CHC+: Couples Health CoOp Plus

Sponsor

RTI International (Other)

Overall Status

Recruiting

CT.gov ID

NCT05310773

Collaborator

Medical Research Council, South Africa (Other)

7,944

Enrollment

Location

Arms

29.9

Anticipated Duration (Months)

265.7

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Substance Use Stigma, Social	Behavioral: Community stigma reduction training Behavioral: Couples Health CoOp Plus (CHC+)	N/A

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 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:

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

7944 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 community stigma reduction training and HIV testing services (HTS)/pre-exposure prophylaxis (PrEP)/anti-retroviral therapy (ART) but no Couples Health CoOp Plus (CHC+); Arm 2 will receive community stigma reduction training with HTS/PrEP/ART and CHC+; Arm 3 will receive neither the community stigma reduction training nor CHC+ but will receive HTS/PrEP/ART; and Arm 4 will receive HTS/PrEP/ART and CHC+ but not the community stigma reduction training. All communities will receive the community stigma assessments at baseline, 4 months, and 8 months follow-up.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 community stigma reduction training and HIV testing services (HTS)/pre-exposure prophylaxis (PrEP)/anti-retroviral therapy (ART) but no Couples Health CoOp Plus (CHC+); Arm 2 will receive community stigma reduction training with HTS/PrEP/ART and CHC+; Arm 3 will receive neither the community stigma reduction training nor CHC+ but will receive HTS/PrEP/ART; and Arm 4 will receive HTS/PrEP/ART and CHC+ but not the community stigma reduction training. All communities will receive the community stigma assessments at baseline, 4 months, and 8 months follow-up.

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

May 6, 2022

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Community Stigma Reduction Training and HTS/ART/PrEP Only Participants in the communities/catchment areas randomized to this arm will complete the community stigma assessments and will receive with stigma reduction training through community 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 reduction training Key aspects of the training include community stigma awareness training 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. Selected modules will be modified from the existing clinic-based training to fit community stigma awareness and attitudes, as needed, to focus on aspects of stigma specific only to young women and men who engage in syndemic-related behaviours who live in their communities. This intervention has been adapted from implementation in clinics in Pretoria for use in a community setting in Cape Town. The stigma reduction training workshops will be delivered in communities randomized to receive this training (N=12 communities; estimated N=1164 participants).
Experimental: Community Stigma Reduction Training and HTS/ART/PrEP with CHC+ Participants in the communities/catchment areas randomized to this arm will complete the community stigma assessments with stigma reduction training through community 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: Community stigma reduction training Key aspects of the training include community stigma awareness training 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. Selected modules will be modified from the existing clinic-based training to fit community stigma awareness and attitudes, as needed, to focus on aspects of stigma specific only to young women and men who engage in syndemic-related behaviours who live in their communities. This intervention has been adapted from implementation in clinics in Pretoria for use in a community setting in Cape Town. The stigma reduction training workshops will be delivered in communities randomized to receive this training (N=12 communities; estimated N=1164 participants). 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).
No Intervention: No Community Stigma Reduction Training and HTS/ART/PrEP Only Participants in the communities/catchment areas randomized to this arm will complete the community stigma assessments but will not receive the stigma reduction training 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 Reduction Training and HTS/ART/PrEP with CHC+ Participants in the communities/catchment areas randomized to this arm will complete the community assessments but not the stigma reduction training 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).

