Leveraging Pharmacy Technicians to Advance the Reach of Modern Antiretroviral Therapy (PHARM ART) in Community Clinics - PROJECT SUMMARY The overarching goal of this proposal is to integrate a pharmacy-technician based model for delivering long- acting injectable cabotegravir-rilpivirine (LA-CAB/RPV) into community-based federally qualified health centers (FQHCs) that care for underserved people with HIV (PWH). LA-CAB/RPV, given every 4 or 8 weeks, is a novel HIV treatment option that positively impacts quality of life and has been shown to improve viral suppression in PWH with adherence challenges. However, rollout has been slow due to complex delivery logistics such as navigating insurance coverage and procuring medication from designated specialty pharmacies. Despite strong interest from PWH and providers, this complexity has prevented many FQHCs, which provide HIV care regardless of ability to pay or insurance, from being able to offer LA-CAB/RPV. Preliminary data from academic HIV clinics demonstrate that a LA-CAB/RPV delivery model which places a pharmacy technician in a key role, along with multidisciplinary case conferences (coalition-building), robust relationships with the specialty pharmacies that supply LA-CAB/RPV (network weaving), and tools for quality monitoring, allows programs to effectively initiate and maintain PWH on treatment. In this study, guided by two implementation science frameworks, the Consolidated Framework of Implementation Research (CFIR 2.0) and Proctor’s implementation outcomes, we will adapt and test the pharm-tech based model in five FQHC clinics in Chicago, assessing cost and equity impacts. Aim 1 will consist of formative work to adapt and refine the pharm tech- based model for the FQHC setting via rapid ethnography and implementation mapping. Aim 2 involves a hybrid Type III implementation-effectiveness study. To evaluate the effect of the PHARM ART model, we will compare the LA-CAB/RPV initiation rate in implementation clinics vs. a group of contemporaneous control clinics using a controlled interrupted time series design over three phases: before the PHARM ART model (pre- implementation phase – 24 months prior to initiation of PHARM ART), during active facilitation by the study team (implementation phase – 21 months), and with cessation of active facilitation (sustainment phase – 21 months). Using electronic medical record data and iterative qualitative and survey research, we will delineate mechanisms by which the PHARM ART model works in the FQHC setting, assess the quality of implementation, and evaluate clinical effectiveness outcomes. In Aim 3 we will estimate cost, budgetary impact and cost-effectiveness of PHARM ART and associated strategies. We will adapt an existing mathematical model to evaluate epidemiologic and economic impact across populations, applying distributional cost- effectiveness analysis (DCEA) to assess health equity impacts, including scenarios with varying levels of baseline viral suppression. The proposed work will provide important information on implementation strategies and cost/equity considerations to guide decisions by clinics and funders to invest in capacity-building.
