Project Khanya: a randomized, hybrid effectiveness-implementation trial of a peer-delivered behavioral intervention for ART adherence and substance use in Cape Town, South Africa.

Background: Substance use is prevalent in South Africa and associated with poor HIV treatment outcomes, yet, it is largely unaddressed in HIV care. Implementing an evidence-based, task-shared intervention for antiretroviral therapy (ART) adherence and substance use integrated into HIV care may be a feasible and effective way to improve HIV treatment outcomes and reduce substance use in this population. Methods: Guided by the RE-AIM framework, a randomized, hybrid type 1 effectiveness-implementation trial (n = 60) is being used to evaluate a peer-delivered intervention that integrates evidence-based intervention components, including Life-Steps (problem solving and motivational skills for HIV medication adherence), behavioral activation to increase alternative, substance-free rewarding activities in one's environment, and relapse prevention skills, including mindfulness. The comparison condition is enhanced standard of care, which includes facilitating a referral to a local substance use treatment clinic (Matrix). Participants are followed for a period of 6 months. Implementation outcomes are defined by Proctor's model for implementation and include mixed methods evaluations of feasibility, acceptability, and fidelity, and barriers and facilitators to implementation. Primary patient-level effectiveness outcomes are ART adherence (Wisepill) and substance use (WHO-ASSIST and urinalysis); viral load is an exploratory outcome. Discussion: Results of this trial will provide important evidence as to whether peer delivery of an integrated intervention for ART adherence and substance use is feasible, acceptable, and effective. Implementation outcomes will provide important insight into using peers as an implementation strategy to extend task sharing models for behavioral health in resource-limited settings globally. Trial registration: ClinicalTrials.gov identifier: NCT03529409. Trial registered on May 18, 2018