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Can a simple finger-prick test help find hidden HIV and syphilis cases?

NCT ID NCT06716450

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study checks if a new self-test for HIV and syphilis is accurate and easy for people to use at home. About 900 adults in Canada will try the test and compare results to lab tests. The study also looks at how peer support can help homeless people in Toronto get tested and treated for these 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

About 900 people

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

Started

Jun 2025

Expected to finish

Dec 2026

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.

Inclusion Criteria: * Are ≥18 years of age. * Can speak/read/write English or French. * Have presented for voluntary testing for HIV and/or syphilis infection in the clinic or community-based setting. * Are willing to participate in the study site's standard of care HIV and syphilis counselling and testing program and receive the study site's standard of care test results. * Are willing to be a participant in the study. * Can provide informed consent i.e. understand and sign or instruct the Observer to sign the informed consent form. * Can complete the required testing on the allocated testing day. * Are willing to provide the necessary fingerstick and venipuncture blood for use in the study protocol testing methods. * Are of unknown HIV and syphilis status (last HIV and syphilis negative test must be a minimum of 3 months prior). Exclusion Criteria: * Do not meet the inclusion criteria. * Are known HIV and/or syphilis positive. * Have ever tested positive for syphilis or HIV at any time. * Have any experience in conducting rapid point-of-care tests on patients for HIV, syphilis or any other infectious disease. * Are familiar with the Multiplo® TP/HIV Self-Test. * Are investigator site employees or immediate family members of sponsor or investigator sites. * Have participated in any prior, or concurrent trial of HIV and syphilis self-tests. * Are a practicing medical healthcare professional (doctor, nurse or HIV counsellor that performs HIV testing with Rapid Tests). * Any condition which, in the opinion of the Observer, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of the assessment, consent form and questionnaire etc. or bias the outcome (e.g. being unable to see/read by forgetting to bring reading glasses, being intoxicated, acute sickness, visibly distressed).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    3 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

  • Cool Aid Community Health Centre

    RECRUITING

    Victoria, British Columbia, V8W 1M8, Canada

  • Hassle Free Clinic

    RECRUITING

    Toronto, Ontario, M5B 1G3, Canada

  • Women's Health in Women's Hands

    RECRUITING

    Toronto, Ontario, M5B 1J3, Canada

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