Providence/Boston Center for AIDS Research (CFAR)

Miriam Hospital, Providence RI

Investigators

Linked publications, trials & patents

Abstract

Long-acting injectable (LAI) antiretroviral treatment (ART) is a new alternative to help overcome the challenges of adhering to daily oral ART. Nonadherence to ART can lead to viral rebound, HIV resistance, opportunistic infections, and propagation of HIV transmission, yet LAI ART brings the hope of improved adherence, viral suppression, and improved long-term control of HIV among persons who have struggled with adherence to oral ART. Unfortunately, access to LAI ART for persons with HIV (PWH) has been complicated by administrative, clinical, and logistical barriers. Despite the challenges, the Immunology Center of The Miriam Hospital/Brown University in Providence, RI, has established a successful pharmacist-led LAI ART program and developed pathways for medication approval, acquisition, storage, and patient assessment, education, counseling, and monitoring. Given the success of this program, there is an opportunity to collaborate with HIV clinics in Ending the HIV Epidemic (EHE)-designated jurisdictions to establish and optimize pharmacist-led LAI ART programs to increase access to HIV treatment options and improve treatment outcomes. Investigators from The Miriam Hospital/Brown University will collaborate with partners in Arkansas (an EHE-designated state) including the University of Arkansas Medical Sciences, and the ARcare Positive Connections program, a Ryan White-funded multi-site HIV clinic network in Arkansas, which has struggled with the roll-out of LAI ART. Using the Exploration, Preparation, Implementation, Sustainment (EPIS) implementation science framework, Evidence Based Quality Improvement (EBQI), and the principles of community engagement, we propose to examine lessons learned from the Immunology Center LAI ART program, assess barriers to LAI ART rollout in the ARcare network, and to develop and implement a sustainable pharmacist-led LAI ART program with assessment of patient outcomes within the ARcare network. Our specific aims include: 1) Using the EPIS framework and EQBI, we will leverage the experience of the Immunology Center LAI ART program (Explore) to develop, pilot test, and optimize an LAI ART program that utilizes a Collaborative Practice Agreement between pharmacists and providers in two ARcare clinics (Preparation, Implementation); and 2) We will expand the LAI ART protocol developed in Aim 1 across three additional ARcare sites with re-examination of implementation barriers and facilitators and assessment of patient outcomes and program sustainment (Preparation, Implementation, Sustainment). This study fulfills the high priority HIV/AIDS research objectives of the National Institutes of Health including evaluating the use of the next generation of HIV therapies that are longer acting and easier to take and adhere to than current regimens and will provide critical data related to improving access to novel LAI HIV treatments; evidence that will contribute to the EHE initiative in the U.S. Furthermore, data from this study will inform future implementation science studies of LAI ART designed to increase access to LAI ART for vulnerable and marginalized PWH including those with poor ART adherence, ART-naïve PWH, and active substance users.