- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04429971
Pre-Exposure Prophylaxis in the Emergency Department (PrEPPED)
Pre-Exposure Prophylaxis Provision in the Emergency Department (PrEPPED): A Pilot Feasibility Study
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10003
- Mount Sinai Beth Israel Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate PreP initiation
PreP screening program with immediate PrEP (iPrEP) initiation in the ED using a PrEP "starter pack" with facilitated linkage to care.
|
ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool
emtricitabine/tenofovir alafenamide or emtricitabine/tenofovir disoproxil
|
Active Comparator: Out-patient care for PrEP initiation
PrEP screening program with referral to out-patient care for PrEP initiation
|
ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool
|
Experimental: PreP Screening Program
Part 1: Targeted ED-based patients
|
ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to completion of ED PrEP screening (Implementation Component)
Time Frame: 30 days post-ED visit
|
Time to completion of screening will be calculated from the time of the patient's first contact with a health educator to the time to completion of all laboratory screening tests.
|
30 days post-ED visit
|
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.
|
30 days post-ED visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PrEPPED Satisfaction and Acceptability Survey (RCT Component)
Time Frame: 30 days post-ED visit
|
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.
|
30 days post-ED visit
|
The VSQ-9 is a visit-specific satisfaction instrument (RCT Component)
Time Frame: 30 days post-ED visit
|
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.
|
30 days post-ED visit
|
CDC Sexual Behavior Questions (CSBQ) (RCT Component)
Time Frame: 30 days post-ED visit
|
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.
|
30 days post-ED visit
|
Number of new STI diagnoses (RCT Component)
Time Frame: 30 days post-ED visit
|
Number of new STI diagnosis at 30-days
|
30 days post-ED visit
|
Number of new HIV Infection (RCT Component)
Time Frame: 30 days post-ED visit
|
Number of new HIV diagnosis at 30-days
|
30 days post-ED visit
|
Visit Rating Questionnaire (VSQ9) (RCT Component)
Time Frame: 30 days post-ED visit
|
The VSQ-9 is a visit-specific satisfaction instrument adapted by the American Medical Group Association from the Visit Rating Questionnaire.
Total scale from 0 to 100 with higher score indicating more satisfaction
|
30 days post-ED visit
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ethan Cowan, MD, Icahn School of Medicine at Mount Sinai
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 19-2596
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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