VaginitisPATNCT06438575
Point of Care Diagnosis of Vaginal Infections
A study testing Xpert® Xpress MVP test in people with Vaginitis and Bacterial Vaginosis, run by Sharon L Hillier at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older, women only
- Conditions the study is for
- Vaginitis, Bacterial Vaginosis, Yeast Vaginitis
- What is being tested?
- Xpert® Xpress MVP test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 351 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2024to 26 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Point of Care Diagnosis of Vaginal Infections to Ensure Accurate Treatment: (PAT Study)
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:
Read more
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.
Read the 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 (1:1) 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 participant's 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.
- Conditions
- Vaginitis, Bacterial Vaginosis, Yeast Vaginitis, Trichomonas Vaginitis
- Being tested
- Xpert® Xpress MVP test, Usual Care
- Keywords
- Point-of-care diagnosis, Vaginitis, Symptomatic
- Medical subject headings
- Vaginitis, Vaginosis, Bacterial, Candidiasis, Vulvovaginal, Trichomonas Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpert® Xpress MVP testDiagnostic test
The Xpert® Xpress MVP is an FDA-cleared point-of-care test for vaginitis diagnosis
Usual CareDiagnostic test
Usual methods used by the healthcare provider for vaginitis diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Other | Vaginitis diagnosis and treatment will be based on usual provider evaluation and treatment during the office visit Receives: Diagnostic Test: Usual Care |
| Same Day Results | Other | 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. Receives: Diagnostic Test: Xpert® Xpress MVP test |
| Healthcare Provider Substudy | Other | Healthcare providers who had at least one patient enrolled in the randomized trial. Receives: Diagnostic Test: Xpert® Xpress MVP test; Diagnostic Test: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Prescribed Appropriate Treatment
Number of participants prescribed appropriate treatment at index visit or within 24 hours of index visit. Appropriate treatment is defined as Centers For Disease Control recommended, or Food and Drug Administration approved treatment based on diagnosis from the self-collected samples. Diagnosis is based on concordant results from two Food and Drug Administration approved diagnostic tests for vaginitis.
Measured: Approximately 24 hours
Secondary outcomes (4)
Number of Participants That Receive Correct Diagnosis of Vaginitis
Number of participants whose vaginitis is correctly diagnosed by their healthcare provider. A positive result from both the Xpert® Xpress MVP and the BD MAX™ Vaginal Panel will be considered the gold standard for diagnosis of vaginitis/vaginosis. Correct diagnosis is based on concordant results from two Food and Drug Administration approved diagnostic tests for vaginitis
Measured: Approximately 2 weeks
Number of Participants Who Experience Resolution of Vaginitis Symptoms
Number of participants who experience resolution of vaginitis symptoms at the two week follow up contact assessed by participant's self-report.
Measured: Approximately 2 weeks
Number of Participants That Are Satisfied With Their Office Visit
Number of participants that respond that they are satisfied or very satisfied with their diagnosis and treatment for vaginitis at the 2-week follow-up visit. Satisfaction is evaluated on a 5-point Likert scale with 1 being very satisfied and 5 being very dissatisfied.
Measured: Approximately 2 weeks
Number of Accurate BD AffirmTM VPIII Test Results
Number of participant samples for which the BD AffirmTM VPIII test results agree with the results from the gold standard, defined as a concordant positive or negative result from both the Xpert® Xpress MVP and the BD MAX™ Vaginal Panel.
Measured: Approximately 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start16 Jun 2024
- Primary completion19 Mar 2025
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for VaginitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharon L Hillier
- Sponsor type
- University, hospital or other
- Collaborators
- Cepheid
- Responsible party
- Sponsor-investigator, Sharon L Hillier, University of Pittsburgh
- Investigators
- Sharon L Hillier, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438575
- Sponsor's protocol ID
- STUDY24010118
- Acronym
- PAT
- Status last verified
- Aug 2025
- First submitted
- 24 May 2024
- Last updated
- 8 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hillier SL, Austin M, Macio I, Meyn LA, Badway D, Beigi R. Diagnosis and Treatment of Vaginal Discharge Syndromes in Community Practice Settings. Clin Infect Dis. 2021 May 4;72(9):1538-1543. doi: 10.1093/cid/ciaa260.
PubMed 32350529Schwebke JR, Gaydos CA, Nyirjesy P, Paradis S, Kodsi S, Cooper CK. Diagnostic Performance of a Molecular Test versus Clinician Assessment of Vaginitis. J Clin Microbiol. 2018 May 25;56(6):e00252-18. doi: 10.1128/JCM.00252-18. Print 2018 Jun.