Outcome Measures

Primary Outcome Measures

Antiretroviral Therapy (ART) Initiation [individual and couple-level] [3-month follow-up]
ART initiation will be measured using initiation information recorded in the participant's clinic medical record.
Antiretroviral Therapy (ART) Initiation [individual and couple-level] [6-month follow-up]
ART initiation will be measured using initiation information recorded in the participant's clinic medical record.
Antiretroviral Therapy (ART) Initiation [individual and couple-level] [9-month follow-up]
ART initiation will be measured using initiation information recorded in the participant's clinic medical record.
Pre-Exposure Prophylaxis (PrEP) Initiation [individual and couple-level] [3-month follow-up]
Pre-exposure prophylaxis (PrEP) initiation will be measured using initiation information recorded in the participant's clinic medical record.
Pre-Exposure Prophylaxis (PrEP) Initiation [individual and couple-level] [6-month follow-up]
Pre-exposure prophylaxis (PrEP) initiation will be measured using initiation information recorded in the participant's clinic medical record.
Pre-Exposure Prophylaxis (PrEP) Initiation [individual and couple-level] [9-month follow-up]
Pre-exposure prophylaxis (PrEP) initiation will be measured using initiation information recorded in the participant's clinic medical record.
Biological: Antiretroviral Therapy (ART) Adherence [individual and couple-level] [3-month follow-up]
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).
Biological: Antiretroviral Therapy (ART) Adherence [individual and couple-level] [6-month follow-up]
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).
Biological: Antiretroviral Therapy (ART) Adherence [individual and couple-level] [9-month follow-up]
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).
Self-Report: Antiretroviral Therapy (ART) Adherence [individual and couple-level] [3-month follow-up]
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+).
Self-Report: Antiretroviral Therapy (ART) Adherence [individual and couple-level] [6-month follow-up]
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+).
Self-Report: Antiretroviral Therapy (ART) Adherence [individual and couple-level] [9-month follow-up]
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+).
Biological: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level] [3-month follow-up]
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).
Biological: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level] [6-month follow-up]
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).
Biological: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level] [9-month follow-up]
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).
Self-Report: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level] [3-month follow-up]
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+).
Self-Report: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level] [6-month follow-up]
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+).
Self-Report: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level] [9-month follow-up]
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+).
Antiretroviral Therapy (ART) Persistence and Discontinuation [individual and couple-level] [3-month follow-up]
Number of antiretroviral therapy (ART) refills since initiation recorded in clinic medical records.
Antiretroviral Therapy (ART) Persistence and Discontinuation [individual and couple-level] [6-month follow-up]
Number of antiretroviral therapy (ART) refills since initiation recorded in clinic medical records.
Antiretroviral Therapy (ART) Persistence and Discontinuation [individual and couple-level] [9-month follow-up]
Number of antiretroviral therapy (ART) refills since initiation recorded in clinic medical records.
Self-Report: Antiretroviral therapy (ART) Persistence and Discontinuation [individual and couple-level] [3-month follow-up]
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+).
Self-Report: Antiretroviral therapy (ART) Persistence and Discontinuation [individual and couple-level] [6-month follow-up]
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+).
Self-Report: Antiretroviral therapy (ART) Persistence and Discontinuation [individual and couple-level] [9-month follow-up]
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+).
Data Extraction: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level [3-month follow-up]
Number of pre-exposure prophylaxis (PrEP) refills since initiation as recorded clinic medical records.
Data Extraction: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level [6-month follow-up]
Number of pre-exposure prophylaxis (PrEP) refills since initiation as recorded clinic medical records.
Data Extraction: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level [9-month follow-up]
Number of pre-exposure prophylaxis (PrEP) refills since initiation as recorded clinic medical records.
Self-Report: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level] [3-month follow-up]
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+).
Self-Report: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level] [6-month follow-up]
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+).
Self-Report: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level] [9-month follow-up]
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+).
Data Extraction: Antiretroviral therapy (ART) Retention [3-month follow-up]
Antiretroviral therapy (ART) retention in care will be measured as attendance to follow-up visits as recorded in clinic medical records.
Data Extraction: Antiretroviral therapy (ART) Retention [6-month follow-up]
Antiretroviral therapy (ART) retention in care will be measured as attendance to follow-up visits as recorded in clinic medical records.
Data Extraction: Antiretroviral therapy (ART) Retention [9-month follow-up]
Antiretroviral therapy (ART) retention in care will be measured as attendance to follow-up visits as recorded in clinic medical records.
Self-Report: Pre-exposure Prophylaxis (PrEP) Retention [individual and couple-level] [3-month follow-up]
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+).
Self-Report: Pre-exposure Prophylaxis (PrEP) Retention [individual and couple-level] [6-month follow-up]
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+).
Self-Report: Pre-exposure Prophylaxis (PrEP) Retention [individual and couple-level] [9-month follow-up]
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+).

