NCT07462611 · University of Texas Southwestern Medical Center
HIV Pre-Exposure Prophylaxis (PrEP) Linkage With Immediate Medications in the Emergency Department Study
(PrEP ED)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
BEHAVIORAL
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 measures
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
Rate of enrolled participants in the ED who attend the first ID clinic appointment. Hypothesis: Same-day oral PrEP initiation in the ED with the possibility of eventual injectable PrEP and the assistance of a PrEP navigator will lead to a 50% retention rate of people successfully navigating to PrEP clinic.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Dallas, Texas
Collaborators
Gilead Sciences
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations