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Venue-Based Couples CoOp in South Africa (Couples CoOp)

Primary Purpose

Alcoholism, HIV Infections

Status
Completed
Phase
Phase 2
Locations
South Africa
Study Type
Interventional
Intervention
Couples Intervention
Women's CoOp
Women's CoOp and Men's Intervention
Sponsored by
RTI International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcoholism focused on measuring Couples, Alcohol use, HIV risk, Outreach

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Research Council

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

VCT/Women's CoOp

Women's CoOp/Men's CoOp

Couples CoOp

Arm Description

Outcomes

Primary Outcome Measures

Reduced alcohol use

Secondary Outcome Measures

reduced gender-based violence

Full Information

First Posted
May 6, 2010
Last Updated
October 8, 2015
Sponsor
RTI International
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Medical Research Council, South Africa
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1. Study Identification

Unique Protocol Identification Number
NCT01121692
Brief Title
Venue-Based Couples CoOp in South Africa
Acronym
Couples CoOp
Official Title
Venue-Based Recruitment and HIV Prevention for Alcohol and Other Drug (AOD) Using Couples in South Africa
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RTI International
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Medical Research Council, South Africa

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, HIV Infections
Keywords
Couples, Alcohol use, HIV risk, Outreach

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VCT/Women's CoOp
Arm Type
Experimental
Arm Title
Women's CoOp/Men's CoOp
Arm Type
Experimental
Arm Title
Couples CoOp
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Couples Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Women's CoOp
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Women's CoOp and Men's Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduced alcohol use
Time Frame
6 month follow up
Secondary Outcome Measure Information:
Title
reduced gender-based violence
Time Frame
6 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Medical Research Council
City
Cape Town
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
20308902
Citation
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.
Results Reference
background
PubMed Identifier
23927691
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.
Results Reference
background
PubMed Identifier
25999767
Citation
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.
Results Reference
background
PubMed Identifier
26175479
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.
Results Reference
background
PubMed Identifier
24316002
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.
Results Reference
background
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
Results Reference
background
PubMed Identifier
29843074
Citation
Speizer IS, Zule WA, Carney T, Browne FA, Ndirangu J, Wechsberg WM. Changing sex risk behaviors, gender norms, and relationship dynamics among couples in Cape Town, South Africa: Efficacy of an intervention on the dyad. Soc Sci Med. 2018 Jul;209:95-103. doi: 10.1016/j.socscimed.2018.05.024. Epub 2018 May 18.
Results Reference
derived
PubMed Identifier
26946991
Citation
Wechsberg WM, Zule WA, El-Bassel N, Doherty IA, Minnis AM, Novak SD, Myers B, Carney T. The male factor: Outcomes from a cluster randomized field experiment with a couples-based HIV prevention intervention in a South African township. Drug Alcohol Depend. 2016 Apr 1;161:307-15. doi: 10.1016/j.drugalcdep.2016.02.017. Epub 2016 Feb 18.
Results Reference
derived
PubMed Identifier
25888856
Citation
Wechsberg WM, El-Bassel N, Carney T, Browne FA, Myers B, Zule WA. Adapting an evidence-based HIV behavioral intervention for South African couples. Subst Abuse Treat Prev Policy. 2015 Feb 24;10:6. doi: 10.1186/s13011-015-0005-6.
Results Reference
derived

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Venue-Based Couples CoOp in South Africa

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