Quick diagnosis of vaginal infections
Point of Care Diagnosis of Vaginal Infections to Ensure Accurate Treatment: (PAT Study)
This study is testing if a quick test for vaginal infections can help people get the right treatment faster and feel more satisfied with their care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 14 Years and up |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06438575 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a point-of-care test, the Xpert® Xpress MVP test, for diagnosing vaginitis compared to standard care. Participants with symptoms of vaginitis will be randomly assigned to either receive usual care or have their diagnosis informed by the rapid test results available within an hour. The study aims to determine if immediate testing leads to more appropriate treatment and higher patient satisfaction. Approximately 300 individuals will be enrolled at Magee-Womens Hospital, where they will self-collect vaginal swabs for testing.
Who should consider this trial
Good fit: Ideal candidates are women experiencing symptoms of vaginitis, such as discharge or itching, who are seeking care at participating offices.
Not a fit: Patients who do not have symptoms of vaginitis or those who have previously participated in this study may not benefit.
Why it matters
Potential benefit: If successful, this approach could lead to faster and more accurate treatment for patients suffering from vaginal infections.
How similar studies have performed: Previous studies have shown promise with point-of-care testing for various conditions, suggesting potential success for this approach in diagnosing vaginitis.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pittsburgh, Pennsylvania
- Magee-Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Sharon L Hillier, PhD — University of Pittsburgh
- Study coordinator: Ingrid Macio, PA-C
- Email: maciis@upmc.edu
- Phone: 4126415455
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.