NCT05310773

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), 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
962

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started May 2022

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 6, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2025

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

3.4 years

First QC Date

February 21, 2022

Last Update Submit

November 19, 2025

Conditions

HIVSubstance UseStigma, Social

Keywords

Pre-exposure prophylaxis (PrEP)Antiretroviral therapy (ART)Alcohol and other drugs (AODs)Human Immunodeficiency Virus (HIV)CouplesSubstance useStigmaCouples Health CoOp (CHC)South AfricaUndetectable=Untransmittable (U=U)Status-neutral

Outcome Measures

Primary Outcomes (24)

  • Antiretroviral Therapy (ART) Initiation [individual and couple-level]

    ART initiation will be measured using initiation information recorded in the participant's clinic medical record.

    3-month follow-up

  • Antiretroviral Therapy (ART) Initiation [individual and couple-level]

    ART initiation will be measured using initiation information recorded in the participant's clinic medical record.

    6-month follow-up

  • Pre-Exposure Prophylaxis (PrEP) Initiation [individual and couple-level]

    Pre-exposure prophylaxis (PrEP) initiation will be measured using initiation information recorded in the participant's clinic medical record.

    3-month follow-up

  • Pre-Exposure Prophylaxis (PrEP) Initiation [individual and couple-level]

    Pre-exposure prophylaxis (PrEP) initiation will be measured using initiation information recorded in the participant's clinic medical record.

    6-month follow-up

  • Biological: Antiretroviral Therapy (ART) Adherence [individual and couple-level]

    ART adherence will be measured using viral load or cluster of differentiation 4 (CD4) count measures recorded in the participant's medical record. Threshold for adherence will be cluster of differentiation 4 (CD4) count (more than 200) and HIV viral load (less than 50 copies per ml).

    3-month follow-up

  • Biological: Antiretroviral Therapy (ART) Adherence [individual and couple-level]

    ART adherence will be measured using viral load or cluster of differentiation 4 (CD4) count measures recorded in the participant's medical record. Threshold for adherence will be cluster of differentiation 4 (CD4) count (more than 200) and HIV viral load (less than 50 copies per ml).

    6-month follow-up

  • Self-Report: Antiretroviral Therapy (ART) Adherence [individual and couple-level]

    Self-report past 30-day use, missed doses and patterns of use of antiretroviral therapy (ART) for self-report adherence will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).

    3-month follow-up

  • Self-Report: Antiretroviral Therapy (ART) Adherence [individual and couple-level]

    Self-report past 30-day use, missed doses and patterns of use of antiretroviral therapy (ART) for self-report adherence will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).

    6-month follow-up

  • Biological: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level]

    Tenofovir Diphosphate (TFV-DP) and FTC Triphosphate (FTC-TP) concentrations in dried blood spots (DBS) with drug concentrations of greater than 700 femtomoles (fmol)/liters(L) will be considered adherent to pre-exposure prophylaxis (PrEP).

    3-month follow-up

  • Biological: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level]

    Tenofovir Diphosphate (TFV-DP) and FTC Triphosphate (FTC-TP) concentrations in dried blood spots (DBS) with drug concentrations of greater than 700 femtomoles (fmol)/liters(L) will be considered adherent to pre-exposure prophylaxis (PrEP).

    6-month follow-up

  • Self-Report: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level]

    Self-report past 30-day use, missed doses and patterns of use of pre-exposure prophylaxis (PrEP) for self-report adherence will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).

    3-month follow-up

  • Self-Report: Pre-Exposure Prophylaxis (PrEP) Adherence [individual and couple-level]

    Self-report past 30-day use, missed doses and patterns of use of pre-exposure prophylaxis (PrEP) for self-report adherence will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).

    6-month follow-up

  • Antiretroviral Therapy (ART) Persistence and Discontinuation [individual and couple-level]

    Number of antiretroviral therapy (ART) refills since initiation recorded in clinic medical records.

    3-month follow-up

  • Antiretroviral Therapy (ART) Persistence and Discontinuation [individual and couple-level]

    Number of antiretroviral therapy (ART) refills since initiation recorded in clinic medical records.

