Optimizing Low Threshold TelePrEP Care in Syringe Service Programs for People who Inject Drugs in Appalachia

ABSTRACT Kentucky’s HIV epidemic displays an especially profound and disproportionate impact among people who inject drugs (PWID): 14.8% of males and 54.2% of females newly diagnosed with HIV in 2021 have an injection drug use-related transmission factor, far exceeding the national average for this exposure category. Notably, KY is home to eight of the top ten counties ranked most vulnerable to the rapid dissemination of HIV among PWID, all of which are rural Appalachian communities that experience critical disparities in availability and provision of HIV-related services. A central pillar of Ending the HIV Epidemic (EHE) is the prevention of new HIV infections through scale up of Pre-Exposure Prophylaxis (PrEP) in key populations. For PWID, PrEP uptake remains severely limited, less than 1% by some estimates, and no evidence-based or evidence- informed PrEP interventions specifically targeted for PWID are available. PWID are impacted by structural barriers to PrEP care, and in rural areas, limited availability of HIV specialty services further restricts access to PrEP. In our ongoing R34 in KY’s Appalachian region, we successfully implemented two brief, low-intensity interventions to promote linkage to co-located PrEP care in rural syringe service programs (SSPs), including a newly adapted strengths-based case management (SBCM-PrEP) intervention designed to address multi-level barriers to PrEP initiation. Our pilot trial has demonstrated proof of concept for integrated PrEP care within rurally-located SSPs and high acceptability among PWID: 96% of PWID participants entered the PrEP care cascade by attending at least one PrEP intervention session, and 86% completed an initial PrEP clinical visit and point of care testing for PrEP eligibility. Nevertheless, just 51% returned for test results, and 28% progressed to PrEP prescription, indicating that augmented intervention support is required to optimize PrEP uptake. Building on this strong foundation, the proposed study will deploy stepped-care adaptive interventions in three rural SSPs in a Sequential Multiple Assignment Randomized Trial (SMART) design to test the optimal intervention pathways for PrEP uptake, defined as PrEP initiation (measured by dispensed prescription for oral PrEP) and persistence in PrEP care (measured by refill verification and biomarker confirmation). The Specific Aims are to: 1: Compare the relative effectiveness of adaptive interventions (AIs) that begin with Peer-led SBCM-PrEP versus those that begin with CDC PrEP education plus text messaging (TM) on patient-level PrEP care outcomes (initiation and persistence) at 1-, 3- and 6-months; 2: Estimate and rank the effectiveness of the four embedded AIs on PrEP care outcomes at 3- and 6-months: (1) CDC PrEP education, continue TM for responders, add mobile outreach for non-responders (NR); (2) CDC PrEP education, continue TM for responders, add peer transitional SBCM for NR; (3) Peer-led SBCM, continue TM for responders, add mobile outreach for NR; (4) Peer-led SBCM, continue TM for responders, add peer transitional SBCM for NR; and, 3: Across interventions, examine the effects of age, baseline injection frequency, perceived HIV risk, PrEP interest, SSP utilization patterns, and other factors, in predicting PrEP care outcomes at 1-, 3- and 6-months to inform optimally-tailored intervention strategy recommendations for PWID subgroups. Directly informed by our pilot trial, our SMART design is poised to identify the optimal combination and sequencing of intervention components required to achieve the greatest likelihood of PrEP initiation. This project will increase the number of rural PWID who benefit from integrated PrEP care within SSPs by testing four embedded AIs that address early disengagement from care.