Decision Support Tool to Integrate PrEP Into Emergency Departments

NCT07279129 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: NCR256674
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

This project will explore the development of a personalized decision support tool to assist with pre-exposure prophylaxis (PrEP) initiation and persistence among patients identified in the emergency department (ED) and urgent care settings as PrEP eligible. First, the investigators will use a sequence of validated implementation science methodologies to develop and validate a decision support tool designed to optimize PrEP persistence by strengthening self-efficacy by addressing the multifaceted medical and social needs of the individual patient. The investigators will then test the preliminary effectiveness of this tool through a pilot stepped wedge implementation trial in two EDs and an urgent care in Baltimore, MD and Washington, DC among 120 PrEP eligible patients to determine PrEP initiation, linkage to care, persistence, and adherence rates.

Conditions

HIV

Keywords

PrEP; Emergency departments; Decision support tools; HIV prevention

Outcome Measures

Primary Outcomes (1)

• Number of participants who self-report taking PrEP in the past 4 months and have any TFV-DP detected in DBS

  PrEP persistence defined as self-report of taking PrEP in the past 4 months and having any TFV-DP detected in DBS

  4 months

Secondary Outcomes (5)

• Number of participants who fill a PrEP prescription from the ED

  1 week

• Number of participants who attend a PrEP clinic visit

  1 week

• Number of participants who self-report PrEP adherence

  4 months

• Number of participants with biological PrEP adherence (effective short-term use)

  1 month

• Number of participants with biological PrEP adherence (effective long-term use)

  4 months

Other Outcomes (11)

• Proportion of eligible patients approached

  from baseline screening in the ED to being approached to be in the study in a 14 month period of time

• Proportion of eligible patients tested for HIV

  from baseline ED screening to study eligibility in a 14 month period of time

• Proportion of eligible patients prescribed PrEP

  from screening eligible to discharge from the ED in a 14 month period of time

Study Arms (2)

ED-PrEP

ACTIVE COMPARATOR

In Phase 1 (Pre-DST) PrEP eligible patients who have agreed to PrEP will receive a PrEP prescription facilitated by a PrEP Champion; there will be no structured engagement intervention (i.e., the DST).

Behavioral: PrEP Delivery

ED-PrEP + DST

EXPERIMENTAL

In Phase 2 (Post-DST) PrEP Champions will integrate the DST into all patient encounters, facilitating the use of the DST as well as the provision of any identified resources.

Behavioral: Decision support tool; Behavioral: PrEP Delivery

Interventions

Decision support tool BEHAVIORAL

Participants enrolled during Phase 2 will engage in all the activities from Phase 1 and will receive the DST intervention. The DST will be designed and programmed to generate results if tablet-based (or to be easily manually scored if paper-based) to display the participant's PrEP knowledge and intention score, self-efficacy score, level of self-perceived risk, as well as generate a list of unmet needs. Upon completion of the DST, the Champion will review these results and discuss them with the participant. Referrals for needed resources will be proactively provided in the ED. After the DST delivery, participants will receive a PrEP prescription and follow-up appointment with a community PrEP provider.

ED-PrEP + DST

PrEP Delivery BEHAVIORAL

Participants enrolled during Phase 1 will receive a 14-day prescription of TDF/FTC or FTC/TAF before leaving the ED and an appointment with a community PrEP provider. The Champion will provide brief HIV prevention and PrEP medication counseling including proper dosing, missed doses, review of medication side effects and efficacy, and risk reduction counseling including condom use. Participants will receive a PrEP information brochure. The Champion will also make the initial appointment with the PrEP community provider for within 7 days of the ED visit. Community PrEP providers will be identified using local resources, CDC PrEP locators, and insurance; appointments will be scheduled according to patient preference. All participants will receive a text message reminder two days prior, and a reminder call one day prior.

ED-PrEP; ED-PrEP + DST

Eligibility Criteria

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

You may qualify if:

• English-speaking
• Self-report being HIV negative (GWU sites) or are found to be HIV rapid test negative (JHH ED)
• Medically stable ED/UC patients (defined as a triage category level 3, 4, 5 using Emergency Severity Index for ED patients only)

You may not qualify if:

• Currently taking PEP, PrEP, or present with signs/symptoms of acute HIV infection
• Pregnant
• Currently taking a nephrotoxic medication
• Diagnosed with medical conditions that are contraindicated with use of TDF/FTC or TAF/FTC
• Have a comorbid medical or psychiatric condition that would make PrEP adherence or ongoing follow-up care difficult
• Admission to the hospital
• Are in police custody/prisoner during the ED visit

Sponsors & Collaborators

• George Washington University: lead
• National Institute of Mental Health (NIMH): collaborator
• Johns Hopkins University: collaborator

Study Sites (2)

George Washington University Emergency Department

Washington D.C., District of Columbia, 20037, United States

Location

Johns Hopkins Hospital Emergency Department

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Amanda D Castel

CONTACT

202-994-8325; acastel@gwu.edu

Bhakti Hansoti

CONTACT

410-735-7077; bhansot1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2025
• First Posted: December 12, 2025
• Study Start (Estimated): January 15, 2027
• Primary Completion (Estimated): April 15, 2028
• Study Completion (Estimated): September 9, 2028
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)