Background of Project

South Africa is home to the highest number of people living with HIV globally and is also burdened with a high level of people with substance use disorder (SUD). A SUD treatment gap exists in South Africa, where only 1-4% of individuals who need treatment receive basic treatment. Workforce shortages are a big problem in low and middle-income countries (LMICs), such as SA. The response to this deficit has been to implement task-sharing models, which increase access to ART and basic mental health services. However, previous efforts to implement task-shared SUD and ART adherence interventions that can be feasibly and sustainably integrated into primary care have been limited.

Previous Work 

The proposed study is based on the previous Khanya study, a Type 1 hybrid randomized effectiveness-implementation trial. Although being a mouthful, the study design is championed for its succinct nature. The traditional research pipeline that encourages a staged approach to move an intervention from efficacy trials to the real world can take a long time. To address this issue, hybrid effectiveness-implementation designs are used to promote the assessment of both effectiveness and implementation outcomes within a single study. The initial Khanya study evaluated the feasibility, acceptability, and appropriateness of a task-shared ART and SUD intervention. Findings showed that Khanya significantly improved ART adherence compared to participants referred to the local clinic. Additionally, data further suggested that the intervention is cost-effective, given the stakeholders’ willingness-to-pay for improved ART adherence. 

Design of Study

The proposed study is a type 2 hybrid effectiveness-implementation trial investigating a peer-delivered, stepped-care approach for integrating HIV and SUD services into primary care. The study design is highly resource-sparing, predominantly due to the stepped-care approach. The least resource-intensive part of the intervention will be delivered first and only individuals who do not respond positively receive the second, more comprehensive, resource-intensive part of the intervention. To provide care for those most in need, participants will be patients with HIV who are struggling with ART adherence and have high substance use risk (indicated by the WHO-ASSIST).

Outcome and Aims:

The primary outcome of the study is improved ART adherence and reduced substance use. Additional aims include assessing the implementation of the intervention ( e.g. reach and uptake measure by participant retention, peer fidelity) and estimating cost-effectiveness relative to enhanced standard of care.

This study will make a valuable contribution to test the efficacy of using a peer-led, stepped-care approach to address ART adherence with co-morbid SUD.