NCT01121692

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

October 12, 2015

Status Verified

October 1, 2015

Enrollment Period

2.3 years

First QC Date

May 6, 2010

Last Update Submit

October 8, 2015

Conditions

AlcoholismHIV Infections

Keywords

CouplesAlcohol useHIV riskOutreach

Outcome Measures

Primary Outcomes (1)

  • Reduced alcohol use

    6 month follow up

Secondary Outcomes (1)

  • reduced gender-based violence

    6 month follow up

Study Arms (3)

VCT/Women's CoOp

EXPERIMENTAL
Behavioral: Women's CoOp

Women's CoOp/Men's CoOp

EXPERIMENTAL
Behavioral: Women's CoOp and Men's Intervention

Couples CoOp

EXPERIMENTAL
Behavioral: Couples Intervention

Interventions

Couples InterventionBEHAVIORAL

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.

Couples CoOp
Women's CoOpBEHAVIORAL

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.

VCT/Women's CoOp
Women's CoOp and Men's InterventionBEHAVIORAL

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.

Women's CoOp/Men's CoOp

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • 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

You may not qualify if:

  • Have been a part of previous Couples' Health CoOp group study activities
  • Are currently enrolled in an HIV research study
  • Women
  • Female
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research Council

Cape Town, South Africa

Location

Related Publications (9)

  • 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.

    PMID: 20308902BACKGROUND

  • 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.

    PMID: 23927691BACKGROUND

  • 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.

    PMID: 25999767BACKGROUND

  • 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.

    PMID: 26175479BACKGROUND

  • 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.

    PMID: 24316002BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 29843074DERIVED

  • 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.

    PMID: 26946991DERIVED

  • 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.

    PMID: 25888856DERIVED

MeSH Terms

Conditions

AlcoholismHIV InfectionsAlcohol Drinking

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDrinking BehaviorBehavior

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2010

First Posted

May 12, 2010

Study Start

May 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

October 12, 2015

Record last verified: 2015-10

Locations

ZA(1)