JMIR Publications

ABSTRACT

Background:

Globally, a substance use disorder (SUD) treatment gap exists, with treatment gaps highest in settings with the fewest resources. As untreated SUD affects HIV care engagement and outcomes, behavioral interventions to support individuals at highest risk for poor HIV and SUD outcomes are needed in primary care settings. Through several rounds of stakeholder feedback, our team has developed and adapted a six session peer-delivered intervention to improve HIV medication adherence and reduce substance use among people with HIV (PWH) in South Africa—"Khanya”—which includes behavioral activation, problem solving, and mindfulness-based relapse prevention skills. Khanya has demonstrated initial feasibility, acceptability, and preliminary effectiveness for improving antiretroviral therapy (ART) adherence compared to enhanced treatment as usual (ETAU) post-treatment.

Objective:

The aim of the current trial (N=160) is to evaluate a stepped-care approach to delivering Khanya and to evaluate the longer-term effectiveness (on both HIV and SUD treatment outcomes over 12 months), implementation outcomes (acceptability, feasibility, fidelity, and uptake), and cost-effectiveness of the intervention compared to enhanced treatment as usual (ETAU).

Methods:

Guided by the Reach, Effectiveness, Adoption, Implementation, & Maintenance (RE-AIM) framework, the current study aims to test in a hybrid Type 2 effectiveness-implementation trial (N=160) the effectiveness and implementation of a stepped-care approach to delivering Khanya for PWH at highest risk for ongoing ART nonadherence and HIV transmission compared to ETAU over 12 months to improve efficiency of intervention delivery and evaluate cost-effectiveness. Primary patient-level effectiveness outcomes include ART adherence, measured through Wisepill, a real-time electronic adherence monitoring device over 12 months, and substance use, measured via urinalysis and self-report over 12 months. Implementation outcomes include feasibility, acceptability, fidelity, and uptake, assessed over six months. We will also conduct a rigorous economic evaluation examining the costs of implementing/sustaining the intervention, as well as its cost-effectiveness from the healthcare sector and societal perspectives.

Results:

The trail began in June 2023. Data collection and monitoring are ongoing, and final analyses are planned after completion of the intervention phase.

Conclusions:

A stepped-care design to maximize optimal use of resources is a necessary step towards roll-out and scale up of accessible intervention programs for PWH with comorbid SUD globally. This trial will produce key information on the effectiveness, implementation, and cost of a peer-delivered, stepped care intervention integrated into primary care, which can help address the global SUD treatment gap. Clinical Trial: ClinicalTrials.gov identifier: NCT05933226 (https://clinicaltrials.gov/study/NCT05933226). Trial was registered on June 27, 2023