NCT00729391

Women-Focused HIV Prevention in the Western Cape

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 720 (actual)
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
• Sex: Female
• Age: 18 Years – 33 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV
• Substance Abuse
• Violence

Interventions

Type	Name	Description
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.
BEHAVIORAL	Nutrition (Attention-Control)	Participants in this group will receive VCT and participate in two group sessions of the nutrition intervention.
BEHAVIORAL	VCT Only	Participants in this group will receive VCT only.

Timeline

• Start date: 2008-09-26
• Primary completion: 2012-01-01
• Completion: 2012-03-01
• First posted: 2008-08-07
• Last updated: 2017-05-18

Locations

1 site across 1 country: South Africa