Women-Focused HIV Prevention in the Western Cape

Phase 2

Completed

• Conditions: HIV; Violence; Substance Abuse
• Interventions: Behavioral: Woman-Focused Intervention (Women's Health CoOp); Behavioral: VCT Only; Behavioral: Nutrition (Attention-Control)

• Registration Number: NCT00729391
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2008-08-05
• Study First Submitted QC: 2008-08-05
• Study First Posted: 2008-08-07
• Study Start: 2008-09-26
• Primary Completion: 2012-01
• Study Completion: 2012-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-16
• Last Update Posted: 2017-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 720

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Woman-Focused Intervention (Women's Health CoOp)	Women's CoOp
3	VCT Only	Voluntary Counseling and Testing
2	Nutrition (Attention-Control)	Nutrition (Attention-Control)

Primary Outcome Measures

Name	Time	Method
Reduction in substance abuse, sexual risk behaviors and victimization.	Baseline, 3-month, 6-month, 9-month and 12-month

Secondary Outcome Measures

Name	Time	Method
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.	6 and 12 month