detected in 100% (24/24) of vaginal samples collected immediately after
unprotected intercourse and in none of the vaginal samples collected more than
24 h after intercourse (0/90). PSA was also present in 98% (83/85) of the
samples collected from the inside of the condom that had failed during
intercourse. Excluding uses where the condom failed during intercourse, PSA was
detected in 2% (1/47) of the postcoital vaginal samples collected after use of
intact condoms and in 41% (14/34) of the samples collected after use of condoms
with known 1-mm punctures. We conclude that PSA shows great promise as a semen
biomarker in clinical trials of barrier methods. We recommend that future
studies further investigate the ability of this biomarker to identify condom
failures and quantify the extent of semen exposure associated with various types
of condom failures.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 10717781 [PubMed - indexed for MEDLINE]

35: AIDS 2000 Jan 7;14(1):85-8

Safety of multiple daily applications of COL-1492, a nonoxynol-9 vaginal gel,
among female sex workers. COL-1492 Phase II Study Group.

Van Damme L, Chandeying V, Ramjee G, Rees H, Sirivongrangson P, Laga M, Perriens
J.

Institute of Tropical Medicine, Antwerp, Belgium.

RATIONALE: COL-1492 is a nonoxynol-9 (N-9)-containing vaginal gel and may be a
potential microbicide. As part of an effectiveness trial, an initial toxicity
study was conducted. OBJECTIVES: The main objective of the reported study was
the assessment of the toxicity of a 52.5 mg N-9 gel, COL-1492, when used a
number of times each day by female sex workers. METHODS: This was a randomized,
placebo-controlled triple-blinded trial among female sex workers. The
participants were asked to use the product for each vaginal sexual act. At each
monthly visit a gynaecological examination with sexually transmitted disease
sampling and colposcopy was performed. Venous blood was drawn for syphilis and
HIV serology. All women received intensive counselling on condom use. Male
condoms and sexually transmitted disease treatment were given free of charge.
RESULTS: Only blinded results on the colposcopic examinations are reported. The
incidence of lesions with or without an epithelial disruption was low: 0.06 and
0.29, respectively, per 100 woman-days in group A; 0.09 and 0.26 respectively
per 100 woman-days in group B. There was no significant difference between the
two arms. CONCLUSION: The multiple daily use of COL-1492 by female sex workers
did not show an increase of local toxicity over that of a placebo. Colposcopy
was discontinued in the autumn of 1997 in accordance with a Data Safety
Monitoring Board decision. In the currently ongoing effectiveness trial the
assessment of the product's toxicity continues to be monitored by simple visual
examination.

Publication Types:
Clinical Trial
Clinical Trial, Phase II
Multicenter Study
Randomized Controlled Trial

PMID: 10714571 [PubMed - indexed for MEDLINE]

36: Health Psychol 2000 Jan;19(1):3-11

Using information, motivational enhancement, and skills training to reduce the
risk of HIV infection for low-income urban women: a second randomized clinical
trial.

Carey MP, Braaten LS, Maisto SA, Gleason JR, Forsyth AD, Durant LE, Jaworski BC.

Department of Psychology, Center for Health and Behavior, Syracuse University,
New York 13244-2340, USA. mpcarey@syr.edu

This randomized clinical trial evaluated an HIV-risk reduction (HIV-RR)
intervention based on the information-motivation-behavioral skills model. At
baseline, 102 women (M age = 29 years; 88% African American) completed a survey
regarding HIV-related knowledge, risk perceptions, behavioral intentions, and
risk behavior. Participants were then assigned to either the HIV-RR intervention
or a health-promotion control group. Postintervention and follow-up data
indicated that women in the HIV-RR program enhanced their knowledge and
strengthened their risk reduction intentions relative to controls. Moreover,
HIV-RR women who expressed "imperfect" intentions also increased their condom
use, talked more with partners about condom use and HIV testing, and were more
likely to have refused unprotected sex.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 10711582 [PubMed - indexed for MEDLINE]

37: Fam Pract 2000 Feb;17(1):56-9

Condom promotion in women attending inner city general practices for cervical
smears: a randomized controlled trial.

Oakeshott P, Kerry S, Hay S, Hay P.

Department of General Practice and Primary Care and Department of Genitourinary
Medicine, St George's Hospital Medical School, London, UK.

BACKGROUND: Although condom promotion schemes have been widely piloted in UK
general practices, there have been no rigorous evaluations of their
effectiveness. OBJECTIVES: To see if a practice-based sexual health education
intervention increases the number of women having smears who are given condoms
and advice on avoiding STDs. To see if this low cost intervention affects
subsequent condom use. METHOD: We conducted a cluster randomized trial of condom
promotion in 1382 women aged <35 years attending 28 South London general
practices for cervical smear tests. RESULTS: More women in intervention than
control practices reported receiving advice on avoiding sexually transmitted
infections (27% versus 10%) and being given condoms (28% versus 1%, P < 0.05).
However, there was no difference in subsequent condom use, even in the 22% of
women reporting >/=2 sexual partners in the previous year. CONCLUSIONS: To
provide evidence of effectiveness, future interventions may need to be more
intensive or focus on higher risk groups.

Publication Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial

PMID: 10673490 [PubMed - indexed for MEDLINE]

38: J Adolesc Health 2000 Jan;26(1):18-26

Parental underestimates of adolescent risk behavior: a randomized, controlled
trial of a parental monitoring intervention.

Stanton BF, Li X, Galbraith J, Cornick G, Feigelman S, Kaljee L, Zhou Y.

Center for Minority Health Research, Department of Pediatrics, University of
Maryland, Baltimore, USA.

OBJECTIVES: To develop and evaluate an intervention (ImPACT) seeking to increase
monitoring (supervision and communication) by parents and guardians of
African-American youth regarding high risk and protective behaviors; and to
develop an instrument to assess parental monitoring, the Parent-Adolescent Risk
Behavior Concordance Scale. DESIGN/INTERVENTION: This research was a randomized,
controlled longitudinal study. Baseline (preintervention), and 2 and 6 months
postintervention data were obtained via a talking MacIntosh computer regarding
youth and parent perceptions of youth involvement in 10 risk behaviors, parental
monitoring and youth-parent communication, and condom-use skills. Intervention
parents and youth received the ImPACT program and a video emphasizing parental
supervision and discussion, followed by a structured discussion and role-play
emphasizing key points. Control parents and youth received an attention-control
program on goal-setting, which also included an at-home video and discussion.
PARTICIPANTS: A total of 237 parents and one each of their youth (ages 12-16
years) recruited from eight public housing developments located in a city in the
mid-Atlantic region. RESULTS: Similarity of youth and parental reporting on the
Parent-Adolescent Risk Behavior Concordance Scale was positively correlated with
protective behaviors, perceived parental monitoring, and good parent-youth
communication. At baseline, parents significantly underestimated their youth's
risk behaviors. However, 2 and 6 months postintervention, the ImPACT program
increased similarity of reports by youth and their parents of youth involvement
in risk and protective behaviors. In addition, at 6 months postintervention,
intervention (compared to control) youths and parents also demonstrated higher
levels of condom-use skills. CONCLUSION: Parental monitoring interventions such
as ImPACT should be given to parents in conjunction with more traditional
youth-centered risk-reduction interventions.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 10638714 [PubMed - indexed for MEDLINE]

39: Am J Public Health 2000 Jan;90(1):57-63

Outcomes of a randomized community-level HIV prevention intervention for women
living in 18 low-income housing developments.

Sikkema KJ, Kelly JA, Winett RA, Solomon LJ, Cargill VA, Roffman RA, McAuliffe
TL, Heckman TG, Anderson EA, Wagstaff DA, Norman AD, Perry MJ, Crumble DA,
Mercer MB.

Department of Psychiatry and Behavioral Medicine, Medical College of Wisconsin,
Milwaukee, USA. kathleen.sikkema@yale.edu

OBJECTIVES: Women in impoverished inner-city neighborhoods are at high risk for
contracting HIV. A randomized, multisite community-level HIV prevention trial
was undertaken with women living in 18 low-income housing developments in 5 US
cities. METHODS: Baseline and 12-month follow-up population risk characteristics
were assessed by surveying 690 women at both time points. In the 9 intervention
condition housing developments, a community-level intervention was undertaken
that included HIV risk reduction workshops and community HIV prevention events
implemented by women who were popular opinion leaders among their peers.
RESULTS: The proportion of women in the intervention developments who had any
unprotected intercourse in the past 2 months declined from 50% to 37.6%, and the
percentage of women's acts of intercourse protected by condoms increased from
30.2% to 47.2%. Among women exposed to intervention activities, the mean
frequency of unprotected acts of intercourse in the past 2 months tended to be
lower at follow-up (mean = 4.0) than at baseline (mean = 6.0). These changes
were corroborated by changes in other risk indicators. CONCLUSIONS:
Community-level interventions that involve and engage women in
neighborhood-based HIV prevention activities can bring about reductions in
high-risk sexual behaviors.

Publication Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial

PMID: 10630138 [PubMed - indexed for MEDLINE]

40: Stat Med 2000 Jan 15;19(1):71-82

A transitional model of barrier methods compliance with unbalanced loss to
follow-up.

Chen PL, Wong E, Dominik R, Steiner MJ.

Family Health International, P.O. Box 13950, Research Triangle Park, North
Carolina 27709, USA.

Differential loss to follow-up can substantially influence the evaluation of
treatment effects on a dichotomous outcome of interest in longitudinal trials.
The use of transitional models incorporating loss to follow-up as an additional
category of response and the nature of the correlated responses can provide a
comprehensive view of a trial with unbalanced loss to follow-up. Under the
Markov assumption, transitional models estimate the probability of changing from
one outcome to another outcome between follow-up visits. Patterns of the
response variable can be described by the estimated transition probabilities.
The effects of intervention and covariates on the outcome of interest can also
be estimated using a conditional likelihood function or a multinomial logit
regression. Data from a randomized barrier method study designed to compare the
proportion of participants using barrier methods consistently in two counselling
groups are used to illustrate the proposed model. Copyright 2000 John Wiley &
Sons, Ltd.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 10623914 [PubMed - indexed for MEDLINE]

41: J Epidemiol Community Health 1999 Jul;53(7):417-22

Association between condom use and HIV infection: a randomised study of self
reported condom use measures.

Weir SS, Roddy RE, Zekeng L, Ryan KA.

Family Health International, Durham, NC 27709, USA.

STUDY OBJECTIVE: To compare the association between different measures of condom
use and prevalent HIV infection. DESIGN: Randomised cross sectional study to
assess association between HIV infection and different measures of self reported
condom use. Female sex workers were randomised to one of five different face to
face questionnaires on condom use. Three questionnaires used always to never
scales to measure use but differed in the reference period for use; a fourth
asked about use in the last 10 coital acts; and the fifth was a retrospective
log of coital acts in the past two weeks. Use was assessed with new clients,
repeat clients, and non-clients. SETTING: Yaounde and Douala, Cameroon.
PARTICIPANTS: 2266 female sex workers. MAIN RESULTS: The association between
condom use and prevalent HIV infection varied for different measures of condom
use. None of the five level measures showed a dose response protective effect of
condom use. Measures aimed at reducing recall bias (measures based on the past
10 coital acts or a coital log) showed little or no association with prevalent
infection. Measures based on the past month or six months had a stronger
association with prevalent infection. Regardless of the type of measure or
reference period, the strongest association between use and infection was for
use with partners who were not clients. CONCLUSION: These findings underscore
challenges described by others of measuring condom use and interpreting the
association between use and prevalent infection.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 10492735 [PubMed - indexed for MEDLINE]

42: Int J STD AIDS 1999 Aug;10(8):548-53

Male polyurethane condoms do not enhance brief HIV-STD risk reduction
interventions for heterosexually active men: results from a randomized test of
concept.

Kalichman SC, Cherry C.

Center for AIDS Intervention Research, Medical College of Wisconsin, Milwaukee
53226, USA.

The current study examined the effects of a brief HIV risk reduction
intervention for men. Participants were recruited (n = 108) from an urban public
health clinic and randomly assigned to one of 3 experimental intervention
conditions: (1) 3 h HIV-STD risk reduction behavioural skills building latex
condom intervention; (2) the same 3 h skills workshop but focused on male
polyurethane condoms; or (3) a 3 h HIV education workshop. Results showed all 3
interventions increased AIDS knowledge and positively influenced attitudes, but
men who received the polyurethane condom skills intervention were more likely to
request condoms at follow ups. In addition, men who received either of the 2
skills interventions evidenced increased condom use at the one-month follow up,
with no differences at 3-month follow up. This study is among the first to test
a brief HIV risk reduction intervention for men and is the first to test whether
polyurethane male condoms enhance HIV risk reduction efforts.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 10471107 [PubMed - indexed for MEDLINE]

43: J Adolesc 1999 Jun;22(3):355-67

The effects of partner insistence of condom usage on perceptions of the partner,
the relationship, and the experience.

Hocking JE, Turk D, Ellinger A.

Department of Speech Communication, University of Georgia, Athens 30602-1725,
USA.

The present study examined the effects of an individual insisting on condom
usage on how he or she is viewed by their partner. Participants were led through
a realistic role-play scenario in which, after dating a new partner for "a
while", they engaged in sexual intercourse. Results were such that after first
time sex, participants indicated feeling more responsible, less at-risk, and
less worried when a condom was used than when no condom was used. Participants
evaluated their partner as more responsible, more caring, and less likely to
have a sexually transmitted disease when a condom was used. Further, when a
condom was used, the relationship was evaluated as enhanced, closer, more
intimate, and more likely to be long lasting. The insistence of condom use by
the participant's partner also resulted in less guilt and regret regarding the
sexual experience itself. These results generally held true for both male and
female participants. Copyright 1999 The Association for Professionals in
Services for Adolescents.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 10462426 [PubMed - indexed for MEDLINE]

44: Gynecol Obstet Invest 1999;48(2):113-8

Comparative study of cervical laminar tents prior to extra-amniotic injection of
ethacridine lactate (Rivanol) and a condom-nelathon catheter method for
second-trimester pregnancy interruption in Vietnam.

Jarnbert A, Klang B, Vinh NT, Ham NN.

Division of International Health Care Research, Department of Public Health
Sciences, Karolinska Institutet, Stockholm, Sweden.

OBJECTIVE: To determine whether the regimen for termination of second-trimester
pregnancies using laminaria tents 12-24 h prior to extra-amniotic ethacridine
lactate (Rivanol) instillation, is more effective in shortening the
insertion-expulsion interval than the presently used method of abortion
induction by a condom/Nelathon catheter. DESIGN: A prospective randomised
comparative study was performed at Uong Bi General Hospital in Quang Ninh
Province, Vietnam, on 91 women undergoing pregnancy termination in the second
trimester. INTERVENTIONS: The subjects were randomly allocated to 2 treatment
groups, receiving either the Nelathon catheter-condom method (n = 50) or by
insertion of a laminaria tent into the cervical canal for preinduction, 13-29 h
before extra-amniotic instillation of ethacridine lactate (n = 34). Seven
subjects were not pretreated with the laminaria tent. MAIN OUTCOME MEASURES: The
insertion-expulsion intervals and the incidence of side effects were assessed.
RESULTS: The mean insertion-expulsion interval in the 2 groups was not
significantly different (mean 27.5 +/- 16.1 and 26.4 +/- 16.4 h, respectively),
calculating the insertion-expulsion interval from the start of active treatment,
i.e. from the instillation of Rivanol or insertion of the Nelathon catheter and
condom, until expulsion of the fetus. CONCLUSIONS: The laminaria-Rivanol method
for pregnancy interruption is not more advantageous than the existing Nelathon
catheter-condom method. Simple, successful and cost-effective methods in
achieving second-trimester abortion in the Vietnamese context have therefore to
be identified and tested.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 10461002 [PubMed - indexed for MEDLINE]

45: Am J Epidemiol 1999 May 15;149(10):950-4

Application of computer-assisted interviews to sexual behavior research.

Kissinger P, Rice J, Farley T, Trim S, Jewitt K, Margavio V, Martin DH.

Department of Medicine, Louisiana State University, New Orleans 70112, USA.

Collection of sensitive data with the use of video-enhanced, computer-assisted,
self-administered interviews (V-CASI) has the potential to reduce interview bias
and improve the validity of the study. The purpose of this study was to compare
responses to sensitive questions elicited by V-CASI and by face-to-face
interview (FTFI) methods. Women attending a New Orleans, Louisiana, public
family planning or sexually transmitted disease clinic from July 1995 to July
1996, diagnosed with a Chlamydia trachomatis infection responded to eight
close-ended behavioral questions (four socially undesirable, two socially
desirable, and two neutral behaviors) using both FTFI and V-CASI techniques in a
randomized crossover design. Of the 280 women included, the mean age was 23
years, 95 percent were African American, and 71 percent felt comfortable using
computers. While kappa scores indicated good-to-excellent agreement between
interview techniques, women tended to admit to socially undesirable behaviors
more often on V-CASI compared with FTFI. Thirty percent of the women gave a
discrepant response between V-CASI and FTFI toward social desirability. Women
who reported a socially undesirable behavior in V-CASI (i.e., more than two sex
partners and infrequent condom usage) were more likely to have a discrepant
response. Utilization of the same logistic regression model to predict condom
use yielded different results when data from V-CASI were used compared with data
from FTFI. The V-CASI technique can reduce social desirability bias and improve
validity in research requiring information on sensitive sexual behaviors.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 10342804 [PubMed - indexed for MEDLINE]

46: Fam Plann Perspect 1999 Mar-Apr;31(2):81-7

Evaluation of the efficacy of a polyurethane condom: results from a randomized,
controlled clinical trial.

Frezieres RG, Walsh TL, Nelson AL, Clark VA, Coulson AH.

Research Division of the California Family Health Council, Los Angeles, USA.

CONTEXT: Condoms made of latex are not comfortable or appropriate for all
consumers. Polyurethane condoms may provide a needed alternative. METHODS: In a
double-masked study, 805 monogamous couples were randomized to use either the
polyurethane condom or the latex condom for six months. Couples recorded the
frequency of intercourse, of condom use and of breakage and slippage throughout
the trial in coital diaries and in detailed reports on the first five uses.
Breakage and slippage rates were determined, and typical-use and consistent-use
pregnancy rates were calculated using life-table analysis, adjusted for use of
emergency contraception. RESULTS: The six-month pregnancy rate during typical
use (adjusted for use of emergency contraception) was 4.8% for the polyurethane
condom and 6.3% for the latex condom. Similarly adjusted pregnancy rates during
consistent use over six completed menstrual cycles--2.4% for the polyurethane
condom and 1.1% for the latex condom--did not differ significantly. Clinical
failure rates (including breakage and slippage occurring during either
intercourse or withdrawal) were 8.5% for the polyurethane condom and 1.6% for
the latex condom. In general, male participants were more satisfied with the
latex condom, and users of latex were significantly less likely to drop out of
the study for condom-related reasons than were users of polyurethane.
CONCLUSIONS: Although polyurethane and latex condoms provide equivalent levels
of contraceptive protection, the polyurethane condom's higher frequency of
breakage and slippage suggests that this condom may confer less protection from
sexually transmitted infections than does the latex condom.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 10224546 [PubMed - indexed for MEDLINE]

47: Drug Alcohol Depend 1999 Mar 1;54(1):57-62

Predictors of increased condom use following HIV intervention with
heterosexually active drug users.

Kwiatkowski CF, Stober DR, Booth RE, Zhang Y.

Department of Psychiatry, University of Colorado Health Sciences, Center, Denver
80211, USA. carol.kwiatkowski@uchsc.edu

Research with injection drug users (IDUs), at risk for acquiring and
transmitting HIV, has focused primarily on their risky drug practices, with far
less attention paid to their risky sex behaviors. The purpose of this study was
to determine what variables were associated with an increase in condom use
following an HIV intervention with 3357 IDUs in nine cities. Participants
reported using condoms during 15% of their sexual encounters prior to the HIV
intervention, and during 22% of their sexual encounters six months later. A
logistic regression analysis indicated that individuals who increased their
condom use were likely to be HIV seropositive (odds ratio OR = 2.49), to have
received AIDS information prior to the intervention (OR = 1.28), to have
multiple sex partners (OR = 2.14), to be single with multiple sex partners (OR =
1.34), or to have exchanged drugs or money for sex (OR = 1.33). Discussion
focuses on the generally low incidence of condom use and the need for increased
intervention, particularly among drug users in monogamous relationships and sex
workers.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 10101617 [PubMed - indexed for MEDLINE]

48: Contraception 1998 Dec;58(6):375-8

Measuring true contraceptive efficacy. A randomized approach--condom vs.
spermicide vs. no method.

Steiner MJ, Hertz-Picciotto I, Schulz KF, Sangi-Haghpeykar H, Earle BB, Trussell
J.

Family Health International, Research Triangle Park, North Carolina 27709, USA.
msteiner@fhi.org

No investigator has attempted to measure prospectively the true efficacy of a
contraceptive method, compared with a control group using no method, because
contraceptive trials focus on women trying to avoid pregnancy and ethical
concerns do not permit the withholding of contraception. We tested the
feasibility of an approach that recruited women who desired pregnancy but were
willing to postpone conception by 1 month. In this protocol, we restricted
frequency and timing of intercourse to one coital act on the most fertile day of
the menstrual cycle, as measured by a luteinizing hormone (LH) detection kit.
Participants were randomized to use either a male latex condom, spermicidal
film, or no method. In this feasibility study we recruited 58 women at three
sites, with one site recruiting 25 women in 5 months. Among 54 women who
completed the study, we found a 12% pregnancy rate for the group using no method
(2/17; 95% confidence interval [CI], 1-36%) and an 11% pregnancy rate for the
group using spermicidal film (2/18; 95% CI, 1-35%). No pregnancies occurred
among the 19 women using condoms (0/19; 95% CI, 0-18%). The wide confidence
intervals illustrate the small sample size of this pilot study and no
conclusions can be drawn about the relative efficacy of the methods. Having
demonstrated the feasibility of this study design, we now urge the initiation of
a large-scale study to evaluate the efficacy of barrier methods using our
randomized approach, with a control arm using no method of contraception.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 10095974 [PubMed - indexed for MEDLINE]

49: Pediatrics 1999 Jan;103(1):107-15

A STD/HIV prevention trial among adolescents in managed care.

Boekeloo BO, Schamus LA, Simmens SJ, Cheng TL, O'Connor K, D'Angelo LJ.

George Washington University Medical Center, Department of Health Care Sciences,
Washington, DC. USA.

OBJECTIVE: To determine if sexually transmitted diseases (STDs), including human
immunodeficiency virus (HIV) infection, risk assessment, and education tools
provided as part of office-based primary care reduce adolescent risky sexual
behaviors. DESIGN: A randomized intervention trial with 3- and 9-month
follow-up. SETTING: Five staff-model managed care sites in Washington, DC (n =
19 pediatricians). PATIENTS: Consecutive 12- to 15-year-olds receiving a general
health examination; 81% minority. Participation rate = 215/432 (50%). Nine-month
follow-up rate = 197/215 (92%). INTERVENTION: Audiotaped STD risk assessment and
education about staying safe (safer = condoms, safest = abstinence). MAIN
OUTCOME MEASURES: Adolescent-reported sexual intercourse and condom use.
RESULTS: More intervention adolescents reported pediatrician discussion on 11/13
sexual topics. Although more vaginal intercourse (odds ratio [OR] = 2.46, 95%
confidence interval [CI] = 1.04-5.84) was reported in the intervention group at
3 months, this was not true of overall sexual intercourse (OR = 1.55, 95% CI
=.73-3.32). More sexually active adolescents reported condom use in the
intervention group at 3 months (OR = 18.05, 95% CI = 1.27-256.03). At 9 months,
there were no group differences in sexual behaviors; however, more signs of STD
were reported by the control (7/103) than the intervention group (0/94).
CONCLUSIONS: STD risk assessment and education tools administered in a single
office visit facilitated STD/HIV prevention education. Any impact on sexual
activity and condom use was short-lived. Further research is needed to develop
brief, office-based sexual risk reduction for young adolescents.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 9917447 [PubMed - indexed for MEDLINE]

50: N Engl J Med 1999 Jan 14;340(2):93-100

A randomized, controlled trial of a behavioral intervention to prevent sexually
transmitted disease among minority women.

Shain RN, Piper JM, Newton ER, Perdue ST, Ramos R, Champion JD, Guerra FA.

Department of Obstetrics and Gynecology, University of Texas Health Science
Center at San Antonio, 78284-7836, USA.

BACKGROUND: African-American and Hispanic women are disproportionately affected
by sexually transmitted diseases, including the acquired immunodeficiency
syndrome (AIDS). In the effort to reduce infection rates, it is important to
create and evaluate behavioral interventions that are specific to the target
populations. METHODS: We enrolled women with nonviral sexually transmitted
diseases in a randomized trial of a sex- and culture-specific behavioral
intervention. The intervention consisted of three small-group sessions of three
to four hours each designed to help women recognize personal susceptibility,
commit to changing their behavior, and acquire necessary skills. The control
group received standard counseling about sexually transmitted diseases. The
design of the intervention was based on the AIDS Risk Reduction Model and
ethnographic data on the study populations. Participants in both groups
underwent screening, counseling, and an interview before randomization and at
the 6- and 12-month follow-up visits. The principal outcome variable was
subsequent chlamydial or gonorrheal infection, which was evaluated on an
intention-to-treat basis by logistic-regression analysis. RESULTS: A total of
424 Mexican-Americans and 193 African-American women were enrolled; 313 were
assigned to the intervention group and 304 to the control group. The rate of
participation in the intervention was 90 percent. The rates of retention in the
sample were 82 and 89 percent at the 6- and 12-month visits, respectively. Rates
of subsequent infection were significantly lower in the intervention group than
in the control group during the first 6 months (11.3 vs. 17.2 percent, P=0.05),
during the second 6 months (9.1 vs. 17.7 percent, P=0.008), and over the entire
12-month study period (16.8 vs. 26.9 percent, P=0.004). CONCLUSIONS: A
risk-reduction intervention consisting of three small-group sessions
significantly decreased the rates of chlamydial and gonorrheal infection among
Mexican-American and African-American women at high risk for sexually
transmitted disease.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 9887160 [PubMed - indexed for MEDLINE]

51: AIDS Educ Prev 1998 Dec;10(6):483-92

Effects of an HIV risk reduction project on sexual risk behavior of low-income
STD patients.

O'Leary A, Ambrose TK, Raffaelli M, Maibach E, Jemmott LS, Jemmott JB 3rd,
Labouvie E, Celentano D.

Rutgers University Department of Psychology, New Brunswick, NJ, USA.

A 10-hour small-group informational and skill-building intervention was tested
among patients (N = 472) attending publicly funded sexually transmitted disease
clinics in Maryland, Georgia, and New Jersey. After completing a 90-minute
interview concerning HIV risk behaviors, condom use self-efficacy and condom
outcome expectancies, participants were randomized to either an intervention or
a control condition. Participants in both conditions displayed significant
reductions in unprotected encounters and number of partners and increases in
condom use. No differences between treatment conditions were observed,
indicating that the motivational effects of the interview may have been stronger
than the effects of the intervention in this population.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 9883284 [PubMed - indexed for MEDLINE]

52: AIDS 1998 Dec 24;12(18):2473-80

Increased protected sex and abstinence among Namibian youth following a HIV
risk-reduction intervention: a randomized, longitudinal study.

Stanton BF, Li X, Kahihuata J, Fitzgerald AM, Neumbo S, Kanduuombe G, Ricardo
IB, Galbraith JS, Terreri N, Guevara I, Shipena H, Strijdom J, Clemens R, Zimba
RF.

Department of Pediatrics and Center for Minority Health Research, University of
Maryland at Baltimore, USA.

OBJECTIVE: To evaluate an HIV risk-reduction intervention among Namibian
adolescents. METHODS: A randomized trial of a 14-session face-to-face
intervention emphasizing abstinence and safer sexual practices conducted among
515 youths (median age 17 years and median grade 11) attending 10 secondary
schools located in two districts in Namibia. Youths were randomly assigned to
the intervention or control condition at the level of the individual. HIV risk
behaviours, intentions and perceptions were assessed at baseline, immediately
post-intervention and at 6 and 12 months post-intervention. RESULTS: Among all
515 youths who enrolled in the programme, rates of either abstinence or sex with
a condom were not different between control and intervention youths at baseline
or in the follow-up period. However, analyses conducted among the subset of
youths who were sexually inexperienced at baseline (n = 255) revealed that a
higher percentage of intervention youths (17%) than control youths (9%, P<0.05)
remained sexually inexperienced one year later. Moreover, in the immediate
post-intervention period, among baseline virgins who subsequently initiated sex,
intervention youths were more likely than control youths to use a condom (18
versus 10%, P<0.05). Additional HIV-related risk behaviours (failure to discuss
previous HIV risk exposure with one's sexual partner and alcohol use),
intentions to use condoms, and perceptions of the ability to use condoms were
positively affected by the intervention. CONCLUSIONS: There is evidence that the
'My Future is My Choice' (MFMC) intervention is reducing HIV risk behaviours
among sexually inexperienced participants aged 15-18. Related risk behaviours
and perceptions are also positively impacted by the intervention.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 9875586 [PubMed - indexed for MEDLINE]

53: Public Health Rep 1998 Jun;113 Suppl 1:31-41

Peer-delivered interventions reduce HIV risk behaviors among out-of-treatment
drug abusers.

