Venue-Based Couples CoOp in South Africa

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Alcoholism HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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VCT/Women's CoOp

Group Type EXPERIMENTAL

Women's CoOp

Intervention Type BEHAVIORAL

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.

Women's CoOp/Men's CoOp

Group Type EXPERIMENTAL

Women's CoOp and Men's Intervention

Intervention Type BEHAVIORAL

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.

Couples CoOp

Group Type EXPERIMENTAL

Couples Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Male
* 18-35
* Identify as Black or Coloured
* Live in one of the target communities- Khayelitsha, Mitchell's Plain and Delft
* Have the same main heterosexual sex partner for at least one year, plan to stay with this partner for at least one year and do not plan to get this partner pregnant within the next year
* Report unprotected sex at least once in the past 90 days with main partner
* Have used alcohol in a tavern or shebeen in the past 90 days
* Spend time in a tavern or shebeen at least weekly

Exclusion

* Have been a part of previous Couples' Health CoOp group study activities
* Are currently enrolled in an HIV research study

Women

Inclusion:

* Female
* 18 or older
* Have the same main heterosexual sex partner for at least one year and plan to stay together with this partner for at least one year and do not plan to get pregnant within the next year with this partner
* Report unprotected sex at least once in the past 90 days with main partner

Exclusion:

* Have been a part of previous Couples' Health CoOp group study activities
* Are currently enrolled in an HIV research study
* Have been a part of the Cape Town Pilot Study or the Western Cape Women's Health CoOp

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No