Trial Outcomes & Findings for 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 (NCT NCT03596151)

Last Updated: 2021-08-24

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

TERMINATED

Study phase

Target enrollment

295 participants

Primary outcome timeframe

Day 1

Results posted on

2021-08-24

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	295
Overall Study COMPLETED	294
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Participants who are deemed evaluable for Neisseria gonorrhoeae (NG).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Click Device n=295 Participants 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.
Ethnicity (NIH/OMB) Unknown or Not Reported	77 Participants n=295 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=295 Participants
Race (NIH/OMB) Asian	13 Participants n=295 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=295 Participants
Race (NIH/OMB) Black or African American	151 Participants n=295 Participants
Race (NIH/OMB) White	80 Participants n=295 Participants
Race (NIH/OMB) More than one race	23 Participants n=295 Participants
Race (NIH/OMB) Unknown or Not Reported	25 Participants n=295 Participants
Region of Enrollment United States	295 participants n=295 Participants
Symptomatic Status Symptomatic	168 Participants n=295 Participants
Symptomatic Status Asymptomatic	127 Participants n=295 Participants
Evaluable for NG Symptomatic	149 Participants n=255 Participants • Participants who are deemed evaluable for Neisseria gonorrhoeae (NG).
Evaluable for NG Asymptomatic	106 Participants n=255 Participants • Participants who are deemed evaluable for Neisseria gonorrhoeae (NG).
Evaluable for CT Symptomatic	149 Participants n=256 Participants • Participants who are deemed evaluable for Chlamydia trachomatis (CT).
Age, Categorical <=18 years	7 Participants n=295 Participants
Age, Categorical Between 18 and 65 years	286 Participants n=295 Participants
Age, Categorical >=65 years	2 Participants n=295 Participants
Age, Continuous	36.2 years STANDARD_DEVIATION 12.7 • n=295 Participants
Sex: Female, Male Female	295 Participants n=295 Participants
Sex: Female, Male Male	0 Participants n=295 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=295 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	194 Participants n=295 Participants
Evaluable for CT Asymptomatic	107 Participants n=256 Participants • Participants who are deemed evaluable for Chlamydia trachomatis (CT).
Evaluable for TV Symptomatic	148 Participants n=255 Participants • Participants who are deemed evaluable for Trichomonas vaginalis (TV).
Evaluable for TV Asymptomatic	107 Participants n=255 Participants • Participants who are deemed evaluable for Trichomonas vaginalis (TV).

PRIMARY outcome

Timeframe: Day 1

Population: 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.

Outcome measures

Outcome measures
Measure	Click Device n=256 Participants 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.
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 Sensitivity	10 Participants
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 Specificity	241 Participants

PRIMARY outcome

Timeframe: Day 1

Population: 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.

Outcome measures

Outcome measures
Measure	Click Device n=255 Participants 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.
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 Sensitivity	0 Participants
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 Specificity	249 Participants

PRIMARY outcome

Timeframe: Day 1

Population: 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.

Outcome measures

Outcome measures
Measure	Click Device n=255 Participants 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.
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 Sensitivity	29 Participants
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 Specificity	212 Participants

PRIMARY outcome

Timeframe: Day 1

Population: 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".

Outcome measures

Outcome measures
Measure	Click Device n=149 Participants 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.
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 Sensitivity	6 Participants
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 Specificity	139 Participants

PRIMARY outcome

Timeframe: Day 1

Population: 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".

Outcome measures

Outcome measures
Measure	Click Device n=149 Participants 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.
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 Sensitivity	0 Participants
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 Specificity	145 Participants

PRIMARY outcome

Timeframe: Day 1

Population: 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".

Outcome measures

Outcome measures
Measure	Click Device n=148 Participants 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.
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 Sensitivity	17 Participants
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 Specificity	124 Participants

PRIMARY outcome

Timeframe: Day 1

Population: 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".

Outcome measures

Outcome measures
Measure	Click Device n=107 Participants 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.
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 Sensitivity	4 Participants
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 Specificity	102 Participants

PRIMARY outcome

Timeframe: Day 1

Population: 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".

Outcome measures

Outcome measures
Measure	Click Device n=106 Participants 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.
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. Sensitivity	0 Participants
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. Specificity	104 Participants

PRIMARY outcome

Timeframe: Day 1

Population: 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".

Outcome measures

Outcome measures
Measure	Click Device n=107 Participants 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.
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. Sensitivity	12 Participants
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. Specificity	88 Participants

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

Antiviral Research Center, 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