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๐Ÿ›๏ธ Verified NIH Protocol โ€ข Sourced via U.S. National Library of Medicine (Last Synced: 2024-05-16)

Comparative Performance of a Vaginal Yeast Test

๐ŸŸข Recruiting Not Applicable ๐Ÿ“Š Observational Clinical Research Sponsor: Uniformed Services University of the Health Sciences

๐Ÿฉบ Protocol Summary

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.

Primary Research Facility: Womack Army Medical Center (Fort Bragg, North Carolina)

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๐Ÿ“ Primary Site Map

Site: Womack Army Medical Center โ€” Fort Bragg, North Carolina

๐Ÿ“ All Participating Trial Locations (3 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. Womack Army Medical Center โ€” Fort Bragg, North Carolina โ€ข Contact: (910) 907-7089
2. Brooke Army Medical Center โ€” Fort Sam Houston, Texas โ€ข Contact: (210) 916-2168
3. Landstuhl Regional Medical Center โ€” United States โ€ข Contact: +49 6371 9464 5462

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๐Ÿ’ฐ Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act ยง 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

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๐Ÿ›๏ธ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT05079711 โ€ข Last Synced: 2024-05-16
View on ClinicalTrials.gov โ†—
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