Comparing a new vaginal yeast test to standard methods
Comparative Performance of the SavvyCheck Vaginal Yeast Test Versus Culture
Uniformed Services University of the Health Sciences · NCT05079711
This study is testing a new vaginal yeast test to see if it works as well as standard methods for women who have symptoms of a yeast infection.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Uniformed Services University of the Health Sciences (fed) |
| Locations | 3 sites (Fort Bragg, North Carolina and 2 other locations) |
| Trial ID | NCT05079711 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the performance of the SavvyCheck Vaginal Yeast Test when used by lay users, comparing its results to those obtained from standard vaginal yeast culture methods. The study will also utilize polymerase chain reaction (PCR) and fungal sequencing to investigate any discrepancies between the two testing methods. The primary focus is to establish sensitivity and specificity criteria for the SavvyCheck test, while secondary objectives include assessing predictive values and concordance with trained user results. The study will enroll symptomatic women who meet specific eligibility criteria to gather comprehensive data.
Who should consider this trial
Good fit: Ideal candidates for this study are symptomatic women aged 18 and older who are beneficiaries of the DoD Military Health System and can provide informed consent.
Not a fit: Patients who do not exhibit symptoms of vaginitis or are not beneficiaries of the DoD Military Health System may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable, user-friendly diagnostic tool for women experiencing vaginal yeast infections.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in evaluating point-of-care diagnostic tests, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Fort Bragg, North Carolina and 2 other locations
- Womack Army Medical Center — Fort Bragg, North Carolina, United States (RECRUITING)
- Brooke Army Medical Center — Fort Sam Houston, Texas, United States (NOT_YET_RECRUITING)
- Landstuhl Regional Medical Center — Landstuhl, Germany (RECRUITING)
Study contacts
- Principal investigator: Elizabeth A Kostas-Polston, PhD — Uniformed Services University of the Health Sciences
- Study coordinator: Elizabeth A Kostas-Polston, PhD
- Email: elizabeth.kostas-polston@usuhs.edu
- Phone: 301.295.1531
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Vulvovaginal Candidiasis, Vaginal candidiasis, Vaginal yeast culture