Point of Care Diagnosis of Vaginal Infections — PAT  

Bacterial Vaginosis Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Trichomonas Vaginitis
• Vaginitis
• Vaginosis, Bacterial

• NCT number: NCT06438575
• Study type: Interventional
• Source: University of Pittsburgh
• Contact: Ingrid Macio, PA-C
• Phone: 4126415455
• Email: maciis@upmc.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Completion date: December 2025