Trial Outcomes & Findings for Clinical Study of a Diagnostic Device for NG, TV and CT in Women (NCT NCT03852316)

Last Updated: 2022-01-13

Results Overview

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)

Recruitment status

COMPLETED

Study phase

Target enrollment

1585 participants

Primary outcome timeframe

Day 1

Results posted on

2022-01-13

Participant Flow

Participants were females 14 to 80 years of age, inclusive, recruited from 10 clinic sites across 7 states at locations including but not limited to: OB/GYN and primary care offices, as well as sexually transmitted disease, teen, public health, and family planning clinics. Participants were enrolled from 27FEB2019 to 02DEC2019.

Participant milestones

Participant milestones
Measure	Click Device Female participants \>=14 years of age who may have been symptomatic or asymptomatic for sexually transmitted infections (STIs). Participants who met the inclusion/exclusion criteria and were enrolled performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods.
Overall Study STARTED	1585
Overall Study COMPLETED	1581
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Click Device Female participants \>=14 years of age who may have been symptomatic or asymptomatic for sexually transmitted infections (STIs). Participants who met the inclusion/exclusion criteria and were enrolled performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods.
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	2
Overall Study Enrolled but Device not Utilized	1

Baseline Characteristics

The number analyzed represents the number of participants that reported a valid Click and a valid PIS result for the pathogen in question.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Click Device n=1585 Participants Female participants \>=14 years of age who may have been symptomatic or asymptomatic for STIs. Participants who met the inclusion/exclusion criteria and were enrolled performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods.
Age, Categorical <=18 years	9 Participants n=1585 Participants
Age, Categorical Between 18 and 65 years	1551 Participants n=1585 Participants
Age, Categorical >=65 years	25 Participants n=1585 Participants
Age, Continuous	35.1 years STANDARD_DEVIATION 14.3 • n=1585 Participants
Sex: Female, Male Female	1585 Participants n=1585 Participants
Sex: Female, Male Male	0 Participants n=1585 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	310 Participants n=1585 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1168 Participants n=1585 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	107 Participants n=1585 Participants
Race (NIH/OMB) American Indian or Alaska Native	12 Participants n=1585 Participants
Race (NIH/OMB) Asian	86 Participants n=1585 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	6 Participants n=1585 Participants
Race (NIH/OMB) Black or African American	876 Participants n=1585 Participants
Race (NIH/OMB) White	414 Participants n=1585 Participants
Race (NIH/OMB) More than one race	70 Participants n=1585 Participants
Race (NIH/OMB) Unknown or Not Reported	121 Participants n=1585 Participants
Region of Enrollment United States	1585 participants n=1585 Participants
Evaluable Results C.trachomatis	1457 Participants n=1585 Participants
Evaluable Results N. gonorrhoeae	1468 Participants n=1585 Participants
Evaluable Results T. vaginalis	1449 Participants n=1585 Participants
Symptomatic Status C. trachomatis : Symptomatic	735 participants n=1457 Participants • The number analyzed represents the number of participants that reported a valid Click and a valid PIS result for the pathogen in question.
Symptomatic Status C. trachomatis : Asymptomatic	722 participants n=1457 Participants • The number analyzed represents the number of participants that reported a valid Click and a valid PIS result for the pathogen in question.
Symptomatic Status N. gonorrhoeae : Symptomatic	746 participants n=1468 Participants • The number analyzed represents the number of participants that reported a valid Click and a valid PIS result for the pathogen in question.
Symptomatic Status N. gonorrhoeae : Asymptomatic	722 participants n=1468 Participants • The number analyzed represents the number of participants that reported a valid Click and a valid PIS result for the pathogen in question.
Symptomatic Status T. vaginalis : Symptomatic	734 participants n=1449 Participants • The number analyzed represents the number of participants that reported a valid Click and a valid PIS result for the pathogen in question.
Symptomatic Status T. vaginalis : Asymptomatic	715 participants n=1449 Participants • The number analyzed represents the number of participants that reported a valid Click and a valid PIS result for the pathogen in question.

PRIMARY outcome

Timeframe: Day 1

Population: Evaluable Population: This population included all samples which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for CT. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result.

Outcome measures

Outcome measures
Measure	Click Device n=1457 Participants Female participants \>=14 years of age who may have been symptomatic or asymptomatic for STIs. Participants who met the inclusion/exclusion criteria and were enrolled performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods.
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 Sensitivity	97.6 percentage of participants Interval 93.2 to 99.2
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 Specificity	98.3 percentage of participants Interval 97.5 to 98.9

PRIMARY outcome

Timeframe: Day 1

Population: Evaluable Population: This population included all samples which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for NG. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result.

