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Rapid dual test for HIV and syphilis could save newborns in guatemala

NCT ID NCT07498153

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study tested a rapid fingerstick test that checks for both HIV and syphilis at the same time in pregnant women visiting prenatal clinics in Guatemala. The goal was to see if this quick, on-the-spot screening would lead to more women being diagnosed and treated during pregnancy, ultimately preventing these infections from passing to their babies. The study enrolled 149 women and provided immediate treatment and ultrasound checks for those who tested positive.

What this could mean

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

Active substance
Chembio HIV/Syphilis rapid POC test
What this could lead to
If successful, this screening approach could increase detection and treatment of syphilis and HIV in pregnant women, reducing infections passed to babies.
What could go wrong
This was a small, short-term study (149 participants over one week) in one location, so results may not apply broadly. The test's accuracy in real-world low-resource settings needs further validation.

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

153 people

The number who actually took part.

Started

Sep 2025

Finished

Oct 2025

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 65 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: * pregnant women at any gestational age * Nonpregnant women may also be included if unsure of pregnancy status and attend clinic for pregnancy care and confirmed to be not pregnant by routine testing such as urine pregnancy tests and/or the absence of an intrauterine pregnancy by ultrasound Exclusion Criteria: * Participants not at clinical sites in Puerto Barrios, Guatemala between 09/27/2025 and 10/03/2025

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Conditions

The condition(s) this trial relates to.

HIV infectious disease sexually transmitted disease syphilis congenital human immunodeficiency virus prevention target congenital syphilis prevention target

As listed by the trial registrant

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

HIV infections Syphilis

Contacts and locations

Locations

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

More trials for these conditions

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