Women-Focused HIV Prevention in the Western Cape

Study Overview
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Brief Summary
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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
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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.

Official Title
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Women-Focused HIV Prevention in the Western Cape

Conditions
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HIV, Substance Abuse, Violence

Intervention / Treatment
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* Behavioral: Woman-Focused Intervention (Women's Health CoOp)
* Behavioral: Nutrition (Attention-Control)
* Behavioral: VCT Only


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 33 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Women's CoOp | Behavioral: Woman-Focused Intervention (Women's Health CoOp)<br>* Participants in this group will receive VCT and participate in two group sessions of the woman-focused intervention.<br>|
| Active Comparator: 2<br>Nutrition (Attention-Control) | Behavioral: Nutrition (Attention-Control)<br>* Participants in this group will receive VCT and participate in two group sessions of the nutrition intervention.<br>|
| Active Comparator: 3<br>Voluntary Counseling and Testing | Behavioral: VCT Only<br>* Participants in this group will receive VCT only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in substance abuse, sexual risk behaviors and victimization. |  | Baseline, 3-month, 6-month, 9-month and 12-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Sexual Risk, Substance Abuse, Victimization, Violence, Voluntary Counseling and Testing (VCT)