Starting HIV Prevention Medicine (PrEP) During an Emergency Department Visit With a Peer Navigator

HIV Prevention, Pre-Exposure Prophylaxis (PrEP)

emtricitabine/tenofovir disoproxil fumarate, pre-exposure prophylaxis, emergency department, patient navigation, peer navigator, same-day PrEP, linkage to care, acceptability, implementation science

The goal of this study is to learn whether adults who visit a hospital emergency department (ED) find it acceptable to start HIV pre-exposure prophylaxis (PrEP) during that same visit, with help from a peer navigator. PrEP is a daily pill that lowers the chance of getting HIV. Many people who could benefit from PrEP use the ED for health care but have no regular doctor, so they may never be offered it. The main questions this study aims to answer are: * Do participants find starting PrEP in the ED acceptable? * How many participants take the first dose, connect with an ongoing PrEP provider, and keep taking PrEP over one year? At Tampa General Hospital, a peer PrEP navigator (a trained study team member) will offer PrEP information to adults in the ED. Adults who agree to join the study and test HIV-negative will: * take their first PrEP pill in the ED while the navigator watches, and leave with a 29-day supply at no cost * choose a community PrEP provider for ongoing care, with help from the navigator * answer short surveys before leaving the ED and by phone at 2-3 days, 30 days, 60 days, 90 days, and 1 year * allow the navigator to confirm follow-up PrEP lab work with their outside provider at about 120 days

RAPID Response (Revolutionary Access to PrEP In the ED) is a single-site, single-group pilot study using a hybrid type 1 effectiveness-implementation design guided by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). The study does not evaluate the efficacy of PrEP. It evaluates the acceptability and feasibility of a peer navigator-led pathway for starting U.S. Food and Drug Administration (FDA)-approved oral PrEP in the ED, continuation after discharge, and linkage to ongoing care. The peer PrEP navigator screens the ED patient tracking board and electronic health record for adults who may benefit from PrEP. All interested adults receive brief PrEP education, HIV and sexually transmitted infection (STI) testing as part of standard care, and a list of vetted community PrEP providers. Patients who consent to the study and have a negative fourth-generation HIV antigen/antibody test before discharge receive emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) 200/300 mg, prescribed by an ED study physician per FDA labeling: one dose taken under navigator observation in the ED and a 29-day take-home supply, paid for by the study. Rarely, if the first dose cannot be taken before discharge, it may be observed by secure video call (or in person at the hospital) within 72 hours. A confirmatory HIV-1 RNA (viral load) result may return after discharge; if positive, PrEP is stopped, study participation ends, and the participant is linked to HIV care. Acceptability is measured with a questionnaire based on the Theoretical Framework of Acceptability (TFA; Sekhon et al., 2017, 2022), given before discharge and at 48-72 hours, 30, 60, 90 and 365 days, with open-ended questions at follow-up. Linkage to care, PrEP continuation, PrEP knowledge before and after education, and safety are also collected. Data are summarized with descriptive statistics and thematic analysis.

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United States