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Rapid STI tests for Moms-to-Be: a game changer?

NCT ID NCT07290439

Knowledge-focused Sponsor: Emory University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Updated 2 times

Summary

This study tests whether point-of-care STI tests, which give results in about 10 minutes, can speed up treatment for pregnant women compared to standard lab tests. About 756 pregnant women at Grady Memorial Hospital will either get the rapid tests or standard testing. The goal is to see if faster diagnosis leads to quicker treatment and better health for mothers and babies.

What this could mean

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

Active substance
Point-of-care STI tests (Syphilis Health Check and Visby Sexual Health Test)
What this could lead to
If successful, this could show that quick, bedside STI testing helps pregnant women get treated faster, potentially reducing infections passed to babies.
What could go wrong
This is an early-stage feasibility study, not a large-scale trial. Results may not apply to other hospitals, and the tests may not be as accurate as standard lab tests.

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 756 people

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

Started

Aug 2026

Expected to finish

Jun 2030

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

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: * Pregnant and clinically indicated for STI testing (syphilis and/or Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) at a prenatal care (PNC ) or labor and delivery (L\&D) triage visit at Grady Memorial Hospital (GMH). Indications for STI testing in pregnancy at GMH: * Syphilis, CT, NG, and TV indicated at first PNC visit * Syphilis serologic testing additionally indicated in 3rd trimester and at delivery * CT/NG/TV additionally indicated in the 3rd trimester for those \<25 or with increased risk \[1\] * Additional testing recommended based on clinical signs or symptoms (e.g., genital lesion or vaginal discharge, new exposure history) * English or Spanish-speaking * If \<16 years of age, has a parent or legal guardian present * Have STI risk factor: * \<25 years of age * Reports current substance use * Reported or documented history of a positive STI * More than one current sex partner * A current sex partner who has concurrent partners * A new sex partner (\<6 months ) * A current sex partner who has an STI * Exchange of sex for money or drugs * Incarceration * No previous prenatal care during the current pregnancy * Able to follow study procedures and provide written informed consent or assent, as appropriate Exclusion Criteria: * Indicated for syphilis test: negative RPR test during this pregnancy * Indicated for syphilis test: ever had a previous syphilis diagnosis (lifetime history) * Indicated for CT/NG/TV test: negative for all three of CT, NG, and TV within the previous 1 month * Indicated for CT/NG/TV test: positive for any of CT, NG, and/or TV and completed treatment \<3 weeks prior Stakeholders: * GMH PNC or L\&D providers, GMH leadership, Georgia Dept of Health leadership * \>=18 years of age * Able to follow study procedures and provide verbal informed consent

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Conditions

The condition(s) this trial relates to.

chlamydia trachomatis infectious disease gonorrhea sexually transmitted disease syphilis trichomonal vulvovaginitis Trichomonas vaginitis urogenital infection trichomoniasis

As listed by the trial registrant

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

Chlamydia trachomatis infection Neisseria gonorrheae infection Sexually transmitted infection Treponema pallidum infection Trichomonas vaginalis vaginitis

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

  • Grady Memorial Hospital

    RECRUITING

    Atlanta, Georgia, 30303, United States

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