HIV Pre-Exposure Prophylaxis (PrEP) Linkage With Immediate Medications in the Emergency Departmen… (NCT07462611) | Clinical Trial Compass
RecruitingNot Applicable
HIV Pre-Exposure Prophylaxis (PrEP) Linkage With Immediate Medications in the Emergency Department Study
United States250 participantsStarted 2026-04-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: 90 days after enrollment
Trial details
NCT IDNCT07462611
SponsorUniversity of Texas Southwestern Medical Center