Cottler LB, Compton WM, Ben Abdallah A, Cunningham-Williams R, Abram F,
Fichtenbaum C, Dotson W.

Department of Psychiatry, Washington University School of Medicine, St. Louis,
MO 63108, USA. cottler@epi.wustl.edu

OBJECTIVE: The purpose of this chapter is to describe the results of a
randomized study (funded by the National Institute on Drug Abuse [NIDA])
comparing a peer-delivered enhanced intervention to the NIDA standard
intervention for reducing human immunodeficiency virus (HIV) risk behaviors.
METHODS: Data come from the ongoing St. Louis Each One Teach One (EOTO) study on
HIV risk behaviors among out-of-treatment crack cocaine users and injecting drug
users (IDUs). The study has a randomized prospective design, and for this
chapter, three risk behaviors were analyzed--the frequency of crack cocaine use
and the number of sex partners and condom use over the past 30-day period. We
report the level of risk at baseline and at the three-month follow-up period to
determine the proportion of individuals improving or worsening based on a
dichotomous outcome in which remaining at low risk or decreasing moderate or
high risk behaviors is considered "improving" and increasing risk behavior or
remaining at moderate or high risk is considered "worsening". RESULTS: Overall,
80% of the sample "improved" their crack cocaine use, meaning they maintained at
low level or reduced their use. Although both the standard and enhanced
intervention groups made substantial improvement in their crack cocaine use,
individuals in the enhanced intervention group were statistically more likely to
reduce their risk than those assigned to the standard intervention (83% vs. 75%,
P < 0.05). As for the number of sex partners, 75% of the overall sample
improved; that is, they reduced the number of sex partners or remained abstinent
or in a one-partner relationship at baseline and follow-up. There was no
statistically significant difference between the enhanced and standard groups
(76% vs 73%). Stratified by gender, the results showed a trend toward
improvement among women assigned to the enhanced intervention compared with
those assigned to the standard. In terms of condom use, the overall sample
worsened more than it improved (65% vs. 44%), and no differences were found
between the enhanced and standard groups. CONCLUSIONS: These findings show that
the use of peers as role models in promoting HIV risk reduction is feasible and
effective among out-of-treatment drug abusers, particularly for drug use itself.
Condom use was found to be more difficult to change than other behaviors.
Possible reasons for this lack of improvement and suggestions for future
interventions are given.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 9722808 [PubMed - indexed for MEDLINE]

54: AIDS Care 1998 Jun;10(3):329-38

Factors associated with changes in sex behaviour among drug users in Puerto
Rico.

Robles RR, Marrero CA, Matos TD, Colon HM, Finlinson HA, Reyes JC, Sahai H.

Research Institute, Mental Health and Anti-Addiction Services Administration,
San Juan, Puerto Rico.

Despite available strategies to prevent sex risk behaviours in Puerto Rico,
heterosexual transmission of HIV continues to increase. Since 1990, heterosexual
contact has been the fastest growing infection risk category among the island's
general population, and the primary transmission route for women and children.
To understand change in sex risk behaviours and factors related to change, 911
drug injectors and 359 crack smokers were recruited from the San Juan
metropolitan area following a stratified cluster design. This study comprised a
total of 1,004 (79.1%) drug users who were assessed at follow-up. Abstinence
from sex behaviour increased from 54.6% to 61.1% (p < 0.01), use of condoms
during vaginal sex also increased from 26.4% to 36.9% (p < 0.01). In
multivariate analysis, significant predictors of abstinence were gender,
injection drug use, HIV seropositivity and not having a steady partner.
Predictors of using condoms during vaginal sex were HIV seropositivity, STD
diagnosis and participation in an HIV preventive programme. These findings
indicate that additional HIV preventive efforts are needed to reduce sex risk
behaviours among drug users who have a steady sex partner, as well as among drug
users who are HIV-negative.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 9828976 [PubMed - indexed for MEDLINE]

55: AIDS 1998 Oct 1;12(14):1851-9

Protection against sexually transmitted diseases by granting sex workers in
Thailand the choice of using the male or female condom: results from a
randomized controlled trial.

Fontanet AL, Saba J, Chandelying V, Sakondhavat C, Bhiraleus P, Rugpao S,
Chongsomchai C, Kiriwat O, Tovanabutra S, Dally L, Lange JM, Rojanapithayakorn
W.

Joint United Nations Programme on HIV/AIDS (UNAIDS), Geneva, Switzerland.

BACKGROUND: The male condom is the most effective barrier method available for
protection against sexually transmitted diseases (STDs), including HIV
infection. There is an urgent need to develop and evaluate other prevention
methods, such as the female condom. This study estimated the additional
protection against STDs offered to sex workers by giving them the option of
using the female condom when clients refused to use a male condom. METHODS: Sex
establishments in four cities in Thailand were randomized into two study groups:
one in which sex workers were instructed to use male condoms consistently (male
condom group); and one in which sex workers had the option of using the female
condom if clients refused or were not able to use male condoms (male/female
condom group). Randomization was done by sex establishments, and not by
individuals, to minimize sharing of female condoms across study groups. The
proportion of unprotected sexual acts (defined as sexual acts in which condoms
were not used, tore, or slipped in or out) and incidence rate of STDs
(gonorrhoea, chlamydial infection, trichomoniasis and genital ulcer disease)
were measured over a 24-week period and compared between the two study groups.
FINDINGS: Results are available from 34 sex establishments (249 women) in the
male/female condom group, and 37 sex establishments (255 women) in the male
condom group. Condom use was very high in both groups (97.9 and 97.3 % of all
sexual acts, respectively, P > 0.05). Male condom use was lower in the
male/female condom group when compared with the male condom group (88.2 and
97.5%, respectively, P < 0.001). However, this reduction in male condom use was
counterbalanced by the use of female condoms in 12.0% of all sexual acts in the
male/female condom group, contributing to a 17% reduction in the proportion of
unprotected sexual acts in this group when compared to the male condom group
(5.9 versus 7.1%, respectively, P = 0.16). Female condom use was sustained over
the entire study period. There was also a 24% reduction in the weighted
geometric mean incidence rate of STDs in the sex establishments of the
male/female condom group compared to the male condom group (2.81 versus 3.69 per
100 person-weeks, P = 0.18).

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 9792386 [PubMed - indexed for MEDLINE]

56: AIDS Educ Prev 1998 Aug;10(4):293-302

Measuring condom use: asking "do you or don't you" isn't enough.

Weir SS, Roddy RE, Zekeng L, Ryan KA, Wong EL.

Family Health International, Durham, NC, USA.

This article compares cross-sectional measures of condom use among 2,269 female
sex workers in Cameroon randomly assigned to receive one of five different
questionnaires measuring condom use. We found that the level of reported condom
use varied depending on the type of survey questions used. Measures based on
2-week coital logs or the past 10 acts categorized more women as "100%" or "0%"
users than always-to-never scales categorized women as "always" or "never"
users. Consistency of use also varied by type of partner. Internal consistency
of responses was high. Future studies should assess differences in prospective
measures of condom use and the level of association between various measures and
infection with sexually transmitted disease.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 9721382 [PubMed - indexed for MEDLINE]

57: N Engl J Med 1998 Aug 20;339(8):504-10

A controlled trial of nonoxynol 9 film to reduce male-to-female transmission of
sexually transmitted diseases.

Roddy RE, Zekeng L, Ryan KA, Tamoufe U, Weir SS, Wong EL.

Epidemiology Unit, Family Health International, Durham, NC 27709, USA.

BACKGROUND: Nonoxynol 9 is a proved spermicide, but whether it is also a
microbicide is uncertain. A truly effective vaginal microbicide would reduce the
susceptibility of women to sexually transmitted diseases, including infection
with the human immunodeficiency virus (HIV). METHODS: We enrolled 1292
HIV-negative female sex workers in Cameroon and enrolled them in a double-blind,
placebo-controlled study in which the participants were randomly assigned to use
either a film containing 70 mg of nonoxynol 9 or a placebo film, inserted into
the vagina before intercourse. All of the women were provided with latex condoms
and were instructed to have their male sexual partners use them. At monthly
follow-up visits, we examined the women with a colposcope for genital lesions,
tested endocervical specimens for gonorrhea and chlamydia infection with DNA
probes, tested for HIV infection, and treated the women for curable sexually
transmitted diseases. RESULTS: The rates of HIV infection (cases per 100
woman-years) were 6.7 in the nonoxynol 9 group and 6.6 in the placebo group
(rate ratio, 1.0; 95 percent confidence interval, 0.7 to 1.5). The rates of
genital lesions were 42.2 cases per 100 woman-years in the nonoxynol 9 group and
33.5 in the placebo group (rate ratio, 1.3; 95 percent confidence interval, 1.0
to 1.6). The rates of gonorrhea were 33.3 and 31.1 cases per 100 woman-years in
the nonoxynol 9 and placebo groups, respectively (rate ratio, 1.1; 95 percent
confidence interval, 0.8 to 1.4). The corresponding rates of chlamydia infection
in the nonoxynol 9 group and the placebo group were 20.6 and 22.2 per 100
woman-years (rate ratio, 0.9; 95 percent confidence interval, 0.7 to 1.3). The
women reported that condoms were used during 90 percent of sexual acts.
CONCLUSIONS: The use of a nonoxynol 9 vaginal film did not reduce the rate of
new HIV, gonorrhea, or chlamydia infection in this group of sex workers who used
condoms and received treatment for sexually transmitted diseases.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 9709043 [PubMed - indexed for MEDLINE]

58: AIDS 1998 Jul 9;12(10):1235-42

Evaluation of a randomized controlled trial of HIV and sexually transmitted
disease prevention in a genitourinary medicine clinic setting.

James NJ, Gillies PA, Bignell CJ.

Department of Public Health Medicine and Epidemiology, University of Nottingham
Medical School, UK.

OBJECTIVE: To evaluate outcomes of a sexual health promotion intervention to
prevent transmission of sexually transmitted diseases (STD) including HIV among
genitourinary medicine clinic attenders. DESIGN: A randomized controlled trial
using pre-test and post-test measurements after 4 months, with clinical
follow-up at 18 months. SETTING: A genitourinary medicine clinic in Nottingham,
UK. PATIENTS: A total of 492 patients were randomly assigned either to an
individually focused counselling and skills training intervention, including
written materials (n = 148), to receive written materials only (n = 162), or to
usual clinic procedure (n = 182). INTERVENTION: Social learning theory provided
the theoretical framework for the intervention, which was informed by previous
research in this setting, and aimed to alter perception of risk for HIV
infection, increase knowledge and attitudes to condoms, and increase condom use.
MAIN OUTCOME MEASURES: The main outcomes of interest were self-reported condom
use and behaviour change. Other outcomes of interest were knowledge and
attitudes to condoms, and re-attendance at the clinic with a diagnosis of STD.
RESULTS: Intervention subjects were significantly more likely than controls to
report carrying condoms when anticipating sexual intercourse with a new sexual
partner (P < or = 0.05), and were more likely to perceive themselves at risk of
HIV infection (P < or = 0.001). There were no significant effects of the
intervention on levels of knowledge about correct condom use, attitudes to
condoms, self-reported condom use or incidence of STD. CONCLUSIONS: The limited
effectiveness of the intervention suggests that condom promotion should
continue, but that additional investment in clinic-based health promotion is
unlikely to result in consequent health gain.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 9677173 [PubMed - indexed for MEDLINE]

59: Science 1998 Jun 19;280(5371):1889-94

Comment in:
Science. 1998 Jun 19;280(5371):1905-6.

The NIMH Multisite HIV Prevention Trial: reducing HIV sexual risk behavior. The
National Institute of Mental Health (NIMH) Multisite HIV Prevention Trial Group.

The efficacy of a behavioral intervention to reduce human immunodeficiency virus
(HIV) risk behaviors was tested in a randomized, controlled trial with three
high-risk populations at 37 clinics from seven sites across the United States.
Compared with the 1855 individuals in the control condition, the 1851
participants assigned to a small-group, seven-session HIV risk reduction program
reported fewer unprotected sexual acts, had higher levels of condom use, and
were more likely to use condoms consistently over a 12-month follow-up period.
On the basis of clinical record review, no difference in overall sexually
transmitted disease (STD) reinfection rate was found between intervention and
control condition participants. However, among men recruited from STD clinics,
those assigned to the intervention condition had a gonorrhea incidence rate
one-half that of those in the control condition. Intervention condition
participants also reported fewer STD symptoms over the 12-month follow-up
period. Study outcomes suggest that behavioral interventions can reduce
HIV-related sexual risk behavior among low-income women and men served in public
health settings. Studies that test strategies for reducing sexual risk behavior
over longer periods of time are needed, especially with populations that remain
most vulnerable to HIV infection.

Publication Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial

PMID: 9632382 [PubMed - indexed for MEDLINE]

60: Sex Transm Infect 1998 Apr;74(2):116-9

A randomized controlled trial comparing nonoxynol-9 lubricated condoms with
silicone lubricated condoms for prophylaxis.

Roddy RE, Cordero M, Ryan KA, Figueroa J.

Family Health International, Durham, North Carolina, USA.

