HIVCHC+NCT05310773
Couples Health CoOp Plus
A study testing Community Stigma Awareness and Education Workshop and Couples Health CoOp Plus (CHC+) in people with HIV and Substance Use, run by RTI International at 1 site in South Africa.
Trial 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+). Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, Substance Use, Stigma, Social
- What is being tested?
- Community Stigma Awareness and Education Workshop and Couples Health CoOp Plus (CHC+)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 962 participants
- Where
- 1 siteSouth Africa
- Study dates
- 6 May 2022to 11 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
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)
Trial locations and contacts
1 site in 1 country.
South Africa1 site
South African Medical Research Council
Cape Town, Western Cape, 7500
About this study
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
This study addresses HIV prevention and treatment for young couples living in Cape Town, South Africa, through a comprehensive biobehavioral multilevel approach-the Couples Health CoOp Plus (CHC+).
Through a cluster randomized trial with a modified factorial design, 24 Cape Town communities consisting of catchment areas for clinics that provide antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP), received either a stigma awareness and education workshop or no workshop with repeated measures. Within clinic catchment areas, 481 couples (young women and their primary male sex partners both aged 18 to 30) were recruited. These couples received HIV testing services (HTS) and/or the Couples Health CoOp Plus (CHC+), depending on their intervention arm.
Read more
The overarching aim of these interventions is to prevent new cases of HIV. It is hypothesized that communities that are assigned to the stigma awareness and education workshop will demonstrate higher levels of social acceptance and fewer cases of enacted/experienced stigma at the community level. Additionally, it is expected couples assigned to the Couples Health CoOp Plus (CHC+) intervention will have greater antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) initiation and adherence, lower alcohol and other drug (AOD) use, less sexual risk, less violence, and more positive relationship norms and communication.
Specifically, the study aims to:
Aim 1: Modify the Couples Health CoOp (CHC) intervention to include antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) in a formative phase and with review from the Community Collaborative Board (CCB) and Peer Advisory Board (PAB).
Aim 2: Evaluate the impact of a stigma awareness and education workshop on community members' attitudes and behaviors toward young women and men who use AODs and other people seeking HIV services (testing/ART/PrEP) and other health services at 4- and 8-month follow-up.
Aim 3: Test the efficacy of the Couples Health CoOp Plus (CHC+) to increase both partners' antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) initiation and adherence (primary outcome) and reduce alcohol and other drug (AOD) use, sexual risk and violence, and enhance positive relationship norms and communication relative to HIV testing services (HTS) (secondary outcomes).
Aim 4: Examine through mixed methods the interaction of a stigma awareness and education workshop and the Couples Health CoOp Plus (CHC+) on increased antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) and initiation, retention, and adherence among young women and their primary partners.
Read the 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, violence, 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 relationship 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) 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), relationship norms, violence, 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 were developed and adapted as part of Aim 1 formative activities.
The study enrolled approximately 20 couples in each of the 24 communities in and around Cape Town, South Africa. Communities surrounding healthcare clinics were paired according to community demographic and socioeconomic factors and randomized to one of four arms:
- stigma awareness and education workshop (community) and HIV testing services (HTS)/antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) (couple);
- 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);
- no stigma awareness and education workshop (community) and HIV testing services (HTS)/antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) (couple);
- 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 were not assigned to receive the CHC+ intervention received 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 was conducted at baseline and at 3- and 6-month follow-up.
Assessment of community stigma occurred at baseline with all 24 communities and the stigma awareness and education workshop occurred in only those randomized to it. The follow-up occurred within all communities at 4- and 8-months post-baseline.
- Conditions
- HIV, Substance Use, Stigma, Social
- Being tested
- Community Stigma Awareness and Education Workshop, Couples Health CoOp Plus (CHC+)
- 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
- Medical subject headings
- Substance-Related Disorders, Social Stigma, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Stigma Awareness and Education WorkshopBehavioural
Key aspects of the workshop included community stigma awareness of people living with HIV, use of antiretroviral therapy (ART), pre-exposure prophylaxis (PrEP) for prevention of HIV and attitudes towards people who use alcohol and drugs. The workshop adapted a stigma-reduction curriculum based on a stigma-reduction toolkit and community HIV prevention project with community peers with skits to address stigmatizing attitudes and behaviors toward young women and men who use AODs and who may need health services, including HIV treatment and prevention. Selected modules were modified from the existing clinic-based training to fit community stigma awareness and attitudes to focus on aspects of stigma specific to young women and men who engage in syndemic-related behaviors who live in their communities. The stigma awareness and education workshop was delivered in communities randomized to receive workshops (N=12 communities).
