Decision Support Tool to Integrate PrEP Into Emergency Departments
ConditionHIV
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeorge Washington University
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Decision support tool
- PrEP Delivery
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
George Washington University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Johns Hopkins University
Collaborator
Source ClinicalTrials.gov