This study is a multi-center study with a minimum of three CLIA-waived intended operator sites in the United States in which prospectively self-collected vaginal specimens obtained from subjects who are symptomatic or asymptomatic for CT, NG, or TV will be evaluated with the Click Sexual Health Test in a Clinical Laboratory Improvement Amendments (CLIA) waived setting. Subjects interested in participating in this study will be assessed for eligibility and asked to give informed consent and assent, if applicable, by the Investigational Review Board (IRB). Only those subjects who meet the inclusion and exclusion criteria may be enrolled in the study.
Study Type
OBSERVATIONAL
Enrollment
309
The Click Device is a single-use (disposable), fully integrated, rapid, compact, device containing a polymerase chain reaction (PCR)-based nucleic acid amplification test (NAAT) for accurate, qualitative detection and differentiation of deoxyribonucleic acid (DNA) for Neisseria gonorrhea (NG), Trichomonas vaginalis (TV), and Chlamydia trachomatis (CT) organisms.
Therafirst Medical Center
Fort Lauderdale, Florida, United States
Planned Parenthood North Central States
Saint Paul, Minnesota, United States
Planned Parenthood of the St. Louis Region and Southwest Missouri
St Louis, Missouri, United States
Lawrence OB/GYN Clinical Research, LLC
Lawrenceville, New Jersey, United States
Planned Parenthood Gulf Coast
Houston, Texas, United States
The percent sensitivity and specificity of the Click Device for detection of CT in self-collected vaginal specimens as compared to Patient Infected Status (PIS) using vaginal specimens collected by a qualified Health Care Provider (HCP)
Time frame: up to 6 months
The percent sensitivity and specificity of the Click Device for detection of NG in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP
Time frame: up to 6 months
The percent sensitivity and specificity of the Click Device for detection of TV in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP
Time frame: up to 6 months
Usability will be measured by 5-point Likert scale responses, yes/no questions, and open text questions from study operators.
Questions are around three domains of interest: i) instructions, ii) operations, and iii) visual interpretation for the Click device for detection of CT, NG, and TV with patient self-collected specimens. The 5-point Likert scale will measure responses to questions in the form of: (1) Strongly Disagree, (2) Disagree, (3) Neutral, (4) Agree, and (5) Strongly Agree
Time frame: up to 6 months
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