Prescribe to Prevent HIV

In the U.S., the 3.6 million people who inject drugs (PWID) are facing an urgent preventable health crisis of rising severe injection-related infections (SIRI), including HIV, due to limited access to two high-priority harm reduction evidence-based interventions: sterile injection equipment and daily oral Pre-exposure prophylaxis (PrEP). Many PWID lack access due to shortages of syringe service programs and clinicians willing to prescribe these interventions. For instance, PWI D in Pennsylvania experienced a 150% rise in acute HIV infections from 2016 to 2019, and a 250% rise in SIR I-related hospitalizations since 2010. Outpatient clinics provide a more accessible venue for implementing harm reduction interventions, and research shows that prescribing injection equipment and PrEP in these settings can reduce SI RI-related hospitalizations by 30% and enhance PrEP uptake among PWID. However, most outpatient clinicians do not offer either, exacerbating the evidence-to-implementation gap and contributing to the ongoing crisis. The "Prescribe to Prevent HIV' (P2PH) trial, aims to co-create and pilot test a strategy bundle for prescribing injection equipment and PrEP across four Pennsylvania Centers of Excellence (COEs) outpatient clinics, integrating implementation science with human-centered design while engaging a community collaborative of individuals with lived experience, clinicians, and community organizations serving PWID throughout all study phases. This will be achieved through two independent aims: Aim 1 focuses on developing a multi-level implementation strategy bundle by identifying barriers and facilitators through 24 semi-structured interviews using the Consolidated Framework for Implementation Research, followed by co-creating the bundle through a user-centric design approach during four focus groups with COE patients and clinical partners. Aim 2 involves pilot testing the implementation bundle in a cluster-randomized, waitlist-controlled design to assess clinician adoption and maintenance of prescribing injection equipment and PrEP, alongside secondary outcomes like SI RI-related hospitalizations and negative HIV tests. Completion of these aims will lay the groundwork for a fully powered cluster-randomized hybrid type 3 trial to test implementation strategies to sustainably enhance outpatient clinic-based prescribing of injection equipment and PrEP for PWID. This proposal will be supported by strong institutional backing and a dedicated mentorship team, along with coursework and experiential learning focused on the methodological and conceptual aspects of conducting research in community-engaged implementation science and clinical trials. Together, these research and career development plans will support my long-term career goal of becoming an independent clinician-investigator and a leading national expert in the implementation of harm reduction evidenced-based interventions in general medical settings.