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

ED2PrEP - Patient Focused, Low-burden Strategies for PrEP Uptake Among Emergency Departments Patients: a Two-arm Hybrid Implementation-effectiveness Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV
• Intervention / Treatment: Behavioral: PVO; Behavioral: TSH

Detailed Description

Severe inequities in HIV pre-exposure prophylaxis (PrEP) access and use persist among Black and Latinx communities most impacted by the HIV epidemic. The Bronx, NY, with over 90% of the population identifying as Black or Latinx, is an Ending the HIV Epidemic (EHE) priority county with the fifth highest HIV diagnosis rate in the U.S. and the lowest PrEP use in NY. Research on barriers to PrEP engagement indicate that the current structure of PrEP access and management is not consonant with the lives, priorities, or needs of the hardest hit communities, further exacerbating ongoing racial/ethnic and socioeconomic disparities in HIV incidence. Many of the same barriers leading to poor PrEP uptake in Black/Latinx communities also drive members of these communities to seek care for sexually transmitted infections (STIs), a known risk factor for HIV, in Emergency Departments (EDs). However, there is a discordance between the type of care likely to preserve the long-term health of those seeking STI care in EDs (longitudinal, behavioral, and prevention-oriented) and the care the ED is optimized to provide (acute, high intensity, life-saving/stabilizing), meaning that both patients and health systems stand to gain from a restructuring of how STI care is delivered in EDs. Innovative, efficient, and sustainable strategies for identifying and engaging high priority populations for HIV prevention seeking sexual healthcare in EDs are thus needed. The study team therefore proposes ED2PrEP, a pragmatic Type III hybrid effectiveness-implementation trial comparing two different strategies for increasing PrEP uptake among patients at risk for HIV accessing STI care in Bronx EDs. The two strategies are (1) Post-Visit Outreach (PVO) involving proactive outreach to patients following a sexual health-related ED visit. PVO will be initiated by a Sexual Health Navigator who will provide PrEP education, counseling, and linkage to existing sexual health/PrEP clinics. (2) Tele-sexual health (TSH) will involve a real-time telehealth visit with a Sexual Health Provider during sexual health-related ED visits. TSH will also include education, counseling, and linkage, in addition to the provider's ability to prescribe PrEP at the time of the visit. The project will compare the effectiveness of two strategies implemented at two different EDs for 9 months. After the first 9-month study period (Months 1-9), there will be a 1-month wash-out period (Month 10). The study team will then switch the strategies at the two ED study sites for a second 9-month study period (Months 11-19). The trial duration is approximately 31 months total which includes the two-arm implementation-effectiveness trial (19 months) and a follow-up period (12 months). Throughout the study period, the study team will collect quantitative and qualitative data to inform implementation outcomes. Patients will receive TSH the same day of their ED visit or PVO within 7 days of their ED visit. All patients 18+ years old presenting to one of the ED study sites with sexual health-related complaints who fulfill eligibility criteria will be included in the two-arm trial. For this pragmatic trial, no individual participant recruitment is needed, as all relevant outcome data and covariates are routinely collected as part of clinical care and will be extracted from the electronic health record (EHR) using standard extraction procedures and New York City Department of Health and Mental Hygiene (NYC DOHMH) HIV Registry. To ensure that both ED sites are equally prepared to implement TSH, the ED site starting with TSH will receive TSH-specific trainings one week prior to the launch of the trial. For the ED site implementing TSH in the second trial period, the study team will practice TSH workflows and procedures with a clinical champion during the one-month wash-out period. Because the PVO strategy involves outreach by a Sexual Health Navigator (SHN) (not a member of ED staff) only after an ED visit is completed with no other involvement from ED staff, no ED-specific trainings are needed for this strategy. The overall study will also include an implementation science study (quantitative and qualitative sub-studies), an economic and cost analysis and seroconversion ascertainment. The trial period will be preceded by a 3-month Optimization Phase to standardize study workflows and procedures.

This registration is specific to the two-arm trial of the study protocol.

