Couples Health CoOp Plus (CHC+)

Multilevel Strategies & Tailored HIV Prevention and Care for Young Couples Who Use Alcohol and Other Drugs Across Cape Town: Couples Health CoOp Plus

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.

Study Overview

• Status: Recruiting
• Conditions: HIV; Substance Use; Stigma, Social
• Intervention / Treatment: Behavioral: Couples Health CoOp Plus (CHC+); Behavioral: Community Stigma Awareness and Education Workshop

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.

• Study Type: Interventional
• Enrollment (Estimated): 7944
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wendee Wechsberg, PhD; Phone Number: 919-541-6422; Email: wmw@rti.org
• Study Contact Backup: Name: Tara Carney, PhD; Phone Number: +27 21 9380326; Email: tara.carney@mrc.ac.za

Study Locations

• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7500
      • Recruiting
      • South African Medical Research Council
      • Contact: Tara Carney, PhD; Phone Number: +27 21 9380326; Email: tara.carney@mrc.ac.za

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Selected Inclusion Criteria (for Couples):

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Community Stigma Awareness and Education Workshop and HTS/ART/PrEP Only; Communities/catchment areas randomized to this arm will complete the community stigma assessments and will receive the community stigma awareness and education workshops. Couples will have access to standard HIV testing services (HTS) with antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) but not the Couples Health CoOp Plus (CHC+) intervention.	Behavioral: Community Stigma Awareness and Education Workshop; Key aspects of the workshop include 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 adapts 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 will be delivered in communities randomized to receive workshops (N=12 communities).
Experimental: Community Stigma Awareness and Education Workshop and HTS/ART/PrEP with CHC+; Communities/catchment areas randomized to this arm will complete the community stigma assessments and will receive the community stigma awareness and education workshops. Couples will have access to the Couples Health CoOp Plus (CHC+) intervention and standard HTS with antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP).	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, gender-based violence (GBV), 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+) incorporates antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) for a biobehavioral approach with an emphasis on uptake and good adherence (N=12 communities; estimated N=240 couples).; Behavioral: Community Stigma Awareness and Education Workshop; Key aspects of the workshop include 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 adapts 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 will be delivered in communities randomized to receive workshops (N=12 communities).
No Intervention: No Community Stigma Awareness and Education Workshop and HTS/ART/PrEP Only; Communities/catchment areas randomized to this arm will complete the community stigma assessments but will not receive the community stigma awareness and education workshops. Couples will have access to standard HIV testing services (HTS) with antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) but not the Couples Health CoOp Plus (CHC+) intervention.
Experimental: No Community Stigma Awareness and Education Workshop and HTS/ART/PrEP with CHC+; Communities/catchment areas randomized to this arm will complete the community assessments but not the community stigma awareness and education workshops. Couples will have access to the Couples Health CoOp Plus (CHC+) intervention and standard HIV testing services (HTS) with antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP).	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, gender-based violence (GBV), 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+) incorporates antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) for a biobehavioral approach with an emphasis on uptake and good adherence (N=12 communities; estimated N=240 couples).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antiretroviral Therapy (ART) Initiation [individual and couple-level]	ART initiation will be measured using initiation information recorded in the participant's clinic medical record.	3-month follow-up
Antiretroviral Therapy (ART) Initiation [individual and couple-level]	ART initiation will be measured using initiation information recorded in the participant's clinic medical record.	6-month follow-up
Antiretroviral Therapy (ART) Initiation [individual and couple-level]	ART initiation will be measured using initiation information recorded in the participant's clinic medical record.	9-month follow-up
Pre-Exposure Prophylaxis (PrEP) Initiation [individual and couple-level]	Pre-exposure prophylaxis (PrEP) initiation will be measured using initiation information recorded in the participant's clinic medical record.	3-month follow-up
Pre-Exposure Prophylaxis (PrEP) Initiation [individual and couple-level]	Pre-exposure prophylaxis (PrEP) initiation will be measured using initiation information recorded in the participant's clinic medical record.	6-month follow-up
Pre-Exposure Prophylaxis (PrEP) Initiation [individual and couple-level]	Pre-exposure prophylaxis (PrEP) initiation will be measured using initiation information recorded in the participant's clinic medical record.	9-month follow-up