OBJECTIVE: We tested the effect of nonoxynol-9 (N-9) in condom lubrication on
the risk of acquiring STD and genital discomfort. METHODS: The study was a
triple masked, randomised controlled trial comparing N-9 lubricated condoms with
plain silicone lubricated condoms among Dominican female sex workers. RESULTS:
Randomisation provided two groups (313 for N-9 and 322 for plain) similar in
baseline characteristics, but extensive loss to follow up occurred (56 women in
each group completed the 24 week follow up). Most vaginal acts with clients were
protected with condoms (99% of vaginal sex) but fewer acts with non-clients were
protected (43% of vaginal sex). No significant differences occurred in rates of
cervical infections (N-9 = 3.4 per 100 person months v plain = 2.8),
trichomoniasis (N-9 = 2.8 v plain = 3.6), or discomfort rates (N-9 = 0.82 v
plain = 0.92). CONCLUSIONS: Plain silicone lubricated condoms are as effective
as N-9 lubricated condoms, cost less, have longer expected shelf life, and
therefore may be the better condom to provide.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 9634323 [PubMed - indexed for MEDLINE]

61: JAMA 1998 May 20;279(19):1529-36

Comment in:
JAMA. 1998 May 20;279(19):1574-5.
JAMA. 1999 Apr 28;281(16):1485-6; discussion 1487-8
JAMA. 1999 Apr 28;281(16):1485; discussion 1487-8.
JAMA. 1999 Apr 28;281(16):1486-8.
JAMA. 1999 Apr 28;281(16):1486; discussion 1487-8.

Abstinence and safer sex HIV risk-reduction interventions for African American
adolescents: a randomized controlled trial.

Jemmott JB 3rd, Jemmott LS, Fong GT.

Department of Psychology, Princeton University, NJ 08544-1010, USA.
jemmott@princeton.edu

CONTEXT: African American adolescents are at high risk of contracting sexually
transmitted infection with human immunodeficiency virus (HIV), but which
behavioral interventions to reduce risk are most effective and who should
conduct them is not known. OBJECTIVE: To evaluate the effects of abstinence and
safer-sex HIV risk-reduction interventions on young inner-city African American
adolescents' HIV sexual risk behaviors when implemented by adult facilitators as
compared with peer cofacilitators. DESIGN: Randomized controlled trial with 3-,
6-, and 12-month follow-up. SETTING: Three middle schools serving low-income
African American communities in Philadelphia, Pa. PARTICIPANTS: A total of 659
African American adolescents recruited for a Saturday program. INTERVENTIONS:
Based on cognitive-behavioral theories and elicitation research, interventions
involved 8 1-hour modules implemented by adult facilitators or peer
cofacilitators. Abstinence intervention stressed delaying sexual intercourse or
reducing its frequency; safer-sex intervention stressed condom use; control
intervention concerned health issues unrelated to sexual behavior. MAIN OUTCOME
MEASURES: Self-reported sexual intercourse, condom use, and unprotected sexual
intercourse. RESULTS: Mean age of the enrollees was 11.8 years; 53% were female
and 92.6% were still enrolled at 12 months. Abstinence intervention participants
were less likely to report having sexual intercourse in the 3 months after
intervention than were control group participants (12.5% vs 21.5%, P=.02), but
not at 6- or 12-month follow-up (17.2% vs 22.7%, P=.14; 20.0% vs 23.1%, P=.42,
respectively). Safer-sex intervention participants reported significantly more
consistent condom use than did control group participants at 3 months (odds
ratio [OR]=3.38; 95% confidence interval [CI], 1.25-9.16) and higher frequency
of condom use at all follow-ups. Among adolescents who reported sexual
experience at baseline, the safer-sex intervention group reported less sexual
intercourse in the previous 3 months at 6- and 12-month follow-up than did
control and abstinence intervention (adjusted mean days over prior 3 months,
1.34 vs 3.77 and 3.03, respectively; P< or =.01 at 12- month follow-up) and less
unprotected intercourse at all follow-ups than did control group (adjusted mean
days, 0.04 vs 1.85, respectively, P<.001, at 12-month follow-up). There were no
differences in intervention effects with adult facilitators as compared with
peer cofacilitators. CONCLUSION: Both abstinence and safer-sex interventions can
reduce HIV sexual risk behaviors, but safer-sex interventions may be especially
effective with sexually experienced adolescents and may have longer-lasting
effects.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 9605896 [PubMed - indexed for MEDLINE]

62: Am J Community Psychol 1998 Feb;26(1):73-96

Timing of HIV interventions on reductions in sexual risk among adolescents.

Rotheram-Borus MJ, Gwadz M, Fernandez MI, Srinivasan S.

Department of Psychiatry, University of California, Los Angeles 90024, USA.

Examined the effectiveness of an HIV intervention program among 151 adolescents
ages 13 to 24 years who were randomly assigned to (a) seven sessions of 1.5 hr
each (10.5 hr); (b) three sessions of 3.5 hr each (10.5 hr); or (c) a
no-intervention condition. Using cognitive-behavioral intervention strategies,
social skills and HIV-related beliefs, perceptions, and norms were targeted in
both the three- and seven-session, small-group intervention conditions.
Regression analysis indicated that over 3 months, the number of unprotected risk
acts and the number of sexual partners were lower in the seven-session condition
compared to the other conditions. Factors mediating risk acts changed in a
complex manner. For example, perceived vulnerability increased for those with
initially lower vulnerability scores among youths in the seven-session condition
compared to others. Self-approval of condom use was also higher for those with
initially low scores in the seven-session compared to the three-session
condition. Self-efficacy for risk avoidance and condom use was significantly
higher in the three-session condition for those with initially low scores
compared to other groups. On the role-play measure, those with higher baseline
scores in the low-pressure situation improved significantly only in the
three-session intervention; in the high-pressure situation, the participants
reported significantly higher scores in the seven-session intervention, and
those with higher scores improved the most. Results suggest the importance of
multisession HIV intervention programs to be delivered with fidelity in
community settings.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 9574499 [PubMed - indexed for MEDLINE]

63: Fam Plann Perspect 1998 Mar-Apr;30(2):73-8

Breakage and acceptability of a polyurethane condom: a randomized, controlled
study.

Frezieres RG, Walsh TL, Nelson AL, Clark VA, Coulson AH.

California Family Health Council, Los Angeles, USA.

CONTEXT: Although the first commercial polyurethane condom was approved for use
several years ago, no U.S. clinical trial has compared its performance to that
of the latex condom. METHODS: In a masked crossover study, 360 couples were
randomized to use three polyurethane condoms and three latex condoms. After each
use, couples recorded condom breaks, condom slips and other aspects of
performance. At completion of the study, couples compared the sensitivity, ease
of use, fit and lubrication of the two types of condoms. RESULTS: The clinical
breakage rate of the polyurethane condom was 7.2%, compared with 1.1% for the
latex condom (relative risk of 6.6, 95% confidence interval of 3.5-12.3). The
complete slippage rate (combining incidents during intercourse and withdrawal)
of the polyurethane condom was 3.6%, compared with 0.6% for the latex condom
(relative risk of 6.0, 95% confidence interval of 2.6-14.2). Most male users
preferred the sensitivity provided by the polyurethane condom to that of the
latex condom. CONCLUSIONS: The clinical breakage rate of the polyurethane condom
is significantly higher than that of the latex condom. However, nearly half of
the users preferred the polyurethane condom, which provides an option for
couples who have rejected conventional condoms or who cannot use latex products.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 9561872 [PubMed - indexed for MEDLINE]

64: Sex Transm Dis 1998 Mar;25(3):139-43

Increasing barrier method use among oral contraceptive users at risk of STDs.
What approach is best?

Steiner MJ, Glover LH, Bou-Saada I, Piedrahita C.

Family Health International, Research Triangle Park, North Carolina 27709, USA.
msteiner@fhi.org

OBJECTIVES: We evaluated whether offering a choice of barrier methods can
increase overall barrier method use without decreasing condom use in women using
oral contraceptives (OCs) for contraception. STUDY DESIGN: We randomized 167 OC
users at risk for sexually transmitted diseases (STDs) into two groups, one
receiving male latex condoms only (Condom group), the other receiving both male
latex condoms and nonoxynol-9 film (Choice group). All participants received
similar hierarchical STD protection counseling. We assessed method use with
daily diaries. RESULTS: The Choice group protected a significantly higher
percentage of their coital acts with a barrier method (month 1 to 2: 29% vs.
22%; month 3 to 4: 33% vs. 21%; and month 5 to 6: 35% vs. 19%; adjusted P =
0.012). Condom use in the Choice group was higher as well (adjusted P = 0.036).
When we used a transitional multilogistic regression approach to account for
differential loss to follow-up in the two groups, results were similar.
CONCLUSIONS: Offering a choice of barrier methods increased overall barrier
method use without decreasing condom use.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 9524991 [PubMed - indexed for MEDLINE]

65: Health Psychol 1997 Sep;16(5):490-5

Effects of a drinking event on behavioral skills and condom attitudes in men:
implications for HIV risk from a controlled experiment.

Gordon CM, Carey MP, Carey KB.

Department of Psychology, Syracuse University, New York 13244-2340, USA.
cmgordon@mailbox.syr.edu

This study experimentally tested the effects of a drinking event on HIV-related
behavioral skills and condom attitudes. Sixty unmarried, heterosexual men were
assigned to 1 of 3 conditions (sober, placebo, or alcohol). Participants who
consumed alcohol demonstrated lower skill to negotiate for condom use relative
to sober controls. More negative condom attitudes were expressed by participants
with stronger sex-related alcohol expectancies, especially when these
expectancies were triggered by subjective intoxication. Hierarchical regression
analyses revealed that the experimental factors accounted for variance in
behavioral skills and condom attitudes beyond that explained by known predictors
of sexual risk.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 9302547 [PubMed - indexed for MEDLINE]

66: AIDS Educ Prev 1997 Aug;9(4):299-313

Lack of positive outcomes from a cognitive-behavioral HIV and AIDS prevention
intervention for inner-city men: lessons from a controlled pilot study.

Kalichman SC, Rompa D, Coley B.

Center for AIDS Intervention Research (CAIR), Medical College of Wisconsin, USA.

African American men are at increasingly high risk for HIV infection, but there
have been few studies of HIV risk reduction interventions for heterosexual
ethnic minority men. The present study randomly assigned 81 African American men
to one of two HIV prevention interventions: a four-session cognitive-behavioral
skills training HIV risk reduction intervention that has been successful with
other populations or a four-session HIV risk education and sensitization control
condition. Men were assessed at baseline, at immediate postintervention, and at
a 3-month follow-up. Forty-five percent of participants dropped out of the
intervention; dropouts were younger, more likely to have used condoms, and less
likely to have been tested for HIV antibodies than men who completed the study.
Outcome analyses showed that both interventions significantly increased
AIDS-related knowledge, initial intentions to change HIV risk behaviors, and
reduced unprotected vaginal intercourse. However, there were no significant
differences between groups on any of the measures at postintervention or
follow-up assessments. Recognizing the limitations of our small sample size, the
results of this initial study caution against generalizing skills training HIV
prevention interventions that have been successful with other populations to
African American heterosexual men.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 9376205 [PubMed - indexed for MEDLINE]

67: AIDS Educ Prev 1997 Feb;9(1 Suppl):90-106

Does parental involvement make a difference? The impact of parent interactive
activities on students in a school-based AIDS prevention program.

Weeks K, Levy SR, Gordon AK, Handler A, Perhats C, Flay BR.

Prevention Research Center, University of Illinois at Chicago 60607, USA.

OBJECTIVES: In this study, we test the effectiveness of involving parents in
school-based AIDS education with respect to altering AIDS-related knowledge,
attitudes, behavioral intentions, communications patterns, and behavior of
students. METHODS: Fifteen high risk school districts (pre-test N = 2,392) were
randomly assigned to one of three conditions: parent-interactive (classroom
curricula + parent-interactive component); parent non-interactive (classroom
curricula only); control (basic AIDS education ordinarily provided by the
school). Students were tested over time in grades 7, 8 and 9. RESULTS: Results
indicate that both treatment conditions (parent-interactive and non-interactive)
had a strong positive impact in enhancing student's knowledge, attitudes,
communication patterns and behavioral intentions. Further, results indicate that
there were no behavioral outcome differences between the treatment groups and
the control condition. Results demonstrate few outcome differences between the
two experimental conditions. CONCLUSIONS: In the two treatment groups
(parent-interactive and parent non-interactive), the program effects appear to
be the result of school-based curricula and of student self-determined
intentions and behaviors, rather than the presence or absence of planned
parental involvement. Whether or not structured or planned parental involvement
becomes part of a school-based educational activity should perhaps be determined
by (a) the existing level of parent-school interaction based on the nature of
the community, (b) the amount of money readily available to follow through on a
program of parent involvement without compromising on student programs, (c) the
age of the child and the sensitivity of the issue, and (d) the ability of the
parent/family to be involved effectively without extraordinary expense or
sacrifice by either parent or school. Our findings speak to the positive role of
the school regardless of parent participation.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 9083601 [PubMed - indexed for MEDLINE]

68: AIDS Educ Prev 1997 Feb;9(1 Suppl):62-76

Evaluation of the HIV risk reduction intervention for women entering inpatient
substance abuse treatment.

Eldridge GD, St Lawrence JS, Little CE, Shelby MC, Brasfield TL, Service JW, Sly
K.

Community Health Program, Jackson State University, Mississippi 39204, USA.

OBJECTIVES: Interventions to lower HIV risk behavior among drug users have
concentrated on reduction of high risk injection practices. Less attention has
been directed to non-injecting drug users and drug-involved women. Female
non-injecting drug users (e.g., women who abuse alcohol or crack cocaine) are
also at substantial risk for sexual transmission of HIV due to multiple
partners, partners who self-inject and share needles, exchange of sex for drugs,
coerced sex, high rates of sexually transmitted diseases, and low rates of
condom use. This study compared the effectiveness of an educational intervention
(EC) against the behavior skills training intervention (BST) in reducing sexual
risk behavior among women (N = 117) court-ordered into inpatient drug treatment.
METHODS: Participants were assessed at baseline, post intervention, and 2 months
after discharge from the drug treatment facility. RESULTS: Women in both
conditions reported high rates of sexual risk behavior prior to the
intervention. Women in both conditions had more positive attitudes toward HIV
prevention and reported greater partner agreement with condom use at the post
intervention assessment. However, these changes were not maintained at follow-up
for women in the EC condition, whereas women in BST continued to show
improvement post discharge. Women in the BST condition showed marked, while
women in EC showed little improvement in communication skills and no improvement
in condom application skill. At follow-up, women in both conditions had reduced
drug use and drug-related high risk sex activities. BST women had increased
their condom use while women in EC evidenced a decrease. Condom use increased
from 35.7% to 49.5% of vaginal intercourse occasions for BST women and decreased
from 28.8% to 15.8% for women in EC. CONCLUSIONS: Results suggest a brief skills
training intervention embedded in drug treatment programs can reduce sexual risk
for HIV-infection after discharge.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 9083599 [PubMed - indexed for MEDLINE]

69: AIDS Educ Prev 1997 Feb;9(1 Suppl):44-61

An impact evaluation of project SNAPP: an AIDS and pregnancy prevention middle
school program.

