Pre-Exposure Prophylaxis in the Emergency Department

NCT04429971 | Completed Results

• 1 other identifier: GCO 19-2596
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

PrEP; HIV/AIDS

Keywords

Feasibility; Implementation

Outcome Measures

Primary Outcomes (2)

• 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.

  30 days post-ED visit

• Number of Participants on PrEP Usage

  90 days

Secondary Outcomes (5)

• PrEPPED Satisfaction and Acceptability Survey (RCT Component)

  30 days post-ED visit

• The VSQ-9 is a Visit-specific Satisfaction Instrument (RCT Component)

  30 days post-ED visit

• CDC Sexual Behavior Questions (CSBQ) (RCT Component)

  30 days post-ED visit

• Number of Participants of New STI Diagnoses (RCT Component)

  30 days, 60 days, and 90 days post-ED visit

• Number of Participants of New HIV Infection (RCT Component)

  90 days post-ED visit

Study Arms (3)

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.

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

Other: PrEP screening program

PreP Screening Program

EXPERIMENTAL

Part 1: Targeted ED-based patients

Other: PrEP screening program

Interventions

PrEP starter pack OTHER

emtricitabine/tenofovir alafenamide or emtricitabine/tenofovir disoproxil

Immediate PreP initiation

PrEP screening program OTHER

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

Immediate PreP initiation; Out-patient care for PrEP initiation; PreP Screening Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Beth Israel Hospital

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Ethan Cowan, MD, MS, FACEP
• Organization: Rutgers New Jersey Medical School

ethan.cowan@rutgers.edu

917-447-4964

Study Officials

• Ethan Cowan, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research and Community Engagement

Model Details: Part 1 of study will enroll 30 participants. Part 2 of study will enroll 40 participants

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: March 18, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: December 9, 2025
• Results First Posted: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)