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

May 5, 2026 updated by: University of Maryland, College Park

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa
        • University of Cape Town

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Khanya
"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.
No Intervention: Enhanced Standard of Care (ESOC)
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Self-Reported Substance Use
Time Frame: 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.
Assessed from baseline across 3-, 6-, and 12-month assessments
Biological Measure of Adherence
Time Frame: Assessed from baseline across 3-, 6-, and 12-month assessments
Biomarker-confirmed ART adherence will be measured with Dried Blood Spot (DBS) testing
Assessed from baseline across 3-, 6-, and 12-month assessments
HIV Clinic Attendance
Time Frame: 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).
Assessed from baseline across 3-, 6-, and 12-month assessments
HIV Viral Load
Time Frame: Assessed from baseline across 6-, and 12-month assessments
Percentage of patients with a detectable viral load
Assessed from baseline across 6-, and 12-month assessments
Employment Status Questionnaire
Time Frame: 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.
Assessed from baseline across 3-, 6-, and 12-month assessments

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability using a quantitative assessment based on RE-AIM
Time Frame: 3-month assessment
15-item acceptability subscale of a pragmatic, quantitative assessment based on RE-AIM developed by the Applied Mental Health Research group (AMHR) at Johns Hopkins University. Total scores are averaged across all items and range from 0 to 3. Higher scores indicate greater acceptability.
3-month assessment
Feasibility using a quantitative assessment based on RE-AIM
Time Frame: 3-month assessment
16-item feasibility subscale of a pragmatic, quantitative assessment based on RE-AIM developed by the Applied Mental Health Research group (AMHR) at Johns Hopkins University. Total scores are averaged across all items and range from 0 to 3. Higher scores indicate greater acceptability.
3-month assessment
Implementation Fidelity
Time Frame: From baseline over 6-months
Independent fidelity ratings of a randomly selected subset (20%) of intervention sessions using a fidelity assessment developed for each session that includes 15-19 items that map onto each core intervention component, and factors unique to the peer delivery implementation strategy (i.e., appropriate self-disclosure, stigmatizing behaviors, common factors including warmth and non-judgment).
From baseline over 6-months
Uptake
Time Frame: From baseline over 6-months
Uptake will be measured as an implementation outcome, including the % of patients who initiate treatment and treatment attendance.
From baseline over 6-months
Health-Related Quality of Life assessed by EQ-5D
Time Frame: Assessed from baseline across 3-, 6-, and 12-month assessments
Health-related quality of life (HRQoL) will be measured with the EQ-5D which is the most widely used of the major HRQoL instruments capable of generating a single health utility index value to calculate quality-adjusted life-years (QALYs), and one of the most sensitive to changes in pain, physical and mental health functioning. This instrument measures HRQoL across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Assessed from baseline across 3-, 6-, and 12-month assessments
CD4 Count
Time Frame: Assessed from baseline across 6-, and 12-month assessments
Absolute CD4 value in the blood to measure immune function and disease progression
Assessed from baseline across 6-, and 12-month assessments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, College Park

Collaborators

National Institute on Drug Abuse (NIDA)
University of Miami
Weill Medical College of Cornell University
University of Cape Town

Investigators

  • Principal Investigator: Jessica F Magidson, MS, PhD, University of Maryland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2023

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

June 27, 2023

First Submitted That Met QC Criteria

June 27, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 077/2022
  • R01DA056102 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After all primary analyses are complete, de-identified data will be uploaded to an NIH-supported data repository and available by request with appropriate permissions from PI.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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