Kirby D, Korpi M, Adivi C, Weissman J.

ETR Associates, Santa Cruz, California 95061-1830, USA.

OBJECTIVES: A theory-based curriculum designed to delay the onset of intercourse
and increase use of condoms was implemented in the classrooms of six Los Angeles
middle schools. METHODS: The curriculum activities were very interactive,
emphasized skill building, and were implemented by well trained peer educators,
including young HIV-positive males and teen mothers. To evaluate the impact of
the curriculum, 102 classrooms of students were randomly assigned to receive
either the existing curriculum or the existing curriculum plus the intervention
curriculum. Students completed confidential questionnaires before program
implementation, five months later, and 17 months later. A total of 1,657
students completed both the baseline and 17-month follow-up questionnaires.
RESULTS: Analyses of these data revealed that the curriculum significantly
increased knowledge, significantly improved only two out of 21 attitudes or
beliefs, and did not significantly change sexual or contraceptive behaviors.
CONCLUSIONS: Well implemented programs that are based on upon theory, use
interactive activities, and utilize well-trained peer educators do not always
change important sexual attitudes and behaviors among middle school youth.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 9083598 [PubMed - indexed for MEDLINE]

70: Am J Public Health 1996 Oct;86(10):1442-5

Preventing HIV/AIDS among high-risk urban women: the cost-effectiveness of a
behavioral group intervention.

Holtgrave DR, Kelly JA.

Department of Psychiatry and Behavioral Medicine, Medical College of Wisconsin,
Milwaukee 53202, USA.

OBJECTIVES: A human immunodeficiency virus (HIV) intervention trial for women at
high risk for acquired immunodeficiency syndrome and attending an urban clinic
was reported previously. The behavioral group intervention was shown to increase
condom use behaviors significantly. This study retrospectively assessed the
intervention's cost-effectiveness. METHODS: Standard methods of cost and
cost-utility analysis were used. RESULTS: The intervention cost was just over
$2000 for each quality-adjusted life-year saved; this is favorable compared with
other life-saving programs. However, the results are sensitive to changes in
some model assumptions. CONCLUSIONS: Under most scenarios, the HIV prevention
intervention was cost-effective.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 8876516 [PubMed - indexed for MEDLINE]

71: Southeast Asian J Trop Med Public Health 1996 Sep;27(3):430-42

Evaluation of HIV/AIDS education initiatives among women in northeastern Thai
villages.

Elkins D, Maticka-Tyndale E, Kuyyakanond T, Kiewying M, Anusornteerakul S,
Chantapreeda N, Choosathan R, Sommapat S, Theerasobhon P, Haswell-Elkins M.

Australian Center for International and Tropical Health and Nutrition,
Queensland Institute of Medical Research, Brisbane, Australia.

A longitudinal, naturalistic experimental design was used in an evaluation of
the effects of an HIV/AIDS educational pamphlet controlling for secular trends
(most specifically media coverage of HIV/AIDS) in Northeastern Thailand. Nine
hundred and fifty-four women from 18 villages completed KAP interviews either in
the autumn of 1991 or 1992 with HIV/AIDS education pamphlets distributed to
every household in 12 of these villages in the spring of 1992. Pamphlets
influenced women's perceptions of personal risk from casual sources and the
degree to which they volunteered that condoms were a means of prevention of HIV
transmission. Both results were related to the content and style of presentation
of information about sources of risk and about condoms in the pamphlets. Secular
trends and an increase in communication between villagers had a significant
influence on knowledge, perceived efficacy of self protection, readiness to use
condoms, and perception of levels and sources of personal risk.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 9185249 [PubMed - indexed for MEDLINE]

72: Health Psychol 1996 Sep;15(5):371-82

Increasing condom use: evaluation of a theory-based intervention to prevent
sexually transmitted diseases in young women.

Bryan AD, Aiken LS, West SG.

Department of Psychology, Arizona State University, Tempe 85287-1104.
asadb@asuvm.inre.asu.edu

A multicomponent intervention to increase condom use in sexually active young
women was designed, implemented, and evaluated in a randomized experiment.
Participants were 198 unmarried female college students (mean age = 18.6 years)
who received a 1-session condom promotion intervention or a control (stress
management) intervention. The condom promotion intervention led to increased
self-reported condom use up to 6 months following intervention as well as
positive changes in perceived benefits of condom use, affective attitudes toward
condom use and condom users, perceived acceptance of sexuality, control over the
sexual encounter, perceived self-efficacy for condom use, and intentions to use
condoms. Mediational analysis illustrated the mechanisms of the condom promotion
intervention effects, linking psychological constructs affected by the
intervention (perceived benefits, acceptance of sexuality, control over the
sexual encounter, attitudes toward condoms, and self-efficacy for condom use) to
condom use intentions.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 8891716 [PubMed - indexed for MEDLINE]

73: Sex Transm Dis 1996 Sep-Oct;23(5):413-4

Nonoxynol-9 in lubricated condoms. Results of a study in female prostitutes.

Ward H, De La Court A, Kitchen V.

Department of Epidemiology and Public Health, Imperial College of Science,
Technology and Medicine, London, United Kingdom.

BACKGROUND AND OBJECTIVES: Debate continues on the efficacy and safety of
intravaginal nonoxynol-9 for the prevention of horizontal transmission of human
immunodeficiency and other sexually transmitted diseases. Little attention has
been paid to the effects of nonoxynol-9 contained in the lubricant of many
condoms. GOAL: To assess the tolerability of different levels of nonoxynol-9 in
condom lubricants. STUDY DESIGN: Pilot, randomized, controlled trial in 70
female prostitutes. RESULTS: There was no association between dose of
nonoxynol-9 and reported symptoms or signs of genital tract inflammation; an
increased dose of nonoxynol-9 was associated with increased numbers of
polymorphonuclear leukocytes on a vaginal wall smear. CONCLUSIONS: There is no
recognized simple method of defining inflammation in the female genital tract.
Future studies of the effects of low-dose nonoxynol-9 on the female genital
tract require highly controlled exposures, plus colposcopy with or without
vaginal biopsy to define inflammation.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 8885074 [PubMed - indexed for MEDLINE]

74: Am J Epidemiol 1996 Sep 1;144(5):512-20

Association between use of spermicide-coated condoms and Escherichia coli
urinary tract infection in young women.

Fihn SD, Boyko EJ, Normand EH, Chen CL, Grafton JR, Hunt M, Yarbro P, Scholes D,
Stergachis A.

Northwest Health Services Research and Development Field Program, Veterans
Affairs Medical Center, Seattle, WA 98108, USA.

Diaphragm/spermicide use increases the risk of urinary tract infection (UTI). To
determine whether spermicide-coated condoms are also associated with an
increased risk of UTI, the authors conducted a case-control study at a large
health maintenance organization in Seattle, Washington. Cases were sexually
active young women with acute UTI caused by Escherichia coli, identified from
computerized laboratory files during 1990-1993. Age-matched controls were
randomly selected from the enrollment files of the plan. Of 1,904 eligible
women, 604 cases and 629 controls (65%) were interviewed. During the previous
year, 40% of the cases and 31% of the controls had been exposed to any type of
condom. The unadjusted odds ratio for UTI increased with frequency of condom
exposure from 0.91 (95% confidence interval (CI) 0.65-1.28) for weekly or less
during the previous month to 2.11 (95% CI 1.37-3.26) for more than once weekly.
Exposure to spermicide-coated condoms conferred a higher risk of UTI, with odds
ratios ranging from 1.09 (95% CI 0.58-2.05) for use weekly or less to 3.05 (95%
CI 1.47-6.35) for use more than once weekly. In multivariate analyses,
intercourse frequency (odds ratio (OR) = 1.14 per weekly episode), history of
UTI (OR = 2.64), and frequency of spermicide-coated condom exposure (OR = 3.34
for more than once weekly and 5.65 for use more than twice weekly) were
independent predictors of UTI. Spermicide-coated condoms were responsible for
42% of the UTIs among women who were exposed to these products.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 8781467 [PubMed - indexed for MEDLINE]

75: Acta Obstet Gynecol Scand 1996 Jul;75(6):579-84

Increased use of condoms among female university students: a 5-year follow-up of
sexual behavior.

Tyden T, Bjorkelund C, Odlind V, Olsson SE.

Department of Obstetrics and Gynecology, University Hospital, Uppsala, Sweden.

OBJECTIVE. To ascertain any changes in sexual behavior and attitudes as an
indication of the impact of intensified information activities aiming at
decreasing the risk of spread of sexually transmitted diseases among university
students. METHODS. In 1989 questionnaires were offered to 275 consecutive female
students visiting the Student Health Center. Identical questionnaires were
mailed to 200 randomly selected women registered at Uppsala University. The
study was repeated in 1994. The study was carried out in Uppsala, a city in
Sweden with 27,000 university students. RESULTS. At the Student Health Center
241 (88%) participated in the study in 1989 and 262 (95%) in 1994. Corresponding
figures in the postal survey were 137 (69%) in 1989 and 151 (76%) in 1994.
Compared with the findings in 1989, in 1994 the sexual behavior was unchanged in
terms of mean age at first intercourse (17.6 years), median number of life
partners (3-4) and median number of sexual partners during the last 12 months
(1), but the awareness of sexually transmitted diseases had increased. Their
attitudes to using condoms had become more positive and the actual use of a
condom had also increased both at the first intercourse and when changing
partner, from 40 to 60%. Concerns about safety of oral contraceptives decreased
significantly. CONCLUSIONS. This follow-up shows that awareness of sexually
transmitted diseases and condom use had increased between 1989 and 1994,
possibly as a result of intensified information efforts.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 8693937 [PubMed - indexed for MEDLINE]

76: Sex Transm Dis 1996 May-Jun;23(3):206-12

Use of spermicide and impact of prophylactic condom use among sex workers in
Santa Fe de Bogota, Colombia.

Farr G, Acosta Castro LA, DiSantostefano R, Claassen E, Olguin F.

Family Health International, Research triangle Park, North Carolina 27709, USA.

BACKGROUND AND OBJECTIVES: Condom use is one of the most important preventive
measures sex workers can take to reduce the risk of becoming infected with a
sexually transmitted disease. However, a client may refuse to use a condom when
requested. Some sexually transmitted disease prevention programs are
recommending that sex workers use spermicide as an alternative prophylaxis when
a condom is refused, yet little is known about the effect of this recommendation
on prophylactic condom use. GOAL: To determine if using spermicide, either in
conjunction with condoms or as a backup, influenced overall condom use among a
group of sex workers at high risk of sexually transmitted diseases in Santa Fe
de Bogota, Colombia. STUDY DESIGN: Participants were assigned randomly to one of
three condom use groups: use of condoms only (Condoms Only), use of condoms and
spermicides concurrently (Condom and Spermicide), or use of spermicide when
condoms were refused (Spermicide as a Backup). A total of 199 sex workers
entered the study and were asked to return for follow-up every 2 weeks for a
period of 12 weeks. RESULTS: Women assigned to the Spermicide as a Backup group
used a condom for an average of 78.1% of their reported acts of intercourse,
compared with an average of 94.5% in the Condom Only and 92.3% in the Condom and
Spermicide groups. However, women in the Spermicide as a Backup group used a
condom or spermicide for an average of 96.9% of their acts of intercourse.
Condoms were used for every intercourse act by less than 5% of the women in the
Spermicide as a Backup groups, compared with 50.7% in the Condom Only group and
41.2% in the Condom and Spermicide group (P 0.001). When condoms were not used,
client refusal was the primary reason reported. The incidence of sexually
transmitted diseases and other urogenital inflammations in all groups was lower
than expected. CONCLUSIONS: Among Colombian sex workers, condom use declined
substantially when women were instructed to use spermicides if they were unable
to persuade their partner to use a condom. However, these same women usually
used the study spermicide as an alternate prophylaxis.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 8724510 [PubMed - indexed for MEDLINE]

77: Arch Pediatr Adolesc Med 1996 Apr;150(4):363-72

A randomized, controlled effectiveness trial of an AIDS prevention program for
low-income African-American youths.

Stanton BF, Li X, Ricardo I, Galbraith J, Feigelman S, Kaljee L.

Division of General Pediatrics, Department of Pediatrics, University of Maryland
Medical School, Baltimore, USA.

BACKGROUND: Some interventions to reduce the risk of the acquired
immunodeficiency syndrome (AIDS) that target youths have resulted in short-term
increases in self-reported condom use. However, long-term intervention effects
have not been assessed. STUDY QUESTION: Can a theoretically and culturally
based, AIDS-risk reduction intervention delivered to naturally formed peer
groups increase self-reported condom use among African-American early
adolescents at 6 and 12 months of follow-up? METHOD: A randomized, controlled
trial of a community-based intervention delivered in eight weekly sessions
involved 76 naturally formed peer groups consisting of 383 (206 intervention and
177 control) African-American youths 9 to 15 years of age. A theory-based,
culturally and developmentally tailored instrument that assessed perceptions,
intentions, and self-reported sexual behaviors was administered to all subjects
at baseline (preintervention) and 6 and 12 months later. RESULTS: At baseline,
36% of youths were sexually experienced, and by 12 months of follow-up, 49% were
sexually experienced. Self-reported condom use rates were significantly higher
among intervention than control youths (85% vs 61%; P<.05) at the 6-month
follow-up. However, by 12 months, rates were no longer significantly higher
among intervention youths. The intervention impact at 6 months was especially
strong among boys (85% vs 57%; P<.05) and among early teens (13 to 15 years old)
(95% vs 60%; P<.01). Self-reported condom use intention was also increased among
intervention youths at 6 months but not at 12 months. Some perceptions were
positively affected at 6 months, but the change did not persist at 12 months.
CONCLUSIONS: High rates of sexual intercourse underscore the urgent need for
effective AIDS-risk reduction interventions that target low-income urban,
African-American preteens and early teens. A developmentally and culturally
tailored intervention based on social-cognitive theory and delivered to
naturally formed peer groups recruited from community settings can increase
self-reported condom use. The strong short-term improvements in behaviors and
intentions followed by some relapse over longer periods argue for a strengthened
program and research focus on sustainability.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 8634730 [PubMed - indexed for MEDLINE]

78: Ann Epidemiol 1996 Mar;6(2):119-25

Changes in HIV risk behavior following alternative residential programs of drug
abuse treatment and AIDS education.

McCusker J, Stoddard AM, Hindin RN, Garfield FB, Frost R.

