Recruiting

PrEP

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT07462611

Conditions

HIV Pre-exposure Prophylaxis

PrEP

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

PrEP Uptake with Rapid Start

Pre-Exposure Prophylaxis (PrEP) Persistence

Study Details

Brief summary:

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.

Conditions

HIV Pre-exposure Prophylaxis

PrEP

Study ID

NCT07462611

Start date

Apr 8, 2026

Status verified date

May, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

250 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Participants who decide to receive PrEP (rapid start)

Rapid start of PrEP in the Emergency Department (ED)

Interventions

PrEP Uptake with Rapid Start

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

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.

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 ]

Central Contacts and Locations

Locations

Parkland Health

Recruiting

Dallas, Texas, United States, 75390

Contacts

Hayden Andrews, MD

214-645-7863Hayden.Andrews@UTSouthwestern.edu

Stephanie Reyes, MA

stephanie.reyes@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jun 2, 2026

Last verified

May, 2026

Keywords

  • PrEP
  • HIV pre-exposure prophylaxis
  • Emergency department

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-06-02.