Point of Care Diagnosis of Vaginal Infections

Launched by SHARON L HILLIER · May 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well a new quick test can diagnose vaginal infections, like bacterial vaginosis and yeast infections, compared to the usual methods used by healthcare providers. Vaginal infections can cause discomfort and symptoms that many women experience, so finding a fast and accurate way to diagnose these issues is important. In this study, women who are having symptoms will be randomly assigned to one of two groups: one group will receive the standard evaluation and treatment, while the second group will have their diagnosis informed by the results of the new point-of-care test.

To participate, women must be experiencing symptoms such as unusual vaginal discharge, odor, or itching and need to be seeking care at one of the participating offices. They should also be able to provide consent and complete study-related tasks, like answering questions and allowing their medical records to be reviewed. After their visit, all participants will be contacted two weeks later to share their experience and how they feel about their treatment. This trial aims to improve how vaginal infections are diagnosed and treated, ultimately leading to better care for women.

Gender

FEMALE

Eligibility criteria

• • 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

Trial Officials