Venue-Based Couples CoOp in South Africa
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
600 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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