HIV/AIDSPrEPPEDNCT04429971
Pre-Exposure Prophylaxis in the Emergency Department
A study testing PrEP screening program and PrEP starter pack in people with HIV/AIDS and PrEP, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Despite an increasing armamentarium of behavioral and biomedical HIV prevention methods, since 2010 rates of new infection have remained around 40,000 annually. The demonstrated efficacy and subsequent approval of emtricitabine/tenofovir disoproxil fumarate for pre-exposure prophylaxis (PrEP) for HIV by the FDA in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- PrEP screening program and PrEP starter pack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2020to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- PrEP screen group:
- Patients 18 years of age and above
- Medically stable as determined by their provider
- Able to speak English
- Willing and able to consent to study participation.
- Not requiring hospital admission for ongoing care.
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- iPrep group:
- ED patients 18 years of age and above
- HIV negative determined by 4th generation rapid testing with no evidence of acute HIV infection as determined by their ED provider
- Medically stable as determined by their primary provider
- Able to speak English
- Able to consent to participation
- Contact information available for linkage
- Not requiring hospital admission for ongoing care.
- Eligible for PrEP based on CDC risk behavior and clinical criteria.
Who cannot join
- PrEP screen group:
- ED patients younger than 18 years of age
- Medically or psychiatrically unstable as determined by the ED provider
- Unable to speak or understand English
- Unable to provide consent for study participation.
- Being admitted to the hospital for ongoing care
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- iPrEP group:
- ED patients younger than 18 years of age
- Known HIV positive or positive rapid HIV test in ED
- Medically or psychiatrically unstable as determined by the ED provider
- Unable to speak or understand English
- Unable to provide consent for study participation
- No means of re-contact upon ED discharge
- No behavioral risk factors indicating need for PrEP
- Medical contraindications to PrEP
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Beth Israel Hospital
New York, New York, 10003
About this study
Official title: Pre-Exposure Prophylaxis Provision in the Emergency Department (PrEPPED): A Pilot Feasibility Study
Despite an increasing armamentarium of behavioral and biomedical HIV prevention methods, since 2010 rates of new infection have remained around 40,000 annually. The demonstrated efficacy and subsequent approval of emtricitabine/tenofovir disoproxil fumarate for pre-exposure prophylaxis (PrEP) for HIV by the FDA in 2012 was thought to represent a turning point that could significantly reduce the number of new infections. Since approval, the promise of PrEP as a transformative intervention has yet to be realized. Despite the implementation of systems for clinical evaluation for and initiation of PrEP by primary care providers, HIV specialists, and STI clinics, numerous barriers to PrEP expansion have been identified, including: 1) patient and provider lack of knowledge, 2) lack of access to medical care among high-risk individuals, 3) provider discomfort and inexperience with screening for risk behaviors, and 4) insurance and affordability. This proposal seeks to expand access to and engagement in PrEP among high risk individuals though an innovative delivery approach in the Emergency Department (ED) while addressing these four barriers.
Read the detailed description
Aim 1: Initiate a targeted ED-based PrEP screening program and optimize its feasibility and acceptability.
- Behavioral risk factor eligibility screening will be performed using the ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool.
- During a 3-month period, use continuous quality improvement methods to decrease the time for completion of PrEP eligibility screening to an interval that is acceptable to ED patients and providers.
Aim 2: Pre-Exposure Prophylaxis Provision in the ED (PrEPPED) Trial:
Identify 40 PrEP eligible patients over a 12-month period who are interested in initiating PrEP in the ED. These patients will be offered immediate PrEP (iPrEP) initiation in the ED with facilitated linkage to comprehensive out-patient care.
- Evaluate the impact of a PrEP "starter pack" on patients agreeing to iPrEP. The primary outcome is engagement in care at 30-days post PrEP initiation visit. Secondary outcomes include retention in care, STI diagnosis, risk behavior and PrEP adherence.
- Collect data on recruitment and attrition rates, as well as means and standard deviations for key measures that will be needed to plan a definitive trial of ED-initiated PrEP.