Biological: Antiretroviral Therapy (ART) Adherence [individual and couple-level]	ART adherence will be measured using viral load or cluster of differentiation 4 (CD4) count measures recorded in the participant's medical record. Threshold for adherence will be cluster of differentiation 4 (CD4) count (more than 200) and HIV viral load (less than 50 copies per ml).	3-month follow-up
Biological: Antiretroviral Therapy (ART) Adherence [individual and couple-level]	ART adherence will be measured using viral load or cluster of differentiation 4 (CD4) count measures recorded in the participant's medical record. Threshold for adherence will be cluster of differentiation 4 (CD4) count (more than 200) and HIV viral load (less than 50 copies per ml).	6-month follow-up
Biological: Antiretroviral Therapy (ART) Adherence [individual and couple-level]	ART adherence will be measured using viral load or cluster of differentiation 4 (CD4) count measures recorded in the participant's medical record. Threshold for adherence will be cluster of differentiation 4 (CD4) count (more than 200) and HIV viral load (less than 50 copies per ml).	9-month follow-up
Self-Report: Antiretroviral Therapy (ART) Adherence [individual and couple-level]	Self-report past 30-day use, missed doses and patterns of use of antiretroviral therapy (ART) for self-report adherence will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	3-month follow-up
Self-Report: Antiretroviral Therapy (ART) Adherence [individual and couple-level]	Self-report past 30-day use, missed doses and patterns of use of antiretroviral therapy (ART) for self-report adherence will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	6-month follow-up
Self-Report: Antiretroviral Therapy (ART) Adherence [individual and couple-level]	Self-report past 30-day use, missed doses and patterns of use of antiretroviral therapy (ART) for self-report adherence will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	9-month follow-up
Biological: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level]	Tenofovir Diphosphate (TFV-DP) and FTC Triphosphate (FTC-TP) concentrations in dried blood spots (DBS) with drug concentrations of greater than 700 femtomoles (fmol)/liters(L) will be considered adherent to pre-exposure prophylaxis (PrEP).	3-month follow-up
Biological: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level]	Tenofovir Diphosphate (TFV-DP) and FTC Triphosphate (FTC-TP) concentrations in dried blood spots (DBS) with drug concentrations of greater than 700 femtomoles (fmol)/liters(L) will be considered adherent to pre-exposure prophylaxis (PrEP).	6-month follow-up
Biological: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level]	Tenofovir Diphosphate (TFV-DP) and FTC Triphosphate (FTC-TP) concentrations in dried blood spots (DBS) with drug concentrations of greater than 700 femtomoles (fmol)/liters(L) will be considered adherent to pre-exposure prophylaxis (PrEP).	9-month follow-up
Self-Report: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level]	Self-report past 30-day use, missed doses and patterns of use of pre-exposure prophylaxis (PrEP) for self-report adherence will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	3-month follow-up
Self-Report: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level]	Self-report past 30-day use, missed doses and patterns of use of pre-exposure prophylaxis (PrEP) for self-report adherence will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	6-month follow-up
Self-Report: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level]	Self-report past 30-day use, missed doses and patterns of use of pre-exposure prophylaxis (PrEP) for self-report adherence will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	9-month follow-up
Antiretroviral Therapy (ART) Persistence and Discontinuation [individual and couple-level]	Number of antiretroviral therapy (ART) refills since initiation recorded in clinic medical records.	3-month follow-up
Antiretroviral Therapy (ART) Persistence and Discontinuation [individual and couple-level]	Number of antiretroviral therapy (ART) refills since initiation recorded in clinic medical records.	6-month follow-up
Antiretroviral Therapy (ART) Persistence and Discontinuation [individual and couple-level]	Number of antiretroviral therapy (ART) refills since initiation recorded in clinic medical records.	9-month follow-up
Self-Report: Antiretroviral therapy (ART) Persistence and Discontinuation [individual and couple-level]	Self-reported time in months on antiretroviral therapy (ART) since initiation will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	3-month follow-up
Self-Report: Antiretroviral therapy (ART) Persistence and Discontinuation [individual and couple-level]	Self-reported time in months on antiretroviral therapy (ART) since initiation will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	6-month follow-up
Self-Report: Antiretroviral therapy (ART) Persistence and Discontinuation [individual and couple-level]	Self-reported time in months on antiretroviral therapy (ART) since initiation will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	9-month follow-up
Data Extraction: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level	Number of pre-exposure prophylaxis (PrEP) refills since initiation as recorded clinic medical records.	3-month follow-up
