Peer Behavioral Activation Utilization to Improve Substance Use and HIV Outcomes in People Receiving Long Acting Injectable-PrEP/ART (PUSH).” - Background. Substance use continues to be a major driver of HIV acquisition and has been associated with suboptimal ART adherence, treatment interruption, and inability to achieve or maintain viral suppression. Though PrEP is a key tool for HIV prevention, awareness, uptake, and adherence are disproportionately lower among people who use drugs. New long-acting injectable (LAI) formulations of PrEP/ART provide a potential biomedical intervention to overcome adherence challenges, however, due to the prolonged subtherapeutic period after LAI discontinuation, ensuring adherence is crucial. A peer-delivered reinforcement-based intervention may be a promising solution for improving LAI adherence. Our team has developed, through several rounds of stakeholder feedback, a peer-delivered behavioral activation and problem-solving intervention, Peer Activate. Peer Activate focuses on problem-solving skills to improve adherence to ART and/or PrEP at multiple levels and includes behavioral activation to promote engagement in rewarding, substance-free activities in one’s environment and structured daily activities to promote treatment adherence. However, Peer Activate has not been evaluated in the context of LAI PrEP/ART. Preliminary Studies. This proposal builds upon our team’s prior studies demonstrating 1) our ability to engage patients with and at risk for HIV and provide LAI PrEP/ART in community-based settings; 2) the feasibility and acceptability of Peer Activate and promise in improving HIV treatment adherence for people who use substances; and 3) promise for cost-effectiveness. Approach. We propose a randomized Type 1 hybrid effectiveness-implementation trial (N=186) to test the effectiveness and implementation of Peer Activate for LAI PrEP/ART (“Peer Activate-LAI”) vs. enhanced treatment as usual for a substance using population living with or at high risk for HIV, evaluating the following over 12 months: (1) Effectiveness: a) LAI PrEP/ART adherence (primary; receipt of all 6 maintenance injections within 7-day window); b) substance use (secondary; urine toxicology, self-report); c) moderators of effectiveness (exploratory); (2) Implementation of Peer Activate-LAI including feasibility, acceptability, fidelity, and adoption guided by RE-AIM and Proctor’s model, assessed using mixed methods, including a rapid ethnographic assessment of how life course factors may affect implementation; and (3) Economic viability of Peer Activate- LAI, including cost of implementation and sustainment and cost-effectiveness from multiple stakeholder perspectives. Implications. This study will inform a potentially scalable, cost-effective model for facilitating effective adherence to LAI formulations of ART/PrEP within substance using populations who to date have had limited support for improving LAI adherence for HIV ART/PrEP.
