Venue-Based Couples CoOp in South Africa

This study has been completed.
Sponsor:
Collaborators:
Medical Research Council, South Africa
Information provided by (Responsible Party):
RTI International
ClinicalTrials.gov Identifier:
NCT01121692
First received: May 6, 2010
Last updated: October 16, 2013
Last verified: October 2013

May 6, 2010
October 16, 2013
May 2010
September 2012   (final data collection date for primary outcome measure)
Reduced alcohol use [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01121692 on ClinicalTrials.gov Archive Site
reduced gender-based violence [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Venue-Based Couples CoOp in South Africa
Venue-Based Recruitment and HIV Prevention for Alcohol and Other Drug (AOD) Using Couples in South Africa

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Alcoholism
  • HIV Infections
  • Behavioral: 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.
  • 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.
  • 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.
  • Experimental: VCT/Women's CoOp
    Intervention: Behavioral: Women's CoOp
  • Experimental: Women's CoOp/Men's CoOp
    Intervention: Behavioral: Women's CoOp and Men's Intervention
  • Experimental: Couples CoOp
    Intervention: Behavioral: Couples Intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT01121692
NIAAA-Wechsberg-AA018076, R01AA018076
No
RTI International
RTI International
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Medical Research Council, South Africa
Not Provided
RTI International
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP