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New All-in-One test could save thousands of babies from infections

NCT ID NCT07388979

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study will check if a new device called MagIA H3S can accurately detect HIV, hepatitis B, hepatitis C, and syphilis in pregnant women in the Democratic Republic of the Congo. About 7,500 pregnant women will take part. The goal is to see if this quick test works as well as standard lab tests, which could help prevent passing these infections to babies.

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.

Participants

About 7,500 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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.

Who is studied

Pregnant women attending antenatal care clinics among the 20 health facilities included for this study in DRCongo.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

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: * Being pregnant, regardless of age or stage of pregnancy (prenatal period); * Having signed an informed consent form at the start of prenatal care (CPN) to participate in the study. Note: for pregnant minors, the consent of a parent or legal guardian is required; * Have chosen to attend prenatal care at the healthcare facility selected for the study; * Plan to give birth at the same healthcare facility where they were included in the study; * Plan to attend postnatal care (PNC) and preschool consultations (PSC) at the same healthcare facility where they were included in the study. * Plan to give birth at the same health facility where they were enrolled; * Plan to attend postnatal consultations (PNC) and preschool consultations (PSC) at the same facility Exclusion Criteria: * Women in labor or who refuse to give their consent.

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Conditions

The condition(s) this trial relates to.

AIDS hepatitis B virus infection hepatitis C virus infection HIV infectious disease syphilis

As listed by the trial registrant

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

HBV (hepatitis B virus) Hepatitis C virus (HCV) HIV (human immunodeficiency virus) Mother to child transmission Performance Point of care sti testing Syphilis Treat B

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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