Project Khanya: results from a pilot randomized type 1 hybrid effectiveness-implementation trial of a peer-delivered behavioural intervention for ART adherence and substance use in HIV care in South Africa.

INTRODUCTION South Africa (SA) has the highest number of people living with HIV (PLWH) globally, and a significant burden of alcohol and other drug use (AOD). Although integrating AOD treatment into HIV care may improve antiretroviral therapy (ART) adherence, this is not typically routine practice in SA or other low-resource settings. Identifying interventions that are feasible and acceptable for implementation is critical to improve HIV and AOD outcomes. METHODS A pilot randomized hybrid type 1 effectiveness-implementation trial (N = 61) was conducted to evaluate the feasibility and acceptability of Khanya, a task-shared, peer-delivered behavioral intervention to improve ART adherence and reduce AOD in HIV care in SA. Khanya was compared to enhanced treatment as usual (ETAU), a facilitated referral to on-site AOD treatment. Implementation outcomes, defined by Proctor's model, included feasibility, acceptability, appropriateness and fidelity. Primary pilot effectiveness outcomes were ART adherence at post-treatment (three months) measured via real-time electronic adherence monitoring, and AOD measured using biomarker and self-report assessments over six months. Data collection was conducted from August 2018 to April 2020. RESULTS AND DISCUSSION Ninety-one percent of participants (n = 56) were retained at six months. The intervention was highly feasible, acceptable, appropriate and delivered with fidelity (>90% of components delivered as intended by the peer). There was a significant treatment-by-time interaction for ART adherence (estimate = -0.287 [95% CI = -0.507, -0.066]), revealing a 6.4 percentage point increase in ART adherence in Khanya, and a 22.3 percentage point decline in ETAU. Both groups evidenced significant reductions in alcohol use measured using phosphatidylethanol (PEth) (F(2,101) = 4.16, p = 0.01), significantly decreased likelihood of self-reported moderate or severe AOD (F(2,104) = 7.02, p = 0.001), and significant declines in alcohol use quantity on the timeline follow-back (F(2,102) = 21.53, p < 0.001). Among individuals using drugs and alcohol, there was a greater reduction in alcohol use quantity in Khanya compared to ETAU over six months (F(2,31) = 3.28, p = 0.05). CONCLUSIONS Results of this pilot trial provide initial evidence of the feasibility and acceptability of the Khanya intervention for improving adherence in an underserved group at high risk for ongoing ART non-adherence and HIV transmission. Implementation results suggest that peers may be a potential strategy to extend task-sharing models for behavioral health in resource-limited, global settings.