HIV PreventionPhase 4RAPID ResponseNCT07901101
Starting HIV Prevention Medicine (PrEP) During an Emergency Department Visit With a Peer Navigator
A Phase 4 study testing RAPID Response peer navigation and Emtricitabine/tenofovir disoproxil fumarate (F/TDF) in people with HIV Prevention and Pre-Exposure Prophylaxis (PrEP), run by University of South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention, Pre-Exposure Prophylaxis (PrEP)
- What is being tested?
- RAPID Response peer navigation and Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 injectable PrEP in the last 12 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Tampa General Hospital
Tampa, Florida, 33606
Bernice K McCoy, PhD, MPH, 813-416-4989, blopez1@usf.edu
Jason Wilson, MD, PhD, CPE, FACEP, 813-843-2110, jwilson2@usf.edu
About this study
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
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:
Read more
- 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
Read the detailed description
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.
- Conditions
- HIV Prevention, Pre-Exposure Prophylaxis (PrEP)
- Being tested
- RAPID Response peer navigation, Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
- Keywords
- emtricitabine/tenofovir disoproxil fumarate, pre-exposure prophylaxis, emergency department, patient navigation, peer navigator, same-day PrEP, linkage to care, acceptability, implementation science
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAPID Response peer navigationBehavioural
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.
Emtricitabine/tenofovir disoproxil fumarate (F/TDF)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Peer Navigator-Facilitated Same-Visit PrEP Initiation | Experimental | 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. Receives: Behavioral: RAPID Response peer navigation; Drug: Emtricitabine/tenofovir disoproxil fumarate (F/TDF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 (before emergency department discharge)
Secondary outcomes (11)
Mean Acceptability Score at Follow-up
Same 14-item TFA-based score (range 1-5; higher = greater acceptability), reported separately at each timepoint.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 90 days after discharge
Percentage of Participants Still Taking PrEP
Percentage of participants who report taking PrEP at the time of contact.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants receive the same peer navigator-facilitated, same-visit PrEP initiation pathway.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Tampa General Hospital
- Responsible party
- Sponsor
- Investigators
- Bernice K McCoy, PhD, MPH, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901101
- Sponsor's protocol ID
- STUDY010459
- Acronym
- RAPID Response
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Sekhon M, Cartwright M, Francis JJ. Development of a theory-informed questionnaire to assess the acceptability of healthcare interventions. BMC Health Serv Res. 2022 Mar 1;22(1):279. doi: 10.1186/s12913-022-07577-3.
PubMed 35232455Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8.
PubMed 28126032
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07901101
- Acronym / sponsor ID
- RAPID Response / STUDY010459
- Conditions
- HIV Prevention, Pre-Exposure Prophylaxis (PrEP)
- Keywords
- emtricitabine/tenofovir disoproxil fumarate, pre-exposure prophylaxis, emergency department, patient navigation, peer navigator, same-day PrEP, linkage to care, acceptability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Tampa General Hospital
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants receive the same peer navigator-facilitated, same-visit PrEP initiation pathway.
| Arm | Type | Receives |
|---|---|---|
| Peer Navigator-Facilitated Same-Visit PrEP Initiation | Experimental | Behavioral: RAPID Response peer navigation, Drug: Emtricitabine/tenofovir disoproxil fumarate (F/TDF)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAPID Response peer navigationA 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. | Behavioural | Peer Navigator-Facilitated Same-Visit PrEP Initiation |
| 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. | Drug | Peer Navigator-Facilitated Same-Visit PrEP Initiation |
Primary outcome
Mean Acceptability Score on the RAPID Response Acceptability Questionnaire
Time frame: Day 0 (before emergency department discharge)
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.
11 secondary outcomes
Mean Acceptability Score at Follow-up
Time frame: 48-72 hours, 30 days, 60 days, 90 days and 365 days after discharge
Percentage of Approached Patients Who Enroll
Time frame: Throughout enrollment, up to 6 months
Number of Participants Who Take the First PrEP Dose
Time frame: Up to 72 hours after discharge
Percentage of Participants Linked to PrEP Care at 30 Days
Time frame: 30 days after discharge
Percentage of Participants Linked to PrEP Care at 90 Days
Time frame: 90 days after discharge
Percentage of Participants Still Taking PrEP
Time frame: 90 days and 365 days after discharge
Percentage of Participants With Follow-up PrEP Laboratory Testing
Time frame: 120 days after discharge
Change in PrEP Knowledge Score
Time frame: Day 0, before and after education
Number of Participants With a New HIV Diagnosis After Starting PrEP
Time frame: Up to 365 days after discharge
Number of Participants Who Stop PrEP Because of Side Effects
Time frame: Up to 365 days after discharge
Time From Navigator Contact to First PrEP Dose
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 35232455Sekhon M, Cartwright M, Francis JJ. Development of a theory-informed questionnaire to assess the acceptability of healthcare interventions. BMC Health Serv Res. 2022 Mar 1;22(1):279. doi: 10.1186/s12913-022-07577-3.
- Background: PubMed 28126032Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bernice K McCoy, PhD, MPH principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RAPID Response peer navigation and Emtricitabine/tenofovir disoproxil fumarate (F/TDF) in people with HIV Prevention and Pre-Exposure Prophylaxis (PrEP), run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bernice K McCoy, PhD, MPH (813-416-4989, blopez1@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Acceptability Score on the RAPID Response Acceptability Questionnaire (time frame: Day 0 (before emergency department discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07901101, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.