N/A
N=351
Point of Care Diagnosis of Vaginal Infections
Vaginitis · Bacterial Vaginosis · Yeast Vaginitis · Trichomonas Vaginitis
Bottom Line
View on ClinicalTrials.gov: NCT06438575 ↗Enrolled (actual)
351
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Number of Participants Prescribed Appropriate Treatment — 61; 104; 58; 21 Participants — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Xpert® Xpress MVP test (Diagnostic_test); Usual Care (Diagnostic_test)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- Female
- Sponsor
- Sharon L Hillier
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Prescribed Appropriate Treatment |
61; 104; 58; 21 | <.001 sig |
| SECONDARY Number of Participants That Receive Correct Diagnosis of Vaginitis |
63; 108; 56; 17 | <.001 sig |
| SECONDARY Number of Participants Who Experience Resolution of Vaginitis Symptoms |
101; 109; 36; 29 | .323 |
| SECONDARY Number of Participants That Are Satisfied With Their Office Visit |
120; 124; 17; 14 | .573 |
| SECONDARY Number of Accurate BD AffirmTM VPIII Test Results |
79; 85; 37; 38 | .890 |
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.
Eligibility Criteria
Primary study
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Inclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT06438575). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.