Venue-Based Couples CoOp in South Africa

Phase 2

Completed

• Conditions: Alcoholism; HIV Infections
• Interventions: Behavioral: Women's CoOp and Men's Intervention; Behavioral: Couples Intervention; Behavioral: Women's CoOp

• Registration Number: NCT01121692
• Lead Sponsor: RTI International

Brief Summary

Couples who use alcohol and other drugs (AOD) in South Africa are at high risk for engaging in risky sex behavior within their relationships and with other sexual partners. In addition, high levels of gender-based violence (GBV) in the Cape Town area intersect with AOD abuse and sex behavior. All of these interconnections raise concern for the importance of HIV prevention strategies within or surrounding drinking venues, where many of these behaviors occur.

The specific aims of this study are as follows:

Aim 1. To characterize the types of drinking venues (e.g., licensure status, size, plumbing, type of alcohol provided), their immediate context (e.g., observed availability and use of other drugs, observable violence and sexual activity), and surrounding neighborhood characteristics (e.g., quality of streets, building structures, and availability of electricity and plumbing) in the sampled neighborhood blocks in several large Black/African and Coloured communities in Cape Town, South Africa.

Aim 2. To refine through qualitative methods the proposed interventions in relation to skills-building to address gender-role expectations, sexual partnering, gender and power, violence, and environments where drinking and sexual risk behaviors occur.

Aim 3. To conduct a randomized group trial to compare the relative efficacy of a comprehensive intervention (Condition 3: Enhanced Couples) to the gender-focused intervention (Condition 2: Gender) and to (Condition 1: Men's Control and Women's CoOp) on reducing alcohol and other drug (AOD) use, sexual risk behavior, and gender-based violence at 6 month follow-ups. Aim 4. To assess the mechanisms through which the intervention effects may occur (e.g., mediators involving self-efficacy and condom mastery, negotiation, and communication skills) and to identify groups for whom the interventions have the greatest effect (e.g., partner characteristics such as race, gender, and age and neighborhood factors such as poverty) on study outcomes of AOD use, sexual risk, and gender-based violence.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-06
• Study First Submitted QC: 2010-05-11
• Study First Posted: 2010-05-12
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-08
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Women's CoOp/Men's CoOp	Women's CoOp and Men's Intervention	-
Couples CoOp	Couples Intervention	-
VCT/Women's CoOp	Women's CoOp	-

Primary Outcome Measures

Name	Time	Method
Reduced alcohol use	6 month follow up

Secondary Outcome Measures

Name	Time	Method
reduced gender-based violence	6 month follow up

Trial Locations

Locations (1)

Medical Research Council; 🇿🇦 Cape Town, South Africa