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Point of Care Diagnosis of Vaginal Infections

NCT06438575 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2026-04-08

Study results available
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Summary

Vaginal infections are a common gynecologic issue and may cause significant symptoms and discomfort for individuals. Point of care tests are used to diagnose infections in the office, with an advantage of quick diagnosis and treatment. Examples of point of care tests are urine pregnancy, rapid strep and COVID-19 tests. This study will enroll persons with vaginal complaints and compare diagnosis and treatment based on usual care to diagnosis and treatment using a Food and Drug Administration-approved point of care test for the diagnosis of vaginitis. The study is being done to better understand diagnosis, treatment, and satisfaction using point of care tests compared to usual care.

Participants will be randomized to one of two study arms:

Arm 1: the healthcare provider will perform their usual evaluation and tests to make the diagnosis and provide treatment, as needed.

Arm 2: the provider will be asked to use the results of the point-of-care test being used in the study to make the diagnosis and provide treatment, as needed.

Regardless of arm, all diagnoses and treatment will be provided through the healthcare provider. All participants will be contacted 2 weeks later to answer a questionnaire related to diagnosis, treatment, current symptoms, and satisfaction with their visit. Medical records related to vaginal complaints, up to 30 days from enrollment, will be reviewed by the study team to obtain information on symptoms, tests performed, results, and treatments prescribed.

Conditions

  • Vaginitis
  • Bacterial Vaginosis
  • Yeast Vaginitis
  • Trichomonas Vaginitis

Interventions

DIAGNOSTIC_TEST

Xpert® Xpress MVP test

The Xpert® Xpress MVP is an FDA-cleared point-of-care test for vaginitis diagnosis

DIAGNOSTIC_TEST

Usual Care

Usual methods used by the healthcare provider for vaginitis diagnosis

Sponsors & Collaborators

  • Cepheid

    collaborator INDUSTRY

  • Sharon L Hillier

    lead OTHER

Principal Investigators

  • Sharon L Hillier, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-16
Primary Completion
2025-03-19
Completion
2025-03-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06438575 on ClinicalTrials.gov