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ERs could become frontline for HIV prevention: new study tests immediate PrEP

NCT ID NCT07462611

Prevention Sponsor: University of Texas Southwestern Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving HIV prevention pills (PrEP) to people right in the emergency room helps them start and stay on prevention. Researchers will enroll 250 HIV-negative adults at risk for HIV in Dallas. Participants get a 30-day pill supply and a clinic appointment to continue PrEP, with the goal of keeping 50% engaged in care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tenofovir disoproxil fumarate / emtricitabine (TDF/FTC) oral pills
What this could lead to
If successful, this could show that starting HIV prevention pills immediately in the emergency room helps more people stay protected from HIV.
What could go wrong
This is a small pilot study (250 people) testing feasibility, not yet proven to work. It may not show a big enough benefit or be practical in other hospitals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Emergencies posterior leukoencephalopathy syndrome HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV pre-exposure prophylaxis PREP

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Parkland Health

    RECRUITING

    Dallas, Texas, 75390, United States

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