NCT05933226Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 7 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 27 Jun 2023
- Start date
- Jun 2023
- Primary completion date
- Feb 2027
- Lead sponsor
- University of Maryland, College Park
- Diseases
- HIV
- NCT number
- NCT05933226
What you commit to
- Study type: Interventional
- Planned participants: 160
- From Jun 2023 to the primary completion date, Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Untreated or undertreated major mental illness that would interfere with study procedures
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Cape Town Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.