Point of Care Diagnosis of Vaginal Infections

NCT06438575 | Completed Results FDA Device

• 1 other identifier: STUDY24010118
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Point-of-care diagnosis; Vaginitis; Symptomatic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants That Receive Correct Diagnosis of Vaginitis

  Approximately 2 weeks

• Number of Participants Who Experience Resolution of Vaginitis Symptoms

  Approximately 2 weeks

• Number of Participants That Are Satisfied With Their Office Visit

  Approximately 2 weeks

• Number of Accurate BD AffirmTM VPIII Test Results

  Approximately 2 weeks

Other Outcomes (1)

• Number of Healthcare Providers That Are Satisfied With Xpert® Xpress MVP Test

  Approximately 14 months

Study Arms (3)

Usual Care

OTHER

Vaginitis diagnosis and treatment will be based on usual provider evaluation and treatment during the office visit

Diagnostic Test: Usual Care

Same Day Results

OTHER

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

Healthcare Provider Substudy

OTHER

Healthcare providers who had at least one patient enrolled in the randomized trial.

Diagnostic Test: Xpert® Xpress MVP test; Diagnostic Test: Usual Care

Interventions

Xpert® Xpress MVP test DIAGNOSTIC_TEST

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

Healthcare Provider Substudy; Same Day Results

Usual Care DIAGNOSTIC_TEST

Usual methods used by the healthcare provider for vaginitis diagnosis

Healthcare Provider Substudy; Usual Care

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sharon L Hillier: lead
• Cepheid: collaborator

Study Sites (1)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

• 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.

  PMID: 32350529 BACKGROUND

• 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.

  PMID: 29643195 BACKGROUND

• 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.

  PMID: 10411793 BACKGROUND

MeSH Terms

Conditions

Vaginitis; Vaginosis, Bacterial; Candidiasis, Vulvovaginal; Trichomonas Vaginitis

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Candidiasis; Mycoses; Vulvovaginitis; Vulvitis; Vulvar Diseases; Trichomonas Infections; Protozoan Infections; Parasitic Diseases

Results Point of Contact

• Title: Dr. Sharon L. Hillier, Professor
• Organization: University of Pittsburgh School of Medicine

hillsl@mwri.magee.edu

412-641-6435

Study Officials

• Sharon L Hillier, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: June 3, 2024
• Study Start: June 16, 2024
• Primary Completion: March 19, 2025
• Study Completion: March 26, 2025
• Last Updated: April 8, 2026
• Results First Posted: April 8, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)