Secondary Outcome Measures

Community Stigma [structural level] [Baseline]
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.
Community Stigma [structural level] [4-month follow-up]
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.
Community Stigma [structural level] [8-month follow-up]
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.
Biological: Drug use [individual level] [Baseline]
Recent drug use (amphetamine, cocaine, methamphetamine, marijuana [THC], opiates and/or Mandrax) will be measured using a rapid urine-based drug screening test panel.
Biological: Drug use [individual level] [3-month follow-up]
Recent drug use (amphetamine, cocaine, methamphetamine, marijuana [THC], opiates and/or Mandrax) will be measured using a rapid urine-based drug screening test panel.
Biological: Drug use [individual level] [6-month follow-up]
Recent drug use (amphetamine, cocaine, methamphetamine, marijuana [THC], opiates and/or Mandrax) will be measured using a rapid urine-based drug screening test panel.
Biological: Drug use [individual level] [9-month follow-up]
Recent drug use (amphetamine, cocaine, methamphetamine, marijuana [THC], opiates and/or Mandrax) will be measured using a rapid urine-based drug screening test panel.
Biological: Alcohol use [individual level] [Baseline]
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.
Biological: Alcohol use [individual level] [3-month follow-up]
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.
Biological: Alcohol use [individual level] [6-month follow-up]
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.
Biological: Alcohol use [individual level] [9-month follow-up]
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.
Self-Report: Gender-Based Violence (GBV) [individual and couple-level] [Baseline]
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).
Self-Report: Gender-Based Violence (GBV) [individual and couple-level] [3-month follow-up]
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).
Self-Report: Gender-Based Violence (GBV) [individual and couple-level] [6-month follow-up]
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).
Self-Report: Gender-Based Violence (GBV) [individual and couple-level] [9-month follow-up]
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).
Self-Report: Sexual Risk [individual and couple-level] [Baseline]
Self-reported frequency of condom use at last sex over the past 3 months measured by the Pretoria Risk Behavior Assessment (PRBA+).
Self-Report: Sexual Risk [individual and couple-level] [3-month follow-up]
Self-reported frequency of condom use at last sex over the past 3 months measured by the Pretoria Risk Behavior Assessment (PRBA+).
Self-Report: Sexual Risk [individual and couple-level] [6-month follow-up]
Self-reported frequency of condom use at last sex over the past 3 months measured by the Pretoria Risk Behavior Assessment (PRBA+).
Self-Report: Sexual Risk [individual and couple-level] [9-month follow-up]
Self-reported frequency of condom use at last sex over the past 3 months measured by the Pretoria Risk Behavior Assessment (PRBA+).
Self-Report: Sexual Risk [individual and couple-level] [Baseline]
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+).
Self-Report: Sexual Risk [individual and couple-level] [3-month follow-up]
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+).
Self-Report: Sexual Risk [individual and couple-level] [6-month follow-up]
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+).
Self-Report: Sexual Risk [individual and couple-level] [9-month follow-up]
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+).
Self-Report: Sexual Risk [individual and couple-level] [Baseline]
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+).
Self-Report: Sexual Risk [individual and couple-level] [3-month follow-up]
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+).
Self-Report: Sexual Risk [individual and couple-level] [6-month follow-up]
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+).
Self-Report: Sexual Risk [individual and couple-level] [9-month follow-up]
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+).
Self-Report: Sexual Risk [individual and couple-level] [Baseline]
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.
Self-Report: Sexual Risk [individual and couple-level] [3-month follow-up]
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.
Self-Report: Sexual Risk [individual and couple-level] [6-month follow-up]
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.
Self-Report: Sexual Risk [individual and couple-level] [9-month follow-up]
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.
Self-Report: Sexual Risk [individual and couple-level] [Baseline]
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.
Self-Report: Sexual Risk [individual and couple-level] [3-month follow-up]
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.
Self-Report: Sexual Risk [individual and couple-level] [6-month follow-up]
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.
Self-Report: Sexual Risk [individual and couple-level] [9-month follow-up]
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.
Self-Report: Gender Norms [individual and couple-level] [Baseline]
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+).
Self-Report: Gender Norms [individual and couple-level] [3-month follow-up]
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+).
Self-Report: Gender Norms [individual and couple-level] [6-month follow-up]
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+).
Self-Report: Gender Norms [individual and couple-level] [9-month follow-up]
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+).
Self-Report: Communication [individual and couple-level] [Baseline]
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+).
Self-Report: Communication [individual and couple-level] [3-month follow-up]
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+).
Self-Report: Communication [individual and couple-level] [6-month follow-up]
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+).
Self-Report: Communication [individual and couple-level] [9-month follow-up]
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+).
Self-Report: Observed or Knowledge of Stigma [individual and couple-level] [Baseline]
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+).
Self-Report: Observed or Knowledge of Stigma [individual and couple-level] [3-month follow-up]
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+).
Self-Report: Observed or Knowledge of Stigma [individual and couple-level] [6-month follow-up]
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+).
Self-Report: Observed or Knowledge of Stigma [individual and couple-level] [9-month follow-up]
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+).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South African Medical Research Council	Cape Town	Western Cape	South Africa	7500

Sponsors and Collaborators

RTI International
Medical Research Council, South Africa

Investigators

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