search
Back to results

Pre-Exposure Prophylaxis in the Emergency Department (PrEPPED)

Primary Purpose

HIV/AIDS, PrEP

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PrEP screening program
PrEP starter pack
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for HIV/AIDS focused on measuring Feasibility, Implementation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mount Sinai Beth Israel Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Immediate PreP initiation

Out-patient care for PrEP initiation

PreP Screening Program

Arm Description

PreP screening program with immediate PrEP (iPrEP) initiation in the ED using a PrEP "starter pack" with facilitated linkage to care.

PrEP screening program with referral to out-patient care for PrEP initiation

Part 1: Targeted ED-based patients

Outcomes

Primary Outcome Measures

Time to completion of ED PrEP screening (Implementation Component)
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.
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.

Secondary Outcome Measures

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.
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.
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 new STI diagnoses (RCT Component)
Number of new STI diagnosis at 30-days
Number of new HIV Infection (RCT Component)
Number of new HIV diagnosis at 30-days
Visit Rating Questionnaire (VSQ9) (RCT Component)
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

Full Information

First Posted
June 10, 2020
Last Updated
August 2, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
search

1. Study Identification

Unique Protocol Identification Number
NCT04429971
Brief Title
Pre-Exposure Prophylaxis in the Emergency Department
Acronym
PrEPPED
Official Title
Pre-Exposure Prophylaxis Provision in the Emergency Department (PrEPPED): A Pilot Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 18, 2020 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
July 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, PrEP
Keywords
Feasibility, Implementation

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Part 1 of study will enroll 30 participants. Part 2 of study will enroll 40 participants
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate PreP initiation
Arm Type
Experimental
Arm Description
PreP screening program with immediate PrEP (iPrEP) initiation in the ED using a PrEP "starter pack" with facilitated linkage to care.
Arm Title
Out-patient care for PrEP initiation
Arm Type
Active Comparator
Arm Description
PrEP screening program with referral to out-patient care for PrEP initiation
Arm Title
PreP Screening Program
Arm Type
Experimental
Arm Description
Part 1: Targeted ED-based patients
Intervention Type
Other
Intervention Name(s)
PrEP screening program
Intervention Description
ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool
Intervention Type
Other
Intervention Name(s)
PrEP starter pack
Intervention Description
emtricitabine/tenofovir alafenamide or emtricitabine/tenofovir disoproxil
Primary Outcome Measure Information:
Title
Time to completion of ED PrEP screening (Implementation Component)
Description
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.
Time Frame
30 days post-ED visit
Title
Engagement in care (Implementation Component)
Description
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.
Time Frame
30 days post-ED visit
Secondary Outcome Measure Information:
Title
PrEPPED Satisfaction and Acceptability Survey (RCT Component)
Description
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.
Time Frame
30 days post-ED visit
Title
The VSQ-9 is a visit-specific satisfaction instrument (RCT Component)
Description
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.
Time Frame
30 days post-ED visit
Title
CDC Sexual Behavior Questions (CSBQ) (RCT Component)
Description
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.
Time Frame
30 days post-ED visit
Title
Number of new STI diagnoses (RCT Component)
Description
Number of new STI diagnosis at 30-days
Time Frame
30 days post-ED visit
Title
Number of new HIV Infection (RCT Component)
Description
Number of new HIV diagnosis at 30-days
Time Frame
30 days post-ED visit
Title
Visit Rating Questionnaire (VSQ9) (RCT Component)
Description
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
Time Frame
30 days post-ED visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ethan Cowan, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Beth Israel Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pre-Exposure Prophylaxis in the Emergency Department

We'll reach out to this number within 24 hrs