Venue-Based Couples CoOp in South Africa

HIV Infections Clinical Trial

— Couples CoOp  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01121692
• Other study ID #: NIAAA-Wechsberg-AA018076
• Secondary ID: R01AA018076
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2010
• Last updated: October 8, 2015
• Start date: May 2010
• Est. completion date: September 2012

Study information

• Verified date: October 2015
• Source: RTI International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcoholism
• HIV Infections

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
South Africa	Medical Research Council	Cape Town

Sponsors (3)

Lead Sponsor	Collaborator
RTI International	Medical Research Council, South Africa, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

South Africa, 

References & Publications (6)

Browne FA, Wechsberg WM. The intersecting risks of substance use and HIV risk among substance-using South African men and women. Curr Opin Psychiatry. 2010 May;23(3):205-9. doi: 10.1097/YCO.0b013e32833864eb. Review. — View Citation

Doherty IA, Myers B, Zule WA, Minnis AM, Kline TL, Parry CD, El-Bassel N, Wechsberg WM. Seek, Test and Disclose: knowledge of HIV testing and serostatus among high-risk couples in a South African township. Sex Transm Infect. 2016 Feb;92(1):5-11. doi: 10.1136/sextrans-2014-051882. Epub 2015 Jul 14. — View Citation

El-Bassel, N., & Wechsberg, W.M. Couple-based behavioral HIV intervention: Placing HIV risk-reduction responsibility on the female and male dyad. Couple and Family Psychology 1(2) 94-105, 2012. doi:10.1037/a0028890

Minnis AM, Doherty IA, Kline TL, Zule WA, Myers B, Carney T, Wechsberg WM. Relationship power, communication, and violence among couples: results of a cluster-randomized HIV prevention study in a South African township. Int J Womens Health. 2015 May 11;7:517-25. doi: 10.2147/IJWH.S77398. eCollection 2015. — View Citation

Wechsberg WM, Doherty IA, Myers B, Morgan-Lopez AA, Emanuel A, Carney T, Kline TL, Zule WA. Contextualizing gender differences and methamphetamine use with HIV prevalence within a South African community. Int J Drug Policy. 2014 May;25(3):583-90. doi: 10.1016/j.drugpo.2013.10.016. Epub 2013 Nov 9. — View Citation

Wechsberg WM, Myers B, Reed E, Carney T, Emanuel AN, Browne FA. Substance use, gender inequity, violence and sexual risk among couples in Cape Town. Cult Health Sex. 2013;15(10):1221-36. doi: 10.1080/13691058.2013.815366. Epub 2013 Aug 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced alcohol use		6 month follow up	No
Secondary	reduced gender-based violence		6 month follow up	No