A Hybrid Implementation-Effectiveness Study of the Pharmacist, Physician, and Patient Navigator Collaborative Care Model to cure Hepatitis C among persons who use drugs with housing insecurity

ABSTRACT Providing access to medications for persons with active substance use and housing insecurity is a remaining challenge to achieving the national goal of HCV elimination by 2030. Our pharmacist-led collaborative care model is designed to offer low-barrier syndemic care, including direct-acting antivirals (DAAs) for hepatitis C to people who use drugs (PWUD) in the community. Through our prior NIDA grant (1R34DA047660), we developed and pilot-tested the “Pharmacist, Physician, Patient Navigator Collaborative Care Model” (PPP- CCM) approach for expanding access to DAAs. Guided by the RE-AIM framework, we will conduct a pragmatic implementation trial using a parallel-group, cluster randomized design to evaluate PPP-CCM’s ability to improve access to DAAs for HCV within a network of supportive housing units in Seattle and King County. We will enroll 16 units, each housing 40-190 individuals, and randomize half of the units to receive point-of-care (POC) HCV screening plus PPP-CCM versus POC HCV screening alone (control) for 12 months, after which we will implement the intervention in control arm units as well. We will evaluate the implementation measures based on RE-AIM (Reach, Adoption, Effectiveness and Maintenance) as well as other clinical outcomes and substance use/HIV behaviors among the two arms. Additionally, we will conduct qualitative research to better understand barriers and facilitators to implementation and maintenance which will inform the development of a toolkit for dissemination to other supportive housing units throughout the state and country.