The Pharmacy-based LAI ART versus Clinic Effectiveness (PLACE) study

About This Grant

ABSTRACT HIV treatment is an essential pillar of the End the HIV Epidemic (EHE) strategy. Yet, in 2021, of the 1.2 million people living with HIV (PLWH) in the US, only 50% were retained in care, 58% achieved viral suppression and significant racial inequities persisted for Black Americans. HIV treatment outcomes are driven by poor access to HIV clinics; and for those who are on treatment, many forget to take their daily oral antiretroviral therapy (ART). Long acting injectable (LAI) ART, approved for every 1- or 2-month administration, can combat memory barriers related to taking a pill every day, but HIV clinic access remains a challenge, especially for Black Americans who are less likely to live near an HIV clinic. To increase equitable LAI ART access and viral suppression, we propose integrating LAI ART in pharmacies. Despite promising evidence that pharmacies with specialized HIV training can increase ART adherence and viral suppression, pharmacies with specialized HIV training are uncommon, likely because no free, widely available HIV treatment pharmacy trainings exist. Our work has shown that expanding HIV services in pharmacies could drastically increase access, but training is critically needed to develop a model for integrating LAI ART specifically into pharmacy workflow. Thus, we propose the Pharmacy- based LAI ART versus Clinic Effectiveness (PLACE) study to evaluate administration of LAI ART within pharmacies versus HIV clinics. We aim to 1) Examine the policy- and pharmacy staff-level barriers and facilitators of adopting LAI ART services in pharmacies among key stakeholders (policy members, pharmacy staff, HIV- clinic staff, and PLWH), 2) Develop and evaluate a pharmacy-based LAI ART training, and 3) Test the integration of pharmacy-based LAI ART delivery in pharmacies compared to HIV clinics on effectiveness, implementation, and clinical outcomes. Guided by the Exploration, Preparation, Implementation, Sustainment framework, this study will include three phases. An exploration phase of 300 online pharmacy staff surveys, and in-depth interviews of 10 Board of pharmacy members who shape pharmacy policy, 40 pharmacy staff, 10 HIV clinic staff (clinicians and nurses) and 40 diverse PLWH that examine the barriers and facilitators to pharmacy-based LAI ART provision. These data will inform the preparation phase which will develop a hybrid (virtual/in-person) LAI ART pharmacy training that will be tested among 100 community pharmacy staff. Finally, an implementation and sustainment phase, will evaluate the acceptability, feasibility, reach by race and ethnicity, uptake, costs, viral suppression and visit adherence of LAI ART service integration in 5 community pharmacies compared with 2 Ryan White funded HIV clinics among 222 LAI ART patients. Findings will inform a model that could be implemented across Ryan White funded clinics to scale pharmacy-based LAI ART services in the US Southeast where efforts to improve equitable HIV treatment and reduce HIV transmission are desperately needed to EHE.