- Being tested
- PrEP screening program, PrEP starter pack
- Keywords
- Feasibility, Implementation
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP screening programOther
ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool
PrEP starter packOther
emtricitabine/tenofovir alafenamide or emtricitabine/tenofovir disoproxil
| Study group | Role | What they receive |
|---|---|---|
| Immediate PreP initiation | Experimental | PreP screening program with immediate PrEP (iPrEP) initiation in the ED using a PrEP "starter pack" with facilitated linkage to care. Receives: Other: PrEP screening program; Other: PrEP starter pack |
| Out-patient care for PrEP initiation | Active comparator | PrEP screening program with referral to out-patient care for PrEP initiation Receives: Other: PrEP screening program |
| PreP Screening Program | Experimental | Part 1: Targeted ED-based patients Receives: Other: PrEP screening program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement in Care (Implementation Component)
Engagement is care is defined by attending at least 1 out-patient clinic appointment with a PrEP provider within 30-days of the ED visit.
Measured: 30 days post-ED visit
Number of Participants on PrEP Usage
Measured: 90 days
Secondary outcomes (5)
PrEPPED Satisfaction and Acceptability Survey (RCT Component)
PrEPPED Satisfaction and Acceptability Survey is a patient satisfaction questionnaire was developed by the study team. It's a series of independent Likert questions from 1-6 addressing different aspects of the program. Full scale from 0 to 18, with higher score indicating more satisfaction.
Satisfaction data were not collected at 30, 60, or 90 days. After study initiation, it was determined by the researchers that the satisfaction items were specific to the emergency department visit experience and not relevant to the follow-up period. Consequently, decision was made to not administer the follow-up satisfaction assessments, therefore, no data was collected so there is no data to report.
Measured: 30 days post-ED visit
The VSQ-9 is a Visit-specific Satisfaction Instrument (RCT Component)
The VSQ-9 is a visit-specific satisfaction instrument adapted by the American Medical Guidelines Regimen Information Program (GRIP) survey. GRIP guide is a self-report to assess PrEP adherence at 30-days post ED visit, with 6 categorical items: excellent, very good, good, fair, poor, and very poor.
Because participants were not required to follow up at a single clinic, post-discharge care settings varied widely. The VSQ-9 assesses satisfaction with a specific clinical encounter, and applying it across multiple, non-standardized settings was deemed inappropriate and unlikely to yield interpretable data. Therefore, decision was made by the researcher to not administer the VSQ-9 at 30, 60, or 90 days. Consequently, no follow-up VSQ-9 data were collected so there is no data to report.
Measured: 30 days post-ED visit
CDC Sexual Behavior Questions (CSBQ) (RCT Component)
CDC Sexual Behavior Questions (CSBQ) to measure HIV risk behavior. CSBQ is a multi-tiered, gender-specific questionnaire developed by the Centers for Disease Control and Prevention HIV-STID Behavioral Surveillance Working Group. Three separate domains - Sexual Behavior, Drug-related HIV risk, and HIV testing. Responses are yes/no with no summation.
Number of participants who engaged in unsafe sexual behavior, was under substance influence and who had a HIV test.
Measured: 30 days post-ED visit
Number of Participants of New STI Diagnoses (RCT Component)
Number of new STI diagnosis between day 1 (day after enrollment) and day 90 (final day of follow-up) broken down into days 1-30, 31-60, 61-90.
Measured: 30 days, 60 days, and 90 days post-ED visit
Number of Participants of New HIV Infection (RCT Component)
Number of new HIV diagnosis at 90-days after enrollment. This question was only asked for those individuals who had not been lost to follow-up.
Measured: 90 days post-ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start18 Mar 2020
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Part 1 of study will enroll 30 participants. Part 2 of study will enroll 40 participants
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ethan Cowan, Icahn School of Medicine at Mount Sinai
- Investigators
- Ethan Cowan, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429971
- Sponsor's protocol ID
- GCO 19-2596
- Acronym
- PrEPPED
- Status last verified
- Nov 2025
- First submitted
- 10 Jun 2020
- Last updated
- 9 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Exposure Prophylaxis Provision in the Emergency Department (PrEPPED): A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT04429971
- Acronym / sponsor ID
- PrEPPED / GCO 19-2596
- Keywords
- Feasibility, Implementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 18 Mar 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Posted 9 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite an increasing armamentarium of behavioral and biomedical HIV prevention methods, since 2010 rates of new infection have remained around 40,000 annually. The demonstrated efficacy and subsequent approval of emtricitabine/tenofovir disoproxil fumarate for pre-exposure prophylaxis (PrEP) for HIV by the FDA in 2012 was thought to represent a turning point that could significantly reduce the number of new infections. Since approval, the promise of PrEP as a transformative intervention has yet to be realized. Despite the implementation of systems for clinical evaluation for and initiation of PrEP by primary care providers, HIV specialists, and STI clinics, numerous barriers to PrEP expansion have been identified, including: 1) patient and provider lack of knowledge, 2) lack of access to medical care among high-risk individuals, 3) provider discomfort and inexperience with screening for risk behaviors, and 4) insurance and affordability. This proposal seeks to expand access to and engagement in PrEP among high risk individuals though an innovative delivery approach in the Emergency Department (ED) while addressing these four barriers.
