Clinical 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) Utilizing Vaginal Swabs

This is a multi-center study with a minimum of three sites in the United States. The study will enroll approximately 1750 female subjects 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.

Study Overview

• Status: Terminated
• Conditions: Gonorrhoea; Trichomoniasis; Chlamydial Infection
• Intervention / Treatment: Device: Click Device

Detailed Description

This study is a multi-center study with a minimum of three Clinical Laboratory Improvement Amendments-waived (CLIA-waived) intended operator sites 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% for any of the three targets. Sites with a prevalence higher than 2% for any of the three targets will be defined as high prevalence sites. The study will enroll approximately 1750 female subjects and will have a study duration of approximately 9 months after enrollment of the first subject. Approximately one-third of the total subjects shall be recruited from low prevalence sites for the infections of interest. 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 hypothesis of this study is that 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. 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): 295
• 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
    • 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, 21231
      • Johns Hopkins Hospital - Medicine - Infectious Diseases
  • Mississippi
    • Jackson, Mississippi, United States, 39213
      • University of Mississippi - Infectious Diseases
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213-3108
      • Magee Women's Hospital of UPMC - Reproductive Infectious Disease Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 99 years (Child, Adult, Older Adult)
• 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 health care provider 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Click Device; One self collected vaginal swab for Click Device testing. Three health care provider collected vaginal swabs for comparator testing.	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 Percent Sensitivity and Percent Specificity of Click Device for Detection of Chlamydia Trachomatis (CT) in Self-collected Vaginal Specimens as Compared to Patient Infection Status (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 Percent Sensitivity and 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 Percent Sensitivity and 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
The Percent Sensitivity and Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of CT as Compared to PIS Using Vaginal Specimens Collected by a Qualified HCP Among Symptomatic Participants	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 Percent Sensitivity and Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of NG as Compared to PIS Using Vaginal Specimens Collected by a Qualified HCP Among Symptomatic Participants	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 Percent Sensitivity and Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of TV as Compared to PIS Using Vaginal Specimens Collected by a Qualified HCP Among Symptomatic Participants	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 Percent Sensitivity and Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of CT as Compared to PIS Using Vaginal Specimens Collected by a Qualified HCP Among Asymptomatic Participants	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 Percent Sensitivity and Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of NG as Compared to PIS Using Vaginal Specimens Collected by a Qualified HCP Among Asymptomatic Participants.	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 Percent Sensitivity and Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of TV as Compared to PIS Using Vaginal Specimens Collected by a Qualified HCP Among Asymptomatic Participants.	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): July 9, 2018
• Primary Completion (Actual): August 20, 2018
• Study Completion (Actual): August 20, 2018

Study Registration Dates

• First Submitted: July 5, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 23, 2018

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: June 22, 2018

More Information

Terms related to this study

• Keywords: device; diagnostic; Chlamydia trachomatis; Neisseria gonorrhoeae; molecular; Trichomonas vaginalis
• Additional Relevant MeSH Terms: Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Parasitic Diseases; Protozoan Infections; Neisseriaceae Infections; Chlamydiaceae Infections; Sexually Transmitted Diseases, Bacterial; Chlamydia Infections; Gonorrhea; Trichomonas Infections
• Other Study ID Numbers: 17-0024; HHSN272201300014I

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