Couples Health CoOp Plus (CHC+)Behavioural
The Couples Health CoOp Plus (CHC+) was adapted from the initial Couples Health CoOp (CHC)-an empowerment-based intervention developed for South African couples that addresses the syndemic of alcohol and other drug (AOD) use, violence, and HIV risk. It is grounded in Social Cognitive Theory and promotes prevention strategies that address the relational context of equality in which sexual risk takes place. The adapted Couples Health CoOp Plus (CHC+) incorporated antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) for a biobehavioral approach with an emphasis on uptake and good adherence (N=12 communities; N=240 couples).
| Study group | Role | What they receive |
|---|---|---|
| Community Stigma Awareness and Education Workshop and HTS/ART/PrEP Only | Experimental | Communities/catchment areas randomized to this arm completed the community stigma assessments and received the community stigma awareness and education workshops. Couples had access to standard HIV testing services (HTS) with antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) but not the Couples Health CoOp Plus (CHC+) intervention. Receives: Behavioral: Community Stigma Awareness and Education Workshop |
| Community Stigma Awareness and Education Workshop and HTS/ART/PrEP with CHC+ | Experimental | Communities/catchment areas randomized to this arm completed the community stigma assessments and received the community stigma awareness and education workshops. Couples had access to the Couples Health CoOp Plus (CHC+) intervention and standard HTS with antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP). Receives: Behavioral: Community Stigma Awareness and Education Workshop; Behavioral: Couples Health CoOp Plus (CHC+) |
| No Community Stigma Awareness and Education Workshop and HTS/ART/PrEP Only | No intervention | Communities/catchment areas randomized to this arm completed the community stigma assessments but did not receive the community stigma awareness and education workshops. Couples had access to standard HIV testing services (HTS) with antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) but not the Couples Health CoOp Plus (CHC+) intervention. |
| No Community Stigma Awareness and Education Workshop and HTS/ART/PrEP with CHC+ | Experimental | Communities/catchment areas randomized to this arm completed the community assessments but not the community stigma awareness and education workshops. Couples had access to the Couples Health CoOp Plus (CHC+) intervention and standard HIV testing services (HTS) with antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP). Receives: Behavioral: Couples Health CoOp Plus (CHC+) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antiretroviral Therapy (ART) Initiation [individual and couple-level]
ART initiation will be measured using initiation information recorded in the participant's clinic medical record.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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+).
Measured: 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+).
Measured: 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).
Measured: 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).
Measured: 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+).
Measured: 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+).
Measured: 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.
Measured: 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.
Measured: 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+).
Measured: 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+).
Measured: 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.
Measured: 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.
Measured: 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+).
Measured: 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+).
Measured: 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.
Measured: 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.
Measured: 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+).
Measured: 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+).
Measured: 6-month follow-up
Secondary outcomes (33)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6-month follow-up
Self-Report: Violence [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).
Measured: Baseline
Self-Report: Violence [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).
Measured: 3-month follow-up
Self-Report: Violence [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).
Measured: 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+).
Measured: 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+).
Measured: 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+).
Measured: 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+).
Measured: 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+).
Measured: 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+).
Measured: 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+).
Measured: 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+).
Measured: 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+).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6-month follow-up
Self-Report: Relationship Norms [individual and couple-level]
Self-reported attitudes about traditional relationship roles, empowerment, and assertiveness will be measured by a modified scale assessing beliefs about relationship norms and the Pretoria Risk Behavior Assessment (PRBA+).
Measured: Baseline
Self-Report: Relationship Norms [individual and couple-level]
Self-reported attitudes about traditional relationship roles, empowerment, and assertiveness will be measured by a modified scale assessing beliefs about relationship norms and the Pretoria Risk Behavior Assessment (PRBA+).
