Clinical Trials Directory

Trials / Completed

CompletedNCT01121692

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
Phase
Phase 2
Study type
Interventional
Enrollment
600 (actual)
Sponsor
RTI International · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALCouples InterventionThe 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 CoOpThe 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 InterventionThe 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.

Timeline

Start date
2010-05-01
Primary completion
2012-09-01
Completion
2012-09-01
First posted
2010-05-12
Last updated
2015-10-12

Locations

1 site across 1 country: South Africa

Source: ClinicalTrials.gov record NCT01121692. Inclusion in this directory is not an endorsement.