Couples Health CoOp Plus (CHC+)

  • End date
    Nov 19, 2024
  • participants needed
  • sponsor
    RTI International
Updated on 19 June 2022
Accepts healthy volunteers


This study addresses HIV prevention and treatment for young couples living in Cape Town, South Africa, through a comprehensive biobehavioral multilevel approach-the Couples Health CoOp Plus (CHC+).

Through a cluster randomized trial with a modified factorial design, 24 Cape Town communities consisting of catchment areas for clinics that provide antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP), will receive either stigma-reduction training or no training with repeated measures. Within clinic catchment areas, 480 couples (young women and their primary male sex partners both aged 18 to 30) will be recruited. These couples will receive HIV testing services (HTS) and/or the Couples Health CoOp Plus (CHC+), depending on their intervention arm.

The overarching aim of these interventions is to prevent new cases of HIV. It is hypothesized that communities that are assigned to the stigma reduction training will demonstrate higher levels of social acceptance and fewer cases of enacted/experienced stigma at the community level. Additionally, it is expected couples assigned to the Couples Health CoOp Plus (CHC+) intervention will have greater antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) initiation and adherence, lower alcohol and other drug (AOD) use, less sexual risk, less gender-based violence (GBV), and more positive gender norms and communication.

Specifically, the study aims to:

Aim 1: Modify the Couples Health CoOp (CHC) intervention to include antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) in a formative phase and with review from the Community Collaborative Board (CCB) and Peer Advisory Board (PAB).

Aim 2: Evaluate the impact of a stigma reduction training and education on community members attitudes and behaviors toward young women and their primary male partners seeking HIV testing services (HTS)/antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) and other sexual and reproductive health services in their local clinics at 4- and 8-month follow-up.

Aim 3: Test the efficacy of the Couples Health CoOp Plus (CHC+) to increase both partners' antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) initiation and adherence (primary outcome) and reduce alcohol and other drug (AOD) use, sexual risk and gender-based violence (GBV), and enhance positive gender norms and communication relative to HIV testing services (HTS) (secondary outcomes).

Aim 4: Examine through mixed methods the interaction of the stigma-reduction training and the Couples Health CoOp Plus (CHC+) on increased antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) and initiation, retention, and adherence among young women and their primary partners.


The Couples Health CoOp Plus (CHC+) was adapted from the Couples Health CoOp (CHC)-an empowerment-based intervention developed for South African couples that addresses the syndemic of alcohol and other drug (AOD) use, gender-based violence (GBV), and HIV risk. It is grounded in Social Cognitive Theory and promoted prevention strategies that addressed the relational context of equality in which sexual risk takes place. The Couples Health CoOp (CHC) has demonstrated efficacy in increasing condom use, improving gender norms, decreasing heavy alcohol use among men, and decreasing HIV incidence among women. Long-term benefits of the Couples Health CoOp (CHC) have been explored including women reporting less fighting with their partner and men reporting being more faithful and loving. As part of this current study (Aim 1), the behavioral Couples Health CoOp (CHC) was adapted to include biomedical HIV strategies antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) and updated materials. Formative qualitative work with a Community Collaborative Board (CCB) and a Peer Advisory Board (PAB) has guided the adaptation and updating of the Couples Health CoOp Plus (CHC+) intervention. The Couples Health CoOp Plus (CHC+) is a 2-module workshop delivered over two days and contains didactic and experiential lessons on alcohol and other drug (AOD) use, a status-neutral approach to the prevention and management of HIV, sexual and reproductive health (SRH), gender norms, gender-based violence (GBV), and tools to improve communication.

Formative findings regarding clinic-level stigma and discrimination showed that stigma reduction training provided in communities surrounding healthcare clinics may reduce stigmatizing behaviors and attitudes that are enacted by family, friends, and other community members toward those seeking healthcare. The stigma reduction survey and training has been developed and adapted as part of Aim 1 formative activities.

The study will enroll 20 couples in 24 communities in and around Cape Town, South Africa. Communities surrounding healthcare clinics will be paired according to community demographic and socioeconomic factors and randomized to one of four arms:

  1. stigma reduction training (community) and HIV testing services (HTS)/antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) (couple);
  2. stigma reduction training (community), and HIV testing services (HTS)/antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) with Couples Health CoOp Plus (CHC+) (couple);
  3. no stigma reduction training (community) and HIV testing services (HTS)/antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) (couple);
  4. no stigma reduction training (community), and HIV testing services (HTS)/antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) with Couples Health CoOp Plus (CHC+) (couple).

As noted, couples in communities that do not receive the CHC+ intervention will receive HIV testing services (HTS), including provision of antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) as part of standard of care.

HIV, alcohol and other drug (AOD), and pregnancy testing will be conducted at baseline and at 3-, 6-, and 9-month follow-up.

Assessment of community stigma occurs at baseline with all 24 communities and the stigma reduction training will occur in only those randomized to it. The follow-up occurs within all communities at 4- and 8-months post-baseline.

Condition HIV, Substance Use, Stigma, Social
Treatment Community stigma reduction training, Couples Health CoOp Plus (CHC+)
Clinical Study IdentifierNCT05310773
SponsorRTI International
Last Modified on19 June 2022


Yes No Not Sure

Inclusion Criteria

Is in a relationship with a primary partner
Had recent condomless sex with their primary partner
Has not taken PrEP or ART in the past 90 days
Has drunk alcohol and/or used drugs at least once a week over the past 90 days

Exclusion Criteria

Not currently pregnant (for women)
Not currently being treated for drug-resistant tuberculosis (TB)
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