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Quick vaginal infection test could beat standard diagnosis

NCT ID NCT06438575

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested whether a rapid point-of-care test (Xpert® Xpress MVP) helps doctors diagnose vaginal infections more accurately than usual methods. 351 women with symptoms like discharge or itching were randomly assigned to either usual care or the rapid test. Researchers then checked if the prescribed treatment matched CDC guidelines, and followed up after two weeks to assess satisfaction and symptom relief.

What this could mean

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

Active substance
Xpert® Xpress MVP test
What this could lead to
If successful, this could show that a quick office test is better than usual methods for diagnosing vaginal infections, leading to more accurate treatment.
What could go wrong
This is a completed study with 351 participants, so results are available but may not apply to all settings. The test may not outperform usual care in all cases.

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

351 people

The number who actually took part.

Started

Jun 2024

Finished

Mar 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 years and older

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.

Primary study Inclusion Criteria: * Complaining of at least one symptom of vaginitis: vaginal discharge, vaginal odor, vulvar or vaginal itch. Women having vulvar or vaginal discomfort such as irritation, burning, pain of less than 2 months duration are also eligible. Pregnant participants who complain of vaginal discharge will be required to have at least one additional vaginal symptom to be eligible. * Seeking care at one of the participating offices. * Able and willing to provide informed consent. * Willing to undergo all study-related assessments and procedures, including self-collection of vaginal swabs, answering questions/surveys, agreeing to the review and collection of information from their medical record from the office (enrollment/index) visit and up to 4 weeks after the office visit. Exclusion Criteria: * Previous participation in this study. * Any condition, that in the opinion of the investigator, would preclude provision of consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives Healthcare Provider Sub-study Inclusion Criteria: * Able and willing to provide informed consent * Provided clinical care to at least one study participant on the date of their study enrollment * Willing to undergo all study-related assessments including answering questions/surveys

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Conditions

The condition(s) this trial relates to.

bacterial vaginosis Trichomonas vaginitis urogenital infection vaginitis vulvovaginal candidiasis

As listed by the trial registrant

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

Bacterial vaginosis Trichomonas vaginitis Vaginitis Yeast vaginitis

Contacts and locations

Locations

  • Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213, United States

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