At a glance
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Point of Care Diagnosis of Vaginal Infections to Ensure Accurate Treatment: (PAT Study)
In Brief
A clinical study evaluating Xpert® Xpress MVP test and Usual Care for Vaginitis and 3 related conditions. Completed, enrolled 351 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
The Xpert® Xpress MVP is an FDA-cleared point-of-care test for vaginitis diagnosis
Usual methods used by the healthcare provider for vaginitis diagnosis