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Couples Health CoOp Plus ( CHC+ )

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202205640398485
Enrollment
3288
Registered
2022-05-09
Start date
2022-05-06
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS Mental and Behavioural Disorders

Interventions

community stigma awareness and education workskhop
community stigma awareness and education workshop and CHC Plus
No intervention
Couples Health CoOp Plus

Sponsors

RTI International
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Antiretroviral Therapy (ART) Initiation [individual and couple-level] ART initiation will be measured using initiation information recorded in the participant’s clinic medical record. ;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. ;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). ;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+). ;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). ;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+). ;Antiretroviral Therapy (ART) Persistence and Discontinuation [individual and couple-level] Number of antiretroviral therapy (ART) refills since initiation recorded in clinic medical records. ;Self-Report: Antiretroviral therapy (ART) Persistence and Discontinuation [individu

Secondary

MeasureTime frame
Community Stigma [structural level] Surveys will be used to measure stigmatizing attitudes and perceptions towards people who use alcohol and other drugs (AODs), living with HIV and seeking and antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) services for prevention. Greater values indicate higher levels of community-level stigma and discrimination. ;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. ;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. ;Self-Report: Gender-Based Violence (GBV) [individual and couple-level] Self-report emotional, physical, and sexual abuse, recent victimization, and family violence & experience of physical & sexual abuse will be measured using the World Health Organization (WHO) assessment of emotional, physical, & sexual abuse and the Revised Risk Behavior Assessment (RRBA). ;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+). ;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+). ;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+). ;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

Countries

South Africa

Contacts

Public ContactBelinda Chamberlain

senior administrator

belinda.chamberlain@mrc.ac.za279380947

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026