PubMed 29643195Wiesenfeld HC, Macio I. The infrequent use of office-based diagnostic tests for vaginitis. Am J Obstet Gynecol. 1999 Jul;181(1):39-41. doi: 10.1016/s0002-9378(99)70433-3.
PubMed 10411793Hillier SL, Macio I, Gallagher R, Meyn L, Beamer M, Zamborsky T, Campbell T, Bunge K, Wiesenfeld HC. Randomized Study of Usual Care vs Xpert(R) Xpress MVP at the Point of Care for Accurate Diagnosis and Appropriate Treatment of Vaginal Infections. Sex Transm Dis. 2026 May 12;53(9):589-95. doi: 10.1097/OLQ.0000000000002343. Online ahead of print.
PubMed 42117698
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Diagnosis of Vaginal Infections to Ensure Accurate Treatment: (PAT Study)
- ClinicalTrials.gov ID
- NCT06438575
- Acronym / sponsor ID
- PAT / STUDY24010118
- Conditions
- Vaginitis, Bacterial Vaginosis, Yeast Vaginitis, Trichomonas Vaginitis
- Keywords
- Point-of-care diagnosis, Vaginitis, Symptomatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Sharon L HillierUniversity, hospital or other
- Collaborators
- Cepheid
- Study start
- 16 Jun 2024 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 3 Jun 2024 (actual)
- Results
- Posted 8 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (1:1) 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 participant's 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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Other | Diagnostic Test: Usual CareVaginitis diagnosis and treatment will be based on usual provider evaluation and treatment during the office visit |
| Same Day Results | Other | Diagnostic Test: Xpert® Xpress MVP testthe 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. |
| Healthcare Provider Substudy | Other | Diagnostic Test: Xpert® Xpress MVP test, Diagnostic Test: Usual CareHealthcare providers who had at least one patient enrolled in the randomized trial. |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Able and willing to provide informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xpert® Xpress MVP testThe Xpert® Xpress MVP is an FDA-cleared point-of-care test for vaginitis diagnosis | Diagnostic test | Healthcare Provider Substudy, Same Day Results |
| Usual CareUsual methods used by the healthcare provider for vaginitis diagnosis | Diagnostic test | Healthcare Provider Substudy, Usual Care |
Primary outcome
Number of Participants Prescribed Appropriate Treatment
Time frame: Approximately 24 hours
Number of participants prescribed appropriate treatment at index visit or within 24 hours of index visit. Appropriate treatment is defined as Centers For Disease Control recommended, or Food and Drug Administration approved treatment based on diagnosis from the self-collected samples. Diagnosis is based on concordant results from two Food and Drug Administration approved diagnostic tests for vaginitis.
4 secondary outcomes
Number of Participants That Receive Correct Diagnosis of Vaginitis
Time frame: Approximately 2 weeks
Number of Participants Who Experience Resolution of Vaginitis Symptoms
Time frame: Approximately 2 weeks
Number of Participants That Are Satisfied With Their Office Visit
Time frame: Approximately 2 weeks
Number of Accurate BD AffirmTM VPIII Test Results
Time frame: Approximately 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32350529Hillier SL, Austin M, Macio I, Meyn LA, Badway D, Beigi R. Diagnosis and Treatment of Vaginal Discharge Syndromes in Community Practice Settings. Clin Infect Dis. 2021 May 4;72(9):1538-1543. doi: 10.1093/cid/ciaa260.
- Background: PubMed 29643195Schwebke JR, Gaydos CA, Nyirjesy P, Paradis S, Kodsi S, Cooper CK. Diagnostic Performance of a Molecular Test versus Clinician Assessment of Vaginitis. J Clin Microbiol. 2018 May 25;56(6):e00252-18. doi: 10.1128/JCM.00252-18. Print 2018 Jun.
- Background: PubMed 10411793Wiesenfeld HC, Macio I. The infrequent use of office-based diagnostic tests for vaginitis. Am J Obstet Gynecol. 1999 Jul;181(1):39-41. doi: 10.1016/s0002-9378(99)70433-3.
- Derived from this study: PubMed 42117698Hillier SL, Macio I, Gallagher R, Meyn L, Beamer M, Zamborsky T, Campbell T, Bunge K, Wiesenfeld HC. Randomized Study of Usual Care vs Xpert(R) Xpress MVP at the Point of Care for Accurate Diagnosis and Appropriate Treatment of Vaginal Infections. Sex Transm Dis. 2026 May 12;53(9):589-95. doi: 10.1097/OLQ.0000000000002343. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Vaginitis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon L Hillier, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xpert® Xpress MVP test in people with Vaginitis and Bacterial Vaginosis, run by Sharon L Hillier at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Prescribed Appropriate Treatment (time frame: Approximately 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06438575, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.