Data Extraction: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level	Number of pre-exposure prophylaxis (PrEP) refills since initiation as recorded clinic medical records.	6-month follow-up
Data Extraction: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level	Number of pre-exposure prophylaxis (PrEP) refills since initiation as recorded clinic medical records.	9-month follow-up
Self-Report: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level]	Self-reported time in months on pre-exposure prophylaxis (PrEP) since initiation on pre-exposure prophylaxis (PrEP) will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	3-month follow-up
Self-Report: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level]	Self-reported time in months on pre-exposure prophylaxis (PrEP) since initiation on pre-exposure prophylaxis (PrEP) will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	6-month follow-up
Self-Report: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level]	Self-reported time in months on pre-exposure prophylaxis (PrEP) since initiation on pre-exposure prophylaxis (PrEP) will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	9-month follow-up
Data Extraction: Antiretroviral therapy (ART) Retention	Antiretroviral therapy (ART) retention in care will be measured as attendance to follow-up visits as recorded in clinic medical records.	3-month follow-up
Data Extraction: Antiretroviral therapy (ART) Retention	Antiretroviral therapy (ART) retention in care will be measured as attendance to follow-up visits as recorded in clinic medical records.	6-month follow-up
Data Extraction: Antiretroviral therapy (ART) Retention	Antiretroviral therapy (ART) retention in care will be measured as attendance to follow-up visits as recorded in clinic medical records.	9-month follow-up
Self-Report: Pre-exposure Prophylaxis (PrEP) Retention [individual and couple-level]	Self-report pre-exposure prophylaxis (PrEP) retention in care will be measured as attendance to follow-up visits using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	3-month follow-up
Self-Report: Pre-exposure Prophylaxis (PrEP) Retention [individual and couple-level]	Self-report pre-exposure prophylaxis (PrEP) retention in care will be measured as attendance to follow-up visits using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	6-month follow-up
Self-Report: Pre-exposure Prophylaxis (PrEP) Retention [individual and couple-level]	Self-report pre-exposure prophylaxis (PrEP) retention in care will be measured as attendance to follow-up visits using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	9-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Community Stigma [structural level]	Surveys will be used to measure stigmatizing attitudes and perceptions towards people who use alcohol and other drugs (AODs), living with HIV and seeking and antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) services for prevention. Greater values indicate higher levels of community-level stigma and discrimination.	Baseline
Community Stigma [structural level]	Surveys will be used to measure stigmatizing attitudes and perceptions towards people who use alcohol and other drugs (AODs), living with HIV and seeking and antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) services for prevention. Greater values indicate higher levels of community-level stigma and discrimination.	4-month follow-up
Community Stigma [structural level]	Surveys will be used to measure stigmatizing attitudes and perceptions towards people who use alcohol and other drugs (AODs), living with HIV and seeking and antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) services for prevention. Greater values indicate higher levels of community-level stigma and discrimination.	8-month follow-up
Biological: Drug use [individual level]	Recent drug use (amphetamine, cocaine, methamphetamine, marijuana [THC], opiates and/or Mandrax) will be measured using a rapid urine-based drug screening test panel.	Baseline
Biological: Drug use [individual level]	Recent drug use (amphetamine, cocaine, methamphetamine, marijuana [THC], opiates and/or Mandrax) will be measured using a rapid urine-based drug screening test panel.	3-month follow-up
Biological: Drug use [individual level]	Recent drug use (amphetamine, cocaine, methamphetamine, marijuana [THC], opiates and/or Mandrax) will be measured using a rapid urine-based drug screening test panel.	6-month follow-up
Biological: Drug use [individual level]	Recent drug use (amphetamine, cocaine, methamphetamine, marijuana [THC], opiates and/or Mandrax) will be measured using a rapid urine-based drug screening test panel.	9-month follow-up
Biological: Alcohol use [individual level]	Recent alcohol (last 10 days) use will be measured by the presence of ethyl glucuronide (EtG), a breakdown product of ethanol, using an ethyl glucuronide (EtG) urine test.	Baseline
Biological: Alcohol use [individual level]	Recent alcohol (last 10 days) use will be measured by the presence of ethyl glucuronide (EtG), a breakdown product of ethanol, using an ethyl glucuronide (EtG) urine test.	3-month follow-up
Biological: Alcohol use [individual level]	Recent alcohol (last 10 days) use will be measured by the presence of ethyl glucuronide (EtG), a breakdown product of ethanol, using an ethyl glucuronide (EtG) urine test.	6-month follow-up
