Venue-Based Couples CoOp in South Africa

Study Overview
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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.

Official Title
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Venue-Based Recruitment and HIV Prevention for Alcohol and Other Drug (AOD) Using Couples in South Africa

Conditions
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Alcoholism, HIV Infections

Intervention / Treatment
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* Behavioral: Couples Intervention
* Behavioral: Women's CoOp
* Behavioral: Women's CoOp and Men's Intervention


Participation Criteria
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Eligibility Criteria
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Men Inclusion: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VCT/Women's CoOp<br> | Behavioral: Women's CoOp<br>* 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.<br>|
| Experimental: Women's CoOp/Men's CoOp<br> | Behavioral: Women's CoOp and Men's Intervention<br>* 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.<br>|
| Experimental: Couples CoOp<br> | Behavioral: Couples Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced alcohol use |  | 6 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduced gender-based violence |  | 6 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Couples, Alcohol use, HIV risk, Outreach