Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky

Rural areas in the United States are increasingly impacted by HIV, tied to the ongoing opioid epidemic, growing stimulant use, and widespread drug injection. Kentucky (KY) is among seven states identified with heavy rural HIV burden and increasing rates of new HIV diagnoses attributable to injection drug use. Rural HIV outbreaks among people who inject drugs (PWID) have occurred recently in KY’s neighboring states, highlighting the urgent need to implement proven HIV prevention and harm reduction strategies for PWID in KY’s rural areas. A key pillar of Ending the HIV Epidemic (EHE): A Plan for America is the prevention of new HIV infections through scale up of evidence-based interventions, including syringe service programs (SSPs) and Pre-exposure prophylaxis (PrEP). Our R21 in KY’s Appalachian region demonstrated consistent utilization of rurally located SSPs by high-risk PWID, making SSPs a critical venue to scale delivery of comprehensive HIV prevention services in rural areas. In a prior RCT conducted by the PI of this application, strengths-based case management (SBCM) interventions were shown to be effective in increasing HIV testing and overcoming barriers to medical care among people who use drugs. Building on this prior work and our ongoing collaboration with rural SSPs in KY, this R34 will adapt and integrate a novel PrEP initiation intervention at point of care in rural SSPs, in two KY counties that are among the nation’s top 10 most vulnerable to HIV among PWID, and conduct a preliminary test of its efficacy. The Specific Aims are to: 1) Assess client, provider, and organization-level facilitators and barriers to integration of a PrEP focused SBCM (SBCM-PrEP) intervention into routine SSP practice. Guided by the PRISM model, we will conduct semi-structured key informant interviews with PWID, clinical care and harm reduction service providers, and facility administrators in our targeted SSP implementation locations, to identify individual and organizational challenges and opportunities to adapt the SBCM-PrEP to enhance client acceptability and compatibility with clinical workflow; 2) Adapt an evidence-based SBCM protocol to provide PrEP intervention services for PWID in SSP sites. Using in-depth interview data from Aim 1, we will adapt, refine and incorporate HIV prevention content most salient to PrEP care into the SBCM-PrEP, following the ADAPT ITT framework; and, 3) Examine feasibility, acceptability and preliminary efficacy of the adapted SBCM-PrEP. 80 participants will be randomized into two conditions for a pilot RCT: CDC-PrEP (an in-use PrEP intervention based on CDC guidelines), or SBCM-PrEP. Primary outcomes will focus on feasibility and acceptability of the intervention, and preliminary efficacy measured by initiation of PrEP 3- and 6- months post-baseline. The proposed study fills a gap in evidence for PrEP studies among rural PWID by testing brief interventions that address both individual and structural challenges to PrEP uptake through an integrated, point of care service delivery model