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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

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

Primary study (ED patients):

Inclusion Criteria:

* 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

Exclusion Criteria:

* Known diagnosis of HIV
* Positive HIV rapid test
* Current use of PrEP, which is defined for purposes of this study as use of PrEP in the last 4 weeks
* Known hypersensitivity or allergy to any PrEP modality
* People who do not want to follow with Parkland ID clinic for ongoing PrEP care
* 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):

Inclusion criteria:

• Clinician in the Parkland ED

Exclusion criteria:

• People under the age of 18 or prisoners.

About the study

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.

What is being tested

• PrEP Uptake with Rapid Start (behavioral)
• Pre-Exposure Prophylaxis (PrEP) Persistence (behavioral)

Sponsor: University of Texas Southwestern Medical Center · Participants: 250 · Started: Apr 8, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07462611

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.