Detailed description
Aim 1: Initiate a targeted ED-based PrEP screening program and optimize its feasibility and acceptability.
- Behavioral risk factor eligibility screening will be performed using the ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool.
- During a 3-month period, use continuous quality improvement methods to decrease the time for completion of PrEP eligibility screening to an interval that is acceptable to ED patients and providers.
Aim 2: Pre-Exposure Prophylaxis Provision in the ED (PrEPPED) Trial:
Identify 40 PrEP eligible patients over a 12-month period who are interested in initiating PrEP in the ED. These patients will be offered immediate PrEP (iPrEP) initiation in the ED with facilitated linkage to comprehensive out-patient care.
- Evaluate the impact of a PrEP "starter pack" on patients agreeing to iPrEP. The primary outcome is engagement in care at 30-days post PrEP initiation visit. Secondary outcomes include retention in care, STI diagnosis, risk behavior and PrEP adherence.
- Collect data on recruitment and attrition rates, as well as means and standard deviations for key measures that will be needed to plan a definitive trial of ED-initiated PrEP.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Part 1 of study will enroll 30 participants. Part 2 of study will enroll 40 participants
| Arm | Type | Receives |
|---|---|---|
| Immediate PreP initiation | Experimental | Other: PrEP screening program, Other: PrEP starter packPreP screening program with immediate PrEP (iPrEP) initiation in the ED using a PrEP "starter pack" with facilitated linkage to care. |
| Out-patient care for PrEP initiation | Active comparator | Other: PrEP screening programPrEP screening program with referral to out-patient care for PrEP initiation |
| PreP Screening Program | Experimental | Other: PrEP screening programPart 1: Targeted ED-based patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients 18 years of age and above
- Medically stable as determined by their provider
- Able to speak English
- Willing and able to consent to study participation.
- Not requiring hospital admission for ongoing care.
Key exclusion criteria (16 listed)
- ED patients younger than 18 years of age
- Medically or psychiatrically unstable as determined by the ED provider
- Unable to speak or understand English
- Unable to provide consent for study participation.
- Being admitted to the hospital for ongoing care
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 |
|---|---|---|
| PrEP screening programICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool | Other | Immediate PreP initiation, Out-patient care for PrEP initiation, PreP Screening Program |
| PrEP starter packemtricitabine/tenofovir alafenamide or emtricitabine/tenofovir disoproxil | Other | Immediate PreP initiation |
Primary outcome
Engagement in Care (Implementation Component)
Time frame: 30 days post-ED visit
Engagement is care is defined by attending at least 1 out-patient clinic appointment with a PrEP provider within 30-days of the ED visit.
Number of Participants on PrEP Usage
Time frame: 90 days
5 secondary outcomes
PrEPPED Satisfaction and Acceptability Survey (RCT Component)
Time frame: 30 days post-ED visit
The VSQ-9 is a Visit-specific Satisfaction Instrument (RCT Component)
Time frame: 30 days post-ED visit
CDC Sexual Behavior Questions (CSBQ) (RCT Component)
Time frame: 30 days post-ED visit
Number of Participants of New STI Diagnoses (RCT Component)
Time frame: 30 days, 60 days, and 90 days post-ED visit
Number of Participants of New HIV Infection (RCT Component)
Time frame: 90 days post-ED visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ethan Cowan, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEP screening program and PrEP starter pack in people with HIV/AIDS and PrEP, run by Icahn School of Medicine at Mount Sinai 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 15 inclusion and 16 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: finished, as of the sponsor's last update on 9 Dec 2025. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement in Care (Implementation Component) (time frame: 30 days post-ED visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2025.