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AlcoholismPhase 2Couples CoOpNCT01121692

Venue-Based Couples CoOp in South Africa

A Phase 2 study testing Couples Intervention, Women's CoOp and Women's CoOp and Men's Intervention in people with Alcoholism and HIV Infections, run by RTI International at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcoholism, HIV Infections
What is being tested?
Couples Intervention, Women's CoOp and Women's CoOp and Men's Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteSouth Africa
Study dates
May 2010to Sep 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • Have used alcohol in a tavern or shebeen in the past 90 days
  • Spend time in a tavern or shebeen at least weekly
  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • Medical Research Council

    Cape Town

Other trials in South Africa

About this study

Official title: 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:

Read more

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.

Being tested
Couples Intervention, Women's CoOp, Women's CoOp and Men's Intervention
Keywords
Couples, Alcohol use, HIV risk, Outreach
Medical subject headings
Alcoholism, HIV Infections, Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Couples InterventionBehavioural

    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 CoOpBehavioural

    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 InterventionBehavioural

    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.

Study groups in NCT01121692
Study groupRoleWhat they receive
VCT/Women's CoOpExperimentalNot described
Receives: Behavioral: Women's CoOp
Women's CoOp/Men's CoOpExperimentalNot described
Receives: Behavioral: Women's CoOp and Men's Intervention
Couples CoOpExperimentalNot described
Receives: Behavioral: Couples Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduced alcohol use

    Measured: 6 month follow up

Secondary outcomes (1)

  1. reduced gender-based violence

    Measured: 6 month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionSep 2012
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01121692
Sponsor's protocol ID
NIAAA-Wechsberg-AA018076
Other IDs
R01AA018076
Acronym
Couples CoOp
Status last verified
Oct 2015
First submitted
6 May 2010
Last updated
12 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20308902

  • 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.

    PubMed 23927691

  • 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.

    PubMed 25999767

  • 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.

    PubMed 26175479

  • 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.

    PubMed 24316002

  • 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

  • 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.

    PubMed 29843074

  • 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.

    PubMed 26946991

  • 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.

    PubMed 25888856

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Couples Intervention, Women's CoOp and Women's CoOp and Men's Intervention in people with Alcoholism and HIV Infections, run by RTI International at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduced alcohol use (time frame: 6 month follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01121692, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.

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