Point of Care Diagnosis of Vaginal Infections
Completed · Not applicable
Conditions studied: Vaginitis, Bacterial Vaginosis, Yeast Vaginitis, Trichomonas Vaginitis
In brief
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.
Key facts
- Study ID
- NCT06438575
- Run by
- Sharon L Hillier
- People needed
- 351
- Starts
- 2024-06-16
- Expected to finish
- 2025-03-26
- Last updated by the study team
- 2026-04-08
Who can join
Age: 14 and older. Sex: female. Healthy volunteers: not accepted.
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
- 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
Where it is running
- Magee-Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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