A Phase 4 interventional study of RAPID Response peer navigation and Emtricitabine/tenofovir disoproxil fumarate (F/TDF) in HIV Prevention and Pre-Exposure Prophylaxis (PrEP), sponsored by University of South Florida. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by University of South Florida · Phase 4, Interventional, and Prevention
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:
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:
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.
University of South Florida is the lead sponsor of 340 studies on the registry; 65 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults in the emergency department who test HIV-negative receive navigator support to start oral PrEP before discharge: first dose taken under observation, a 29-day take-home supply at no cost, help choosing a community PrEP provider, and follow-up contacts through 1 year.
Behavioral: RAPID Response peer navigation · Drug: Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
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.
Mean Acceptability Score on the RAPID Response Acceptability Questionnaire
Mean of 14 items based on the Theoretical Framework of Acceptability (TFA), each rated 1 (strongly disagree) to 5 (strongly agree). Possible range 1-5; higher scores mean greater acceptability of starting PrEP in the emergency department.
Time frame: Day 0 (before emergency department discharge)
Mean Acceptability Score at Follow-up
Same 14-item TFA-based score (range 1-5; higher = greater acceptability), reported separately at each timepoint.
Time frame: 48-72 hours, 30 days, 60 days, 90 days and 365 days after discharge
Percentage of Approached Patients Who Enroll
Number of patients who consent divided by the number of patients aged 18 or older approached by the peer navigator, as a percentage.
Time frame: Throughout enrollment, up to 6 months
Number of Participants Who Take the First PrEP Dose
Count of enrolled participants whose first dose is observed in the emergency department or, by exception, by video or in person within 72 hours
Time frame: Up to 72 hours after discharge
Percentage of Participants Linked to PrEP Care at 30 Days
Percentage of participants who attend a visit with a community PrEP provider within 30 days of discharge, confirmed by the navigator.
Time frame: 30 days after discharge
Percentage of Participants Linked to PrEP Care at 90 Days
Percentage of participants with a confirmed visit with an ongoing PrEP provider by 90 days.
Time frame: 90 days after discharge
Percentage of Participants Still Taking PrEP
Percentage of participants who report taking PrEP at the time of contact.
Time frame: 90 days and 365 days after discharge
Percentage of Participants With Follow-up PrEP Laboratory Testing
Percentage of participants whose outside PrEP provider confirms follow-up PrEP labs and a PrEP prescription.
Time frame: 120 days after discharge
Change in PrEP Knowledge Score
Number correct on a 9-item true/false PrEP knowledge check (range 0-9; higher = more knowledge), after education minus before education.
Time frame: Day 0, before and after education
Number of Participants With a New HIV Diagnosis After Starting PrEP
Count of participants with a positive HIV result after the first dose, including a positive confirmatory HIV-1 RNA test after discharge.
Time frame: Up to 365 days after discharge
Number of Participants Who Stop PrEP Because of Side Effects
Count of participants who report stopping PrEP because of side effects.
Time frame: Up to 365 days after discharge
Time From Navigator Contact to First PrEP Dose
Median minutes from the navigator's first bedside contact to the observed first dose.
Time frame: Day 0
Plan to share: Yes — De-identified individual participant data for participants who agreed to future use of their data will be shared after the primary results are published.
Supporting information: Study protocol, Informed consent form
Time frame: Beginning after publication of primary results and ending 5 years after study closure.
Access criteria: Written request to the Principal Investigator describing the proposed use; a new Institutional Review Board determination; and a signed data use agreement.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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