Measured: 3-month follow-up
Self-Report: Relationship Norms [individual and couple-level]
Self-reported attitudes about traditional relationship roles, empowerment, and assertiveness will be measured by a modified scale assessing beliefs about relationship norms and the Pretoria Risk Behavior Assessment (PRBA+).
Measured: 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+).
Measured: 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+).
Measured: 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+).
Measured: 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 stigma items adapted from previous research.
Measured: 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 stigma items adapted from previous research.
Measured: 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 stigma items adapted from previous research.
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start6 May 2022
- Primary completion11 Sep 2025
- Study completion11 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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) were randomly assigned to the four arms of the study (6 communities per arm). Arm 1 received 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 received the stigma awareness and education workshop with HTS/PrEP/ART and CHC+; Arm 3 received neither the stigma awareness and education workshop nor CHC+ but received HTS/PrEP/ART; and Arm 4 received HTS/PrEP/ART and CHC+ but not the stigma awareness and education workshop. All communities received the community stigma assessments at baseline, 4 months, and 8 months follow-up.
- Masking
- None (open label)
- Enrolment
- 962 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, South Africa
- Responsible party
- Principal investigator, Felicia A. Browne, ScD, MPH, RTI International
- Investigators
- Felicia Browne, ScD, MPH, Principal investigator, RTI InternationalTara Carney, PhD, Principal investigator, Medical Research Council, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310773
- Sponsor's protocol ID
- R01DA049612
- Acronym
- CHC+
- Status last verified
- Nov 2025
- First submitted
- 21 Feb 2022
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38848400
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05310773
- Acronym / sponsor ID
- CHC+ / R01DA049612
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 962 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- Medical Research Council, South Africa
- Study start
- 6 May 2022 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study addresses HIV prevention and treatment for young couples living in Cape Town, South Africa, through a comprehensive biobehavioral multilevel approach-the Couples Health CoOp Plus (CHC+).
Through a cluster randomized trial with a modified factorial design, 24 Cape Town communities consisting of catchment areas for clinics that provide antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP), received either a stigma awareness and education workshop or no workshop with repeated measures. Within clinic catchment areas, 481 couples (young women and their primary male sex partners both aged 18 to 30) were recruited. These couples received HIV testing services (HTS) and/or the Couples Health CoOp Plus (CHC+), depending on their intervention arm.
The overarching aim of these interventions is to prevent new cases of HIV. It is hypothesized that communities that are assigned to the stigma awareness and education workshop will demonstrate higher levels of social acceptance and fewer cases of enacted/experienced stigma at the community level. Additionally, it is expected couples assigned to the Couples Health CoOp Plus (CHC+) intervention will have greater antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) initiation and adherence, lower alcohol and other drug (AOD) use, less sexual risk, less violence, and more positive relationship norms and communication.
Specifically, the study aims to:
Aim 1: Modify the Couples Health CoOp (CHC) intervention to include antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) in a formative phase and with review from the Community Collaborative Board (CCB) and Peer Advisory Board (PAB).
Aim 2: Evaluate the impact of a stigma awareness and education workshop on community members' attitudes and behaviors toward young women and men who use AODs and other people seeking HIV services (testing/ART/PrEP) and other health services at 4- and 8-month follow-up.
Aim 3: Test the efficacy of the Couples Health CoOp Plus (CHC+) to increase both partners' antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) initiation and adherence (primary outcome) and reduce alcohol and other drug (AOD) use, sexual risk and violence, and enhance positive relationship norms and communication relative to HIV testing services (HTS) (secondary outcomes).
Aim 4: Examine through mixed methods the interaction of a stigma awareness and education workshop and the Couples Health CoOp Plus (CHC+) on increased antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) and initiation, retention, and adherence among young women and their primary partners.
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, violence, 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 relationship 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) 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), relationship norms, violence, 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 were developed and adapted as part of Aim 1 formative activities.
The study enrolled approximately 20 couples in each of the 24 communities in and around Cape Town, South Africa. Communities surrounding healthcare clinics were paired according to community demographic and socioeconomic factors and randomized to one of four arms:
- stigma awareness and education workshop (community) and HIV testing services (HTS)/antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) (couple);
- 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);
- no stigma awareness and education workshop (community) and HIV testing services (HTS)/antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) (couple);
- 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 were not assigned to receive the CHC+ intervention received 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 was conducted at baseline and at 3- and 6-month follow-up.
