Chlamydial InfectionNCT03852316
Clinical Study of a Diagnostic Device for NG, TV and CT in Women
A study testing Click Device in people with Chlamydial Infection and Gonococcal Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chlamydial Infection, Gonococcal Infection, Trichomoniasis
- What is being tested?
- Click Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,585 participants
- Where
- 10 sitesUnited States
- Study dates
- 27 Feb 2019to 2 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 99 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Johns Hopkins Hospital - Medicine - Infectious Diseases
Baltimore, Maryland, 21205
Cook County Health and Hospitals System - Ruth M Rothstein CORE Center
Chicago, Illinois, 60612
South Florida Clinical Trials
Hialeah, Florida, 33016
University of Mississippi - Infectious Diseases
Jackson, Mississippi, 39202
Impact Clinical Trials
Las Vegas, Nevada, 89106
Axis Clinical Trials
Los Angeles, California, 90036
Florida International University - Student Health Center
Miami, Florida, 33199
Philadelphia Department of Public Health - Health Center 1
Philadelphia, Pennsylvania, 19145
University of California, San Diego - Antiviral Research Center
San Diego, California, 92103-8208
San Francisco Department of Public Health - San Francisco City Clinic
San Francisco, California, 94103-4030
About this study
Official 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
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.
Read the 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.
- Conditions
- Chlamydial Infection, Gonococcal Infection, Trichomoniasis
- Being tested
- Click Device
- Keywords
- Chlamydia trachomatis, Device, Diagnostic, Neisseria gonorrohoeae, Trichomonas vaginalis
- Medical subject headings
- Chlamydia Infections, Gonorrhea, Trichomonas Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Click DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Click Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: Day 1
Secondary outcomes (6)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start27 Feb 2019
- Primary completion2 Dec 2019
- Study completion2 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chlamydial InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,585 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852316
- Sponsor's protocol ID
- 18-0024
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2019
- Last updated
- 13 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03852316
- Acronym / sponsor ID
- 18-0024
- Conditions
- Chlamydial Infection, Gonococcal Infection, Trichomoniasis
- Keywords
- Chlamydia trachomatis, Device, Diagnostic, Neisseria gonorrohoeae, Trichomonas vaginalis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,585 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 2 Dec 2019 (actual)
- Study completion
- 2 Dec 2019 (actual)
- First posted
- 25 Feb 2019 (actual)
- Results
- Posted 13 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Click Device | Experimental | Device: Click DeviceEach 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 |
Who may qualify
- Ages
- 14 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Click DeviceA 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. | Device | Click Device |
Primary outcome
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)
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)
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)
6 secondary outcomes
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
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Click Device in people with Chlamydial Infection and Gonococcal Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.