Women-Focused HIV Prevention in the Western Cape (WC-WHC)

United States Department of Health and Human Services (HHS)

Status and phase: Completed; Phase 3; Phase 2

Conditions: HIV; Substance Abuse; Violence

Treatments: Behavioral: VCT Only; Behavioral: Woman-Focused Intervention (Women's Health CoOp); Behavioral: Nutrition (Attention-Control)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00729391

R01HD058320

Details and patient eligibility

About

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.

Full 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.

Enrollment: 720 patients

Sex: Female

Ages: 18 to 33 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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720 participants in 3 patient groups

1

Experimental group

Description:

Women's CoOp

Treatment:

Behavioral: Woman-Focused Intervention (Women's Health CoOp)

2

Active Comparator group

Description:

Nutrition (Attention-Control)

Treatment:

Behavioral: Nutrition (Attention-Control)

3

Active Comparator group

Description:

Voluntary Counseling and Testing

Treatment:

Behavioral: VCT Only