PrEP for HIV Prevention

(RAPID Response Trial)

BK
AB
Overseen ByAshley Bader, MBA, BSN, RN CCRP, CCRC
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of South Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

BK

Bernice K McCoy, PhD, MPH

Principal Investigator

University of South Florida

Are You a Good Fit for This Trial?

This trial is for adults visiting the emergency department who test negative for HIV and are interested in starting daily medicine to prevent HIV. Participants should not already be taking PrEP or have a regular provider offering it.

Inclusion Criteria

Patient in the Tampa General Hospital emergency department
Able to provide informed consent
Negative fourth-generation HIV antigen/antibody test during the emergency department visit
See 2 more

Exclusion Criteria

I currently have an active hepatitis B infection.
Positive or indeterminate HIV test result
Creatinine clearance below 60 mL/min
See 4 more

What Are the Treatments Tested in This Trial?

Interventions

  • Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
  • RAPID Response peer navigation

Trial Overview

The study tests if starting PrEP (a daily pill called Emtricitabine/tenofovir) during an ER visit, with help from a peer navigator, is acceptable and helps people keep using PrEP over time. Participants get their first dose in the ER and support finding ongoing care.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Peer Navigator-Facilitated Same-Visit PrEP InitiationExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials
433
Recruited
198,000+

Tampa General Hospital

Collaborator

Trials
22
Recruited
4,400+