Comparative Performance of a Vaginal Yeast Test

NCT05079711 | Recruiting

• 1 other identifier: USUHS.2020-058
• Study Type: observational
• Target: 1,200
• Locations: 2 countries
• Sites: 3

Brief Summary

The purpose of this study is to establish lay user performance criteria for the SavvyCheck Vaginal Yeast Test in comparison to standard vaginal yeast culture and identification method for Candida (the Reference Method). Polymerase chain reaction (PCR) and sequencing of fungi will be used as an aid to explain the nature of the discrepancy in the case of discordant results between the lay user-performed SavvyCheck Vaginal Yeast Test and standard vaginal yeast culture and identification method for Candida.

Conditions

Vulvovaginal Candidiasis

Keywords

Vaginal candidiasis, Vaginal yeast culture

Outcome Measures

Primary Outcomes (1)

• Assess sensitivity and specificity between lay user-performed SavvyCheck Vaginal Yeast Test result compared to the Reference Method (vaginal Candida yeast culture)

  Calculation of sensitivity and specificity of the lay user-performed SavvyCheck Vaginal Yeast Test as compared to the Reference Method (vaginal Candida yeast culture)

  12 months

Secondary Outcomes (2)

• Assess positive and negative predictive values of the lay-user SavvyCheck Vaginal Yeast Test result as compared to the Reference Method (vaginal Candida yeast culture)

  12 months

• Assess concordance between the lay user-performed SavvyCheck Vaginal Yeast test result and the trained user-performed result.

  12 months

Other Outcomes (3)

• Assess concordance between the lay user-performed SavvyCheck Vaginal Yeast test result -vs vaginal wet mount microscopy

  12 months

• Assess concordance between the lay user-performed SavvyCheck Vaginal Yeast test result -vs. PCR and sequencing

  12 months

• Assess concordance between the Reference Method results (vaginal yeast culture) -vs PCR and sequencing

  12 months

Study Arms (2)

Symptomatic for vaginal yeast

Women presenting to the clinic with symptoms of vulvovaginal candidiasis.

Device: SavvyCheck Vaginal Yeast Test (rapid, point-of-care diagnostic test)

Asymptomatic for vaginal yeast

Women presenting to the clinic with no symptoms of vulvovaginal candidiasis.

Device: SavvyCheck Vaginal Yeast Test (rapid, point-of-care diagnostic test)

Interventions

SavvyCheck Vaginal Yeast Test (rapid, point-of-care diagnostic test) DEVICE

The SavvyCheck Vaginal Yeast Test is a lateral flow immunochromatographic qualitative test for detection of Candida antigen in vaginal secretions, sampled by a swab as an aid for identification of vulvovaginal candidiasis (VVC), as a primary cause of vaginal yeast infections. The SavvyCheck Vaginal Yeast Test is designed for use by women experiencing vaginal symptoms, including: increased vaginal discharge, vaginal itching, vaginal soreness and irritation, rash on the labia, and genital burning that may worsen during urination. The SavvyCheck Vaginal Yeast Test is indicated for OTC use.

Asymptomatic for vaginal yeast; Symptomatic for vaginal yeast

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women experiencing vulvovaginal symptoms of candidiasis vaginitis.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women, aged 18 years and older, symptomatic and asymptomatic for vaginitis will be enrolled in the study. We estimate that it will require a total enrollment of up to 600 symptomatic women at all clinical sites combined, to achieve the target of at least n=216 Reference Method (vaginal Candida yeast culture) positives. In addition, a combined total of 320 asymptomatic women will be enrolled in the study from the four clinical sites combined, to achieve the target of at least n=170 Reference Method (vaginal Candida yeast culture) negatives.

You may qualify if:

• Symptomatic Women Symptomatic women include those women who present with a complaint consistent with symptoms of vaginitis (e.g., increased vaginal discharge, vaginal itching, vaginal soreness and irritation, rash on the labia, and genital burning that may worsen during urination). Enrollment will continue at each clinical site until our target number of 216 Reference Method (vaginal Candida yeast culture) positives have been collected. We estimate up to 600 symptomatic women will be enrolled to meet our target.
• DoD Military Health System beneficiary
• Have a healthcare appointment at a recruitment clinic
• years of age or older
• Must speak and understand English
• Able to provide informed consent
• Women experiencing vaginal symptoms, including: increased discharge, itching, soreness and irritation, rash on the labia, and genital burning that may worsen during urination
• Must determine the test is applicable to her based on her symptoms after she has read the outside device labeling (box label)
• Asymptomatic Women Asymptomatic women include those women who do not present with a complaint consistent with vaginitis. Enrollment will continue at each clinical site until our target number of 170 Reference Method (vaginal Candida yeast culture) negatives have been collected. We estimate up to 320 asymptomatic women will be enrolled to meet our target.
• DoD Military Health System beneficiary
• Have a healthcare appointment at a recruitment clinic
• years of age or older
• Must speak and understand English
• Able to provide informed consent
• Healthy women appearing for routine care without symptoms of vaginal yeast infection

You may not qualify if:

• If any of the following criteria are met, a potential subject will be excluded from the study:
• Currently menstruating
• History of any clinical therapies and/or interventions related to gender confirmation (transgender person)
• Use of any vaginal medication, taken by mouth or vaginally, within the last 7 days
• Use of any vaginal product within 24 hours, including contraception (cream, gel, or foam), or douching solutions
• NOTE: Women who currently have an intrauterine device (IUD) placed are eligible to participate

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead
• Savvyon Diagnostics Ltd.: collaborator

Study Sites (3)

Womack Army Medical Center

Fort Bragg, North Carolina, 28310, United States

RECRUITING

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

NOT YET RECRUITING

Landstuhl Regional Medical Center

Landstuhl, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Five vaginal swabs; one collected by the subject and four collected by a healthcare provider (healthcare provider only will use a swab randomization scheme). The five swabs will be analyzed by: * Vaginal wet mount microscopy (1 swab) * Reference Method (vaginal Candida yeast culture) (1 swab) * Subject and trained user-performed SavvyCheck Vaginal Yeast Test (2 swabs; 1 each) * PCR and sequencing of fungi (1 swab; analysis to be conducted in discordant cases only)

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Study Officials

• Elizabeth A Kostas-Polston, PhD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth A Kostas-Polston, PhD

CONTACT

301.295.1531; elizabeth.kostas-polston@usuhs.edu

Mary B Engler, PhD

CONTACT

301.295.3427; mary.engler@usuhs.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: October 15, 2021
• Study Start: March 18, 2022
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); DE (1)