HIV Pre-Exposure Prophylaxis (PrEP) Linkage With Immediate Medications in the Emergency Department Study

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07462611
Status
Recruiting
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Conditions

  • HIV Pre-exposure Prophylaxis
  • PrEP

Eligibility Criteria

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

Interventions

  • PrEP Uptake with Rapid Start — BEHAVIORAL
    For participants who test negative for HIV and are interested in PrEP, the navigator will notify the ED clinician who will discuss starting PrEP with the subject in shared decision making as per standard care. If they decide to initiate PrEP, the ED clinician will complete standard care testing for someone starting PrEP, prescribe a 30-day supply of oral tenofovir disoproxil fumarate / emtricitabine (TDF/FTC), and place a referral to Parkland ID clinic. The rapid-start TDF/FTC can be immediately filled at the co-located Parkland Anderson pharmacy where it is on formulary or other retail pharmacy of subject's choice. The participants will complete a brief survey assessing facilitators/barriers to PrEP initiation.
  • Pre-Exposure Prophylaxis (PrEP) Persistence — BEHAVIORAL
    After rapid start PrEP initiation in the ED, the subject will continue on the PrEP modality of their choice in ID clinic with options to include long-acting injectables. Participants will be followed for 12 months with a final survey assessing facilitators/barriers to PrEP persistence to be administered in the final clinic visit. After study completion, participants can continue to receive PrEP through standard care.

Study Details

Our primary objective is to increase HIV pre-exposure prophylaxis (PrEP) awareness and uptake among people who want, need, or would benefit from PrEP in Dallas, TX through a pilot program of immediate PrEP prescribing in the Parkland Memorial Hospital Emergency Department (ED) with linkage to PrEP clinic. Leveraging the previous work of the Parkland Center for Clinical Innovation (PCCI) which created an automated electronic health record (EHR) based HIV prediction tool and prior success with a robust ED HIV navigation program, a PrEP navigator would approach patients in the Parkland ED for PrEP initiation. Through standard care prescribing by their ED clinician, subjects would leave the ED with a prescription for rapid-start oral PrEP and a clinic appointment to persist on the PrEP modality of their choice which will include long-acting injectable options.

Key Dates

Start date
Apr 8, 2026
Status verified
May 2026
Primary completion
Oct 31, 2027
Completion
Apr 1, 2028

Study Design

Enrollment
250 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Other: Participants who decide to receive PrEP (rapid start)
    Rapid start of PrEP in the Emergency Department (ED)

Primary Outcome Measure

Evaluate the feasibility of this novel navigation program of rapid-start PrEP in the ED with connection to longitudinal PrEP care and options for long-acting PrEP. [ Time Frame: 90 days after enrollment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Parkland HealthDallasTexas75390
Hayden Andrews, MD
[email protected]
214-645-7863
Stephanie Reyes, MA
[email protected]

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By research site
Parkland Health· Dallas, TX

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