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Completed

NCT Number: NCT03852316

Clinical Study of a Diagnostic Device for NG, TV and 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.

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Key information

Conditions

Chlamydial Infection Bacterial Infections Bacterial Infections and Mycoses Chlamydia Infections Chlamydiaceae Infections Communicable Diseases Disease Genital Diseases Gonococcal Infection Gonorrhea Gram-Negative Bacterial Infections Infections Neisseriaceae Infections Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Protozoan Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Trichomonas Infections Trichomoniasis Urogenital Diseases

Age range

14 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Axis Clinical Trials, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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.
  • Enrollment in this study previously.
  • 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.

Treatment and study plan

Click Device

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.

Primary outcomes

  1. 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

    Time frame: 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)

  2. 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

    Time frame: 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)

  3. 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

    Time frame: 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 outcomes

  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 Asymptomatic Participants

    Time frame: 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)

  2. 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

    Time frame: 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)

  3. 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

    Time frame: 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)

  4. 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

    Time frame: 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)

  5. 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

    Time frame: 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)

  6. 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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 25, 2019
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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