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Search / Trial NCT05933226

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

Launched by UNIVERSITY OF MARYLAND, COLLEGE PARK · Jun 27, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

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

ClinConnect Summary

The clinical trial titled "Project Khanya" is investigating a new support program to help people living with HIV in South Africa stick to their medication and manage their substance use. This program is designed to be delivered by trained counselors who have personal experience with substance use, making them relatable to participants. The study will compare this new approach, called the "Khanya stepped care package," to standard care, which includes referrals to local treatment programs for substance use. The goal is to see if the Khanya program can lead to better health outcomes over a 12-month period.

To be eligible for the trial, participants must be at least 18 years old, HIV positive, and currently taking HIV medication. They should also have a moderate risk of substance use, as measured by a specific questionnaire, and show signs of not taking their HIV medication regularly. However, those with severe addiction issues or untreated mental health conditions that could interfere with the study cannot participate. If you join the trial, you'll receive support tailored to your needs, and your progress will be monitored over the course of the study. This is a chance to receive help and contribute to important research that could benefit others in similar situations.

Gender

ALL

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

About University Of Maryland, College Park

The University of Maryland, College Park, is a leading research institution dedicated to advancing knowledge and innovation in various fields, including health and medicine. As a prominent clinical trial sponsor, the university leverages its extensive resources, interdisciplinary expertise, and commitment to rigorous scientific inquiry to facilitate impactful clinical research. The institution fosters collaborations among faculty, healthcare professionals, and industry partners to enhance patient care and drive advancements in medical science, ensuring compliance with ethical standards and regulatory requirements throughout the research process.

Locations

Cape Town, Western Cape, South Africa

Patients applied

0 patients applied

Trial Officials

Jessica F Magidson, MS, PhD

Principal Investigator

University of Maryland

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported