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

Not Applicable

Completed

• Conditions: Chlamydial Infection; Gonococcal Infection; Trichomoniasis
• Interventions: Device: Click Device

• Registration Number: NCT03852316
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-02-21
• Study First Posted: 2019-02-25
• Study Start: 2019-02-27
• Primary Completion: 2019-12-02
• Study Completion: 2019-12-02
• Disposition First Submitted: 2020-12-01
• Results First Submitted: 2021-11-24
• Results First Submitted QC: 2022-01-06
• Disposition First Submitted QC: 2022-01-06
• Last Update Submitted: 2022-01-06
• Results First Posted: 2022-01-13
• Disposition First Posted: 2022-01-13
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1585

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Click Device	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

Primary Outcome Measures

Name	Time	Method
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	Day 1	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)
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	Day 1	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)
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	Day 1	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)

Secondary Outcome Measures

Name	Time	Method
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	Day 1	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)
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	Day 1	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)
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	Day 1	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)
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	Day 1	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)
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	Day 1	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)
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	Day 1	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)

Trial Locations

Locations (10)

University of Mississippi - Infectious Diseases; 🇺🇸 Jackson, Mississippi, United States

Axis Clinical Trials; 🇺🇸 Los Angeles, California, United States

South Florida Clinical Trials; 🇺🇸 Hialeah, Florida, United States

Johns Hopkins Hospital - Medicine - Infectious Diseases; 🇺🇸 Baltimore, Maryland, United States

Cook County Health and Hospitals System - Ruth M Rothstein CORE Center; 🇺🇸 Chicago, Illinois, United States

Philadelphia Department of Public Health - Health Center 1; 🇺🇸 Philadelphia, Pennsylvania, United States

University of California, San Diego - Antiviral Research Center; 🇺🇸 San Diego, California, United States

San Francisco Department of Public Health - San Francisco City Clinic; 🇺🇸 San Francisco, California, United States

Florida International University - Student Health Center; 🇺🇸 Miami, Florida, United States

Impact Clinical Trials; 🇺🇸 Las Vegas, Nevada, United States