Chlamydial InfectionNCT03596151

Clinical 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) Utilizing Vaginal Swabs

A study testing Click Device in people with Chlamydial Infection and Gonorrhoea, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 14 to 99 years, women onlyHealthy volunteers can take part
Conditions the study is for: Chlamydial Infection, Gonorrhoea, 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: 295 participants
Where: 8 sitesUnited States
Study dates: 9 Jul 2018to 20 Aug 2018
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 health care provider 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.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Johns Hopkins Hospital - Medicine - Infectious Diseases
Baltimore, Maryland, 21231
Cook County Health and Hospitals System - Ruth M Rothstein CORE Center
Chicago, Illinois, 60612
University of Mississippi - Infectious Diseases
Jackson, Mississippi, 39213
Axis Clinical Trials
Los Angeles, California, 90036
Florida International University - Student Health Center
Miami, Florida, 33199
Magee Women's Hospital of UPMC - Reproductive Infectious Disease Research
Pittsburgh, Pennsylvania, 15213-3108
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

Other trials in United States

About this study

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.

Read the detailed description

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.

Conditions: Chlamydial Infection, Gonorrhoea, Trichomoniasis
Being tested: Click Device
Keywords: Chlamydia trachomatis, device, diagnostic, molecular, Neisseria gonorrhoeae, 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 groups in NCT03596151
Study group	Role	What they receive
Click Device	Experimental	One self collected vaginal swab for Click Device testing. Three health care provider collected vaginal swabs for comparator testing. Receives: Device: Click Device

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jul 201820 Aug 2018

First posted23 Jul 2018
Study start9 Jul 2018
Primary completion20 Aug 2018
Study completion20 Aug 2018

Why it stopped: To optimize device

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: 295 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03596151
Sponsor's protocol ID: 17-0024
Other IDs: HHSN272201300014I
Status last verified: 22 Jun 2018
First submitted: 5 Jul 2018
Last updated: 24 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical 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) Utilizing Vaginal Swabs
ClinicalTrials.gov ID: NCT03596151
Acronym / sponsor ID: 17-0024
Conditions: Chlamydial Infection, Gonorrhoea, Trichomoniasis
Keywords: Chlamydia trachomatis, device, diagnostic, molecular, Neisseria gonorrhoeae, Trichomonas vaginalis
Study type: Interventional
Recruitment status: TerminatedReason stopped: To optimize device
Enrolment: 295 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study start: 9 Jul 2018 (actual)
Primary completion: 20 Aug 2018 (actual)
Study completion: 20 Aug 2018 (actual)
First posted: 23 Jul 2018 (actual)
Results: Posted 24 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 DeviceOne self collected vaginal swab for Click Device testing. Three health care provider collected vaginal swabs for comparator testing.

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 health care provider to collect three additional vaginal swabs.

Key exclusion criteria (2 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.

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 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
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 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
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 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
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 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
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 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
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 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
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 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
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 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.
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 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.
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)

Results and safety

Results posted to the registry on 24 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Click Device	295	294

Primary outcome: 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

Time frame: Day 1. Count of participants. Unit: Participants

Measure	Click Device n = 256
Sensitivity	10
Specificity	241

Population analysed: 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.

Primary outcome: 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

Time frame: Day 1. Count of participants. Unit: Participants

Measure	Click Device n = 255
Sensitivity	0
Specificity	249

Population analysed: 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.

Primary outcome: 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

Time frame: Day 1. Count of participants. Unit: Participants

Measure	Click Device n = 255
Sensitivity	29
Specificity	212

Population analysed: 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.

Primary outcome: 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

Time frame: Day 1. Count of participants. Unit: Participants

Measure	Click Device n = 149
Sensitivity	6
Specificity	139

Population analysed: 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".

Adverse events

Time frame: 2 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Click Device	0 of 294 (0%)	0 of 294 (0%)	0 of 294

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
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.

8 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 Gonorrhoea, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 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 2 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: stopped early, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 24 Aug 2021). 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 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 (time frame: Day 1). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03596151.

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 24 Aug 2021.