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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Click Device | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Axis Clinical Trials | Los Angeles | California | 90036 | United States | ||
| University of California, San Diego - Antiviral Research Center |
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Participants were females 14 to 80 years of age, inclusive, recruited from 10 clinic sites across 7 states at locations including but not limited to: OB/GYN and primary care offices, as well as sexually transmitted disease, teen, public health, and family planning clinics. Participants were enrolled from 27FEB2019 to 02DEC2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Click Device | Female participants >=14 years of age who may have been symptomatic or asymptomatic for sexually transmitted infections (STIs). Participants who met the inclusion/exclusion criteria and were enrolled performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 19, 2021 | Nov 19, 2021 |
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| Day 1 |
| 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 |
| San Diego |
| California |
| 92103-8208 |
| United States |
| San Francisco Department of Public Health - San Francisco City Clinic | San Francisco | California | 94103-4030 | United States |
| South Florida Clinical Trials | Hialeah | Florida | 33016 | United States |
| Florida International University - Student Health Center | Miami | Florida | 33199 | United States |
| Cook County Health and Hospitals System - Ruth M Rothstein CORE Center | Chicago | Illinois | 60612 | United States |
| Johns Hopkins Hospital - Medicine - Infectious Diseases | Baltimore | Maryland | 21205 | United States |
| University of Mississippi - Infectious Diseases | Jackson | Mississippi | 39202 | United States |
| Impact Clinical Trials | Las Vegas | Nevada | 89106 | United States |
| Philadelphia Department of Public Health - Health Center 1 | Philadelphia | Pennsylvania | 19145 | United States |
| COMPLETED |
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| NOT COMPLETED |
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The baseline analysis population includes all participants that were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Click Device | Female participants >=14 years of age who may have been symptomatic or asymptomatic for STIs. Participants who met the inclusion/exclusion criteria and were enrolled performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Evaluable Results | This population includes participants with a valid Click and valid PIS result for the pathogen in question. | Count of Participants | Participants |
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| Symptomatic Status | The number analyzed represents the number of participants that reported a valid Click and a valid PIS result for the pathogen in question. | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Evaluable Population: This population included all samples which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for CT. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 |
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| Primary | 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) | Evaluable Population: This population included all samples which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for NG. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 |
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| Primary | 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) | Evaluable Population: This population included all samples which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for TV. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 |
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| Secondary | 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) | Evaluable Asymptomatic Population: This population included all samples from asymptomatic participants which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for CT. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 |
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| Secondary | 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) | Evaluable Asymptomatic Population: This population included all samples from asymptomatic participants which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for NG. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 |
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| Secondary | 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) | Evaluable Asymptomatic Population: This population included all samples from asymptomatic participants which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for TV. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 |
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| Secondary | 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) | Evaluable Symptomatic Population: This population included all samples from symptomatic participants which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for CT. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 |
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| Secondary | 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) | Evaluable Symptomatic Population: This population included all samples from symptomatic participants which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for NG. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 |
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| Secondary | 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) | Evaluable Symptomatic Population: This population included all samples from symptomatic participants which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for TV. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 |
|
Adverse Events (AEs) were collected from the time of swab collection to the time that the participant left the clinic on the same day.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Click Device | Female participants >=14 years of age who may have been symptomatic or asymptomatic for STIs. Participants who met the inclusion/exclusion criteria and were enrolled performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods. | 0 | 1,585 | 0 | 1,585 | 0 | 1,585 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sheldon Morris, MD, MPH | University of California, San Diego | 619-543-4761 | shmorris@ucsd.edu |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 5, 2021 | Nov 19, 2021 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 7, 2019 | Jan 16, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002690 | Chlamydia Infections |
| D006069 | Gonorrhea |
| D014245 | Trichomonas Infections |
| D004194 | Disease |
| ID | Term |
|---|---|
| D002694 | Chlamydiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D016870 | Neisseriaceae Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
|
|
| Unknown or Not Reported |
|
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| N. gonorrhoeae |
|
|
| T. vaginalis |
|
|
| C. trachomatis : Asymptomatic |
|
|
| N. gonorrhoeae : Symptomatic |
|
|
| N. gonorrhoeae : Asymptomatic |
|
|
| T. vaginalis : Symptomatic |
|
|
| T. vaginalis : Asymptomatic |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|