Overview

This trial is active, not recruiting.

Conditions hiv, substance abuse, violence
Treatments woman-focused intervention (women's coop), nutrition (attention-control), vct only
Phase phase 3
Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator Medical Research Council, South Africa
Start date September 2008
End date March 2012
Trial size 720 participants
Trial identifier NCT00729391, R01HD058320

Summary

The purpose of this study is to test the effectiveness of a woman-focused HIV prevention intervention combined with voluntary counseling and testing (VCT), compared to VCT only, and VCT combined with an attention-control nutrition intervention.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Women's CoOp
woman-focused intervention (women's coop)
Participants in this group will receive VCT and participate in two group sessions of the woman-focused intervention.
(Active Comparator)
Nutrition (Attention-Control)
nutrition (attention-control)
Participants in this group will receive VCT and participate in two group sessions of the nutrition intervention.
(Active Comparator)
Voluntary Counseling and Testing
vct only
Participants in this group will receive VCT only.

Primary Outcomes

Measure
Reduction in substance abuse, sexual risk behaviors and victimization.
time frame: Baseline, 3-month, 6-month, 9-month and 12-month

Secondary Outcomes

Measure
The moderating effect of victimization and the mediating effects of HIV risk knowledge, condom skills, sexual negotiation assertiveness, and relationship power on the effectiveness of the woman-focused groups.
time frame: 6 and 12 month

Eligibility Criteria

Female participants from 18 years up to 33 years old.

Inclusion Criteria: - To be eligible for the study, participants must be: (a) female; (b) report use of at least two drugs—alcohol, marijuana, methamphetamine (tik), Mandrax (methaqualone), cocaine (crack and/or powder), heroin (Thai White), glue, MDMA (ecstasy), or LSD—at least once a week in the past 90 days; (c) be sexually active within the past 30 days with a male partner; (d) be aged 18 to 33 years; (e) live in the communities around the airport; and (f) provide verbal consent to be screened for eligibility and written consent to participate in the study. Exclusion Criteria: - If participants do not meet all of the inclusion criteria, they will be excluded from the study.

Additional Information

Official title Women-Focused HIV Prevention in the Western Cape
Description Surveillance data indicate that HIV risk and substance use is a serious problem among South African women. This study, funded by the National Institute on Child Health and Human Development (NICHD), builds on findings from a recently completed pilot study among women in less affluent townships and communities in the Western Cape (Wechsberg et al., 2008). The pilot study tested the effectiveness of an evidence-based woman-focused intervention in reducing drug use, sexual risk, and victimization by addressing the intersection of these factors among 100 poor, substance-using women of colour. The primary aim of this study is to test the effectiveness, through a randomized controlled trial (RCT), of VCT plus a woman-focused intervention relative to VCT only to increase knowledge and skills to reduce substance abuse, sexual risk, and victimization, and to an equal-attention (nutrition) control group at 3-, 6-, 9-, and 12-month follow-ups. A secondary aim is to examine the moderating effect of victimization (i.e., sexual and physical) and the mediating effects of HIV risk knowledge, condom use skills, sexual negotiation assertiveness, and relationship power on the effectiveness of the woman-focused groups to decrease risk related to drug use, sexual risk, and sex-related-victimization relative to the rapid testing group and to the equal-attention control group.
Trial information was received from ClinicalTrials.gov and was last updated in May 2011.
Information provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).