Point of Care Test for Vaginal Infections

(PAT Trial)

This trial aims to determine if a quick, in-office test can diagnose and treat vaginal infections more effectively than usual methods. Participants will receive either a typical evaluation or a point-of-care test, the Xpert® Xpress MVP test, which provides results in about an hour. Researchers seek to discover which approach leads to better diagnosis, treatment, and patient satisfaction. Individuals experiencing symptoms like unusual discharge, odor, or itching for less than two months and seeking care may be suitable for this study. As an unphased study, this trial offers an opportunity to contribute to innovative research that could enhance diagnostic methods for vaginal infections.

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your healthcare provider.

Research has shown that the Xpert® Xpress MVP test is safe for diagnosing vaginal infections. The FDA has approved this test, confirming its safety and effectiveness. As a point-of-care test, it can quickly provide results during a doctor's visit by detecting DNA from bacteria and fungi that commonly cause vaginal infections.

Since the test is FDA-cleared and widely used in medical settings, no major safety issues have been reported. It does not involve medication or invasive methods, reducing the risk of side effects. Participants in studies have not reported any harmful effects from the test itself.

Researchers are excited about the Xpert® Xpress MVP test because it offers a rapid, on-the-spot diagnosis for vaginal infections, delivering results in about an hour. Unlike standard methods, which rely on traditional lab cultures or clinician evaluations that can take days, this test provides immediate data that can guide treatment decisions during the same office visit. This immediacy not only enhances patient care by enabling quicker, more accurate treatment but also reduces the anxiety and inconvenience of waiting for lab results.

Research shows that the Xpert Xpress MVP test excels at diagnosing vaginal infections. Studies have found it to be both highly sensitive and specific, accurately detecting infections such as bacterial vaginosis, yeast infections, and trichomoniasis. In this trial, participants in the "Same Day Results" arm will have the Xpert Xpress MVP test conducted in real time during their office visit, providing results in about an hour. This rapid option enables providers to use the test results for immediate diagnosis and treatment. The FDA has approved the test, which can be used in clinics with minimal handling, quickly assisting doctors in selecting the best treatment for these common infections.¹⁵⁶⁷⁸