• Study Type: Interventional
• Enrollment (Actual): 1560
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10031
      • City University of New York - Hunter College
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for Two-Arm Trial:

• 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

Exclusion Criteria for Two-Arm Trial:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Post Visit Outreach (PVO); Outreach by trained patient navigators/educators after patients' ED visit for education, counseling, linkage to preventive/sexual health care.	Behavioral: PVO; post-visit outreach
Experimental: Tele-Sexual Healthcare (TSH) visit during the ED visit; Tele-sexual health visit with a specialist offered during the ED visit to patients.	Behavioral: TSH; tele-sexual health visit during the ED visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 6 months and 12 months following visit to the ED. The number/percentage of participants will be summarized by study arm.	Within 6 and 12 months after index ED visit
Post-exposure prophylaxis (PEP) initiation	PEP initiation will be defined as the number of participants not known to have HIV indicated for PEP AND receiving PEP at the time of their index ED visit, as captured in the electronic health record. The number/percentage of participants will be summarized by study arm.	At the time of ED visit (baseline)
Confirmation of HIV testing	Confirmation of HIV testing will be defined as the percentage of participants not known to have HIV AND receiving HIV testing at the time of the index ED visit. This will be confirmed based on the receipt of tests for HIV, as captured in the electronic health record. The number/percentage of participants with confirmed HIV tests will be summarized by study arm.	At the time of ED visit (baseline)
Confirmation of HIV and STI testing	Confirmation of HIV and STI testing will be defined as the percentage of participants not known to have HIV AND receiving HIV and STI testing at the time of the index ED visit. This will be confirmed based on the receipt of tests for HIV and sexually transmitted infections (i.e., gonorrhea and chlamydia from any anatomic site, or syphilis) within 6 months after the index ED visit, as captured in the electronic health record. The number/percentage of participants with confirmed HIV and STI testing, respectively, will be summarized by study arm.	Within 6 months after index ED visit
Linkage to status neutral healthcare	Linkage to status neutral healthcare will be defined as the percentage of participants not known to have HIV attending a clinical appointment for sexual healthcare or healthcare related to HIV, as captured in the electronic health record, within 3 months following visit to the ED. The number/percentage of participants will be summarized by study arm.	Within 3 months after index ED visit
Retention in PrEP	Retention in PrEP will be defined as the percentage of participants who are retained in PrEP care within 6 months and 12 months following initial PrEP prescription, as captured in the electronic health record. The number/percentage of participants will be summarized by study arm.	Within 6 months and 12 months after initial PrEP prescription
Incident HIV Diagnoses	Incident HIV diagnoses, defined as HIV diagnoses among participants not known to have HIV when exposed to the intervention strategies, will be determined using multiple data sources (EHR, surveys) and will be defined as any positive diagnosis of HIV occurring from the time of the ED visit through the end of study period. While Montefiore EHR data will be used to establish incident diagnoses of HIV among participants who test positive for HIV at a Montefiore site during the study period, there is a potential for misclassification of patients who may be diagnosed with HIV at a non-Montefiore site after inclusion in the study. To improve ascertainment of HIV status, a one-time match with the NYC DOHMH HIV Registry will be performed ~1 year after study enrollment is closed. Incident diagnoses of HIV helps to assess the effectiveness of PrEP strategies.	Up to ~19 months after index visit (at end of study period)
PrEP Persistence	PrEP Persistence will be assessed as a composite variable and is defined as the percentage of participants not known to have HIV who are retained in PrEP care, based on data in the electronic health record EHR about having a subsequent prescription for PrEP medications AND survey responses about current PrEP use. The number/percentage of participants who meet criteria for PrEP persistence at 6 months and 12 months after initial PrEP prescription, will be summarized by study arm.	6 months and 12 months after initial PrEP prescription
HIV Viral RNA levels	Laboratory quantification of circulating HIV virus among individuals diagnosed with HIV in the study will be reported. Circulating HIV RNA concentrations will be determined based upon data obtained from the EHR. Results will be summarized by study arm using basic descriptive statistics.	3 and 12 months after index ED visit

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Uriel Felsen, MD, MS, Albert Einstein College Of Medicine; Principal Investigator: Viraj V Patel, MD, MPH, Albert Einstein College Of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): February 13, 2026
• Study Completion (Estimated): November 13, 2026

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 20, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 2021-13724; R01AI169636 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All deidentified participant level data related to study outcomes.
• IPD Sharing Time Frame: 6 months after publication of primary outcomes for 5 years.
• IPD Sharing Access Criteria: Appropriate Institutional Review Board (IRB) approvals, research plans approved by study Multiple Principal Investigators (MPIs), and data sharing agreements executed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No