RECRUITING

Comparative Performance of a Vaginal Yeast Test

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Comparative Performance of the SavvyCheck Vaginal Yeast Test Versus Culture

Quick Facts

Study Start:2022-03-18
Study Completion:2026-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05079711

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. DoD Military Health System beneficiary
  2. 2. Have a healthcare appointment at a recruitment clinic
  3. 3. 18 years of age or older
  4. 4. Must speak and understand English
  5. 5. Able to provide informed consent
  6. 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. 7. Must determine the test is applicable to her based on her symptoms after she has read the outside device labeling (box label)
  8. 1. DoD Military Health System beneficiary
  9. 2. Have a healthcare appointment at a recruitment clinic
  10. 3. 18 years of age or older
  11. 4. Must speak and understand English
  12. 5. Able to provide informed consent
  13. 6. Healthy women appearing for routine care without symptoms of vaginal yeast infection
  1. 1. Currently menstruating
  2. 2. History of any clinical therapies and/or interventions related to gender confirmation (transgender person)
  3. 3. Use of any vaginal medication, taken by mouth or vaginally, within the last 7 days
  4. 4. Use of any vaginal product within 24 hours, including contraception (cream, gel, or foam), or douching solutions

Contacts and Locations

Study Contact

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

Principal Investigator

Elizabeth A Kostas-Polston, PhD
PRINCIPAL_INVESTIGATOR
Uniformed Services University of the Health Sciences

Study Locations (Sites)

Womack Army Medical Center
Fort Bragg, North Carolina, 28310
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
United States

Collaborators and Investigators

Sponsor: Uniformed Services University of the Health Sciences

  • Elizabeth A Kostas-Polston, PhD, PRINCIPAL_INVESTIGATOR, Uniformed Services University of the Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-18
Study Completion Date2026-08-30

Study Record Updates

Study Start Date2022-03-18
Study Completion Date2026-08-30

Terms related to this study

Keywords Provided by Researchers

  • Vaginal candidiasis, Vaginal yeast culture

Additional Relevant MeSH Terms

  • Vulvovaginal Candidiasis