Venue-Based Couples CoOp in South Africa

NCT01121692 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2015-10-12

No results posted yet for this study

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.

Conditions

  • Alcoholism
  • HIV Infections

Interventions

BEHAVIORAL

Couples Intervention

The Couples intervention is a merged intervention of three interventions (Women CoOp, men as partners's and couples). Couples attend together for two half day workshops and work on exercises on communication and problem solving, including a commitment pledge of fidelity.

BEHAVIORAL

Women's CoOp

The Women's CoOp is a gender-focused intervention discussing women's risk in relationship to HIV and also discusses issues of HIV with South African women including skills for violence prevention. During this intervention, participants will also demonstrate the proper use of male and female condoms on penile and vaginal models. They attend two half day workshops.

BEHAVIORAL

Women's CoOp and Men's Intervention

The Men's CoOp is adapted from Men as Partners, the Women's CoOp and the Couples intervention and contain similar material with a concentration on gender roles and violence prevention. Men attend two half day workshops.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH
  • Medical Research Council, South Africa

    collaborator OTHER
  • RTI International

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01121692 on ClinicalTrials.gov