Actively Recruiting
Comparative Performance of a Vaginal Yeast Test
Led by Uniformed Services University of the Health Sciences · Updated on 2024-05-16
1200
Participants Needed
3
Research Sites
232 weeks
Total Duration
On this page
Sponsors
U
Uniformed Services University of the Health Sciences
Lead Sponsor
S
Savvyon Diagnostics Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Comparative Performance of a Vaginal Yeast Test
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 years or older
- DoD Military Health System beneficiaries
- Have a healthcare appointment at a recruitment clinic
- Must speak and understand English
- Able to provide informed consent
- For symptomatic women: experiencing vaginal symptoms such as increased discharge, itching, soreness, rash on the labia, or genital burning that worsens during urination
- For asymptomatic women: healthy and attending routine care without symptoms of vaginal yeast infection
- Must determine the test applies to her symptoms after reading the device labeling
You will not qualify if you...
- Currently menstruating
- History of any clinical therapies 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 creams, gels, foams, or douching solutions
- Note: Women with an intrauterine device (IUD) are eligible to participate
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Womack Army Medical Center
Fort Bragg, North Carolina, United States, 28310
Actively Recruiting
2
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Not Yet Recruiting
3
Landstuhl Regional Medical Center
Landstuhl, Germany
Actively Recruiting
Research Team
E
Elizabeth A Kostas-Polston, PhD
CONTACT
M
Mary B Engler, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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