Clinical Study of a Diagnostic Device for NG, TV and CT in Women
Condition: Chlamydial Infection; Gonococcal Infection; Trichomoniasis
MeSH terms: Infections; Communicable Diseases; Trichomonas Infections; Gonorrhea; Chlamydia Infections
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      This is a multi-center study with a minimum of three clinical sites across diverse
      geographical areas in the United States. Approximately one-third of the total number of sites
      will have a patient population of low Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT),
      or Trichomonas vaginalis (TV) prevalence. Low prevalence sites are defined as sites with a
      prevalence < / = 2 percent for any of the three targets. Sites with a prevalence higher than
      2 percent for any of the three targets will be defined as high prevalence sites. 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, approximately 60 minutes in length. The hypothesis of this study is that Click
      Diagnostics Sexual Health Test performs substantially equivalent to the NAAT (Nucleic Acid
      Amplification Test) predicate system, and the identification of each organism (CT, NG, and
      TV) in self-collected vaginal swabs by women using the Click device will agree with the
      Patient Infected Status (PIS) with a high sensitivity and specificity. The primary objective
      is to assess the performance of the Click device for detection of CT, NG, and TV in
      self-collected vaginal specimens as compared to 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. The secondary
      objectives are: 1) to assess the performance of the Click device for detection of CT, NG, and
      TV in self-collected vaginal specimens among symptomatic subjects as compared to PIS
      determined by three approved comparator assays using vaginal specimens collected by a
      qualified HCP; 2) to assess the performance of the Click device for detection of CT, NG, and
      TV in self-collected vaginal specimens among asymptomatic subjects as compared to PIS
      determined by three approved comparator assays using vaginal specimens collected by a
      qualified HCP.
    

Intervention name(s): Click Device
Intervention type(s): Device
Intervention description(s): A single-use device containing a polymerase chain reaction (PCR)-based nucleic acid amplification test (NAAT) for detection of deoxyribonucleic acid (DNA) from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) in self-collected vaginal specimens.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Chlamydia trachomatis; Device; Diagnostic; Neisseria gonorrohoeae; Trichomonas vaginalis