JMIR Research Protocols · Published 2026-07-02 · DOI 10.2196/94153
Jessica F Magidson, Abigail C Hines, Sybil Hlombekazi Majokweni, Lwandile Tokwe, Bronwyn Myers, Stefani Du Toit, Kristen Regenauer, Lena S Andersen, Warren Burnhams, Catherine Orrell, Sean M Murphy, Goodman Sibeko, Noah Triplett, Esonasethu Ndwandwa, Neliswa Naledi Kotelo, Tianzhou Ma, Steven A. Safren, John Joska
Abstract BackgroundA substance use disorder (SUD) treatment gap exists globally, with the greatest gaps in settings with the fewest resources. Integrating SUD care into primary care is needed to expand access to SUD care and support adherence to chronic disease services, especially HIV, in high-burden areas. Guided by stakeholder feedback, our team has previously adapted and piloted a peer-delivered behavioral intervention for antiretroviral therapy (ART) adherence for people with HIV and SUD in HIV care (“Khanya ObjectiveThis study builds upon prior work to conduct a fully powered, randomized hybrid type 2 effectiveness-implementation trial (n=160) to evaluate the effectiveness of a stepped-care model of Khanya MethodsThe trial is being conducted at two public primary care clinics that integrate HIV and other chronic disease services in a high-prevalence HIV setting in South Africa. We are recruiting people with HIV who self-report SUD and demonstrate one or more indicators of ART nonadherence. Eligible participants are randomized 1:1 to KhanyaKhanyaKhanya ResultsFunded in August 2022, recruitment for the trial began in June 2023, and primary data collection is projected to be completed in February 2027. Recruitment for the clinical trial (n=162) was completed in March 2026. It is projected that all exit interviews will be completed by March 2027. ConclusionsThis trial builds upon formative work to evaluate the effectiveness, implementation, and cost of a peer-delivered, stepped care intervention integrated into primary care. A stepped-care design to maximize optimal use of resources and integration into primary care is a necessary step to increase accessible intervention programs for people with HIV with comorbid SUD globally.
Abstract from DOAJ. Public domain (CC0 1.0).
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Magidson, J., Hines, A., Majokweni, S., et al. (2026). A Stepped Care, Peer-Delivered Intervention to Improve Substance Use and HIV Medication Adherence in Primary Care in South Africa (Project Khanya): Protocol for a Hybrid Type 2 Effectiveness-Implementation Randomized Controlled Trial. JMIR Research Protocols. https://doi.org/10.2196/94153