School of Public Health, University of Massachusetts, Amherst, USA.

We compared the effectiveness in changing human immunodeficiency virus (HIV)
risk behavior of two different approaches to acquired immunodeficiency syndrome
(AIDS) education given by residential drug abuse treatment programs differing in
their planned duration. Two randomized controlled trials compared (a) a 6-month
with a 12-month therapeutic community (TC) program, and (b) a 6-month with a
3-month relapse prevention (RP) program. Three composite variables assessing HIV
risk (a) drug injection, (b) sexual partners, and (c) condom use-were measured
for the 3 months prior to admission and follow-up. The TC program comprised a
four-part AIDS information intervention. The RP program comprised a 21- or
42-session small-group program in the principles of RP, 5 skills-building AIDS
education sessions, and 6 other health education sessions. Four hundred
ninety-five clients were enrolled in the study and completed a follow-up
interview within 6 months of exit (79% of those enrolled). Clients in the RP
program reduced their drug injection and condom use risk. Female clients in the
TC program reduced their condom use risk. There were no differential effects on
risk behavior change of either planned duration (randomization assignment) or
program type (RP versus TC). Thus, differences in the treatment programs,
including AIDS education components, had no apparent effect on HIV risk behavior
change. The contribution of residential drug abuse treatment programs to AIDS
prevention remains unproved.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 8775591 [PubMed - indexed for MEDLINE]

79: Health Educ Q 1996 Feb;23(1):34-47

Comment in:
Health Educ Q. 1996 Nov;23(4):413-4.

The effect of sex education on adolescents' use of condoms: applying the Solomon
four-group design.

Kvalem IL, Sundet JM, Rivo KI, Eilertsen DA, Bakketeig LS.

Institute of Psychology, University of Oslo, Norway.
ingela.kvalem@psykologi.uio.no

A school-based sex education program was developed in order to prevent sexually
transmitted diseases and unwanted pregnancies. A Solomon four-group design, with
random assignment to the different conditions, was used to evaluate an
intervention based on cognitive social learning theory and social influence
theory. The main goal of the intervention was to increase use of condoms. A
stratified sample of 124 classes (2,411 students) was drawn at random from all
the upper secondary schools (high schools/colleges) in one county in Norway. The
results indicate a consistent interaction between pretest and intervention,
which seems to have an effect on condom use. Pretest or intervention alone did
not contribute to this effect. The interaction effect appeared among the
students with few sexual partners. Several possible explanations to the observed
interaction effect and the implication for future interventions are discussed.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 8822400 [PubMed - indexed for MEDLINE]

80: J Pediatr 1996 Feb;128(2):288-95

Behavioral intervention to increase condom use among high-risk female
adolescents.

Orr DP, Langefeld CD, Katz BP, Caine VA.

Department of Pediatrics, Indiana University School of Medicine, Indianapolis,
USA.

OBJECTIVE: To determine whether condom use among high-risk female adolescents
could be increased by a behavioral intervention, with the use of infection with
Chlamydia trachomatis as a biomarker of condom practices. DESIGN: Prospective,
randomized, controlled intervention. SETTING: Urban family planning and sexually
transmitted disease clinics. PARTICIPANTS: Two hundred nine female adolescents,
aged 15 through 19 years, who were treated for C. trachomatis genitourinary
infection, were randomly assigned to standard (control) or experimental
(behavioral intervention) groups. One hundred twelve subjects returned for
follow-up 5 to 7 months after enrollment and comprise the study subjects.
MEASUREMENTS: Subjects completed a multiinstrument questionnaire measuring
sexual behavior, condom practices, attitudes and beliefs, cognitive complexity,
sociodemographics, and motivation at enrollment and follow-up. Endourethral and
endocervical sites were sampled for C. trachomatis. RESULTS: Among the 112
subjects who returned for repeated examination, those who had received the
experimental intervention reported increased use of condoms by their sexual
partners for protection against sexually transmitted diseases (odds ratio = 2.4;
p = 0.02) and for vaginal intercourse (odds ratio = 3.1; p = 0.005) at the
6-month follow-up. Multivariable logistic regression analysis controlling for
condom use at enrollment demonstrated that the experimental intervention (odds
ratio = 2.8; p = 0.03) and the higher cognitive complexity (odds ratio = 4.6; p
= 0.02) independently contributed to greater condom use at follow-up. Despite
greater use of condoms among the group who had received the intervention, use
remained inconsistent and rates of reinfection with C. trachomatis were not
significantly different (26% vs 17%; p = 0.3). CONCLUSION: Although a brief
behavioral intervention among high-risk female adolescents can increase condom
use by their sexual partners, incident infection does not appear to be reduced,
because condom use remained inconsistent.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 8636834 [PubMed - indexed for MEDLINE]

81: Public Health Rep 1996;111 Suppl 1:99-107

Quality assurance of HIV prevention counseling in a multi-center randomized
controlled trial. Project RESPECT Study Group.

Kamb ML, Dillon BA, Fishbein M, Willis KL.

Division of HIV/AIDS Prevention, NCHSTP, Centers for Disease Control and
Prevention, Atlanta, GA 30333, USA.

Current HIV prevention counseling strategies rely largely on interventions aimed
at changing behaviors. Among these is HIV prevention counseling and testing,
which has been a prominent component in the federally supported strategies for
HIV/AIDS prevention in the United States. To assess the efficacy of HIV
counseling in reducing risk behaviors and preventing HIV infection and other
sexually transmitted diseases, a multicenter, randomized controlled trial is
being conducted among sexually transmitted disease clinic patients (Project
RESPECT). The trial compares three separate HIV prevention strategies on
increasing condom use and decreasing new cases of sexually transmitted diseases.
The strategies are (a) Enhanced HIV Prevention Counseling, a 4-session
individual counseling intervention based on behavioral and social science
theory; (b) HIV Prevention Counseling, a 2-session individual pre- and post test
counseling strategy that attempts to increase perception of risk and reduce risk
behaviors using small, achievable steps; and (c) HIV Education, a brief
2-session pre- and post-test strategy that is purely informational. One
difficulty in conducting randomized trials of behavioral interventions is
assuring that the interventions are being conducted both as conceptualized and
in a consistent manner by different counselors and, for multicenter studies, at
different study sites. This article describes the quality assurance measures
that have been used for Project RESPECT. These have included development of
standard tools, standard training, frequent observation and feedback to study
personnel, and process evaluation.

Publication Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial

PMID: 8862164 [PubMed - indexed for MEDLINE]

82: Health Psychol 1996 Jan;15(1):56-60

Alcohol's effects on requisites for sexual risk reduction in men: an initial
experimental investigation.

Gordon CM, Carey MP.

Department of Psychology, Syracuse University, New York 13244-2340, USA.

The effects of alcohol intoxication on mediators of condom use were examined in
a laboratory-based experiment. Twenty men were randomly assigned to either an
alcohol or a nonalcohol beverage administration condition. Participants in the
experimental condition drank vodka and tonic to achieve a blood alcohol level of
0.08%, whereas controls drank tonic only. All participants then completed a
battery of measures related to condom and AIDS-related knowledge, motivation to
use condoms, and behavioral self-efficacy regarding condom use. Findings from
this exploratory study, which should be considered preliminary because of the
small sample size, indicated that participants who received alcohol tended to
report more negative attitudes toward condoms and lower self-efficacy to
initiate condom use than controls. AIDS knowledge, appraisal of social norms
regarding condom use, and perceived risk of infection were unaffected by alcohol
consumption.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 8788541 [PubMed - indexed for MEDLINE]

83: J Sex Marital Ther 1996 Spring;22(1):9-21

AIDS prevention in high-risk African American women: behavioral, psychological,
and gender issues.

Hetherington SE, Harris RM, Bausell RB, Kavanagh KH, Scott DE.

University of Maryland at Baltimore School of Nursing 21230, USA.

A three-year longitudinal intervention study was implemented to reduce high-risk
drug and sexual behaviors in methadone-dependent African American women.
Participants were recruited from four inner-city methadone maintenance programs
and randomly assigned either to an eight-week peer counseling and leadership
training group or to a control group. The 107 trainees and 97 controls completed
pretests and posttests at two, four, and seven months. This paper focuses on
final data related to the subjects' sexual beliefs, attitudes, knowledge, and
behaviors that put them at risk for HIV/AIDS. Reasons for not using condoms are
categorized and discussed. Despite the women's awareness of the seriousness of
AIDS, perceived powerlessness to negotiate condom use, negative attitudes about
the use of condoms, influence of drugs, and unavailablility of condoms
interfered with safer sex practices. The inability of education alone to prevent
many high-risk sexual behaviors suggests that more serious consideration be
given to expanded distribution of condoms as well as needle exchange programs
and legalization of illicit drugs.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 8699500 [PubMed - indexed for MEDLINE]

84: Arch Pediatr Adolesc Med 1996 Jan;150(1):17-24

Sexually transmitted diseases, human immunodeficiency virus, and pregnancy
prevention. Combined contraceptive practices among urban African-American early
adolescents.

Stanton BF, Li X, Galbraith J, Feigelman S, Kaljee L.

Department of Pediatrics, University of Maryland, Baltimore, USA.

OBJECTIVE: To evaluate the success of efforts to educate youth not only to use
prescription contraceptives to avoid pregnancy, but also to use condoms to avoid
sexually transmitted diseases, including infection with the human
immunodeficiency virus. METHODS: Longitudinal study of 383 African-American
youth aged 9 to 15 years enrolled in a randomized, controlled trial of an
acquired immunodeficiency syndrome (AIDS) risk reduction intervention. Data
about contraceptive practices were obtained at baseline and 6, 12, and 18 months
later using a culturally and developmentally appropriate risk assessment tool
administered with "talking" computers (Macintosh, Apple Computer Inc, Cupertino,
Calif). RESULTS: Approximately three fourths of sexually active youth used some
form of contraception in each 6-month round, with almost half of the youth using
combinations of contraceptives. Among all youth at baseline and among control
youth throughout the study, more than half used condoms and more than two thirds
who used oral contraceptives also used condoms. Receipt of an AIDS education
intervention was associated with use of more effective contraceptive practices
(eg, condoms and another prescription or nonprescription method of birth
control). After receiving the intervention, more than 80% of the youth who used
oral contraceptives also used condoms. Contraceptive practices showed
considerable stability. Knowledge about AIDS was positively associated with use
of more effective contraceptive methods. CONCLUSIONS: Many youth are using
condoms and prescription birth control simultaneously, and these use rates can
be increased through AIDS education interventions.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 8542001 [PubMed - indexed for MEDLINE]

85: Obstet Gynecol 1996 Jan;87(1):27-9

Comparison of probe sheaths for endovaginal sonography.

Rooks VJ, Yancey MK, Elg SA, Brueske L.

Department of Radiology, Tripler Army Medical Center, Honolulu, Hawaii, USA.

OBJECTIVE: To compare the effectiveness of commercially available probe covers
with less expensive condoms. METHODS: During a 10-month period, sonographers
performed endovaginal ultrasound examinations on patients by randomly testing
either commercially available probe covers or condoms on the vaginal probe.
After use, the sheaths were tested for damage by filling them with water to
observe for leakage and thereby determine the breakage rate. RESULTS:
Perforations were noted in 15 of 180 probe covers and three of 180 condoms (8.3
versus 1.7%, P < .05; relative risk [RR] 5.4, 95% confidence interval [CI]
1.4-18.5). Potential contamination of the endovaginal probe occurred during nine
of 174 examinations and one of 178 examinations in which probe covers and
condoms, respectively, were used (P < .05; RR 9.7, 95% CI 1.2-67.7). CONCLUSION:
Condoms are less expensive and superior to commercially available probe covers
for covering the ultrasound probe during endovaginal examinations.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 8532260 [PubMed - indexed for MEDLINE]

86: Am J Public Health 1995 Nov;85(11):1526-30

Comment in:
Am J Public Health. 1995 Nov;85(11):1485-8.

Quality of condom use as reported by female clients of a family planning clinic.

Oakley D, Bogue EL.

School of Nursing, University of Michigan, Ann Arbor 48109-0482, USA.

OBJECTIVES. This study analyzed the prevalence and determinants of the quality
of condom use after a woman's first visit to a family planning clinic. METHODS.
This report presents data from 360 female family planning clients who reported
using condoms as their primary method of contraception for at least 1 sexually
active month during the study's follow-up period after their first clinic visit.
RESULTS. Only 1% always engaged in all five use behaviors studied: using a
condom for each sexual intercourse, putting the condom on before first entry,
withdrawal after intercourse while there is still an erection, holding on to the
condom's rim during withdrawal, and using foam. Multiple linear regression
indicated that more effective condom use was reported by women who had not had
an induced abortion, were not using condoms just because they were starting oral
contraceptive pill regimens, had more knowledge about birth control in general,
had received a nursing intervention, and had more communication with their
partner. CONCLUSIONS. Increasing attention needs to be devoted to understanding
determinants of the specific actions that differentiate between more and less
effective contraceptive use.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 7485665 [PubMed - indexed for MEDLINE]

87: JAMA 1995 Oct 25;274(16):1271-6

Comment in:
JAMA. 1996 Feb 28;275(8):593-4; discussion 594-5.
JAMA. 1996 Feb 28;275(8):593; discussion 594-5.

A randomized controlled trial of an HIV sexual risk-reduction intervention for
young African-American women.

DiClemente RJ, Wingood GM.

School of Public Health, Department of Health Behavior, University of Alabama,
Birmingham 35294-2010, USA.

OBJECTIVE--To evaluate the efficacy of a community-based social skills human
immunodeficiency virus (HIV) prevention intervention to enhance consistent
condom use. DESIGN--A randomized, single-blind controlled trial.
SETTING--Bayview-Hunter's Point neighborhood of San Francisco, Calif, a
predominantly African-American community that is economically disadvantaged.
PARTICIPANTS--A sample of 128 sexually active, heterosexual, African-American
women 18 through 29 years of age was recruited using street outreach techniques.
Participants completed a structured baseline interview; 100 women (78.1%)
completed 3-month follow-up interviews. INTERVENTION--Women randomized to the
social skills intervention completed five sessions that emphasized ethnic and
gender pride, HIV risk-reduction information, sexual self-control, sexual
assertiveness and communication skills, proper condom use skills, and developing
partner norms supportive of consistent condom use. Women randomized to the HIV
education condition participated in a single session that provided HIV
risk-reduction information. Women randomized to the delayed HIV education
control condition received no HIV risk-reduction information until all follow-up
interviews were completed. MAIN OUTCOME MEASURES--Consistent condom use, HIV
risk-reduction knowledge, sexual self-control, sexual assertiveness, sexual
communication, and partner norms supportive of consistent condom use.
RESULTS--Compared with the delayed HIV education control condition, women in the
social skills intervention demonstrated increased consistent condom use
(adjusted odds ratio [OR], 2.1; 95% confidence interval [CI], 1.03 to 4.15; P =
.04), greater sexual self-control (adjusted OR, 1.9; 95% CI, 1.00 to 3.60; P =
.05), greater sexual communication (adjusted OR, 4.1; 95% CI, 1.67 to 10.01; P =
.002), greater sexual assertiveness (adjusted OR, 1.8; 95% CI, 1.01 to 3.27; P =
.05), and increased partners' adoption of norms supporting consistent condom use
(adjusted OR, 2.1; 95% CI, 1.08 to 3.87; P = .03). No statistically significant
differences in outcome variables were observed between the HIV education
condition relative to the delayed HIV education control condition.
CONCLUSION--Community-based HIV risk-reduction programs that are gender relevant
and culturally sensitive and provide social skills training can effectively
enhance consistent condom use.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 7563531 [PubMed - indexed for MEDLINE]

88: AIDS 1995 Jul;9 Suppl 1:S7-13

Results of a model AIDS prevention program for high school students in the
Philippines.

Aplasca MR, Siegel D, Mandel JS, Santana-Arciaga RT, Paul J, Hudes ES, Monzon
OT, Hearst N.

Research Institute for Tropical Medicine, Department of Health, Alabang,
Muntinlupa, Metro Manila, Philippines.

OBJECTIVES: To describe the sexual practices of high school students; to
describe the process of development of a school-based AIDS prevention program;
and to evaluate the effect of this program on students' AIDS-related knowledge,
attitudes and AIDS-preventive behaviors. SUBJECTS AND METHODS: A
cluster-randomized, controlled trial with pretest/post-test evaluation was
conducted in four demographically similar public high schools in a semi-urban
district of Metro Manila, the Philippines. Of 845 high school students who
participated in the baseline survey, 804 (95%) completed a postintervention
questionnaire. INTERVENTION: An AIDS prevention program was developed by public
high school teachers together with local AIDS experts, social scientists and
health educators. The teacher-led AIDS program was designed to provide students
with accurate information about AIDS, particularly in dispelling misconceptions
about casual contagion, to foster positive attitudes towards people with AIDS
and to develop skills aimed at clarifying values and assessing intended
behavior. RESULTS: At baseline, 11% of students (20% of males and 4% of females)
reported ever having had sexual intercourse (mean age 14 years). Among these,
condom use was low (24%). After implementation of the AIDS prevention program,
statistically significant effects favoring the intervention group were observed
in knowledge and attitudes towards people with AIDS. While there was no
statistically significant overall effect on intended preventive behavior, the
program appeared to delay the students' intended onset of sexual activity.
CONCLUSIONS: A sizable number of Filipino high school students are sexually
active but condom use is low. School-based AIDS prevention programs can be
developed and implemented in developing countries with the assistance of school
personnel to address sexual issues. Our program was successful in increasing
AIDS-related knowledge and improving attitudes towards people with AIDS.
Supplementation with other preventive activities may be needed to achieve
lasting changes in students' risk-taking behavior.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 8562004 [PubMed - indexed for MEDLINE]

89: Am J Public Health 1995 Jun;85(6):817-22

Video-based sexually transmitted disease patient education: its impact on condom
acquisition.

O'Donnell LN, Doval AS, Duran R, O'Donnell C.

Education Development Center Inc., Newton, Mass 02158, USA.

OBJECTIVES. This study assessed the impact of video-based educational
interventions on condom acquisition among men and women seeking services at a
large sexually transmitted disease clinic in the South Bronx, New York. METHODS.
During 1992, 3348 African American and Hispanic patients were enrolled in a
clinical trial of video-based interventions designed to promote safer sex
behaviors, including increased condom use. Patients were assigned to one of
three groups: control, video, or video plus interactive group discussion.
Subjects were given a coupon to redeem for free condoms at a pharmacy several
blocks from the clinic. Rates of condom acquisition were assessed by level of
intervention. RESULTS. In comparison with a control group, subjects who viewed
videos were significantly more likely to redeem coupons for condoms (21.2%
redemption rate vs 27.6%). However, participation in interactive sessions after
video viewing augmented the positive effects of video viewing alone (27.6%
redemption rate vs 36.9%). Gender and ethnicity were significantly associated
with outcomes. CONCLUSIONS. The condom acquisition are almost doubled with the
use of culturally appropriate, video-based interventions. Designed to present
minimal disruption to clinical services, these interventions can be implemented
in clinics servicing at-risk men and women.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 7762716 [PubMed - indexed for MEDLINE]

90: J Consult Clin Psychol 1995 Apr;63(2):221-37

Cognitive-behavioral intervention to reduce African American adolescents' risk
for HIV infection.

St Lawrence JS, Brasfield TL, Jefferson KW, Alleyne E, O'Bannon RE 3rd, Shirley
A.

Community Health Program, Jackson State University, Mississippi 39217-0105, USA.

Two hundred forty-six African American adolescents were randomly assigned to an
educational program or an 8-week intervention that combined education with
behavior skills training including correct condom use, sexual assertion,
refusal, information provision, self-management, problem solving, and risk
recognition. Skill-trained participants (a) reduced unprotected intercourse, (b)
increased condom-protected intercourse, and (c) displayed increased behavioral
skills to a greater extent than participants who received information alone. The
patterns of change differed by gender. Risk reduction was maintained 1 year
later for skill-trained youths. It was found that 31.1% of youths in the
education program who were abstinent at baseline had initiated sexual activity 1
year later, whereas only 11.5% of skills training participants were sexually
active. The results indicate that youths who were equipped with information and
specific skills lowered their risk to a greater degree, maintained risk
reduction changes better, and deferred the onset of sexual activity to a greater
extent than youths who received information alone.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 7751483 [PubMed - indexed for MEDLINE]

91: Public Health Nurs 1995 Apr;12(2):99-108

A description of the gender differences in risk behaviors in young adults with
genital herpes.

Swanson JM, Dibble SL, Trocki K.

Department of Nursing, Samuel Merritt College, Oakland, California 94609, USA.

The purpose of this paper is to describe gender differences in risk
behaviors--substance use and sexual behavior--in young adults with genital
herpes. Two-hundred fifty-two young adults with genital herpes were recruited
into the study via newspaper advertisements in a West Coast metropolitan area.
As a part of a large randomized clinical trial, participants completed
questionnaires measuring demographic characteristics and the risk behaviors of
substance use and sexual behavior. Participants had a mean age of 27.1 years and
were largely Caucasian, employed, college-educated, and heterosexual. Women were
two years younger than men and had less income. Gender differences were found in
both substance use and sexual behavior. Men were more likely to report current
use of illicit drugs than were women. Men were also more likely to report a
history of gonorrhea, and urethral discharge. Women reported initiating sex at
an older age and having fewer sexual partners over their lifetimes than men.
There were no gender differences in use of condoms or spermicides specifically
to prevent transmission of genital herpes. Further study is needed of these
young adults as they are at high risk for transmission of the disease and also
for contracting other sexually transmitted diseases (STDs), including human
immunodeficiency virus (HIV) infection. Sensitive interventions are needed with
this high-risk population.

Publication Types:
Clinical Trial
Randomized Controlled Trial
Review
Review, Tutorial

PMID: 7739990 [PubMed - indexed for MEDLINE]

92: AIDS Educ Prev 1995 Apr;7(2):145-59

Development and evaluation of an HIV-risk reduction program for female college
students.

Sikkema KJ, Winett RA, Lombard DN.

Center for AIDS Intervention Research (CAIR), Medical College of Wisconsin,
Milwaukee, USA.

College students are engaging in high rates of behavior related to risk of
infection from Human Immunodeficiency Virus (HIV) and other sexually transmitted
diseases (STDs). A cognitive-behavioral skills training program for heterosexual
college females focused on sexual assertiveness skills and the reduction of
risk-related behaviors was designed and evaluated compared with an
education-only program. Participants completed pre-intervention,
post-intervention, and one-month follow-up assessments of: (a) HIV/STD-related
knowledge and beliefs; (b) sexual, alcohol, and drug-related behaviors; and (c)
sexual assertiveness role-plays. Skills training participants compared to
education-only participants scored higher on sexual assertiveness skills,
specific knowledge of HIV infection, and self-efficacy to perform lower risk
sexual behaviors and reported a reduction in risk-related behaviors at
post-intervention and follow-up assessments. The effectiveness of behavioral
skills in HIV risk-reduction programs for college students is discussed.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 7619644 [PubMed - indexed for MEDLINE]

93: J Sch Health 1995 Apr;65(4):145-51

Impact of a school-based AIDS prevention program on risk and protective behavior
for newly sexually active students.

Levy SR, Perhats C, Weeks K, Handler AS, Zhu C, Flay BR.

Prevention Research Center, University of Illinois at Chicago 60607, USA.

This project assessed the impact of a school-based AIDS prevention program on
student participation in sexual risk and protective behaviors such as use of
condoms and use of condoms with foam and intention to participate in such
behaviors. The paper focuses on students who became sexually active for the
first time between the seventh and eighth grade ("changers," n = 312). The
school-based intervention was developed using social cognitive theory and the
social influences model of behavior change. Using an experimental, longitudinal
design, 15 high-risk school districts were divided randomly into two treatment
(10 districts) and one control (five districts) conditions. Students in both
treatment conditions received a 10-lesson classroom program in the seventh grade
with a five-lesson booster in the eighth grade, while control students received
basic AIDS education (current practice in their districts) in compliance with
state mandates. Results indicated classroom programs had an impact on certain
protective behaviors and on frequency of sexual activity the past month.
Post-intervention measures also indicated the program affected students'
intentions to perform specific protective behaviors.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 7603052 [PubMed - indexed for MEDLINE]

94: Sex Transm Dis 1995 Mar-Apr;22(2):97-103

The effectiveness of video-based interventions in promoting condom acquisition
among STD clinic patients.

O'Donnell L, San Doval A, Duran R, O'Donnell CR.

Education Development Center, Inc., Newton, MA 02160, USA.

GOAL OF THIS STUDY: This study examined the effectiveness of video-based patient
education interventions on promoting condom use among men and women seeking
services at a large public STD clinic in New York City. METHODS: Culturally
sensitive video-based interventions designed to promote safer sex behaviors were
evaluated in a randomized study of black and Hispanic male and female STD clinic
patients. Subjects (n = 1,653) were randomly assigned to one of three groups: 1)
control, 2) video viewing, and 3) video viewing followed by participation in an
interactive group session led by a trained facilitator. The authors examined 1)
the effectiveness of interventions in increasing STD and condom-related
knowledge, positive attitudes about condoms, human immunodeficiency virus/STD
risk perceptions, and self-efficacy and 2) the relationships among these
variables, level of intervention, and condom acquisition, a behavioral measure
of condom use. RESULTS: Compared with a control group, subjects assigned to
video viewing demonstrated greater knowledge about condoms and STDs, more
positive attitudes about condom use, increased human immunodeficiency virus/STD
risk perceptions, greater self-efficacy, and higher rates of condom acquisition.
Subjects assigned to video viewing followed by interactive sessions demonstrated
still further increases in risk perceptions, self-efficacy, and condom
acquisition, but not in knowledge or condom attitudes. A significant proportion
of the association between the behavioral outcome of condom acquisition and
level of intervention is attributable to the impact of interventions on risk
perception and self-efficacy. CONCLUSIONS: Based on extensive formative research
that identified barriers to safer sex behaviors, video-based interventions were
developed to promote condom use among black and Hispanic men and women attending
STD clinics. Designed to be integrated into clinic services, these interventions
help improve knowledge, promote positive attitudes about condoms, and increase
condom acquisition among individuals at high risk of acquiring and transmitting
human immunodeficiency virus infection and other STDs.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 7624818 [PubMed - indexed for MEDLINE]

95: AIDS Educ Prev 1995 Feb;7(1):50-9

Behavioral training and AIDS risk reduction: overcoming barriers to condom use.

Weisse CS, Turbiasz AA, Whitney DJ.

Department of Psychology, Union College, Schenectady, New York 12308, USA.

To assess the short- and long-term effects of an AIDS-prevention workshop on
undergraduates' attitudes about condom use and AIDS, 31 participants and 31
controls were studied immediately after training sessions as well as three
months later. The workshop was aimed at reducing embarrassment to purchase
condoms, encouraging positive attitudes about condoms, and promoting knowledge
about AIDS. To help students overcome their embarrassment over condom purchases,
a behavioral intervention was included allowing students to make condom
purchases at nearby drug stores. Results revealed that participants reported
less embarrassment over condom purchases after training sessions and that this
effect became even stronger over time. Knowledge about AIDS and positive
attitudes about condoms also increased immediately after the workshop, but these
changes did not persist. Results suggest that AIDS prevention workshops may lead
to transient changes unless a specific skill (i.e., condom purchasing) is
targeted via behavioral training.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 7772456 [PubMed - indexed for MEDLINE]

96: Int J STD AIDS 1995 Jan-Feb;6(1):35-41

Sexual behaviour in the city of Lisbon.

Amaro F, Dantas AM, Teles Lda C.

Technical University of Lisbon, Portugal.

This study of sexual behaviour in the city of Lisbon is based on data obtained
from 2 random samples, one of individuals aged 16-20 (n = 400) and another of
individuals over the age of 20 (n = 400). Samples have been stratified by
district, gender and age. Data were obtained by personal interview and by
questionnaires completed confidentially by the interviewees. The data include
the age of first sexual intercourse, the number of sexual partners, the
prevalence of casual relations and the type of sexual practices according to sex
and age group. Results show that despite the high risk of exposure to HIV in a
significant percentage of the population, AIDS is seen as a personal threat by
only 20% of the population. Six per cent of the adults (aged 21 and over) and
12% of the young people (16-20) replied that they had not yet considered the
problem; 73.5% of the adults and 67.4% of the young people stated that they did
not feel threatened by the disease. Data suggest that the differences between
men and women have decreased. Among the sexually active population, only 12% of
individuals under 21 and 8% of the adults use condoms regularly. The awareness
of infidelity among couples is much lower than in reality.(ABSTRACT TRUNCATED AT
250 WORDS)

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 7727580 [PubMed - indexed for MEDLINE]

97: Fam Plann Perspect 1995 Jan-Feb;27(1):29-33

Predictors of condom acquisition after an STD clinic visit.

