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HIV prevention pills offered in the ER: a small step forward

NCT ID NCT04429971

Prevention Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tested whether offering HIV prevention medication (PrEP) in the emergency department is feasible. 26 adults at high risk for HIV were enrolled. The goal was to see if people would start PrEP and follow up with a clinic within 30 days. The study aimed to overcome common barriers like lack of access to regular healthcare.

What this could mean

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

Active substance
emtricitabine/tenofovir (PrEP medication)
What this could lead to
If successful, this approach could make it easier for people at high risk of HIV to start prevention medication without needing a separate doctor's visit.
What could go wrong
This was a very small pilot study with only 26 participants, so results may not apply to everyone. It only tested if the idea was feasible, not if it actually prevents HIV infections.

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

26 people

The number who actually took part.

Started

Mar 2020

Finished

Jul 2023

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.

Inclusion Criteria: PrEP screen group: * Patients 18 years of age and above * Medically stable as determined by their provider * Able to speak English * Willing and able to consent to study participation. * Not requiring hospital admission for ongoing care. iPrep group: * ED patients 18 years of age and above * HIV negative determined by 4th generation rapid testing with no evidence of acute HIV infection as determined by their ED provider * Medically stable as determined by their primary provider * Able to speak English * Able to consent to participation * Contact information available for linkage * Not requiring hospital admission for ongoing care. * Eligible for PrEP based on CDC risk behavior and clinical criteria. Exclusion Criteria: PrEP screen group: * ED patients younger than 18 years of age * Medically or psychiatrically unstable as determined by the ED provider * Unable to speak or understand English * Unable to provide consent for study participation. * Being admitted to the hospital for ongoing care iPrEP group: * ED patients younger than 18 years of age * Known HIV positive or positive rapid HIV test in ED * Medically or psychiatrically unstable as determined by the ED provider * Unable to speak or understand English * Unable to provide consent for study participation * No means of re-contact upon ED discharge * No behavioral risk factors indicating need for PrEP * Medical contraindications to PrEP * Pregnant or breastfeeding

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Conditions

The condition(s) this trial relates to.

AIDS 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/AIDS PREP

Contacts and locations

Locations

  • Mount Sinai Beth Israel Hospital

    New York, New York, 10003, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.