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Rapid HIV tests could end the epidemic by diagnosing in minutes

NCT ID NCT04793750

Diagnosis Sponsor: Johns Hopkins University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested three rapid, point-of-care HIV tests to see how well they work compared to standard lab tests. Researchers enrolled 224 adults at high risk for HIV in Baltimore. The goal was to see if faster results help more people start treatment or prevention the same day.

What this could mean

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

Active substance
Cepheid GeneXpert HIV-1 Qual POC HIV VL test, DPP HIV-Syphilis test system, OraQuick
What this could lead to
If these tests work well, they could help diagnose HIV in minutes instead of days, getting people into care or prevention the same day.
What could go wrong
This is a completed study with 224 participants in one city, so results may not apply everywhere. The tests may not be as accurate as lab tests.

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

224 people

The number who actually took part.

Started

Aug 2021

Finished

Mar 2025

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: * Aged 18 years or older * Living with or at high risk for HIV (MSM/transgender; injection drug use (IDU); known STI or being screened for STI; part of a high STI prevalence network \[e.g., in the Sexual Health clinic\]) * Willing to undergo phlebotomy and collection of oral fluid samples * Willing to complete a questionnaire * Willing to have laboratory results shared with the clinician(s) associated with their care * Willing to attend follow-up visits * Willing for samples to be transferred to the CDC for analysis and storage Exclusion Criteria: * Aged \<18 years * Unwilling to undergo study procedures * Any other reason deemed pertinent by the study team

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease sexually transmitted disease syphilis

As listed by the trial registrant

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

HIV infections Syphilis

Contacts and locations

Locations

  • Johns Hopkins Hospital Emergency Department (JHHED)

    Baltimore, Maryland, 21287, United States

  • The Baltimore City Health Department (BCHD) Health and Wellness Center, Sexual Health Clinics

    Baltimore, Maryland, 21217, United States

  • The John G. Bartlett Specialty Practice (JGBSP)

    Baltimore, Maryland, 21287, United States

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