NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: University of Maryland, College Park
Conditions: Human Immunodeficiency Virus, Alcohol-Related Disorders, Drug Use, Substance Use
Interventions: Khanya
Countries: South Africa
The purpose of this study is to evaluate a stepped care behavioral intervention for HIV medication adherence and substance use ("Khanya") integrated into an HIV primary care setting in South Africa. The intervention is specifically designed to be implemented by non-specialist counselors with lived substance use experience (i.e., peers), using a task sharing, stepped care model in local primary care clinics. The Khanya stepped care package will be compared to usual care, enhanced with referral to a local outpatient substance use treatment program (Enhanced Standard of Care - ESOC) over 12 months.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * HIV positive and on ART * ≥18 years of age * At least moderate substance use risk in the past 3 months for at least one non-tobacco substance (measured by the WHO- ASSIST: score ≥11 for alcohol, ≥4 for non-tobacco drugs) * ART nonadherence and/or risk of virologic failure, defined as at least one of the following in the past 12 months 1) re-engaging in care after ≥1 month of being out of care (confirmed by pharmacy refill data) 2) ≥1 episodes of VL \>400 copies/mL 3) on second- or third-line ARTs. Exclusion Criteria: * Severe risk/likely dependence for opiates (WHO ASSIST score \>26) because opiate substitution therapy is largely not available * Severe alcohol dependence symptoms that may warrant medical management of potential withdrawal symptoms/stabilization prior to study participation * Inability to provide informed consent or complete study procedures in isiXhosa or English * In third trimester of pregnancy during baseline * Currently enrolled in another study or treatment program focused on substance use (including Matrix) or ART adherence. * Untreated or undertreated major mental illness that would interfere with study procedures
- Cape Town, Western Cape, South Africa