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| ID | Type | Description | Link |
|---|---|---|---|
| HHSN272201300014I |
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To optimize device
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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 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Click Device | Experimental | One self collected vaginal swab for Click Device testing. Three health care provider collected vaginal swabs for comparator testing. |
|
| 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 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) |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Click Device | The study population was comprised of female participants >=14 years of age who visited any of the participating clinics for any reason, who may have been symptomatic or asymptomatic for STIs 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 who met the inclusion/exclusion criteria were offered enrollment into the study. Participants who enrolled in the study provided clinical and demographic information, 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. Participants completed the study in a single visit. |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 15, 2021 |
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|
| 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 |
| San Diego |
| California |
| 92103-8208 |
| United States |
| San Francisco Department of Public Health - San Francisco City Clinic | San Francisco | California | 94103-4030 | 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 | 21231 | United States |
| University of Mississippi - Infectious Diseases | Jackson | Mississippi | 39213 | United States |
| Magee Women's Hospital of UPMC - Reproductive Infectious Disease Research | Pittsburgh | Pennsylvania | 15213-3108 | United States |
| COMPLETED |
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| NOT COMPLETED |
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The baseline analysis population includes all participants who were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Click Device | The study population was comprised of female participants >=14 years of age who visited any of the participating clinics for any reason, who 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 |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Symptomatic Status | Count of Participants | Participants |
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| Evaluable for NG | Participants who are deemed evaluable for Neisseria gonorrhoeae (NG). | Count of Participants | Participants |
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| Evaluable for CT | Participants who are deemed evaluable for Chlamydia trachomatis (CT). | Count of Participants | Participants |
| |||||||||||||||||
| Evaluable for TV | Participants who are deemed evaluable for Trichomonas vaginalis (TV). | Count of Participants | 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 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) | This population includes all participants with samples that provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for CT. An evaluable result is indicated if both the Click device and the PIS provide a valid positive or negative result. | Posted | Count of Participants | Participants | Day 1 |
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| ||||||||||||||||||||||||||||
| Primary | 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) | This population includes all participants with samples that provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for NG. An evaluable result is indicated if both the Click device and the PIS provide a valid positive or negative result. | Posted | Count of Participants | Participants | Day 1 |
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| Primary | 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) | This population includes all participants with samples that provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for TV. An evaluable result is indicated if both the Click device and the PIS provide a valid positive or negative result. | Posted | Count of Participants | Participants | Day 1 |
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| Primary | 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) | This population includes all symptomatic participants with samples that provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for CT. An evaluable result is indicated if both the Click device and the PIS provide a valid positive or negative result. If a participant reported "Yes" to any of the symptoms on the Clinical Symptoms Assessment form, the participant is classified as Symptomatic. Otherwise, the participant is classified as "Asymptomatic". | Posted | Count of Participants | Participants | Day 1 |
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| Primary | 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) | This population includes all symptomatic participants with samples that provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for NG. An evaluable result is indicated if both the Click device and the PIS provide a valid positive or negative result. If a participant reported "Yes" to any of the symptoms on the Clinical Symptoms Assessment form, the participant is classified as Symptomatic. Otherwise, the participant is classified as "Asymptomatic". | Posted | Count of Participants | Participants | Day 1 |
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| Primary | 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) | This population includes all symptomatic participants with samples that provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for TV. An evaluable result is indicated if both the Click device and the PIS provide a valid positive or negative result. If a participant reported "Yes" to any of the symptoms on the Clinical Symptoms Assessment form, the participant is classified as Symptomatic. Otherwise, the participant is classified as "Asymptomatic". | Posted | Count of Participants | Participants | Day 1 |
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| Primary | 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) | This population includes all asymptomatic participants with samples that provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for CT. An evaluable result is indicated if both the Click device and the PIS provide a valid positive or negative result. If a participant reported "Yes" to any of the symptoms on the Clinical Symptoms Assessment form, the participant is classified as Symptomatic. Otherwise, the participant is classified as "Asymptomatic". | Posted | Count of Participants | Participants | Day 1 |
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| Primary | 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) | This population includes all asymptomatic participants with samples that provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for NG. An evaluable result is indicated if both the Click device and the PIS provide a valid positive or negative result. If a participant reported "Yes" to any of the symptoms on the Clinical Symptoms Assessment form, the participant is classified as Symptomatic. Otherwise, the participant is classified as "Asymptomatic". | Posted | Count of Participants | Participants | Day 1 |
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| Primary | 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) | This population includes all asymptomatic participants with samples that provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for TV. An evaluable result is indicated if both the Click device and the PIS provide a valid positive or negative result. If a participant reported "Yes" to any of the symptoms on the Clinical Symptoms Assessment form, the participant is classified as Symptomatic. Otherwise, the participant is classified as "Asymptomatic". | Posted | Count of Participants | Participants | Day 1 |
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2 months
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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 | The study population was comprised female participants >=14 years of age who visited any of the participating clinics for any reason, who 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 | 294 | 0 | 294 | 0 | 294 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sheldon Morris, MD, MPH | Antiviral Research Center, University of California, San Diego | 619-543-4761 | shmorris@ucsd.edu |
| Jul 16, 2021 |
| Prot_SAP_000.pdf |
| 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 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Asymptomatic |
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| Asymptomatic |
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| Asymptomatic |
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