HIV/AIDS Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Antiretroviral Therapy (ART) Initiation [individual and couple-level] ART initiation will be measured using initiation information recorded in the participant’s clinic medical record. ;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
| Measure | Time frame |
|---|---|
| Community Stigma [structural level] Surveys will be used to measure stigmatizing attitudes and perceptions towards people who use alcohol and other drugs (AODs), living with HIV and seeking and antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) services for prevention. Greater values indicate higher levels of community-level stigma and discrimination. ;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
senior administrator