Point of Care Diagnosis of Vaginal Infections

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.

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