Clinical trial NCT05310773: Couples Health CoOp Plus
Official title: Multilevel Strategies & Tailored HIV Prevention and Care for Young Couples Who Use Alcohol and Other Drugs Across Cape Town: Couples Health CoOp Plus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Substance Use
Stigma, Social
Keywords: Pre-exposure prophylaxis (PrEP)
Antiretroviral therapy (ART)
Alcohol and other drugs (AODs)
Human Immunodeficiency Virus (HIV)
Couples
Substance use
Stigma
Couples Health CoOp (CHC)
South Africa
Undetectable=Untransmittable (U=U)
Status-neutral
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: Medical Research Council, South Africa
First posted: 2022-04-05
Enrollment: 7944
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 24 communities in clinic catchment areas (clinics selected and approved by City Health) that provide antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) will be randomly assigned to the four arms of the study (6 communities per arm). Arm 1 will receive the stigma awareness and education workshop and HIV testing services (HTS)/pre-exposure prophylaxis (PrEP)/anti-retroviral therapy (ART) but no Couples Health CoOp Plus (CHC+); Arm 2 will receive the stigma awareness and education workshop with HTS/PrEP/ART and CHC+; Arm 3 will receive neither the stigma awareness and education workshop nor CHC+ but will receive HTS/PrEP/ART; and Arm 4 will receive HTS/PrEP/ART and CHC+ but not the stigma awareness and education workshop. All communities will receive the community stigma assessments at baseline, 4 months, and 8 months follow-up.
Primary purpose: OTHER

Brief 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), will receive either a stigma awareness and education workshop or no workshop 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 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 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 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 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 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.

Detailed description: 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 workshop has been developed and adapted as part of Aim 1 formative activities.

The study will enroll 20 couples in each of the 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 awareness and education workshop (community) and HIV testing services (HTS)/antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) (couple);
2. stigma awareness and education workshop (community), and HIV testing services (HTS)/antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) with Couples Health CoOp Plus (CHC+) (couple);
3. no stigma awareness and education workshop (community) and HIV testing services (HTS)/antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) (couple);
4. no stigma awareness and education workshop (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 awareness and education workshop will occur in only those randomized to it. The follow-up occurs within all communities at 4- and 8-months post-baseline.

Eligibility criteria: Selected Inclusion Criteria (for Couples):

* 18 to 30 years old
* 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

Selected Exclusion Criteria (for Couples):

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

Selected Inclusion Criteria (for Community Members):

