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

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

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.

Study Overview

• Status: Completed
• Conditions: Gonococcal Infection; Trichomoniasis; Chlamydial Infection
• Intervention / Treatment: Device: Click Device

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.

• Study Type: Interventional
• Enrollment (Actual): 1585
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90036
      • Axis Clinical Trials
    • San Diego, California, United States, 92103-8208
      • University of California, San Diego - Antiviral Research Center
    • San Francisco, California, United States, 94103-4030
      • San Francisco Department of Public Health - San Francisco City Clinic
  • Florida
    • Hialeah, Florida, United States, 33016
      • South Florida Clinical Trials
    • Miami, Florida, United States, 33199
      • Florida International University - Student Health Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Cook County Health and Hospitals System - Ruth M Rothstein CORE Center
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Hospital - Medicine - Infectious Diseases
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • University of Mississippi - Infectious Diseases
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Impact Clinical Trials
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19145
      • Philadelphia Department of Public Health - Health Center 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 99 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Click Device; Each subject (females 14 years of age and older) will perform a self-collection vaginal swab for the Click device and be randomized to a particular order for three vaginal swab collections (performed by Health Care Providers (HCP) as defined by state/local regulatory authorities) for comparator methods. N=1750	Device: Click Device; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 * TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 * TN / (TN + FP)	Day 1
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	The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 * TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 * TN / (TN + FP)	Day 1
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	The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 * TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 * TN / (TN + FP)	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	If a participant reported "Yes" to any of the following symptoms, the participant is classified as Symptomatic: Unusual vaginal discharge; Vaginal irritation (itching, burning, soreness); Lower abdominal/pelvic pain; Painful urination; Increased urinary frequency; Abnormal bleeding/spotting; Pain or bleeding with sex/intercourse. Otherwise, the participant is classified as "Asymptomatic". The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 * TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 * TN / (TN + FP)	Day 1
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	If a participant reported "Yes" to any of the following symptoms, the participant is classified as Symptomatic: Unusual vaginal discharge; Vaginal irritation (itching, burning, soreness); Lower abdominal/pelvic pain; Painful urination; Increased urinary frequency; Abnormal bleeding/spotting; Pain or bleeding with sex/intercourse. Otherwise, the participant is classified as "Asymptomatic". The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 * TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 * TN / (TN + FP)	Day 1
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	If a participant reported "Yes" to any of the following symptoms, the participant is classified as Symptomatic: Unusual vaginal discharge; Vaginal irritation (itching, burning, soreness); Lower abdominal/pelvic pain; Painful urination; Increased urinary frequency; Abnormal bleeding/spotting; Pain or bleeding with sex/intercourse. Otherwise, the participant is classified as "Asymptomatic". The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 * TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 * TN / (TN + FP)	Day 1
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	If a participant reported "Yes" to any of the following symptoms, the participant is classified as Symptomatic: Unusual vaginal discharge; Vaginal irritation (itching, burning, soreness); Lower abdominal/pelvic pain; Painful urination; Increased urinary frequency; Abnormal bleeding/spotting; Pain or bleeding with sex/intercourse. Otherwise, the participant is classified as "Asymptomatic". The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 * TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 * TN / (TN + FP)	Day 1
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	If a participant reported "Yes" to any of the following symptoms, the participant is classified as Symptomatic: Unusual vaginal discharge; Vaginal irritation (itching, burning, soreness); Lower abdominal/pelvic pain; Painful urination; Increased urinary frequency; Abnormal bleeding/spotting; Pain or bleeding with sex/intercourse. Otherwise, the participant is classified as "Asymptomatic". The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 * TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 * TN / (TN + FP)	Day 1
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	If a participant reported "Yes" to any of the following symptoms, the participant is classified as Symptomatic: Unusual vaginal discharge; Vaginal irritation (itching, burning, soreness); Lower abdominal/pelvic pain; Painful urination; Increased urinary frequency; Abnormal bleeding/spotting; Pain or bleeding with sex/intercourse. Otherwise, the participant is classified as "Asymptomatic". The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 * TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 * TN / (TN + FP)	Day 1

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2019
• Primary Completion (Actual): December 2, 2019
• Study Completion (Actual): December 2, 2019

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Device; Diagnostic; Chlamydia trachomatis; Trichomonas vaginalis; Neisseria gonorrohoeae
• Additional Relevant MeSH Terms: Pathologic Processes; Sexually Transmitted Diseases; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Parasitic Diseases; Protozoan Infections; Neisseriaceae Infections; Chlamydiaceae Infections; Sexually Transmitted Diseases, Bacterial; Infections; Communicable Diseases; Chlamydia Infections; Gonorrhea; Trichomonas Infections
• Other Study ID Numbers: 18-0024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No