O'Donnell L, San Doval A, Duran R, O'Donnell CR.

Education Development Center, Newton, Mass., USA.

Data from a survey of 691 men and women who made patient visits to an
inner-city, sexually transmitted disease (STD) clinic and were given coupons to
redeem for condoms at a neighborhood pharmacy show that only 22% of the sample
did so. Gender, ethnicity, marital status and education were not significant
predictors of whether study participants redeemed their coupons. Factors that
significantly predicted coupon redemption included the extent of acculturation
and age, with those who were older and less acculturated more likely to do so.
Other significant factors were having a primary sexual partner and having had
more than one sexual partner in the last month; having ever had an STD was
negatively associated with coupon redemption. A perception of being at high STD
risk and a favorable attitude about condoms also significantly predicted condom
acquisition. All these variables, except for attitude toward condoms and a
history of an STD, remained significant when entered into a logistic regression
controlling for the influence of all independently significant predictors.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 7720850 [PubMed - indexed for MEDLINE]

98: Am J Public Health 1994 Dec;84(12):1918-22

The effects of HIV/AIDS intervention groups for high-risk women in urban
clinics.

Kelly JA, Murphy DA, Washington CD, Wilson TS, Koob JJ, Davis DR, Ledezma G,
Davantes B.

Department of Psychiatry and Mental Health Sciences, Medical College of
Wisconsin, Milwaukee 53226.

OBJECTIVE. This study reports the results of a behavior change intervention
offered to women at high risk for human immunodeficiency virus (HIV) infection
seen in an urban primary health care clinic. METHODS. Participants were 197
women randomly assigned to either an HIV/acquired immunodeficiency syndrome
(AIDS) risk reduction group or a comparison group. Women in the HIV/AIDS
intervention group attended five group sessions focusing on risk education;
skills training in condom use, sexual assertiveness, problem solving, and risk
trigger self-management; and peer support for change efforts. Women in the
comparison group attended sessions on health topics unrelated to AIDS. RESULTS.
At the 3-month follow-up, women in the HIV/AIDS intervention group had increased
in sexual communication and negotiation skills. Unprotected sexual intercourse
had declined significantly and condom use had increased from 26% to 56% of all
intercourse occasions. Women in the comparison group showed no change.
CONCLUSIONS. Socially disadvantaged women can be assisted in reducing their risk
of contracting HIV infection. Risk reduction behavior change interventions
should be offered routinely in primary health care clinics serving low-income
and high-risk patients.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 7998630 [PubMed - indexed for MEDLINE]

99: Psychol Rep 1994 Dec;75(3 Pt 2):1531-7

A methodological comparison of survey techniques in obtaining self-reports of
condom-related behaviors.

Williams BL, Suen H.

Department of Health Science, Kinesiology, Recreation/Dance, College of
Education, University of Arkansas, Fayetteville 72701.

To obtain more accurate accounts of sexual attitudes and practices, researchers
must explore innovative ways to overcome the reluctance of individuals to
disclose sensitive and perhaps incriminating information about themselves. The
differences among selected modes of inquiry and survey techniques used to gather
self-reports about sensitive contraceptive behaviors among young adults were
examined in this study. Comparisons were made between the randomized response
versus the direct-inquiry survey techniques and personal interview versus
self-administered modes of inquiry relative to the reporting of sensitive
condom-related sexual practices of 352 students at a large northeastern
university. Findings indicated that the "controlled-choice" randomized-response
technique was less effective in obtaining self-reports about condom-related
practices than were direct-inquiry techniques. Recommendations for
investigations are proposed.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 7886177 [PubMed - indexed for MEDLINE]

100: Ann Epidemiol 1994 Nov;4(6):466-71

Human immunodeficiency virus type 1 antibody status and changes in risk behavior
among drug users.

McCusker J, Bigelow C, Stoddard AM, Zorn M.

School of Public Health, University of Massachusetts, Amherst.

The associations of human immunodeficiency virus type 1 (HIV-1) antibody status
and recent testing with risk behavior change were examined in a cohort of drug
users enrolled in a randomized trial of acquired immunodeficiency syndrome
(AIDS) education programs at a short-term inpatient detoxification facility.
Four hundred ninety-seven subjects completed baseline interviews, and 402 (81%)
of them had analyzable follow-up information. Changes in eight ordinal
self-reported drug and sexual behaviors were assessed using the cumulative logit
model for repeated ordinal response data. There was only limited evidence for
differential behavior change by either perceived serostatus or recent testing,
which was mainly confined to sharing of injection equipment among those who
continued to inject, and condom use.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 7804502 [PubMed - indexed for MEDLINE]

101: Health Psychol 1994 Sep;13(5):397-403

Reducing inner-city women's AIDS risk activities: a study of single, pregnant
women.

Hobfoll SE, Jackson AP, Lavin J, Britton PJ, Shepherd JB.

Applied Psychology Center, Kent State University, Ohio 44242.

Behavioral change reduces risk of HIV infection and development of AIDS. We
compared 206 inner-city women who were randomly assigned to a 4-session
AIDS-prevention group or to one of two controls, a health-promotion group or a
no-intervention group. AIDS-prevention and health-promotion groups provided
information, behavioral competency training, and social support. Only the
AIDS-prevention group focused on AIDS-specific knowledge and skills. The
AIDS-prevention group produced moderate, consistent increases in knowledge and
safer sex behaviors in comparison with either the health-promotion or
no-intervention group. Self-report and objective changes were sustained 6 months
after intervention for both African-American and European-American women.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 7805634 [PubMed - indexed for MEDLINE]

102: Aust N Z J Obstet Gynaecol 1994 May;34(2):182-5

Randomized prospective intervention study of human cervical wart virus
infection.

Ward BG, Thomas IL.

Royal Women's Hospital, Brisbane, Queensland.

Between February, 1988, and January, 1991, 222 women with histologically proven
cervical wart virus infection without dysplasia were randomized to be managed by
1 of 4 protocols. Group 1 acted as control, Group 2 were asked to use condoms
for 6 months, Group 3 underwent local ablative therapy and Group 4 were asked to
use condoms after ablative therapy. Assessment at 2 and 3 years of follow-up
showed no statistically significant superiority for treatment over observation.
Defaulters from follow-up were over 50% by the completion of the study.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 7980309 [PubMed - indexed for MEDLINE]

103: MMWR Morb Mortal Wkly Rep 1993 Nov 19;42(45):880-3

Distribution of STD clinic patients along a stages-of-behavioral-change
continuum--selected sites, 1993.

Human immunodeficiency virus (HIV) counseling and testing are important
components of the public health effort to contain the acquired immunodeficiency
syndrome (AIDS) epidemic. Project RESPECT is a multicenter randomized trial
being conducted by CDC at five sexually transmitted disease (STD) clinics to
evaluate the efficacy of HIV counseling interventions in preventing HIV and
other STDs. Because consistent and proper use of latex condoms is one method to
substantially reduce the risk for transmitting HIV and other STDs (1), the HIV
prevention interventions being evaluated focus primarily on increasing
consistent condom use with primary and other sex partners during vaginal and
anal sex. Before initiating the randomized trial, pilot studies were conducted
to better characterize the population and to develop an operationally feasible
enhanced intervention. This report describes the results of one pilot study.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 8232171 [PubMed - indexed for MEDLINE]

104: J Epidemiol Community Health 1993 Apr;47(2):134-8

Evaluation of an AIDS education programme for young adults.

Bellingham K, Gillies P.

Department of Public Health Medicine and Epidemiology, University Hospital and
Medical School, Nottingham.

STUDY OBJECTIVES--To evaluate the impact of an AIDS education programme designed
for young adults. DESIGN--A randomised trial with a pre-post test design.
SETTING--Participants were drawn from six youth training centres in the city of
Nottingham, England. STUDY POPULATION--All trainees aged 16-19 years attending
the six centres were included in the sample and centres were randomly allocated
to experimental (n = 173) and control (n = 164) groups. The response rate to
both questionnaires was high (71%). MEASUREMENTS AND MAIN RESULTS--Data on
sexual behaviour, knowledge, and attitudes towards HIV/AIDS were obtained by
confidential questionnaire. Two thirds of the sample were sexually active. There
were no differences between groups at pre-test and no differences by sex. The
experimental group had a significantly higher level of knowledge than the
control group post-test. Significantly more experimental than control trainees
knew post-test that HIV could be transmitted via anal sex and through broken
skin. In addition, twice as many experimental (53%) as control trainees (25%; p
< 0.001) were aware that a cure for AIDS was unlikely in the near future. There
were no observed effects on sexual behaviour, intentions, or attitudes.
CONCLUSIONS--The Streetwize UK educational programme had a significant impact on
young adults' knowledge of HIV/AIDS transmission and prevention in the short
term. If community based AIDS education is to do more than merely inform,
however, resources must be made available for peer led interventions and skills
training.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 8326271 [PubMed - indexed for MEDLINE]

105: J Adolesc Health 1993 Mar;14(2):115-9

A pilot study of AIDS education and counseling of high-risk adolescents in an
office setting.

Mansfield CJ, Conroy ME, Emans SJ, Woods ER.

Division of Adolescent and Young Adult Medicine, Harvard Medical School, Boston,
Massachusetts.

Little is known about interventions in office practices aimed toward reducing
behaviors that put adolescents at risk for human immunodeficiency virus (HIV)
acquisition. We therefore targeted a pilot study of HIV education and counseling
to high-risk adolescents. Ninety adolescent patients (mean age, 17.6 +/- 2.0
years) were interviewed in a hospital-based adolescent clinic by two physicians
and randomized to two groups: 1) a standard care group that was interviewed
about high-risk behaviors at 0 and 2 months; and 2) an intervention group that
was similarly interviewed but was also given a detailed discussion about HIV
risks and prevention. At follow-up (mean, 2.6 +/- 0.8 months), 25% of patients
reported less sexual activity (standard care, 32%; intervention, 18%) toward a
trend. The reduction in mean number of partners per month was 0.4 +/- 0.9, (p =
0.0001). Fifty-four percent of the patients reported that they used condoms more
often than previously with no significant difference between the two groups. Use
of condoms ("always use") increased in both groups significantly (p = 0.03
standard care, p = 0.02 intervention). Use of condoms at last intercourse
increased in the intervention group (37% to 42%, p = 0.03). In the interval,
there were no significant differences between the groups in the number of newly
diagnosed sexually transmitted diseases or in the number of patients seeking HIV
testing. The number of patients stating that they shared needles decreased from
3 to 0. Both the intervention and standard care groups reported a reduction in
high-risk behaviors that was temporally related to the discussion of this
subject in the clinic.(ABSTRACT TRUNCATED AT 250 WORDS)

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 8476874 [PubMed - indexed for MEDLINE]

106: AIDS Educ Prev 1993 Winter;5(4):352-66

Social network, support and influence: relationships with drug use and
protective AIDS behavior.

Zapka JG, Stoddard AM, McCusker J.

School of Public Health, University of Massachusetts at Amherst.

One reason for difficulty in long-term maintenance of behavior changes by
injection drug users (IDUs) is the concomitant support or distraction from the
IDUs social environment. This study explored the relationship of social
factors--e.g., encouragement from friends, beliefs about social norms--with drug
injection behaviors. Subjects were clients in a short-term residential
detoxification program. Self-reports of drug and AIDS-protective behaviors were
gathered at baseline and at least 6 months following a trial of enhanced vs.
informational educational interventions. Results provide support both for the
general hypothesis about the influence of peers and drug-use partners prior and
subsequent to detoxification and for the greater effectiveness of the enhanced
intervention on social factors. Particularly important to improved drug use
behavior were decreased number of friends who inject drugs (social network),
increased number of people to talk with when upset (social support), and
increased argument skills about safe drug use (social influence).

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 8297714 [PubMed - indexed for MEDLINE]

107: Contraception 1992 Sep;46(3):279-88

Study to determine the correlation between condom breakage in human use and
laboratory test results.

Steiner M, Foldesy R, Cole D, Carter E.

Family Health International, Research Triangle Park, NC 27709.

The present study examined the value of laboratory tests in predicting condom
breakage for 20 lots of latex condoms which differed in age, storage history and
laboratory test performance. Two-hundred-sixty-two participating U.S. couples
used a total of 4589 latex condoms (mean = 229 condoms per lot, range 224-235).
Breakage rates ranged from 3.5 percent for a brand new condom lot to 18.6
percent for a lot that was 81 months old at the time of the study. The
statistical predictor models, separately using ultimate elongation from the
tensile test, the Condom Quality Index from the airburst volume test, and the
percent of condoms failing the airburst volume test as the independent variables
and the condom breakage rate as the dependent variable, all appear to have a
high level of accuracy in predicting condom breakage in use. The three models
had correlation coefficients (R2s) of 0.81, 0.74 and 0.69, respectively. Perhaps
the most unexpected result was that the age of the condom lot was the best
predictor of condom breakage during use (correlation coefficient (R2) = 0.92).
Although the present investigation does not provide sufficient justification to
use age as the only factor for decisions on condom lot disposition, it does
provide some guidance.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 1451523 [PubMed - indexed for MEDLINE]

108: Public Health Rep 1992 Sep-Oct;107(5):500-4

15-month followup of women methadone patients taught skills to reduce
heterosexual HIV transmission.

el-Bassel N, Schilling RF.

School of Social Work, Columbia University, New York, NY 10025.

Heterosexual contact with intravenous drug users accounts for a growing
proportion of cases of acquired immunodeficiency syndrome (AIDS) among women. In
an earlier study designed to reduce sexual risk behavior, the authors randomly
assigned 91 methadone maintained women to information-only or skills-building
conditions. Modest outcomes favored participants in the skills-building group.
In this 15-month followup of 62 remaining study participants, skills-training
group members were more likely than controls to use condoms. In comparison with
controls, members in the skills-building group felt more comfortable talking
about safe sex, perceived themselves as more able to reduce their exposure to
AIDS, but were more likely to attribute AIDS risk to luck. No associations were
found between group condition and number of sexual partners or frequency of
buying and carrying condoms. Some gains associated with a group intervention
tended to be maintained over time, indicating that preventive interventions
composed of multiple sessions and conducted in treatment settings may have
promise as useful strategies to prevent human immunodeficiency virus (HIV)
infection. Nevertheless, decay was evident in other domains, suggesting that
prevention specialists should consider booster sessions or other means of
maintaining changes in risk behavior.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 1410230 [PubMed - indexed for MEDLINE]