• At least 18 years old

Primary outcomes:
measure: Antiretroviral Therapy (ART) Initiation [individual and couple-level]
timeFrame: 3-month follow-up
measure: Antiretroviral Therapy (ART) Initiation [individual and couple-level]
timeFrame: 6-month follow-up
measure: Pre-Exposure Prophylaxis (PrEP) Initiation [individual and couple-level]
timeFrame: 3-month follow-up
measure: Pre-Exposure Prophylaxis (PrEP) Initiation [individual and couple-level]
timeFrame: 6-month follow-up
measure: Biological: Antiretroviral Therapy (ART) Adherence [individual and couple-level]
timeFrame: 3-month follow-up
measure: Biological: Antiretroviral Therapy (ART) Adherence [individual and couple-level]
timeFrame: 6-month follow-up
measure: Self-Report: Antiretroviral Therapy (ART) Adherence [individual and couple-level]
timeFrame: 3-month follow-up
measure: Self-Report: Antiretroviral Therapy (ART) Adherence [individual and couple-level]
timeFrame: 6-month follow-up
measure: Biological: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level]
timeFrame: 3-month follow-up
measure: Biological: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level]
timeFrame: 6-month follow-up
measure: Self-Report: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level]
timeFrame: 3-month follow-up
measure: Self-Report: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level]
timeFrame: 6-month follow-up
measure: Antiretroviral Therapy (ART) Persistence and Discontinuation [individual and couple-level]
timeFrame: 3-month follow-up
measure: Antiretroviral Therapy (ART) Persistence and Discontinuation [individual and couple-level]
timeFrame: 6-month follow-up
measure: Self-Report: Antiretroviral therapy (ART) Persistence and Discontinuation [individual and couple-level]
timeFrame: 3-month follow-up
measure: Self-Report: Antiretroviral therapy (ART) Persistence and Discontinuation [individual and couple-level]
timeFrame: 6-month follow-up
measure: Data Extraction: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level
timeFrame: 3-month follow-up
measure: Data Extraction: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level
timeFrame: 6-month follow-up
measure: Self-Report: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level]
timeFrame: 3-month follow-up
measure: Self-Report: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level]
timeFrame: 6-month follow-up
measure: Data Extraction: Antiretroviral therapy (ART) Retention
timeFrame: 3-month follow-up
measure: Data Extraction: Antiretroviral therapy (ART) Retention
timeFrame: 6-month follow-up
measure: Self-Report: Pre-exposure Prophylaxis (PrEP) Retention [individual and couple-level]
timeFrame: 3-month follow-up
measure: Self-Report: Pre-exposure Prophylaxis (PrEP) Retention [individual and couple-level]
timeFrame: 6-month follow-up
Secondary outcomes:
measure: Community Stigma [structural level]
timeFrame: Baseline
measure: Community Stigma [structural level]
timeFrame: 4-month follow-up
measure: Community Stigma [structural level]
timeFrame: 8-month follow-up
measure: Biological: Drug use [individual level]
timeFrame: Baseline
measure: Biological: Drug use [individual level]
timeFrame: 3-month follow-up
measure: Biological: Drug use [individual level]
timeFrame: 6-month follow-up
measure: Biological: Alcohol use [individual level]
timeFrame: Baseline
measure: Biological: Alcohol use [individual level]
timeFrame: 3-month follow-up
measure: Biological: Alcohol use [individual level]
timeFrame: 6-month follow-up
measure: Self-Report: Gender-Based Violence (GBV) [individual and couple-level]
timeFrame: Baseline
measure: Self-Report: Gender-Based Violence (GBV) [individual and couple-level]
timeFrame: 3-month follow-up
measure: Self-Report: Gender-Based Violence (GBV) [individual and couple-level]
timeFrame: 6-month follow-up
measure: Self-Report: Sexual Risk [individual and couple-level]
timeFrame: Baseline
measure: Self-Report: Sexual Risk [individual and couple-level]
timeFrame: 3-month follow-up
measure: Self-Report: Sexual Risk [individual and couple-level]
timeFrame: 6-month follow-up
measure: Self-Report: Sexual Risk [individual and couple-level]
timeFrame: Baseline
measure: Self-Report: Sexual Risk [individual and couple-level]
timeFrame: 3-month follow-up
measure: Self-Report: Sexual Risk [individual and couple-level]
timeFrame: 6-month follow-up
measure: Self-Report: Sexual Risk [individual and couple-level]
timeFrame: Baseline
measure: Self-Report: Sexual Risk [individual and couple-level]
timeFrame: 3-month follow-up
measure: Self-Report: Sexual Risk [individual and couple-level]
timeFrame: 6-month follow-up
measure: Self-Report: Sexual Risk [individual and couple-level]
timeFrame: Baseline
measure: Self-Report: Sexual Risk [individual and couple-level]
timeFrame: 3-month follow-up
measure: Self-Report: Sexual Risk [individual and couple-level]
timeFrame: 6-month follow-up
measure: Self-Report: Sexual Risk [individual and couple-level]
timeFrame: Baseline
measure: Self-Report: Sexual Risk [individual and couple-level]
timeFrame: 3-month follow-up
measure: Self-Report: Sexual Risk [individual and couple-level]
timeFrame: 6-month follow-up
measure: Self-Report: Gender Norms [individual and couple-level]
timeFrame: Baseline
measure: Self-Report: Gender Norms [individual and couple-level]
timeFrame: 3-month follow-up
measure: Self-Report: Gender Norms [individual and couple-level]
timeFrame: 6-month follow-up
measure: Self-Report: Communication [individual and couple-level]
timeFrame: Baseline
measure: Self-Report: Communication [individual and couple-level]
timeFrame: 3-month follow-up
measure: Self-Report: Communication [individual and couple-level]
timeFrame: 6-month follow-up
measure: Self-Report: Observed or Knowledge of Stigma [individual and couple-level]
timeFrame: Baseline
measure: Self-Report: Observed or Knowledge of Stigma [individual and couple-level]
timeFrame: 3-month follow-up
measure: Self-Report: Observed or Knowledge of Stigma [individual and couple-level]
timeFrame: 6-month follow-up
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: South African Medical Research Council
state: Western Cape
Study officials:
affiliation: RTI International
name: Felicia Browne, ScD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Research Council, South Africa
name: Tara Carney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wechsberg WM, Carney T, Browne FA, van der Drift IM, Kline TL, Nyblade LL, Ndirangu J, Orrell C, Bonner CP, Caron E. Multilevel strategies to end HIV for young couples in Cape Town: Study protocol for a cluster randomized trial. PLoS One. 2024 Jun 7;19(6):e0305056. doi: 10.1371/journal.pone.0305056. eCollection 2024.