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Completed

NCT Number: NCT00729391

Women-Focused HIV Prevention in the Western Cape

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.

Completed

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Key information

Conditions

HIV Chemically-Induced Disorders Mental Disorders Substance Abuse Substance-Related Disorders Violence

Age range

18 year–33 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Cape Town, Western Cape, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Woman-Focused Intervention (Women's Health CoOp)

Behavioral

Participants in this group will receive VCT and participate in two group sessions of the woman-focused intervention.

Nutrition (Attention-Control)

Behavioral

Participants in this group will receive VCT and participate in two group sessions of the nutrition intervention.

VCT Only

Behavioral

Participants in this group will receive VCT only.

Primary outcomes

  1. Reduction in substance abuse, sexual risk behaviors and victimization.

    Time frame: Baseline, 3-month, 6-month, 9-month and 12-month

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Nih

Collaborators

  • Medical Research Council, South Africa

Registry information

Acronym: WC-WHC

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Aug 7, 2008
Registry last updated
May 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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