RecruitingNot ApplicableNCT05933226

Project Khanya: Peer-Delivered Intervention to Improve HIV Medication Adherence and Substance Use in South Africa

A Stepped Care, Peer-Delivered Intervention to Improve ART Adherence and SUD in Primary Care

Sponsor

University of Maryland, College Park

Enrollment

160 participants

Start Date

Jun 21, 2023

Study Type

INTERVENTIONAL

Conditions

Substance Use Drug Use Human Immunodeficiency Virus Alcohol-Related Disorders

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria6

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

Interventions

BEHAVIORALKhanya

"Khanya" is a peer-delivered, behavioral intervention to improve HIV medication adherence and reduce problematic SUD symptoms. Participants will either receive Khanya Step 1 or if they continue to struggle with ART adherence, they will be stepped up to the more intensive intervention, Khanya Step 2.