University of South Florida
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…
Inclusion Criteria: * Age 18 years or older * Patient in the Tampa General Hospital emergency department * Negative fourth-generation HIV antigen/antibody test during the emergency department visit * Medically stable and able to take part in education * Able to provide informed consent Exclusion Criteria: * Positive or indeterminate HIV test result * Signs or symptoms of acute (recent) HIV infection * Creatinine clearance below 60 mL/min * Active hepatitis B infection * Known allergy to tenofovir or emtricitabine * Currently taking PrEP, or took PrEP in the last 3 months * Received injectab…
A trained peer navigator identifies interested adults, coordinates HIV testing and the PrEP order, obtains the medication from the hospital outpatient pharmacy, observes the first dose, arranges a warm handoff to a community PrEP provider chosen by the participant, and contacts the participant during follow-up.
One 200 mg/300 mg tablet by mouth once daily, prescribed per FDA labeling. 30-day supply paid for by the study: first dose taken in the ED plus 29 tablets to take home.