Assessment of community stigma occurred at baseline with all 24 communities and the stigma awareness and education workshop occurred in only those randomized to it. The follow-up occurred within all communities at 4- and 8-months post-baseline.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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) were randomly assigned to the four arms of the study (6 communities per arm). Arm 1 received 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 received the stigma awareness and education workshop with HTS/PrEP/ART and CHC+; Arm 3 received neither the stigma awareness and education workshop nor CHC+ but received HTS/PrEP/ART; and Arm 4 received HTS/PrEP/ART and CHC+ but not the stigma awareness and education workshop. All communities received the community stigma assessments at baseline, 4 months, and 8 months follow-up.
| Arm | Type | Receives |
|---|---|---|
| Community Stigma Awareness and Education Workshop and HTS/ART/PrEP Only | Experimental | Behavioral: Community Stigma Awareness and Education WorkshopCommunities/catchment areas randomized to this arm completed the community stigma assessments and received the community stigma awareness and education workshops. Couples had access to standard HIV testing services (HTS) with antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) but not the Couples Health CoOp Plus (CHC+) intervention. |
| Community Stigma Awareness and Education Workshop and HTS/ART/PrEP with CHC+ | Experimental | Behavioral: Community Stigma Awareness and Education Workshop, Behavioral: Couples Health CoOp Plus (CHC+)Communities/catchment areas randomized to this arm completed the community stigma assessments and received the community stigma awareness and education workshops. Couples had access to the Couples Health CoOp Plus (CHC+) intervention and standard HTS with antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP). |
| No Community Stigma Awareness and Education Workshop and HTS/ART/PrEP Only | No intervention | –Communities/catchment areas randomized to this arm completed the community stigma assessments but did not receive the community stigma awareness and education workshops. Couples had access to standard HIV testing services (HTS) with antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) but not the Couples Health CoOp Plus (CHC+) intervention. |
| No Community Stigma Awareness and Education Workshop and HTS/ART/PrEP with CHC+ | Experimental | Behavioral: Couples Health CoOp Plus (CHC+)Communities/catchment areas randomized to this arm completed the community assessments but not the community stigma awareness and education workshops. Couples had access to the Couples Health CoOp Plus (CHC+) intervention and standard HIV testing services (HTS) with antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Stigma Awareness and Education WorkshopKey aspects of the workshop included community stigma awareness of people living with HIV, use of antiretroviral therapy (ART), pre-exposure prophylaxis (PrEP) for prevention of HIV and attitudes towards people who use alcohol and drugs. The workshop adapted a stigma-reduction curriculum based on a stigma-reduction toolkit and community HIV prevention project with community peers with skits to address stigmatizing attitudes and behaviors toward young women and men who use AODs and who may need health services, including HIV treatment and prevention. Selected modules were modified from the existing clinic-based training to fit community stigma awareness and attitudes to focus on aspects of stigma specific to young women and men who engage in syndemic-related behaviors who live in their communities. The stigma awareness and education workshop was delivered in communities randomized to receive workshops (N=12 communities). | Behavioural | Community Stigma Awareness and Education Workshop and HTS/ART/PrEP Only, Community Stigma Awareness and Education Workshop and HTS/ART/PrEP with CHC+ |
| Couples Health CoOp Plus (CHC+)The Couples Health CoOp Plus (CHC+) was adapted from the initial Couples Health CoOp (CHC)-an empowerment-based intervention developed for South African couples that addresses the syndemic of alcohol and other drug (AOD) use, violence, and HIV risk. It is grounded in Social Cognitive Theory and promotes prevention strategies that address the relational context of equality in which sexual risk takes place. The adapted Couples Health CoOp Plus (CHC+) incorporated antiretroviral therapy (ART)/pre-exposure prophylaxis (PrEP) for a biobehavioral approach with an emphasis on uptake and good adherence (N=12 communities; N=240 couples). | Behavioural | Community Stigma Awareness and Education Workshop and HTS/ART/PrEP with CHC+, No Community Stigma Awareness and Education Workshop and HTS/ART/PrEP with CHC+ |
Primary outcome
Antiretroviral Therapy (ART) Initiation [individual and couple-level]
Time frame: 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]
Time frame: 6-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]
Time frame: 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]
Time frame: 6-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]
Time frame: 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]
Time frame: 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).
