CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 351 enrolled
Drug / intervention
Xpert® Xpress MVP test +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06438575
NCT06438575N/ACompleted

Point of Care Diagnosis of Vaginal Infections to Ensure Accurate Treatment: (PAT Study)

Sharon L Hillier·interventional·Posted Jun 3, 2024·Updated Apr 8, 2026

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsCepheid

Timeline

N/ACompletedFinished
20252026
First PostedJun 3, 2024
Enrollment StartJun 16, 2024
Primary CompletionMar 19, 2025
Study CompletionMar 26, 2025
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 2.1 years ago

Interventions

Xpert® Xpress MVP testother

The Xpert® Xpress MVP is an FDA-cleared point-of-care test for vaginitis diagnosis

Usual Careother

Usual methods used by the healthcare provider for vaginitis diagnosis