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NOT YET RECRUITING
NCT07901101
PHASE4

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

Sponsor: University of South Florida

View on ClinicalTrials.gov

Summary

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

Official title: RAPID Response (Revolutionary Access to PrEP In the ED): A Pilot Implementation Study of Peer Navigator-Facilitated, Same-Visit Initiation of Oral HIV Pre-Exposure Prophylaxis in the Emergency Department

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-11

Completion Date

2028-05

Last Updated

2026-10-28

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

RAPID Response peer navigation

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.

DRUG

Emtricitabine/tenofovir disoproxil fumarate (F/TDF)

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.

Locations (1)

Tampa General Hospital

Tampa, Florida, United States