Point of Care Diagnosis of Vaginal Infections (PAT)

Point of Care Diagnosis of Vaginal Infections to Ensure Accurate Treatment: (PAT Study)

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.

Study Overview

• Status: Completed
• Conditions: Vaginitis; Bacterial Vaginosis; Trichomonas Vaginitis; Yeast Vaginitis
• Intervention / Treatment: Diagnostic test: Usual Care; Diagnostic test: Xpert® Xpress MVP test

Detailed Description

The goal of this randomized clinical trial is to evaluate whether same day testing using the Xpert® Xpress MVP test in a patient care setting results in a higher degree of appropriate treatment of vaginitis compared to standard of care for persons having vaginitis symptoms. Approximately 300 individuals who are complaining of vaginitis symptoms and are seeking care at one of the study participating offices within Magee-Womens Hospital will be invited to participate. In this study, the office visit will serve as the enrollment visit. After obtaining informed consent, participants will complete a brief questionnaire and self-collect three vaginal swabs for three tests that are FDA-cleared for vaginitis diagnosis: Xpert® Xpress MVP, BD MAX™ Vaginal Panel, and BD AffirmTM VPIII Microbial Identification Test. Participants will be randomized (1:1) into one of two arms after collecting swabs:

Arm 1, vaginitis diagnosis and treatment will be based on usual provider evaluation and treatment during the office visit. The Xpert® Xpress MVP test will be batched with delayed results made available to the provider following the participant's 2-week study follow-up telephone contact

. Arm 2, the Xpert® Xpress MVP test will be run in real time as a point of care test at the time of the office visit and the results will be made available to the provider in approximately one hour. Providers will be asked to use the MVP test result for diagnosis and treatment of the participant

All participants, regardless of arm, will complete a follow-up telephone contact approximately two weeks after their office visit to assess symptom resolution and satisfaction. Review and collection of electronic medical record information related to the office visit evaluation, testing, diagnosis and treatment will also be included.

A Healthcare Provider Sub study will also be performed. The sub study will include a baseline questionnaire completed by clinicians at participating offices and then a follow-up questionnaire administered to clinicians who provided care for at least one study participant. The sub study will help investigators understand how providers feel about point-of-care testing for vaginitis.

• Study Type: Interventional
• Enrollment (Actual): 351
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Womens Hospital of UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual Care; Vaginitis diagnosis and treatment will be based on usual provider evaluation and treatment during the office visit	Diagnostic test: Usual Care; Usual methods used by the healthcare provider for vaginitis diagnosis
Other: Same Day Results; the Xpert® Xpress MVP test will be run in real time as a point of care test at the time of the office visit and the results will be made available to the provider in approximately one hour. Providers will be asked to use the MVP test result for diagnosis and treatment of the participant.	Diagnostic test: Xpert® Xpress MVP test; The Xpert® Xpress MVP is an FDA-cleared point-of-care test for vaginitis diagnosis
Other: Healthcare Provider Substudy; Healthcare providers who had at least one patient enrolled in the randomized trial.	Diagnostic test: Usual Care; Usual methods used by the healthcare provider for vaginitis diagnosis; Diagnostic test: Xpert® Xpress MVP test; The Xpert® Xpress MVP is an FDA-cleared point-of-care test for vaginitis diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Prescribed Appropriate Treatment	Number of participants prescribed appropriate treatment at index visit or within 24 hours of index visit. Appropriate treatment is defined as Centers For Disease Control recommended, or Food and Drug Administration approved treatment based on diagnosis from the self-collected samples. Diagnosis is based on concordant results from two Food and Drug Administration approved diagnostic tests for vaginitis.	Approximately 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants That Receive Correct Diagnosis of Vaginitis	Number of participants whose vaginitis is correctly diagnosed by their healthcare provider. A positive result from both the Xpert® Xpress MVP and the BD MAX™ Vaginal Panel will be considered the gold standard for diagnosis of vaginitis/vaginosis. Correct diagnosis is based on concordant results from two Food and Drug Administration approved diagnostic tests for vaginitis	Approximately 2 weeks
Number of Participants Who Experience Resolution of Vaginitis Symptoms	Number of participants who experience resolution of vaginitis symptoms at the two week follow up contact assessed by participant's self-report.	Approximately 2 weeks
Number of Participants That Are Satisfied With Their Office Visit	Number of participants that respond that they are satisfied or very satisfied with their diagnosis and treatment for vaginitis at the 2-week follow-up visit. Satisfaction is evaluated on a 5-point Likert scale with 1 being very satisfied and 5 being very dissatisfied.	Approximately 2 weeks
Number of Accurate BD AffirmTM VPIII Test Results	Number of participant samples for which the BD AffirmTM VPIII test results agree with the results from the gold standard, defined as a concordant positive or negative result from both the Xpert® Xpress MVP and the BD MAX™ Vaginal Panel.	Approximately 2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Healthcare Providers That Are Satisfied With Xpert® Xpress MVP Test	Number of healthcare providers that respond that they are satisfied or very satisfied with the turnaround time using the Xpert® Xpress MVP to diagnose and treat their patients' vaginitis. Satisfaction is evaluated on a 5-point Likert scale with 1 being very satisfied and 5 being very dissatisfied.	Approximately 14 months

Collaborators and Investigators

• Sponsor: Sharon L Hillier
• Collaborators: Cepheid
• Investigators: Principal Investigator: Sharon L Hillier, PhD, University of Pittsburgh

Publications and helpful links

General Publications

• Hillier SL, Austin M, Macio I, Meyn LA, Badway D, Beigi R. Diagnosis and Treatment of Vaginal Discharge Syndromes in Community Practice Settings. Clin Infect Dis. 2021 May 4;72(9):1538-1543. doi: 10.1093/cid/ciaa260.
• Schwebke JR, Gaydos CA, Nyirjesy P, Paradis S, Kodsi S, Cooper CK. Diagnostic Performance of a Molecular Test versus Clinician Assessment of Vaginitis. J Clin Microbiol. 2018 May 25;56(6):e00252-18. doi: 10.1128/JCM.00252-18. Print 2018 Jun.
• Wiesenfeld HC, Macio I. The infrequent use of office-based diagnostic tests for vaginitis. Am J Obstet Gynecol. 1999 Jul;181(1):39-41. doi: 10.1016/s0002-9378(99)70433-3.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2024
• Primary Completion (Actual): March 19, 2025
• Study Completion (Actual): March 26, 2025

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Vaginitis; Symptomatic; Point-of-care diagnosis
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Genital Diseases, Female; Protozoan Infections; Parasitic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Vulvar Diseases; Vulvitis; Mycoses; Vaginal Diseases; Vulvovaginitis; Candidiasis; Trichomonas Infections; Vaginosis, Bacterial; Candidiasis, Vulvovaginal; Vaginitis; Trichomonas Vaginitis
• Other Study ID Numbers: STUDY24010118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No