    6-month follow-up

  • Self-Report: Antiretroviral therapy (ART) Persistence and Discontinuation [individual and couple-level]

    Self-reported time in months on antiretroviral therapy (ART) since initiation will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).

    3-month follow-up

  • Self-Report: Antiretroviral therapy (ART) Persistence and Discontinuation [individual and couple-level]

    Self-reported time in months on antiretroviral therapy (ART) since initiation will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).

    6-month follow-up

  • Data Extraction: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level

    Number of pre-exposure prophylaxis (PrEP) refills since initiation as recorded clinic medical records.

    3-month follow-up

  • Data Extraction: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level

    Number of pre-exposure prophylaxis (PrEP) refills since initiation as recorded clinic medical records.

    6-month follow-up

  • Self-Report: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level]

    Self-reported time in months on pre-exposure prophylaxis (PrEP) since initiation on pre-exposure prophylaxis (PrEP) will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).

    3-month follow-up

  • Self-Report: Pre-Exposure Prophylaxis (PrEP) Persistence and Discontinuation [individual and couple-level]

    Self-reported time in months on pre-exposure prophylaxis (PrEP) since initiation on pre-exposure prophylaxis (PrEP) will be measured using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).

    6-month follow-up

  • Data Extraction: Antiretroviral therapy (ART) Retention

    Antiretroviral therapy (ART) retention in care will be measured as attendance to follow-up visits as recorded in clinic medical records.

    3-month follow-up

  • Data Extraction: Antiretroviral therapy (ART) Retention

    Antiretroviral therapy (ART) retention in care will be measured as attendance to follow-up visits as recorded in clinic medical records.

    6-month follow-up

  • Self-Report: Pre-exposure Prophylaxis (PrEP) Retention [individual and couple-level]

    Self-report pre-exposure prophylaxis (PrEP) retention in care will be measured as attendance to follow-up visits using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).

    3-month follow-up

  • Self-Report: Pre-exposure Prophylaxis (PrEP) Retention [individual and couple-level]

    Self-report pre-exposure prophylaxis (PrEP) retention in care will be measured as attendance to follow-up visits using the Revised Risk Behavior Assessment (RRBA)/Pretoria Risk Behavior Assessment (PRBA+).

    6-month follow-up

Secondary Outcomes (33)

  • Community Stigma [structural level]

    Baseline

  • Community Stigma [structural level]

    4-month follow-up

  • Community Stigma [structural level]

    8-month follow-up

  • Biological: Drug use [individual level]

    Baseline

  • Biological: Drug use [individual level]

    3-month follow-up

  • +28 more secondary outcomes

Study Arms (4)

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.

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).

Behavioral: Community Stigma Awareness and Education WorkshopBehavioral: 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).

Behavioral: Couples Health CoOp Plus (CHC+)

Interventions

Community Stigma Awareness and Education WorkshopBEHAVIORAL

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).

Community Stigma Awareness and Education Workshop and HTS/ART/PrEP OnlyCommunity Stigma Awareness and Education Workshop and HTS/ART/PrEP with CHC+
Couples Health CoOp Plus (CHC+)BEHAVIORAL

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).

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+

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South African Medical Research Council

Cape Town, Western Cape, 7500, South Africa

Location

Related Publications (1)

  • 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.

    PMID: 38848400BACKGROUND

MeSH Terms

Conditions

Substance-Related DisordersSocial StigmaAcquired Immunodeficiency Syndrome

Interventions

Clathrin Heavy Chains

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersSocial BehaviorBehaviorHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

ClathrinVesicular Transport ProteinsMembrane ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Felicia Browne, ScD, MPH

    RTI International

    PRINCIPAL INVESTIGATOR

  • Tara Carney, PhD

    Medical Research Council, South Africa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Social Epidemiologist

Study Record Dates

First Submitted

February 21, 2022

First Posted

April 5, 2022

Study Start

May 6, 2022

Primary Completion

September 11, 2025

Study Completion

September 11, 2025

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)