Women-Focused HIV Prevention in the Western Cape (WC-WHC)
|ClinicalTrials.gov Identifier: NCT00729391|
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : May 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV Substance Abuse Violence||Behavioral: Woman-Focused Intervention (Women's Health CoOp) Behavioral: Nutrition (Attention-Control) Behavioral: VCT Only||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||720 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Women-Focused HIV Prevention in the Western Cape|
|Actual Study Start Date :||September 26, 2008|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||March 2012|
Behavioral: Woman-Focused Intervention (Women's Health CoOp)
Participants in this group will receive VCT and participate in two group sessions of the woman-focused intervention.
Active Comparator: 2
Behavioral: Nutrition (Attention-Control)
Participants in this group will receive VCT and participate in two group sessions of the nutrition intervention.
Active Comparator: 3
Voluntary Counseling and Testing
Behavioral: VCT Only
Participants in this group will receive VCT only.
- Reduction in substance abuse, sexual risk behaviors and victimization. [ Time Frame: Baseline, 3-month, 6-month, 9-month and 12-month ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729391
|Cape Town, Western Cape, South Africa|