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Five-Minute Finger-Prick test could speed syphilis diagnosis in pregnancy

NCT ID NCT06829602

Diagnosis Sponsor: McMaster University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study tests whether a rapid finger-prick blood test for syphilis and HIV can be used in a prenatal clinic for pregnant people at risk. The test gives results in five minutes, potentially speeding up diagnosis and treatment. Participants will provide feedback on their experience, and researchers will measure how often the test is accepted and how well it works in practice.

What this could mean

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

Active substance
Rapid Syphilis/HIV point-of-care test (INSTI Multiplex HIV/Syphilis Duo Antibody Test)
What this could lead to
If successful, this rapid test could help prevent syphilis complications in pregnancy by enabling faster diagnosis and treatment in high-risk settings.
What could go wrong
This is a small feasibility study, so results may not apply broadly. The test may not be widely adopted or may not significantly improve outcomes.

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 77 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

13 to 49 years

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.

1. Pregnant people Inclusion Criteria: * Pregnant clients with at least one risk factor for syphilis infection: 1. Substance use or accessed addiction services in the past 1 year 2. Unstable housing in the past 1 year 3. Multiple sexual partners in the past 1 year 4. History of a sexually transmitted or blood-borne infection (STBBI) 5. Late to prenatal care (initial prenatal visit \>20 weeks) * Eligible for syphilis screening at that clinic visit, as per Public Health guidelines Exclusion Criteria: * Previous syphilis diagnosis * Not competent to consent to study participation 2. Sexual partners Inclusion Criteria: * Sexual partners of pregnant clients who are newly diagnosed with syphilis * Physically present in the clinic Exclusion Criteria: * Previous syphilis diagnosis * Not competent to consent to study participation

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Conditions

The condition(s) this trial relates to.

syphilis congenital syphilis prevention target

As listed by the trial registrant

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

Syphilis

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

  • Maternity Centre of Hamilton

    RECRUITING

    Hamilton, Ontario, Canada

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