An interventional study of Xpert® Xpress MVP test and Usual Care in Vaginitis, Bacterial Vaginosis and Yeast Vaginitis, sponsored by Sharon L Hillier. Completed at 1 site in United States. Open to female participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by Sharon L Hillier · Not applicable, Interventional, and Diagnostic
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.
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.
98 studies on the registry are indexed under Vaginitis; 12 are open to participants now.
This study's enrollment of 351 is above the median of 108 across 71 interventional studies indexed under Vaginitis.
Browse Vaginitis studies →This is the only study on the registry with Sharon L Hillier as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Primary study
Inclusion Criteria:
Exclusion Criteria:
Healthcare Provider Sub-study
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vaginitis diagnosis and treatment will be based on usual provider evaluation and treatment during the office visit
Diagnostic Test: Usual Care
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.
Diagnostic Test: Xpert® Xpress MVP test
Healthcare providers who had at least one patient enrolled in the randomized trial.
Diagnostic Test: Xpert® Xpress MVP test · Diagnostic Test: Usual Care
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
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.
Time frame: Approximately 24 hours
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Approximately 2 weeks
Number of Healthcare Providers That Are Satisfied With Xpert® Xpress MVP Test
Number of healthcare providers that respond that they are satisfied or very satisfied with the turnaround time using the Xpert® Xpress MVP to diagnose and treat their patients' vaginitis. Satisfaction is evaluated on a 5-point Likert scale with 1 being very satisfied and 5 being very dissatisfied.
Time frame: Approximately 14 months
| Milestone | Usual Care | Same Day Results | Healthcare Provider Substudy |
|---|---|---|---|
| Started | 137 | 139 | 75 |
| Completed | 137 | 139 | 75 |
| Not completed | 0 | 0 | 0 |
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.
| Participants | Usual Care | Same Day Results |
|---|---|---|
| Appropriate treatment provided | 61 | 104 |
| Appropriate treatment not provided | 58 | 21 |
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
| Participants | Usual Care | Same Day Results |
|---|---|---|
| Correct diagnosis by provider | 63 | 108 |
| Incorrect/incomplete diagnosis | 56 | 17 |
Number of participants who experience resolution of vaginitis symptoms at the two week follow up contact assessed by participant's self-report.
| Participants | Usual Care | Same Day Results |
|---|---|---|
| Yes, symptoms resolved | 101 | 109 |
| No, symptoms did not resolve | 36 | 29 |
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.
| Participants | Usual Care | Same Day Results |
|---|---|---|
| Satisfied, very satisfied | 120 | 124 |
| Dissatisfied, very dissatisfied, neutral | 17 | 14 |
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.
| Participants | Usual Care | Same Day Results |
|---|---|---|
| Correct diagnosis | 79 | 85 |
| Incorrect diagnosis | 37 | 38 |
Number of healthcare providers that respond that they are satisfied or very satisfied with the turnaround time using the Xpert® Xpress MVP to diagnose and treat their patients' vaginitis. Satisfaction is evaluated on a 5-point Likert scale with 1 being very satisfied and 5 being very dissatisfied.
| Participants | Healthcare Providers With Patient in Same Day Results Arm |
|---|---|
| Satisfied or very satisfied | 52 |
| Neither dissatisfied or satisfied | 1 |
Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care | 0/137 (0%) | 0/137 (0%) | — |
| Same Day Results | 0/139 (0%) | 0/139 (0%) | — |
| Age, Continuous(years) | Usual Care | Same Day Results | Healthcare Provider Substudy | Total |
|---|---|---|---|---|
| Median | 32 (27 to 42) | 33 (26 to 39) | — | 33 (27 to 41) |
| Age, Customized(Participants) | Usual Care | Same Day Results | Healthcare Provider Substudy | Total |
|---|---|---|---|---|
| <30 years | 53 | 53 | 15 | 121 |
| 30-39 years | 44 | 54 | 34 | 132 |
| 40-49 years | 25 | 21 | 13 | 59 |
| 50-59 years | 4 | 9 | 6 | 19 |
| 60 years and older | 11 | 2 | 7 | 20 |
| Sex: Female, Male(Participants) | Usual Care | Same Day Results | Healthcare Provider Substudy | Total |
|---|---|---|---|---|
| Female | 137 | 139 | 68 | 344 |
| Male | 0 | 0 | 7 | 7 |
| Ethnicity (NIH/OMB)(Participants) | Usual Care | Same Day Results | Healthcare Provider Substudy | Total |
|---|---|---|---|---|
| Hispanic or Latino | 9 | 10 | — | 19 |
| Not Hispanic or Latino | 128 | 129 | — | 257 |
| Unknown or Not Reported | 0 | 0 | — | 0 |
| Race (NIH/OMB)(Participants) | Usual Care | Same Day Results | Healthcare Provider Substudy | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | — | 0 |
| Asian | 3 | 3 | — | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | — | 0 |
| Black or African American | 70 | 67 | — | 137 |
| White | 55 | 57 | — | 112 |
| More than one race | 5 | 11 | — | 16 |
| Unknown or Not Reported | 4 | 1 | — | 5 |
| Region of Enrollment(participants) | Usual Care | Same Day Results | Healthcare Provider Substudy | Total |
|---|---|---|---|---|
| United States | 137 | 139 | 75 | 351 |
| Pregnancy status(Participants) | Usual Care | Same Day Results | Healthcare Provider Substudy | Total |
|---|---|---|---|---|
| Not pregnant | 125 | 131 | — | 256 |
| Pregnant | 12 | 8 | — | 20 |
| Number of current vaginitis symptoms(Participants) | Usual Care | Same Day Results | Healthcare Provider Substudy | Total |
|---|---|---|---|---|
| One | 42 | 37 | — | 79 |
| Two | 62 | 54 | — | 116 |
| Three | 23 | 39 | — | 62 |
| Four or more | 10 | 9 | — | 19 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2024 to primary completion in Mar 2025, 9 months.
Results were first posted in Apr 2026, 1 year after primary completion.
Of 22 interventional studies with no phase under Vaginitis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's 9 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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