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Quick ER test could spot HIV and syphilis in pregnant women, saving babies

NCT ID NCT07525076

Diagnosis Sponsor: The University of Texas Health Science Center, Houston 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 test a rapid fingerstick test for HIV and syphilis in pregnant women who come to the emergency department without prior prenatal care. Researchers want to see if offering this test leads to more women being diagnosed and starting treatment right away. The goal is to prevent passing these infections to their babies.

What this could mean

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

Active substance
Chembio DPP® HIV-Syphilis rapid point-of-care test
What this could lead to
If successful, this approach could help more pregnant women get diagnosed and treated for HIV or syphilis during their ER visit, potentially preventing infections in their babies.
What could go wrong
This is an implementation study, not a treatment trial, so it won't prove a cure. Results depend on how well the test works in a busy ER, and not all patients may accept testing.

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 1,400 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

May 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

14 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Pregnancy * Presentation to the ED or obstetrical triage during the index pregnancy. * No established prenatal care (≤1 visit) and/or no documented HIV or syphilis testing during the current pregnancy. Exclusion Criteria: * Medically unstable or critically ill at the time of ED presentation. * Incarcerated at the time of ED presentation. * Decline participation in testing (opt-out) or refuse survey participation.

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Conditions

The condition(s) this trial relates to.

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 infection

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

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

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