Trial Outcomes & Findings for Point of Care Diagnosis of Vaginal Infections (NCT NCT06438575)

Last Updated: 2026-04-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

351 participants

Primary outcome timeframe

Approximately 24 hours

Results posted on

2026-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Care Vaginitis diagnosis and treatment will be based on usual provider evaluation and treatment during the office visit	Same Day Results 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.	Healthcare Provider Substudy Healthcare providers with at least one patient enrolled in the randomized trial.
Overall Study STARTED	137	139	75
Overall Study COMPLETED	137	139	75
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age was collected as a categorical variable for the providers

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Approximately 24 hours

Population: Diagnosis is based on concordant results from two Food and Drug Administration approved diagnostic tests for vaginitis in 244 participants. 32 participants had discordant results for one or more of the following: bacterial vaginosis, yeast, Trichomonas vaginalis.

Outcome measures

Outcome measures
Measure	Usual Care n=119 Participants Vaginitis diagnosis and treatment will be based on usual provider evaluation and treatment during the office visit	Same Day Results n=125 Participants 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.
Number of Participants Prescribed Appropriate Treatment Appropriate treatment provided	61 Participants	104 Participants
Number of Participants Prescribed Appropriate Treatment Appropriate treatment not provided	58 Participants	21 Participants

SECONDARY outcome

Timeframe: Approximately 2 weeks

Population: Correct diagnosis is based on concordant results from two Food and Drug Administration approved diagnostic tests for vaginitis in 244 participants. 32 participants had discordant results for one or more of the following: bacterial vaginosis, yeast, Trichomonas vaginalis.

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

Outcome measures

Outcome measures
Measure	Usual Care n=119 Participants Vaginitis diagnosis and treatment will be based on usual provider evaluation and treatment during the office visit	Same Day Results n=125 Participants 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.
Number of Participants That Receive Correct Diagnosis of Vaginitis Correct diagnosis by provider	63 Participants	108 Participants
Number of Participants That Receive Correct Diagnosis of Vaginitis Incorrect/incomplete diagnosis	56 Participants	17 Participants

SECONDARY outcome

Timeframe: Approximately 2 weeks

Population: One participant did not respond to the 2-week follow-up questionnaire.

Number of participants who experience resolution of vaginitis symptoms at the two week follow up contact assessed by participant's self-report.

Outcome measures

Outcome measures
Measure	Usual Care n=137 Participants Vaginitis diagnosis and treatment will be based on usual provider evaluation and treatment during the office visit	Same Day Results n=138 Participants 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.
Number of Participants Who Experience Resolution of Vaginitis Symptoms Yes, symptoms resolved	101 Participants	109 Participants
Number of Participants Who Experience Resolution of Vaginitis Symptoms No, symptoms did not resolve	36 Participants	29 Participants

SECONDARY outcome

Timeframe: Approximately 2 weeks

Population: One participant did not respond to the 2-week follow-up questionnaire.

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.

Outcome measures

Outcome measures
Measure	Usual Care n=137 Participants Vaginitis diagnosis and treatment will be based on usual provider evaluation and treatment during the office visit	Same Day Results n=138 Participants 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.
Number of Participants That Are Satisfied With Their Office Visit Satisfied, very satisfied	120 Participants	124 Participants
Number of Participants That Are Satisfied With Their Office Visit Dissatisfied, very dissatisfied, neutral	17 Participants	14 Participants

SECONDARY outcome

Timeframe: Approximately 2 weeks

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.

Outcome measures

Outcome measures
Measure	Usual Care n=116 Participants Vaginitis diagnosis and treatment will be based on usual provider evaluation and treatment during the office visit	Same Day Results n=123 Participants 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.
Number of Accurate BD AffirmTM VPIII Test Results Correct diagnosis	79 Participants	85 Participants
Number of Accurate BD AffirmTM VPIII Test Results Incorrect diagnosis	37 Participants	38 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Approximately 14 months

Population: Healthcare providers with at least one patient enrolled in the same day results arm that utilized the Xpert® Xpress MVP to diagnose and treat their patients' vaginitis. Twenty two providers without a patient in the same day results arm were excluded.

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.

Outcome measures

Outcome measures
Measure	Usual Care n=53 Participants Vaginitis diagnosis and treatment will be based on usual provider evaluation and treatment during the office visit	Same Day Results 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.
Number of Healthcare Providers That Are Satisfied With Xpert® Xpress MVP Test Satisfied or very satisfied	52 Participants	—
Number of Healthcare Providers That Are Satisfied With Xpert® Xpress MVP Test Neither dissatisfied or satisfied	1 Participants	—

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Same Day Results

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sharon L. Hillier, Professor

