Decision Support Tool to Integrate PrEP Into Emergency Departments

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
George Washington University
Study ID
NCT07279129
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jan 15, 2027
Status verified
Dec 2025
Primary completion
Apr 15, 2028
Completion
Sep 9, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Active Comparator: ED-PrEP
    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).
  • Experimental: ED-PrEP + DST
    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.

Primary Outcome Measure

Number of participants who self-report taking PrEP in the past 4 months and have any TFV-DP detected in DBS [ Time Frame: 4 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
George Washington University Emergency DepartmentWashington D.C.District of Columbia20037
Amanda D Castel
[email protected]
202-994-8325
Amanda D Castel (PRINCIPAL_INVESTIGATOR)
Johns Hopkins Hospital Emergency DepartmentBaltimoreMaryland21287
Bhakti Hansoti
[email protected]
410-735-7077
Bhakti Hansoti (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By condition
HIV
By specialty
Infectious disease
By research site
George Washington University Emergency Department· Washington D.C., DCJohns Hopkins Hospital Emergency Department· Baltimore, MD

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