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
  Purpose

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.


Condition Intervention Phase
Alcoholism
HIV Infections
Behavioral: Couples Intervention
Behavioral: Women's CoOp
Behavioral: Women's CoOp and Men's Intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Venue-Based Recruitment and HIV Prevention for Alcohol and Other Drug (AOD) Using Couples in South Africa

Resource links provided by NLM:


Further study details as provided by RTI International:

Primary Outcome Measures:
  • Reduced alcohol use [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • reduced gender-based violence [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]

Enrollment: 600
Study Start Date: May 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VCT/Women's CoOp 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.
Experimental: Women's CoOp/Men's CoOp 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: Couples CoOp 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121692

Locations
South Africa
Medical Research Council
Cape Town, South Africa
Sponsors and Collaborators
RTI International
Medical Research Council, South Africa
  More Information

Publications:
Responsible Party: RTI International
ClinicalTrials.gov Identifier: NCT01121692     History of Changes
Other Study ID Numbers: NIAAA-Wechsberg-AA018076, R01AA018076
Study First Received: May 6, 2010
Last Updated: October 16, 2013
Health Authority: United States: Federal Government

Keywords provided by RTI International:
Couples
Alcohol use
HIV risk
Outreach

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Alcoholism
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014