Peer support program to improve HIV treatment and reduce substance use in South Africa
A Stepped Care, Peer-Delivered Intervention to Improve ART Adherence and SUD in Primary Care
This study is testing a peer support program to see if it can help people in South Africa stick to their HIV treatment and reduce substance use better than standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Maryland, College Park Academic / other |
| Locations | 1 site (Cape Town, Western Cape) |
| Trial ID | NCT05933226 on ClinicalTrials.gov |
What this trial studies
This study evaluates the Khanya intervention, a peer-delivered behavioral program aimed at improving adherence to HIV medication and addressing substance use issues among patients in South Africa. The intervention is implemented by non-specialist counselors who have personal experience with substance use, utilizing a stepped care model within local primary care clinics. Participants will receive the Khanya intervention and be compared to those receiving standard care enhanced with referrals to outpatient substance use treatment over a 12-month period. The study aims to address the significant treatment gap for substance use disorders and HIV care in low-resource settings.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV-positive individuals aged 18 and older who are on antiretroviral therapy and exhibit moderate to high risk for substance use.
Not a fit: Patients with severe opiate dependence or severe alcohol dependence requiring medical management may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve HIV medication adherence and reduce substance use among patients in South Africa.
How similar studies have performed: Other studies have shown success with peer-delivered interventions in similar contexts, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cape Town, Western Cape
- University of Cape Town — Cape Town, Western Cape, South Africa (Recruiting)
Study contacts
- Principal investigator: Jessica F Magidson, MS, PhD — University of Maryland
- Study coordinator: Jessica F Magidson, MS, PhD
- Email: jmagidso@umd.edu
- Phone: 301-405-5095
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.