Couples Health CoOp Plus

Summary

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), received either a stigma awareness and education workshop or no workshop with repeated measures. Within clinic catchment areas, 481 couples (young women and their primary male sex partners both aged 18 to 30) were recruited. These couples received 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 awareness and education workshop 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 violence, and more positive relationship 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 awareness and education workshop on community members' attitudes and behaviors toward young women and men who use AODs and other people seeking HIV services (testing/ART/PrEP) and other health services 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 violence, and enhance positive relationship norms and communication relative to HIV testing services (HTS) (secondary outcomes).

Aim 4: Examine through mixed methods the interaction of a stigma awareness and education workshop 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.

Conditions

• HIV
• Substance Use
• Stigma, Social

Interventions

BEHAVIORAL

Community Stigma Awareness and Education Workshop

Key aspects of the workshop included community stigma awareness of people living with HIV, use of antiretroviral therapy (ART), pre-exposure prophylaxis (PrEP) for prevention of HIV and attitudes towards people who use alcohol and drugs. The workshop adapted a stigma-reduction curriculum based on a stigma-reduction toolkit and community HIV prevention project with community peers with skits to address stigmatizing attitudes and behaviors toward young women and men who use AODs and who may need health services, including HIV treatment and prevention. Selected modules were modified from the existing clinic-based training to fit community stigma awareness and attitudes to focus on aspects of stigma specific to young women and men who engage in syndemic-related behaviors who live in their communities. The stigma awareness and education workshop was delivered in communities randomized to receive workshops (N=12 communities).

BEHAVIORAL

Couples Health CoOp Plus (CHC+)

The Couples Health CoOp Plus (CHC+) was adapted from the initial Couples Health CoOp (CHC)-an empowerment-based intervention developed for South African couples that addresses the syndemic of alcohol and other drug (AOD) use, violence, and HIV risk. It is grounded in Social Cognitive Theory and promotes prevention strategies that address the relational context of equality in which sexual risk takes place. The adapted Couples Health CoOp Plus (CHC+) incorporated antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) for a biobehavioral approach with an emphasis on uptake and good adherence (N=12 communities; N=240 couples).

Sponsors & Collaborators

• Medical Research Council, South Africa

  collaborator OTHER

• RTI International

  lead OTHER

Principal Investigators

• Felicia Browne, ScD, MPH · RTI International

• Tara Carney, PhD · Medical Research Council, South Africa

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-05-06

Primary Completion

2025-09-11

Completion

2025-09-11

Countries

• South Africa

Study Locations