Clinical Study of a Diagnostic Device for NG, TV and CT in Women

Completed · Not applicable

Conditions studied: Chlamydial Infection, Gonococcal Infection, Trichomoniasis

In brief

This is a multi-center study with a minimum of three sites in the United States. The study will enroll approximately 1750 female subjects, 14 years of age and older, and will have a study duration of approximately 9 months after enrollment of the first subject. Female subjects seen at the participating sites for any reason will be evaluated for enrollment in this study. All subjects will be managed per standard of care as applicable. Subjects who are enrolled in the study will perform self-collection of a vaginal swab to be tested by Click device and allow the health care provider (HCP) to collect three additional vaginal swabs to be tested by recognized FDA-cleared comparator methods. Subjects will complete the study in a single visit. The primary objective is to assess the performance of the Click device for detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) in self-collected vaginal specimens as compared to Patient Infected Status (PIS) determined by three approved comparator assays using vaginal specimens collected by a qualified HCP in support of obtaining FDA clearance. and a Clinical Laboratory Improvement Amendments (CLIA) Waiver.

Key facts

Study ID: NCT03852316
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 1585
Starts: 2019-02-27
Expected to finish: 2019-12-02
Last updated by the study team: 2022-01-13

Who can join

Age: 14 and older, up to 99. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Willing and able to give voluntary written informed consent (or the parent/legal guardian will provide parental permission) before any study-related procedure is performed.
Female at birth. (Pregnant and breastfeeding women are eligible.)
Age > / = 14 years at the time of enrollment.
Able to read and understand the procedural information provided for the study.
Able and willing to follow all study procedures, including performing self-collection of one vaginal swab and permitting a licensed HCP to collect three additional vaginal swabs.

You may not qualify if…

Have a medical condition, serious intercurrent illness, or other circumstance that, in the Investigator's judgment, could jeopardize the subject's safety, or could interfere with study procedures.
Enrollment in this study previously.
Use of antiperspirants and deodorants or the following vaginal products: douches, washes, lubricants, vaginal wipes, vaginal moisturizers, or feminine hygiene spray in the genital area, within 48 hours prior to enrollment.

Where it is running

Axis Clinical Trials — Los Angeles, California, United States
University of California, San Diego - Antiviral Research Center — San Diego, California, United States
San Francisco Department of Public Health - San Francisco City Clinic — San Francisco, California, United States
South Florida Clinical Trials — Hialeah, Florida, United States
Florida International University - Student Health Center — Miami, Florida, United States
Cook County Health and Hospitals System - Ruth M Rothstein CORE Center — Chicago, Illinois, United States
Johns Hopkins Hospital - Medicine - Infectious Diseases — Baltimore, Maryland, United States
University of Mississippi - Infectious Diseases — Jackson, Mississippi, United States
Impact Clinical Trials — Las Vegas, Nevada, United States
Philadelphia Department of Public Health - Health Center 1 — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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