Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438575
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-24
Brief Title:
Point of Care Diagnosis of Vaginal Infections
Sponsor:
Sharon L Hillier
Organization:
University of Pittsburgh
Study Overview
Official Title:
Point of Care Diagnosis of Vaginal Infections to Ensure Accurate Treatment PAT Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAT
Brief 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
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
Detailed Description:
The goal of this randomized clinical trial is to evaluate whether same day testing using the Xpert Xpress MVP test in a patient care setting results in a higher degree of appropriate treatment of vaginitis compared to standard of care for persons having vaginitis symptoms Approximately 300 individuals who are complaining of vaginitis symptoms and are seeking care at one of the study participating offices within Magee-Womens Hospital will be invited to participate In this study the office visit will serve as the enrollment visit After obtaining informed consent participants will complete a brief questionnaire and self-collect three vaginal swabs for three tests that are FDA-cleared for vaginitis diagnosis Xpert Xpress MVP BD MAX Vaginal Panel and BD AffirmTM VPIII Microbial Identification Test Participants will be randomized 11 into one of two arms after collecting swabs
Arm 1 vaginitis diagnosis and treatment will be based on usual provider evaluation and treatment during the office visit The Xpert Xpress MVP test will be batched with delayed results made available to the provider following the participants 2-week study follow-up telephone contact
Arm 2 the Xpert Xpress MVP test will be run in real time as a point of care test at the time of the office visit and the results will be made available to the provider in approximately one hour Providers will be asked to use the MVP test result for diagnosis and treatment of the participant
All participants regardless of arm will complete a follow-up telephone contact approximately two weeks after their office visit to assess symptom resolution and satisfaction Review and collection of electronic medical record information related to the office visit evaluation testing diagnosis and treatment will also be included
A Healthcare Provider Sub study will also be performed The sub study will include a baseline questionnaire completed by clinicians at participating offices and then a follow-up questionnaire administered to clinicians who provided care for at least one study participant The sub study will help investigators understand how providers feel about point-of-care testing for vaginitis
Arm 1 vaginitis diagnosis and treatment will be based on usual provider evaluation and treatment during the office visit The Xpert Xpress MVP test will be batched with delayed results made available to the provider following the participants 2-week study follow-up telephone contact
Arm 2 the Xpert Xpress MVP test will be run in real time as a point of care test at the time of the office visit and the results will be made available to the provider in approximately one hour Providers will be asked to use the MVP test result for diagnosis and treatment of the participant
All participants regardless of arm will complete a follow-up telephone contact approximately two weeks after their office visit to assess symptom resolution and satisfaction Review and collection of electronic medical record information related to the office visit evaluation testing diagnosis and treatment will also be included
A Healthcare Provider Sub study will also be performed The sub study will include a baseline questionnaire completed by clinicians at participating offices and then a follow-up questionnaire administered to clinicians who provided care for at least one study participant The sub study will help investigators understand how providers feel about point-of-care testing for vaginitis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None