NCT07462611 HIV Pre-Exposure Prophylaxis (PrEP) Linkage With Immediate Medications in the Emergency Department Study
| NCT ID | NCT07462611 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | HIV Pre-exposure Prophylaxis |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2026-04-08 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2026-04-08 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT07462611 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV Pre-exposure Prophylaxis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07462611 currently recruiting?
Yes, NCT07462611 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Texas Southwestern Medical Center to inquire about joining.
Where is the NCT07462611 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT07462611 clinical trial?
NCT07462611 is sponsored by University of Texas Southwestern Medical Center. The trial plans to enroll 250 participants.
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