Project Khanya: Peer-Delivered Intervention to Improve HIV Medication Adherence and Substance Use in South Africa
Human Immunodeficiency Virus, Alcohol-Related Disorders, Drug Use
About this trial
This is an interventional health services research trial for Human Immunodeficiency Virus focused on measuring Immunologic Deficiency Syndrome, Substance Use, Acquired Immunodeficiency Syndrome, Immune system diseases, behavioral symptoms, RNA Virus Infections, HIV Infections, Alcohol Use, Drug Use, Treatment Adherence and Compliance, Delivery and Health Care, Task Sharing, Mental Health, Global Health, South Africa, Cost Effectiveness, Implementation Science
Eligibility Criteria
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
Sites / Locations
- University of Cape TownRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Khanya
Enhanced Standard of Care (ESOC)
Khanya is a peer-delivered, behavioral intervention to improve HIV medication adherence and reduce problematic SUD symptoms. Khanya is delivered as a stepped-care package in which the least resource-intensive part of the intervention (i.e., Life-Steps, a single session problem solving intervention for HIV medication adherence) will be delivered first. Only individuals randomized to the Khanya intervention who are still struggling with HIV medication adherence after the first session will be stepped up to receive the more comprehensive, resource-intensive part of the intervention (i.e., six additional sessions of the intervention). Khanya Step 2 includes evidence-based treatment components to improve ART adherence and SU, including motivational interviewing, behavioral activation, and mindfulness-based relapse prevention strategies, which have previously been piloted in this community.
Enhanced Standard of Care (ESOC) includes the local standard of care, which is referral to a free local outpatient substance use treatment program, enhanced with facilitated referrals. To enhance the standard of care, study staff will provide participants with a detailed description of the program's referral process and offer to help the participant set up an intake at the program. Additionally, the team will follow up on the referral. Participants in this arm will also receive Wisepill, a wireless adherence monitoring advice, at the baseline assessment.