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Pocket-sized HIV test could bring same-day diagnosis to community clinics

NCT ID NCT07730801

Diagnosis Sponsor: Unity Health Toronto 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This trial is testing whether the GeneXpert system, a portable device that can run multiple tests, can accurately detect HIV, chlamydia, gonorrhea, hepatitis C, and HPV in community health centers and clinics. Researchers will compare its results to standard lab tests and track whether patients get treated faster. The study involves 2,500 people across Canada who are already seeking testing for these infections.

What this could mean

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

Active substance
GeneXpert system (Xpert HIV-1 Qual XC, CT/NG, HCV VL Fingerstick, HPV tests)
What this could lead to
If successful, this could make rapid, same-visit HIV and STBBI testing widely available in community clinics, helping more people get diagnosed and treated quickly.
What could go wrong
This is an early-stage feasibility study, not a large-scale rollout. The test's accuracy in real-world community settings may differ from lab results, and not all sites may adopt the system.

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 2,500 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 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

16 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: * Individuals accessing STBBI testing at specific locations who are ≥ 16 years of age * Able to provide informed consent. Exclusion Criteria: * Unable to provide signed informed consent (e.g., intoxicated) * In the opinion of the site PI /study operator, the participant is unable to complete the study elements. * Participants who have previously enrolled in the study.

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Conditions

The condition(s) this trial relates to.

chlamydia infectious disease chlamydia trachomatis infectious disease gonorrhea hepatitis C virus infection HIV infectious disease human papilloma virus infection

As listed by the trial registrant

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

Chlamydia Gonorrhea HCV HIV HPV

How to take part

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

  1. The places running it

    2 sites. 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

  • Anishnawbe Health Toronto

    Toronto, Ontario, Canada

  • Women's Health In Women's Hands Community Health Centre

    Toronto, Ontario, Canada

More trials for these conditions

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