Abstract The Ryan White HIV/AIDS Program is an essential platform for reducing health disparities among people with HIV (PWH) and scaling up evidence-based strategies to strengthen the HIV care continuum. We propose an implementation-science study based in New York Ryan White Part A (RWPA) programs, to inform the delivery of long-acting injectable (LAI) antiretroviral therapy (ART) and related supportive services to low- income, largely Black and Latino/a PWH who have struggled with daily oral ART adherence. As a major biomedical advance de-necessitating adherence to daily dosing, LAI ART could greatly increase opportunities for health, survival and transmission prevention, particularly in populations confronting complex barriers to viral load suppression. However, optimizing the public health impact of LAI ART will require implementation science to assess perceptions and preferences around LAI versus daily oral regimens, identify support services and delivery mechanisms suited to promoting LAI uptake and engagement, and address the role of provider beliefs as to which patients should be offered LAI options. In the absence of this groundwork, LAI ART may primarily reach those who are already relatively advantaged, and even exacerbate HIV disparities. The proposed project aims to: (1) Elicit perceptions, barriers/facilitators and expectations of LAI versus daily oral ART delivery options, in six focus groups of RWPA medical case management (MCM) patients, core staff and prescribing providers; (2) Quantify preferences and drivers of engagement in ART delivery and support strategies, including options for LAI and daily oral ART, via discrete choice experiments (DCEs) with 200 patients and 200 providers; and (3) Select and pilot strategies to promote LAI ART uptake, adherence and impact in real-world care settings. Timely formative work on patient and provider perceptions and preferences will be essential to a successful, equitable rollout of LAI ART. The proposed study will yield valuable insights into barriers and facilitators of LAI ART engagement in RWPA MCM programs designed for PWH with documented adherence barriers. Specifically, focus groups and DCEs will elucidate how (and which) RWPA-funded services (e.g., for patient assessment, joint care planning, health education, home visits, and accompaniment to appointments) may be applied or adapted to enhance LAI ART outcomes. Aim 3 pilot testing and a follow-up RCT will further inform LAI ART delivery strategy refinement and scale-up, by measuring both implementation and clinical outcomes of strategies emerging from the proposed project. Through a partnership between the Institute for Implementation Science and Population Health (ISPH) at the City University of New York, the New York City Health Department and six RWPA service provider agencies, products from the proposed project and follow-up RCT will be translated to local HIV services planning and practice improvements, while being disseminated nationally and internationally through peer-reviewed publications, presentations at scientific conferences and posting on New York’s ISPH-designed/maintained Ending-the-Epidemic Dashboard website.

Project Narrative/Relevance to Public Health In its focus on long-acting injectable (LAI) antiretroviral therapy (ART) delivery in the low-income Ryan White patient population, this project addresses the Ending the HIV Epidemic ‘Treatment’ pillar and NIH’s priorities for reducing health disparities and for implementation research on “the next generation of HIV therapies.” LAI ART is a scientific advance with potential to close gaps between retention and viral suppression (VS) and increase heath equity, but realizing that potential will depend on reach to those who have been failed by current ART regimens. The proposed study and subsequent cluster-randomized controlled trial of LAI ART delivery approaches will yield insights and field-tested strategies to optimize the public health impact of LAI ART.