Comparative Performance of a Vaginal Yeast Test

Launched by UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES · Oct 14, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new test called the SavvyCheck Vaginal Yeast Test to see how well it performs compared to the standard method used to diagnose vaginal yeast infections, specifically caused by a fungus called Candida. The goal is to find out if women can successfully use this home test and how its results compare with those from lab tests. The researchers will also investigate any differences in results using advanced techniques to understand why they might not match.

To participate, you need to be a woman aged 18 or older who is a beneficiary of the DoD Military Health System and has an appointment at a recruitment clinic. If you have symptoms like increased vaginal discharge, itching, or soreness, you may be eligible to join the study. Women without symptoms who are healthy and seeking routine care can also participate. If you decide to take part, you will use the SavvyCheck test and provide samples for the standard lab test. It’s essential to note that if you are currently menstruating or have used certain vaginal products recently, you won’t be able to join. This trial can help improve how vaginal yeast infections are diagnosed and treated in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • Inclusion Criteria for Symptomatic Women
• • 1. DoD Military Health System beneficiary
• • 2. Have a healthcare appointment at a recruitment clinic
• • 3. 18 years of age or older
• • 4. Must speak and understand English
• • 5. Able to provide informed consent
• • 6. Women experiencing vaginal symptoms, including: increased discharge, itching, soreness and irritation, rash on the labia, and genital burning that may worsen during urination
• • 7. 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.
• Inclusion Criteria for Asymptomatic Women:
• • 1. DoD Military Health System beneficiary
• • 2. Have a healthcare appointment at a recruitment clinic
• • 3. 18 years of age or older
• • 4. Must speak and understand English
• • 5. Able to provide informed consent
• • 6. Healthy women appearing for routine care without symptoms of vaginal yeast infection
• Exclusion Criteria:
• If any of the following criteria are met, a potential subject will be excluded from the study:
• • 1. Currently menstruating
• • 2. History of any clinical therapies and/or interventions related to gender confirmation (transgender person)
• • 3. Use of any vaginal medication, taken by mouth or vaginally, within the last 7 days
• • 4. 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