Self-Report: Antiretroviral Therapy (ART) Adherence [individual and couple-level]
Time frame: 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]
Time frame: 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+).
Biological: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level]
Time frame: 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]
Time frame: 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).
Self-Report: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level]
Time frame: 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]
Time frame: 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+).
Antiretroviral Therapy (ART) Persistence and Discontinuation [individual and couple-level]
Time frame: 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]
Time frame: 6-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]
Time frame: 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]
Time frame: 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+).
Data Extraction: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level
Time frame: 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
Time frame: 6-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]
Time frame: 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]
Time frame: 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+).
Data Extraction: Antiretroviral therapy (ART) Retention
Time frame: 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
Time frame: 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.
Self-Report: Pre-exposure Prophylaxis (PrEP) Retention [individual and couple-level]
Time frame: 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]
Time frame: 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+).
33 secondary outcomes
Community Stigma [structural level]
Time frame: Baseline
Community Stigma [structural level]
Time frame: 4-month follow-up
Community Stigma [structural level]
Time frame: 8-month follow-up
Biological: Drug use [individual level]
Time frame: Baseline
Biological: Drug use [individual level]
Time frame: 3-month follow-up
Biological: Drug use [individual level]
Time frame: 6-month follow-up
Biological: Alcohol use [individual level]
Time frame: Baseline
Biological: Alcohol use [individual level]
Time frame: 3-month follow-up
Biological: Alcohol use [individual level]
Time frame: 6-month follow-up
Self-Report: Violence [individual and couple-level]
Time frame: Baseline
Self-Report: Violence [individual and couple-level]
Time frame: 3-month follow-up
Self-Report: Violence [individual and couple-level]
Time frame: 6-month follow-up
Self-Report: Sexual Risk [individual and couple-level]
Time frame: Baseline
Self-Report: Sexual Risk [individual and couple-level]
Time frame: 3-month follow-up
Self-Report: Sexual Risk [individual and couple-level]
Time frame: 6-month follow-up
Self-Report: Sexual Risk [individual and couple-level]
Time frame: Baseline
Self-Report: Sexual Risk [individual and couple-level]
Time frame: 3-month follow-up
Self-Report: Sexual Risk [individual and couple-level]
Time frame: 6-month follow-up
Self-Report: Sexual Risk [individual and couple-level]
Time frame: Baseline
Self-Report: Sexual Risk [individual and couple-level]
Time frame: 3-month follow-up
Self-Report: Sexual Risk [individual and couple-level]
Time frame: 6-month follow-up
Self-Report: Sexual Risk [individual and couple-level]
Time frame: Baseline
Self-Report: Sexual Risk [individual and couple-level]
Time frame: 3-month follow-up
Self-Report: Sexual Risk [individual and couple-level]
Time frame: 6-month follow-up
Self-Report: Relationship Norms [individual and couple-level]
Time frame: Baseline
Self-Report: Relationship Norms [individual and couple-level]
Time frame: 3-month follow-up
Self-Report: Relationship Norms [individual and couple-level]
Time frame: 6-month follow-up
Self-Report: Communication [individual and couple-level]
Time frame: Baseline
Self-Report: Communication [individual and couple-level]
Time frame: 3-month follow-up
Self-Report: Communication [individual and couple-level]
Time frame: 6-month follow-up
Self-Report: Observed or Knowledge of Stigma [individual and couple-level]
Time frame: Baseline
Self-Report: Observed or Knowledge of Stigma [individual and couple-level]
Time frame: 3-month follow-up
Self-Report: Observed or Knowledge of Stigma [individual and couple-level]
Time frame: 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Background: PubMed 38848400Wechsberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felicia Browne, ScD, MPH principal investigator
RTI International
Tara Carney, PhD principal investigator
Medical Research Council, South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Stigma Awareness and Education Workshop and Couples Health CoOp Plus (CHC+) in people with HIV and Substance Use, run by RTI International at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antiretroviral Therapy (ART) Initiation [individual and couple-level] (time frame: 3-month follow-up). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05310773, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.