Pre-Exposure Prophylaxis in the Emergency Department

NCT ID: NCT04429971

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-18
• Study Completion Date: 2023-07-31

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.

1. Behavioral risk factor eligibility screening will be performed using the ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool.

2. 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.

1. 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.

2. 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.

Conditions

HIV/AIDS; PrEP

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Immediate PreP initiation

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

Group Type: EXPERIMENTAL

PrEP screening program

Intervention Type: OTHER

ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool

PrEP starter pack

Intervention Type: OTHER

emtricitabine/tenofovir alafenamide or emtricitabine/tenofovir disoproxil

Out-patient care for PrEP initiation

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

Group Type: ACTIVE_COMPARATOR

PrEP screening program

Intervention Type: OTHER

ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool

PreP Screening Program

Part 1: Targeted ED-based patients

Group Type: EXPERIMENTAL

PrEP screening program

Intervention Type: OTHER

ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool

Interventions

PrEP screening program

ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool

Intervention Type: OTHER

PrEP starter pack

emtricitabine/tenofovir alafenamide or emtricitabine/tenofovir disoproxil

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Ethan Cowan

Director of Research and Community Engagement

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ethan Cowan, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Beth Israel Hospital

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GCO 19-2596

Identifier Type: -

Identifier Source: org_study_id