Clinical trial NCT03151928: Diagnostic Accuracy By Providers Study
Official title: Diagnostic Accuracy By Providers Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginitis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Becton Dickinson Life Sciences
First posted: 2017-05-12
Enrollment: 299
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women presenting to primary care offices with symptoms of vaginitis

Brief summary: The validation study is intended to provide comparative data on the diagnosis of vaginal infections as performed in primary care settings versus the diagnosis provided through standard diagnostic testing performed in a reference laboratory. The clinician and lab diagnoses will be compared to those obtained using the BD MAX Vaginal Panel on the BD MAX System.

Detailed description: The primary goals of this study are to:

1. Compare the level of agreement of clinician diagnosed bacterial vaginosis (BV) to vaginal swab samples evaluated for BV using Nugent's criteria and the BD MAX Vaginal Panel
2. Compare the level of agreement of clinician diagnosed trichomonas vaginalis (TV) to the laboratory diagnosis of TV identified by quantitative PCR using the GeneXpert system by Cepheid and the BD MAX Vaginal Panel.
3. Compare the level of agreement of clinician diagnosed yeast vaginitis to laboratory diagnosis of yeast identified with culture and the BD MAX Vaginal Panel.

The secondary goals of this study include:

1. Being able to describe the patterns of testing among clinicians in community practices providing routine care for women presenting with symptoms of vaginitis.
2. Describe the treatments prescribed for women presenting with vaginitis and how these prescribed treatments are distributed in women with laboratory-confirmed diagnoses.

Eligibility criteria: Inclusion Criteria:

1. Female, Age 18-40
2. Presenting with symptoms of vaginitis; vaginal discharge, vaginal odor, vulvar or vaginal itch, vulvar or vaginal discomfort (i.e. irritation, burning pain or vulvar edema).
3. Able and willing to provide verbal consent.
4. Willingness to undergo all study-related assessments and procedures, including the collection of multiple vaginal swabs, answer questions related to demographic and health information and follow all other study-related procedures.

Exclusion:

Women who meet any of the following criteria by participant report will be excluded from the study:

1.) 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.

Primary outcomes:
measure: BV Result Agreement
timeFrame: enrollment
measure: Trichomonas (TV) Result Agreement
timeFrame: enrollment
measure: Yeast Result Agreement
timeFrame: enrollment
Secondary outcomes:
measure: Patterns of clinician testing
timeFrame: enrollment
measure: Prescribed Treatments
timeFrame: enrollment
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC/associated community clinics
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Sharon L Hillier, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.