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NCT07462611Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 2 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
250 (estimated)
First submitted
2 Mar 2026
Start date
8 Apr 2026
Primary completion date
31 Oct 2027
Lead sponsor
University of Texas Southwestern Medical Center
Diseases
HIV
NCT number
NCT07462611

What you commit to

  • Study type: Interventional
  • Planned participants: 250
  • From 8 Apr 2026 to the primary completion date, 31 Oct 2027
  • 1 site 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.

Other illness

  • Known diagnosis of HIV
  • Positive HIV rapid test
  • Known hypersensitivity or allergy to any PrEP modality

Age

  • Adults unable to consent, people under the age of 18, women who are known to be pregnant or breast feeding at time of study enrollment, or prisoners
    • Sub-study subjects (ED clinicians):
  • People under the age of 18 or prisoners.

Other

  • Current use of PrEP, which is defined for purposes of this study as use of PrEP in the last 4 weeks
  • People who do not want to follow with Parkland ID clinic for ongoing PrEP care

Who the study is looking for

  • Able to comprehend and provide signed, written informed consent prior to initiation of study procedures.
  • Negative HIV rapid test
  • At least one of the following criteria:
    • Requesting PrEP from their ED clinician
    • Score \>75% on the PCCI HIV Prediction Tool
    • Prior bacterial STI diagnosis
    • Seeking STI testing
    • Referred by their ED clinician as someone who otherwise meets a CDC PrEP indication
  • Clinician in the Parkland ED

Criteria the registry did not label

  • Primary study (ED patients):

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Parkland Health
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.