Clinical trial NCT03852316: Clinical Study of a Diagnostic Device for NG, TV and CT in Women
Official title: Pivotal Study of a Single-Use, Point-of-Care Molecular Diagnostic Device for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chlamydial Infection
Gonococcal Infection
Trichomoniasis
Keywords: Chlamydia trachomatis
Device
Diagnostic
Neisseria gonorrohoeae
Trichomonas vaginalis
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2019-02-25
Enrollment: 1585
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Female at birth. (Pregnant and breastfeeding women are eligible.)
3. Age \> / = 14 years at the time of enrollment.
4. Able to read and understand the procedural information provided for the study.
5. 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.

Exclusion Criteria:

1. 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.
2. Enrollment in this study previously.
3. 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.

Primary outcomes:
measure: The i) Percent Sensitivity and ii) Percent Specificity of Click Device for Detection of Chlamydia Trachomatis (CT) in Self-collected Vaginal Specimens as Compared to PIS Using Vaginal Specimens Collected by a Qualified HCP
timeFrame: Day 1
measure: The i) Percent Sensitivity and ii) Percent Specificity of Click Device for Detection of Neisseria Gonorrhoeae (NG) in Self-collected Vaginal Specimens as Compared to PIS Using Vaginal Specimens Collected by a Qualified HCP
timeFrame: Day 1
measure: The i) Percent Sensitivity and ii) Percent Specificity of Click Device for Detection of Trichomonas Vaginalis (TV) in Self-collected Vaginal Specimens as Compared to PIS Using Vaginal Specimens Collected by a Qualified HCP
timeFrame: Day 1
Secondary outcomes:
measure: The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of CT From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Asymptomatic Participants
timeFrame: Day 1
measure: The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of NG From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Asymptomatic Participants
timeFrame: Day 1
measure: The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of TV From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Asymptomatic Participants
timeFrame: Day 1
measure: The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of CT From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Symptomatic Participants
timeFrame: Day 1
measure: The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of NG From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Symptomatic Participants
timeFrame: Day 1
measure: The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of TV From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Symptomatic Participants
timeFrame: Day 1
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: San Diego
country: United States
facility: University of California, San Diego - Antiviral Research Center
state: California
city: San Francisco
country: United States
facility: San Francisco Department of Public Health - San Francisco City Clinic
state: California
city: Hialeah
country: United States
facility: South Florida Clinical Trials
state: Florida
city: Miami
country: United States
facility: Florida International University - Student Health Center
state: Florida
city: Chicago
country: United States
facility: Cook County Health and Hospitals System - Ruth M Rothstein CORE Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hospital - Medicine - Infectious Diseases
state: Maryland
city: Jackson
country: United States
facility: University of Mississippi - Infectious Diseases
state: Mississippi
city: Las Vegas
country: United States
facility: Impact Clinical Trials
state: Nevada
city: Philadelphia
country: United States
facility: Philadelphia Department of Public Health - Health Center 1
state: Pennsylvania
Study officials:
References: