Actively Recruiting
HIV Pre-Exposure Prophylaxis (PrEP) Linkage With Immediate Medications in the Emergency Department Study
Led by University of Texas Southwestern Medical Center · Updated on 2026-06-02
250
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to improve awareness and use of HIV pre-exposure prophylaxis (PrEP) among people who want, need, or could benefit from it in Dallas, TX. The study focuses on a pilot program offering immediate PrEP prescriptions in the Parkland Memorial Hospital Emergency Department (ED), linking patients to a dedicated PrEP clinic. It builds on previous work using an electronic health record-based HIV prediction tool and a successful ED HIV navigation program to identify and support eligible patients. Participants who qualify will be approached by a PrEP navigator in the ED based on specific criteria such as request for PrEP, high risk score, history of bacterial STIs, or clinician referral. After consent, participants receive education on all FDA-approved PrEP options and undergo a rapid HIV test. Those testing negative may receive a 30-day supply of oral PrEP from their ED clinician with referral to a PrEP clinic for ongoing care, including options for long-acting injectable PrEP. Participants choosing injectable PrEP may continue oral PrEP if needed while awaiting injections. Those testing positive for HIV or found pregnant will not enroll but receive standard care. Throughout the study, participants will be followed in the PrEP clinic for up to 12 months with regular visits every three months. Surveys will assess their experiences, satisfaction, barriers, and adherence to PrEP. Researchers will track prescription fills and injection schedules as adherence markers. The main outcome is to evaluate the feasibility of this rapid-start navigation program and connection to long-term PrEP care. Safety and persistence with PrEP will also be monitored during follow-up. Participants can continue PrEP through standard care after the study ends.
CONDITIONS
Brief Title
HIV Pre-Exposure Prophylaxis (PrEP) Linkage With Immediate Medications in the Emergency Department Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide signed, written informed consent before study procedures
- Negative HIV rapid test
- At least one of the following: requesting PrEP from ED clinician, score >75% on PCCI HIV Prediction Tool, prior bacterial STI diagnosis, seeking STI testing, or referred by ED clinician as meeting CDC PrEP indication
- Clinician working in Parkland ED (for sub-study)
You will not qualify if you...
- Known diagnosis of HIV
- Positive HIV rapid test
- Current use of PrEP within the last 4 weeks
- Known allergy or hypersensitivity to any PrEP medication
- Unwilling to follow up with Parkland ID clinic for ongoing PrEP care
- Adults unable to consent, people under 18, pregnant or breastfeeding women at enrollment, or prisoners
- People under 18 or prisoners (for sub-study)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Initial 30 days from rapid start
Participants who test negative for HIV and choose to start PrEP will receive a rapid start of oral PrEP medications in the Emergency Department and complete a brief survey on facilitators and barriers to PrEP initiation.
1 visit in the Emergency Department to start PrEP
Duration - Up to 12 months
Participants continue PrEP care at the Parkland ID clinic with options to include long-acting injectable PrEP if preferred. They will have follow-up visits approximately every 3 months to monitor and adjust PrEP as needed.
At least 4 clinic visits (every 3 months)
Duration - At 12 months with a 3-month grace period
At the 12-month clinic visit, participants complete a final survey assessing satisfaction and barriers to PrEP persistence. Participants can continue PrEP through standard care after study completion.
1 final clinic visit
Trial Site Locations
Total: 1 location
1
Parkland Health
Dallas, Texas, United States, 75390
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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