Biological: Alcohol use [individual level]	Recent alcohol (last 10 days) use will be measured by the presence of ethyl glucuronide (EtG), a breakdown product of ethanol, using an ethyl glucuronide (EtG) urine test.	9-month follow-up
Self-Report: Gender-Based Violence (GBV) [individual and couple-level]	Self-report emotional, physical, and sexual abuse, recent victimization, and family violence & experience of physical & sexual abuse will be measured using the World Health Organization (WHO) assessment of emotional, physical, & sexual abuse and the Revised Risk Behavior Assessment (RRBA).	Baseline
Self-Report: Gender-Based Violence (GBV) [individual and couple-level]	Self-report emotional, physical, and sexual abuse, recent victimization, and family violence & experience of physical & sexual abuse will be measured using the World Health Organization (WHO) assessment of emotional, physical, & sexual abuse and the Revised Risk Behavior Assessment (RRBA).	3-month follow-up
Self-Report: Gender-Based Violence (GBV) [individual and couple-level]	Self-report emotional, physical, and sexual abuse, recent victimization, and family violence & experience of physical & sexual abuse will be measured using the World Health Organization (WHO) assessment of emotional, physical, & sexual abuse and the Revised Risk Behavior Assessment (RRBA).	6-month follow-up
Self-Report: Gender-Based Violence (GBV) [individual and couple-level]	Self-report emotional, physical, and sexual abuse, recent victimization, and family violence & experience of physical & sexual abuse will be measured using the World Health Organization (WHO) assessment of emotional, physical, & sexual abuse and the Revised Risk Behavior Assessment (RRBA).	9-month follow-up
Self-Report: Sexual Risk [individual and couple-level]	Self-reported frequency of condom use at last sex over the past 3 months measured by the Pretoria Risk Behavior Assessment (PRBA+).	Baseline
Self-Report: Sexual Risk [individual and couple-level]	Self-reported frequency of condom use at last sex over the past 3 months measured by the Pretoria Risk Behavior Assessment (PRBA+).	3-month follow-up
Self-Report: Sexual Risk [individual and couple-level]	Self-reported frequency of condom use at last sex over the past 3 months measured by the Pretoria Risk Behavior Assessment (PRBA+).	6-month follow-up
Self-Report: Sexual Risk [individual and couple-level]	Self-reported frequency of condom use at last sex over the past 3 months measured by the Pretoria Risk Behavior Assessment (PRBA+).	9-month follow-up
Self-Report: Sexual Risk [individual and couple-level]	Self-reported frequency of alcohol and other drug (AOD) use prior to sex in the last 3 months as measured by the Pretoria Risk Behavior Assessment (PRBA+).	Baseline
Self-Report: Sexual Risk [individual and couple-level]	Self-reported frequency of alcohol and other drug (AOD) use prior to sex in the last 3 months as measured by the Pretoria Risk Behavior Assessment (PRBA+).	3-month follow-up
Self-Report: Sexual Risk [individual and couple-level]	Self-reported frequency of alcohol and other drug (AOD) use prior to sex in the last 3 months as measured by the Pretoria Risk Behavior Assessment (PRBA+).	6-month follow-up
Self-Report: Sexual Risk [individual and couple-level]	Self-reported frequency of alcohol and other drug (AOD) use prior to sex in the last 3 months as measured by the Pretoria Risk Behavior Assessment (PRBA+).	9-month follow-up
Self-Report: Sexual Risk [individual and couple-level]	Self-reported number of sex partners, concurrent sexual partners and sex trading partners over the past 3 months measured by the Pretoria Risk Behavior Assessment (PRBA+).	Baseline
Self-Report: Sexual Risk [individual and couple-level]	Self-reported number of sex partners, concurrent sexual partners and sex trading partners over the past 3 months measured by the Pretoria Risk Behavior Assessment (PRBA+).	3-month follow-up
Self-Report: Sexual Risk [individual and couple-level]	Self-reported number of sex partners, concurrent sexual partners and sex trading partners over the past 3 months measured by the Pretoria Risk Behavior Assessment (PRBA+).	6-month follow-up
Self-Report: Sexual Risk [individual and couple-level]	Self-reported number of sex partners, concurrent sexual partners and sex trading partners over the past 3 months measured by the Pretoria Risk Behavior Assessment (PRBA+).	9-month follow-up
Self-Report: Sexual Risk [individual and couple-level]	Self-report responses on the single item measured by the Pretoria Risk Behavior Assessment (PRBA+) will be used to assess use of contraception and types of contraception.	Baseline
Self-Report: Sexual Risk [individual and couple-level]	Self-report responses on the single item measured by the Pretoria Risk Behavior Assessment (PRBA+) will be used to assess use of contraception and types of contraception.	3-month follow-up
Self-Report: Sexual Risk [individual and couple-level]	Self-report responses on the single item measured by the Pretoria Risk Behavior Assessment (PRBA+) will be used to assess use of contraception and types of contraception.	6-month follow-up
Self-Report: Sexual Risk [individual and couple-level]	Self-report responses on the single item measured by the Pretoria Risk Behavior Assessment (PRBA+) will be used to assess use of contraception and types of contraception.	9-month follow-up
Self-Report: Sexual Risk [individual and couple-level]	Self-report responses on single-item questions will be used to assess the extent to which participants perceive themselves as at risk for HIV infection measured by the Pretoria Risk Behavior Assessment (PRBA+). Higher levels indicate greater perceived HIV risk.	Baseline
Self-Report: Sexual Risk [individual and couple-level]	Self-report responses on single-item questions will be used to assess the extent to which participants perceive themselves as at risk for HIV infection measured by the Pretoria Risk Behavior Assessment (PRBA+). Higher levels indicate greater perceived HIV risk.	3-month follow-up
Self-Report: Sexual Risk [individual and couple-level]	Self-report responses on single-item questions will be used to assess the extent to which participants perceive themselves as at risk for HIV infection measured by the Pretoria Risk Behavior Assessment (PRBA+). Higher levels indicate greater perceived HIV risk.	6-month follow-up
Self-Report: Sexual Risk [individual and couple-level]	Self-report responses on single-item questions will be used to assess the extent to which participants perceive themselves as at risk for HIV infection measured by the Pretoria Risk Behavior Assessment (PRBA+). Higher levels indicate greater perceived HIV risk.	9-month follow-up
Self-Report: Gender Norms [individual and couple-level]	Self-reported attitudes about traditional gender roles, empowerment, and assertiveness will be measured by the Gender ideology Scale (GIS) and the Pretoria Risk Behavior Assessment (PRBA+).	Baseline
Self-Report: Gender Norms [individual and couple-level]	Self-reported attitudes about traditional gender roles, empowerment, and assertiveness will be measured by the Gender ideology Scale (GIS) and the Pretoria Risk Behavior Assessment (PRBA+).	3-month follow-up
Self-Report: Gender Norms [individual and couple-level]	Self-reported attitudes about traditional gender roles, empowerment, and assertiveness will be measured by the Gender ideology Scale (GIS) and the Pretoria Risk Behavior Assessment (PRBA+).	6-month follow-up
Self-Report: Gender Norms [individual and couple-level]	Self-reported attitudes about traditional gender roles, empowerment, and assertiveness will be measured by the Gender ideology Scale (GIS) and the Pretoria Risk Behavior Assessment (PRBA+).	9-month follow-up
Self-Report: Communication [individual and couple-level]	Self-reported communication between partners regarding testing, HIV and sexually transmitted infection (STI) status, other partners, sexual negotiation, and condom use as measured by the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	Baseline
Self-Report: Communication [individual and couple-level]	Self-reported communication between partners regarding testing, HIV and sexually transmitted infection (STI) status, other partners, sexual negotiation, and condom use as measured by the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	3-month follow-up
Self-Report: Communication [individual and couple-level]	Self-reported communication between partners regarding testing, HIV and sexually transmitted infection (STI) status, other partners, sexual negotiation, and condom use as measured by the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	6-month follow-up
Self-Report: Communication [individual and couple-level]	Self-reported communication between partners regarding testing, HIV and sexually transmitted infection (STI) status, other partners, sexual negotiation, and condom use as measured by the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	9-month follow-up
Self-Report: Observed or Knowledge of Stigma [individual and couple-level]	Observations or knowledge of stigma perpetrated by others in the community will be measured by the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	Baseline
Self-Report: Observed or Knowledge of Stigma [individual and couple-level]	Observations or knowledge of stigma perpetrated by others in the community will be measured by the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	3-month follow-up
Self-Report: Observed or Knowledge of Stigma [individual and couple-level]	Observations or knowledge of stigma perpetrated by others in the community will be measured by the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	6-month follow-up
Self-Report: Observed or Knowledge of Stigma [individual and couple-level]	Observations or knowledge of stigma perpetrated by others in the community will be measured by the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).	9-month follow-up

Collaborators and Investigators

• Sponsor: RTI International
• Collaborators: Medical Research Council, South Africa
• Investigators: Principal Investigator: Felicia Browne, ScD, MPH, RTI International; Principal Investigator: Tara Carney, PhD, Medical Research Council, South Africa; Principal Investigator: Wendee Wechsberg, PhD, RTI International

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2022
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: February 21, 2022
• First Submitted That Met QC Criteria: March 25, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: South Africa; Stigma; Human Immunodeficiency Virus (HIV); Substance use; Pre-exposure prophylaxis (PrEP); Couples; Antiretroviral therapy (ART); Undetectable=Untransmittable (U=U); Alcohol and other drugs (AODs); Couples Health CoOp (CHC); Status-neutral
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: R01DA049612 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No