Planning for implementation of Long-Acting Injectables in Status-neutral HIV primary care (the PLANS study)

Long-acting injectable HIV antiretroviral medications (LAIs) are a breakthrough in HIV treatment and prevention, alleviate daily medication challenges, and are extremely efficacious. While LAIs have the potential to transform and improve health outcomes for people living with HIV or with vulnerability to HIV infection, clinical implementation of LAIs has been suboptimal, including for populations most impacted by HIV. Without evidence-based implementation models that address systems level determinants, the potential for LAIs to help end the HIV epidemic is unlikely to be realized. One approach to meaningfully address health system barriers is by leveraging existing, organically developed efforts designed by system insiders: pharmacists and providers in federally qualified health centers (FQHCs) in the Bronx, NY (a high-priority jurisdiction with >2% HIV prevalence). Currently, clinical pharmacists have organically developed ad hoc implementation efforts where they play an integral role in LAI delivery, including patient counseling, coordination, procurement, cost coverage, delivery, with similar workflows for HIV prevention and treatment using LAIs (i.e., a status-neutral (SN) model). These efforts show promise and warrant systematic study and protocolization to guide potential replication and scale-up. Using rigorous implementation science methods and leveraging expertise from committed multidisciplinary stakeholders (including pharmacists, patients, providers, nurses, administrators, and researchers), this R21 study will develop, formalize, and pilot an embedded SN-LAI implementation model: “Planning for implementation of Long-Acting iNjectables in Status-neutral HIV primary care FQHCs (the PLANS study)”. We will first identify context-specific determinants of SN-LAI implementation and systematically identify existing or perceived barriers and facilitators (Aim1a) using innovative systems journey mapping interviews with patients and key informants. We will use these data to systematically develop, protocolize, and refine a package of SN-LAI implementation strategies with stakeholders (Aim 1b). In a test of concept, we will then pilot strategies for acceptability, feasibility, appropriateness, fidelity, and explore indicators of strategy effectiveness (Aim 2) in a Bronx FQHC to understand the potential of this organically- driven, multidisciplinary approach to overcome system-level barriers and enhance status-neutral LAI implementation. Project Number: 1R21MH142385-01 | Fiscal Year: 2026 | NIH Institute/Center: National Institute of Mental Health (NIMH) | Principal Investigator: Dana Watnick (+2 co-PIs) | Institution: ALBERT EINSTEIN COLLEGE OF MEDICINE, BRONX, NY | Award Amount: $462,000 | Activity Code: R21 | Study Section: Special Emphasis Panel[ZRG1 SCIL-G (91)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11269881