Reaching persons with HIV who are out of care through Expedited access to Long-Acting Injectable antiretroviral therapy -"RELAI"

Nearly half of new HIV infections in the United States (US) arise from persons with HIV (PWH) who are known to be living with HIV but who are out of care. Novel interventions to reach and rapidly suppress PWH who are out of care are urgently needed, particularly in the rural Southeastern US where limited HIV care access and persistently high HIV incidence results in poor HIV-related health outcomes. Long-acting injectable antiretroviral therapy (LAI) is a tremendous advance in HIV therapy, replacing daily pills with every-other-month injections. FDA labeling for LAI currently supports use for PWH who are virally suppressed, but efficacy of LAI suppressing viral replication among viremic PWH has now been shown. Despite the potential advantages of this less-frequent dosing option, few LAI studies have engaged PWH who are out of care. Field-based LAI, where injections are given in the community rather than in a clinic, may extend LAI access to difficult-to-reach populations of PWH. In this study, investigators will evaluate field-based LAI in North Carolina (NC) for PWH who are out of care. The study explores the determinants, acceptability, feasibility, and impact on HIV viral suppression of field-based LAI, which includes field-based delivery (implementation strategy) of LAI (evidence-based intervention). The study’s Aims map to the five steps within a modified Implementation Mapping framework, engaging key agents in the patient, clinic, community, and policymaking sectors via a combination of formative work (Aim 1a), workshop- based procedural co-production (Aim 1b), and pilot testing (Aim 2). Specifically, in Aim 1a, investigators will recruit ~40 key informants for in-depth interviews and focus group discussions. Guided by the Consolidated Framework for Implementation Research, this aim examines barriers or facilitators of field-based LAI, including internal and external influences relevant to future implementation trials. Aim 1b utilizes preferences and determinants elicited in Aim 1a in sequential workshops with key informants to co-produce and refine field-based LAI procedures and protocols for Aim 2 (Phase I) and future implementation trials (Phase II). Finally, in Aim 2, using established methods for identifying and tracing PWH who are out of care at an academic HIV clinic in NC, investigators will enroll 40 PWH who are out of care into a longitudinal pilot study of field-based LAI, following participants for 7-months, which corresponds to the first five injections. PWH who are contacted and eligible but decline LAI will be offered enrollment for a one-time survey, capturing reasons for declining. Primary outcomes are acceptability and feasibility of field-based LAI, assessed through administrative records, exit interviews, and surveys at 0, 3, and 7 months. Secondary outcomes are 7-month viral suppression, re-engagement with in-clinic care, care retention, and drug resistance. Ending the HIV epidemic is not possible without engaging PWH who are out of care and not suppressed, particularly in rural regions of the US where the epidemic continues to expand. The proposed study engages crucial key informants and tests a strategy to rapidly suppress viremia via field-based LAI among a high-priority population of PWH, informing future implementation science trials. Project Number: 1R34MH139436-01A1 | Fiscal Year: 2025 | NIH Institute/Center: National Institute of Mental Health (NIMH) | Principal Investigator: Sarah Rutstein | Institution: UNIV OF NORTH CAROLINA CHAPEL HILL, CHAPEL HILL, NC | Award Amount: $684,765 | Activity Code: R34 | Study Section: Population and Public Health Approaches to HIV/AIDS Study Section[PPAH] View on NIH RePORTER: https://reporter.nih.gov/project-details/11190414