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Venue-Based Couples CoOp in South Africa

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01121692
Acronym
Couples CoOp
Enrollment
600
Registered
2010-05-12
Start date
2010-05-31
Completion date
2012-09-30
Last updated
2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholism, HIV Infections

Keywords

Couples, Alcohol use, HIV risk, Outreach

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.

Interventions

BEHAVIORALCouples 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.

BEHAVIORALWomen'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.

BEHAVIORALWomen'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

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Medical Research Council, South Africa
CollaboratorOTHER
RTI International
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Reduced alcohol use6 month follow up

Secondary

MeasureTime frame
reduced gender-based violence6 month follow up

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026