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Comparative Performance of a Vaginal Yeast Test
Comparative Performance of a Vaginal Yeast Test

NCT05079711

Active Not RecruitingN/A

Sponsor: Uniformed Services University of the Health Sciences

Conditions: Vulvovaginal Candidiasis

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

Countries: United States, Germany

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

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
Locations (3)
  • Fort Bragg, North Carolina, United States
  • Fort Sam Houston, Texas, United States
  • Landstuhl, Germany