Outcome measures

Outcome measures
Measure	Click Device n=1468 Participants Female participants \>=14 years of age who may have been symptomatic or asymptomatic for STIs. Participants who met the inclusion/exclusion criteria and were enrolled performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods.
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 Sensitivity	97.4 percentage of participants Interval 86.5 to 99.5
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 Specificity	99.4 percentage of participants Interval 98.9 to 99.7

PRIMARY outcome

Timeframe: Day 1

Population: Evaluable Population: This population included all samples which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for TV. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result.

Outcome measures

Outcome measures
Measure	Click Device n=1449 Participants Female participants \>=14 years of age who may have been symptomatic or asymptomatic for STIs. Participants who met the inclusion/exclusion criteria and were enrolled performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods.
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 Sensitivity	99.2 percentage of participants Interval 95.5 to 99.9
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 Specificity	96.9 percentage of participants Interval 95.8 to 97.7

SECONDARY outcome

Timeframe: Day 1

Population: Evaluable Asymptomatic Population: This population included all samples from asymptomatic participants which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for CT. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result.

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)

Outcome measures

Outcome measures
Measure	Click Device n=722 Participants Female participants \>=14 years of age who may have been symptomatic or asymptomatic for STIs. Participants who met the inclusion/exclusion criteria and were enrolled performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods.
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 Sensitivity	95.8 percentage of participants Interval 86.0 to 98.8
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 Specificity	99.0 percentage of participants Interval 97.9 to 99.5

SECONDARY outcome

Timeframe: Day 1

Population: Evaluable Asymptomatic Population: This population included all samples from asymptomatic participants which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for NG. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result.

Outcome measures

Outcome measures
Measure	Click Device n=722 Participants Female participants \>=14 years of age who may have been symptomatic or asymptomatic for STIs. Participants who met the inclusion/exclusion criteria and were enrolled performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods.
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 Sensitivity	94.4 percentage of participants Interval 74.2 to 99.0
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 Specificity	99.4 percentage of participants Interval 98.5 to 99.8

SECONDARY outcome

Timeframe: Day 1

Population: Evaluable Asymptomatic Population: This population included all samples from asymptomatic participants which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for TV. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result.

Outcome measures

Outcome measures
Measure	Click Device n=715 Participants Female participants \>=14 years of age who may have been symptomatic or asymptomatic for STIs. Participants who met the inclusion/exclusion criteria and were enrolled performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods.
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 Sensitivity	100 percentage of participants Interval 92.7 to 100.0
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 Specificity	98.0 percentage of participants Interval 96.7 to 98.9

SECONDARY outcome

Timeframe: Day 1

Population: Evaluable Symptomatic Population: This population included all samples from symptomatic participants which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for CT. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result.

Outcome measures

Outcome measures
Measure	Click Device n=735 Participants Female participants \>=14 years of age who may have been symptomatic or asymptomatic for STIs. Participants who met the inclusion/exclusion criteria and were enrolled performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods.
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 Sensitivity	98.7 percentage of participants Interval 93.0 to 99.8
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 Specificity	97.7 percentage of participants Interval 96.3 to 98.6

SECONDARY outcome

Timeframe: Day 1

Population: Evaluable Symptomatic Population: This population included all samples from symptomatic participants which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for NG. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result.

Outcome measures

Outcome measures
Measure	Click Device n=746 Participants Female participants \>=14 years of age who may have been symptomatic or asymptomatic for STIs. Participants who met the inclusion/exclusion criteria and were enrolled performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods.
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 Sensitivity	100 percentage of participants Interval 83.9 to 100.0
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 Specificity	99.4 percentage of participants Interval 98.6 to 99.8

SECONDARY outcome

Timeframe: Day 1

Population: Evaluable Symptomatic Population: This population included all samples from symptomatic participants which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for TV. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result.

Outcome measures

Outcome measures
Measure	Click Device n=734 Participants Female participants \>=14 years of age who may have been symptomatic or asymptomatic for STIs. Participants who met the inclusion/exclusion criteria and were enrolled performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods.
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 Sensitivity	98.6 percentage of participants Interval 92.6 to 99.8
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 Specificity	95.8 percentage of participants Interval 93.9 to 97.1

Adverse Events

Click Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sheldon Morris, MD, MPH

University of California, San Diego

Phone: 619-543-4761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60