ED2PrEP - Patient Focused, Low-burden Strategies for PrEP Uptake Among Emergency Departments

NCT05588193 | Active Not Recruiting

• 2 other identifiers: 2021-13724R01AI169636
• Study Type: interventional
• Target: 1,560
• Locations: 1 country
• Sites: 2

Brief Summary

Severe inequities in HIV pre-exposure prophylaxis (PrEP) access and use in communities hardest hit by the HIV epidemic persist, further exacerbating ongoing racial/ethnic and socioeconomic disparities in HIV incidence. In these same communities, many patients at risk for HIV seek care for sexually transmitted infections (STIs) in Emergency Departments (EDs), but the structure of traditional ED care is poorly suited to address HIV prevention or provide PrEP. To advance the Prevent objective of the Ending the HIV Epidemic (EHE) initiative, ED2PrEP will leverage an implementation science approach to rigorously test two innovative strategies for increasing PrEP uptake among patients seeking STI care in EDs in one of the 48 EHE-identified geographic hotspots.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• PrEP Uptake

  PrEP uptake will be defined as the percentage of participants not known to have HIV (either by HIV test result or self-reporting) AND who are prescribed any medication to be used as HIV PrEP, as captured in the electronic health record, within 3 months following visit to the emergency department (ED). The number/percentage of participants will be summarized by study arm. PrEP Uptake within 3 months will be used to evaluate the effectiveness of PrEP strategies.

  Within 3 months after index ED visit

Secondary Outcomes (9)

• PrEP Uptake

  Within 6 and 12 months after index ED visit

• Post-exposure prophylaxis (PEP) initiation

  At the time of ED visit (baseline)

• Confirmation of HIV testing

  At the time of ED visit (baseline)

• Confirmation of HIV and STI testing

  Within 6 months after index ED visit

• Linkage to status neutral healthcare

  Within 3 months after index ED visit

Study Arms (2)

Post Visit Outreach (PVO)

EXPERIMENTAL

Outreach by trained patient navigators/educators after patients' ED visit for education, counseling, linkage to preventive/sexual health care.

Behavioral: PVO

Tele-Sexual Healthcare (TSH) visit during the ED visit

EXPERIMENTAL

Tele-sexual health visit with a specialist offered during the ED visit to patients.

Behavioral: TSH

Interventions

TSH BEHAVIORAL

tele-sexual health visit during the ED visit

Tele-Sexual Healthcare (TSH) visit during the ED visit

PVO BEHAVIORAL

post-visit outreach

Post Visit Outreach (PVO)

Eligibility Criteria

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

You may qualify if:

• Patient is \>=18 years at time of index ED visit
• Patient presents to one of the Montefiore ED study sites
• The ED provider applies at least one of the pre-selected International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes to the encounter and manual review by SHN confirms the visit is related to sexual health

You may not qualify if:

• Patient is admitted to the hospital from the ED
• Known HIV-positive status

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (2)

City University of New York - Hunter College

New York, New York, 10031, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Study Officials

• Uriel Felsen, MD, MS

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

• Viraj V Patel, MD, MPH

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 20, 2022
• Study Start: October 1, 2024
• Primary Completion: February 13, 2026
• Study Completion (Estimated): November 13, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: 6 months after publication of primary outcomes for 5 years.
• Access Criteria: Appropriate Institutional Review Board (IRB) approvals, research plans approved by study Multiple Principal Investigators (MPIs), and data sharing agreements executed.

Locations

US (2)