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NCT07901101Not yet recruitingPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 28 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
50 (estimated)
First submitted
21 Oct 2026
Start date
1 Nov 2026
Primary completion date
31 May 2027
Lead sponsor
University of South Florida
Diseases
HIV
NCT number
NCT07901101

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 50
  • From 1 Nov 2026 to the primary completion date, 31 May 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently taking PrEP, or took PrEP in the last 3 months
  • Received injectable PrEP in the last 12 months

Other illness

  • Positive or indeterminate HIV test result
  • Signs or symptoms of acute (recent) HIV infection
  • Active hepatitis B infection
  • Known allergy to tenofovir or emtricitabine

Lab values

  • Creatinine clearance below 60 mL/min

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tampa General Hospital
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.