NCT07279129Not yet recruitingPhase 1
Decision Support Tool to Integrate PrEP Into Emergency Departments
A Pilot Feasibility Study to Integrate PrEP Into Emergency Departments Using Decision Support Tools
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 6 Nov 2025
- Start date
- 1 Oct 2026
- Primary completion date
- 15 Apr 2028
- Lead sponsor
- George Washington University
- Diseases
- HIV
- NCT number
- NCT07279129
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 120
- From 1 Oct 2026 to the primary completion date, 15 Apr 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking PEP, PrEP, or present with signs/symptoms of acute HIV infection
- Currently taking a nephrotoxic medication
Other illness
- 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
Other
- Pregnant
- Admission to the hospital
- Are in police custody/prisoner during the ED visit
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Hospital Emergency Department Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| George Washington University Emergency Department Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.