University of Pittsburgh School of Medicine

Phone: 412-641-6435

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Usual Care n=137 Participants Vaginitis diagnosis and treatment will be based on usual provider evaluation and treatment during the office visit	Same Day Results n=139 Participants 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.	Healthcare Provider Substudy n=75 Participants Healthcare providers with at least one patient enrolled in the randomized trial.	Total n=351 Participants Total of all reporting groups
Age, Continuous	32 years n=137 Participants • Age was collected as a categorical variable for the providers	33 years n=139 Participants • Age was collected as a categorical variable for the providers	—	33 years n=276 Participants • Age was collected as a categorical variable for the providers
Age, Customized <30 years	53 Participants n=137 Participants	53 Participants n=139 Participants	15 Participants n=75 Participants	121 Participants n=351 Participants
Age, Customized 30-39 years	44 Participants n=137 Participants	54 Participants n=139 Participants	34 Participants n=75 Participants	132 Participants n=351 Participants
Age, Customized 40-49 years	25 Participants n=137 Participants	21 Participants n=139 Participants	13 Participants n=75 Participants	59 Participants n=351 Participants
Age, Customized 50-59 years	4 Participants n=137 Participants	9 Participants n=139 Participants	6 Participants n=75 Participants	19 Participants n=351 Participants
Age, Customized 60 years and older	11 Participants n=137 Participants	2 Participants n=139 Participants	7 Participants n=75 Participants	20 Participants n=351 Participants
Sex: Female, Male Female	137 Participants n=137 Participants	139 Participants n=139 Participants	68 Participants n=75 Participants	344 Participants n=351 Participants
Sex: Female, Male Male	0 Participants n=137 Participants	0 Participants n=139 Participants	7 Participants n=75 Participants	7 Participants n=351 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=137 Participants • Race and ethnicity not collected on healthcare providers.	10 Participants n=139 Participants • Race and ethnicity not collected on healthcare providers.	—	19 Participants n=276 Participants • Race and ethnicity not collected on healthcare providers.
Ethnicity (NIH/OMB) Not Hispanic or Latino	128 Participants n=137 Participants • Race and ethnicity not collected on healthcare providers.	129 Participants n=139 Participants • Race and ethnicity not collected on healthcare providers.	—	257 Participants n=276 Participants • Race and ethnicity not collected on healthcare providers.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=137 Participants • Race and ethnicity not collected on healthcare providers.	0 Participants n=139 Participants • Race and ethnicity not collected on healthcare providers.	—	0 Participants n=276 Participants • Race and ethnicity not collected on healthcare providers.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=137 Participants • Race and ethnicity not collected on healthcare providers.	0 Participants n=139 Participants • Race and ethnicity not collected on healthcare providers.	—	0 Participants n=276 Participants • Race and ethnicity not collected on healthcare providers.
Race (NIH/OMB) Asian	3 Participants n=137 Participants • Race and ethnicity not collected on healthcare providers.	3 Participants n=139 Participants • Race and ethnicity not collected on healthcare providers.	—	6 Participants n=276 Participants • Race and ethnicity not collected on healthcare providers.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=137 Participants • Race and ethnicity not collected on healthcare providers.	0 Participants n=139 Participants • Race and ethnicity not collected on healthcare providers.	—	0 Participants n=276 Participants • Race and ethnicity not collected on healthcare providers.
Race (NIH/OMB) Black or African American	70 Participants n=137 Participants • Race and ethnicity not collected on healthcare providers.	67 Participants n=139 Participants • Race and ethnicity not collected on healthcare providers.	—	137 Participants n=276 Participants • Race and ethnicity not collected on healthcare providers.
Race (NIH/OMB) White	55 Participants n=137 Participants • Race and ethnicity not collected on healthcare providers.	57 Participants n=139 Participants • Race and ethnicity not collected on healthcare providers.	—	112 Participants n=276 Participants • Race and ethnicity not collected on healthcare providers.
Race (NIH/OMB) More than one race	5 Participants n=137 Participants • Race and ethnicity not collected on healthcare providers.	11 Participants n=139 Participants • Race and ethnicity not collected on healthcare providers.	—	16 Participants n=276 Participants • Race and ethnicity not collected on healthcare providers.
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=137 Participants • Race and ethnicity not collected on healthcare providers.	1 Participants n=139 Participants • Race and ethnicity not collected on healthcare providers.	—	5 Participants n=276 Participants • Race and ethnicity not collected on healthcare providers.
Region of Enrollment United States	137 participants n=137 Participants	139 participants n=139 Participants	75 participants n=75 Participants	351 participants n=351 Participants
Pregnancy status Not pregnant	125 Participants n=137 Participants • Pregnancy status not collected for providers	131 Participants n=139 Participants • Pregnancy status not collected for providers	—	256 Participants n=276 Participants • Pregnancy status not collected for providers
Pregnancy status Pregnant	12 Participants n=137 Participants • Pregnancy status not collected for providers	8 Participants n=139 Participants • Pregnancy status not collected for providers	—	20 Participants n=276 Participants • Pregnancy status not collected for providers
Number of current vaginitis symptoms One	42 Participants n=137 Participants • This measure is not relevant to providers	37 Participants n=139 Participants • This measure is not relevant to providers	—	79 Participants n=276 Participants • This measure is not relevant to providers
Number of current vaginitis symptoms Two	62 Participants n=137 Participants • This measure is not relevant to providers	54 Participants n=139 Participants • This measure is not relevant to providers	—	116 Participants n=276 Participants • This measure is not relevant to providers
Number of current vaginitis symptoms Three	23 Participants n=137 Participants • This measure is not relevant to providers	39 Participants n=139 Participants • This measure is not relevant to providers	—	62 Participants n=276 Participants • This measure is not relevant to providers
Number of current vaginitis symptoms Four or more	10 Participants n=137 Participants • This measure is not relevant to providers	9 Participants n=139 Participants • This measure is not relevant to providers	—	19 Participants n=276 Participants • This measure is not relevant to providers