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

Not Applicable

Recruiting

• Conditions: Alcohol-Related Disorders; Human Immunodeficiency Virus; Drug Use; Substance Use
• Interventions: Behavioral: Khanya

• Registration Number: NCT05933226
• Lead Sponsor: University of Maryland, College Park

Brief 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.

Detailed Description

South Africa is home the highest number of people living with HIV in the world and has a high burden of substance use disorder (SUD). Globally, a SUD treatment gap exists, particularly in low and middle-income countries (LMICs), such as South Africa, where only 1-4% of individuals receive minimally adequate treatment. Workforce shortages are also severe in LMICS, and countries such as South Africa have responded to this through the implementation of task sharing models to expand access to antiretroviral therapy (ART) and mental health services. However, efforts to implement task shared, SUD treatment and ART adherence interventions that can be feasibly and sustainably integrated into primary care are limited. Therefore, the purpose of this study is to help fill this gap in care by evaluating Khanya, a peer-delivered, behavioral intervention to improve HIV care outcomes and reduce substance use. The present study is a hybrid effectiveness-implementation trial designed to evaluate Khanya compared to usual care, enhanced with referral to a local outpatient substance use treatment program (Enhanced Standard of Care - ESOC) over 12 months. To provide care for those most in need, participants will be patients with HIV who are struggling with ART adherence and have elevated SUD risk. In this study, Khanya will be delivered as a stepped-care package in which the least resource-intensive part of the intervention (i.e., 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). Primary effectiveness outcomes in this clinical trial include ART adherence and SUD outcomes.

Study Timeline

• Study Start: 2023-06-21
• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-07-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23
• Primary Completion: 2026-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Khanya	Khanya	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 SUD, including motivational interviewing, behavioral activation, and mindfulness-based relapse prevention strategies, which have previously been piloted in this community.

Primary Outcome Measures

Name	Time	Method
Changes in HIV Medication Adherence	Assessed from baseline through 12-month assessment	Percentage of prescribed antiretroviral therapy (medications) taken as measured by real time wireless monitoring device (Wisepill)
Biological Measure of Substance Use	Assessed from baseline across 3-, 6-, and 12-month assessments	Biomarker-verified substance use

Secondary Outcome Measures

Name	Time	Method
Biological Measure of Adherence	Assessed from baseline across 3-, 6-, and 12-month assessments	Biomarker-confirmed ART adherence will be measured with Dried Blood Spot (DBS) testing
HIV Clinic Attendance	Assessed from baseline across 3-, 6-, and 12-month assessments	Number of days participants in each condition were on-time to, late to, or missed an HIV clinic appointment (extracted from clinic records).
Changes in Self-Reported Substance Use	Assessed from baseline across 3-, 6-, and 12-month assessments	Self-reported substance use will be assessed primarily by the World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHO-ASSIST). It is a measure used to assess substance use risk for alcohol, cannabis, cocaine, opiates, and amphetamines, hallucinogens, and other drugs. Standardized cutoff scores are used to categorize risk levels: low risk (0-3 for illicit drugs/0-10 for alcohol), moderate risk (4-26 for illicit drugs/11-26 for alcohol), or high risk (\> 26) for substance use-related problems.
Employment Status Questionnaire	Assessed from baseline across 3-, 6-, and 12-month assessments	Employment status of the participant with a range of locally appropriate response options including, but not limited to: working full-time, working part-time, unemployed or laid off and looking for work, in school or training, retired, disabled, in the military.
HIV Viral Load	Assessed from baseline across 6-, and 12-month assessments	Percentage of patients with a detectable viral load

Trial Locations

Locations (1)

University of Cape Town; 🇿🇦 Cape Town, Western Cape, South Africa