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Decision Support Tool to Integrate PrEP Into Emergency Departments

NCT07279129 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-12-12

No results posted yet for this study

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

Interventions

BEHAVIORAL

Decision support tool

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.

BEHAVIORAL

PrEP Delivery

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Johns Hopkins University

    collaborator OTHER

  • George Washington University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2027-01-15
Primary Completion
2028-04-15
Completion
2028-09-09

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07279129 on ClinicalTrials.gov