Trial Outcomes & Findings for COVID-19 Screening Program (NCT NCT05216627)

Results Overview

How often they use the POC screening program

Recruitment status

COMPLETED

Target enrollment

61 participants

Primary outcome timeframe

fourteen weeks

Results posted on

2024-07-31

Participant Flow

Participant milestones

Participant milestones
Measure	PSOM Staff, Trainees, or Faculty Who Participate in the Point of Care Testing The cohort will be offered access to a self-administered saliva-based viral test is a small funnel and a tube in which participants will put their saliva into. When they are ready to self-collect their saliva sample, they will be instructed to not eat or drink for 30 minutes prior to collecting their saliva and to collect saliva in an isolated room. We will evaluate the implementation of this viral test. Self-administered saliva-based viral testing: Participants will be instructed on how to inactivate the virus and bring their sample to their laboratory's central PCR machine, where they will take an assay test. They will be instructed to collect saliva into a 1.5 milliliter (mL) collection tube containing inactivation buffer (TCEP and EDTA) using a small funnel and inactivate at 95°C for 10 minutes. Participants will then transfer 6ul of saliva into 2 PCR tubes containing amplification master mix and primers, put tubes in a heat block or PCR machine at 65°C for 45 minutes and assess fluorescence using a simple battery-powered fluorescence viewer. Once they assess their sample, they will be instructed to dispose of the saliva sample safely and in accordance with best laboratory practices. No saliva samples will be collected by the research team at any time as part of this study.
Overall Study STARTED	61
Overall Study COMPLETED	61
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Some participants did not provide their age.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PSOM Staff, Trainees, or Faculty Who Participate in the Point of Care Testing n=61 Participants The cohort will be offered access to a self-administered saliva-based viral test is a small funnel and a tube in which participants will put their saliva into. When they are ready to self-collect their saliva sample, they will be instructed to not eat or drink for 30 minutes prior to collecting their saliva and to collect saliva in an isolated room. We will evaluate the implementation of this viral test. Self-administered saliva-based viral testing: Participants will be instructed on how to inactivate the virus and bring their sample to their laboratory's central PCR machine, where they will take an assay test. They will be instructed to collect saliva into a 1.5 milliliter (mL) collection tube containing inactivation buffer (TCEP and EDTA) using a small funnel and inactivate at 95°C for 10 minutes. Participants will then transfer 6ul of saliva into 2 PCR tubes containing amplification master mix and primers, put tubes in a heat block or PCR machine at 65°C for 45 minutes and assess fluorescence using a simple battery-powered fluorescence viewer. Once they assess their sample, they will be instructed to dispose of the saliva sample safely and in accordance with best laboratory practices. No saliva samples will be collected by the research team at any time as part of this study.
Age, Continuous	37.9 years STANDARD_DEVIATION 14.5 • n=45 Participants • Some participants did not provide their age.
Sex: Female, Male Female	32 Participants n=61 Participants
Sex: Female, Male Male	29 Participants n=61 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=61 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	59 Participants n=61 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=61 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=61 Participants
Race (NIH/OMB) Asian	13 Participants n=61 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=61 Participants
Race (NIH/OMB) Black or African American	4 Participants n=61 Participants
Race (NIH/OMB) White	39 Participants n=61 Participants
Race (NIH/OMB) More than one race	2 Participants n=61 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=61 Participants
Region of Enrollment United States	61 Participants n=61 Participants
Study Participation Level Lab Captains	15 Participants n=61 Participants
Study Participation Level Non-Captains	46 Participants n=61 Participants

PRIMARY outcome

Timeframe: fourteen weeks

Population: Lab-wide screening test completion was reported to the study team by captains on behalf of participants from their respective labs. Fifteen captains participated over the course of the program.

How often they use the POC screening program

Outcome measures

Outcome measures
Measure	PSOM Staff, Trainees, or Faculty Who Participate in the Point of Care Testing n=15 Participants The cohort will be offered access to a self-administered saliva-based viral test is a small funnel and a tube in which participants will put their saliva into. When they are ready to self-collect their saliva sample, they will be instructed to not eat or drink for 30 minutes prior to collecting their saliva and to collect saliva in an isolated room. We will evaluate the implementation of this viral test. Self-administered saliva-based viral testing: Participants will be instructed on how to inactivate the virus and bring their sample to their laboratory's central PCR machine, where they will take an assay test. They will be instructed to collect saliva into a 1.5 milliliter (mL) collection tube containing inactivation buffer (TCEP and EDTA) using a small funnel and inactivate at 95°C for 10 minutes. Participants will then transfer 6ul of saliva into 2 PCR tubes containing amplification master mix and primers, put tubes in a heat block or PCR machine at 65°C for 45 minutes and assess fluorescence using a simple battery-powered fluorescence viewer. Once they assess their sample, they will be instructed to dispose of the saliva sample safely and in accordance with best laboratory practices. No saliva samples will be collected by the research team at any time as part of this study.
Use of a Voluntary COVID-19 Point of Care (POC) Screening Program	238 total completed screening tests reported

PRIMARY outcome

Timeframe: fourteen weeks

Population: Only the 15 lab captains completed surveys related to this outcome. As such, results for this outcome were only collected from the 15 lab captains, not all participants. Screening tests were conducted by the 15 lab captains on behalf of participants from their respective labs.

Self-reported acceptability of implementing POC screening program using the Acceptability of Intervention Measure (i.e., "Point of care testing is acceptable to me"). Scale values: 1 (completely disagree) to 5 (completely agree).

Outcome measures

Outcome measures
Measure	PSOM Staff, Trainees, or Faculty Who Participate in the Point of Care Testing n=82 survey responses The cohort will be offered access to a self-administered saliva-based viral test is a small funnel and a tube in which participants will put their saliva into. When they are ready to self-collect their saliva sample, they will be instructed to not eat or drink for 30 minutes prior to collecting their saliva and to collect saliva in an isolated room. We will evaluate the implementation of this viral test. Self-administered saliva-based viral testing: Participants will be instructed on how to inactivate the virus and bring their sample to their laboratory's central PCR machine, where they will take an assay test. They will be instructed to collect saliva into a 1.5 milliliter (mL) collection tube containing inactivation buffer (TCEP and EDTA) using a small funnel and inactivate at 95°C for 10 minutes. Participants will then transfer 6ul of saliva into 2 PCR tubes containing amplification master mix and primers, put tubes in a heat block or PCR machine at 65°C for 45 minutes and assess fluorescence using a simple battery-powered fluorescence viewer. Once they assess their sample, they will be instructed to dispose of the saliva sample safely and in accordance with best laboratory practices. No saliva samples will be collected by the research team at any time as part of this study.
Acceptability of Implementing a Voluntary COVID-19 Point of Care (POC) Screening Program	4.36 score on a scale Standard Deviation 0.72

PRIMARY outcome

Timeframe: fourteen weeks

Population: Only the 15 lab captains completed surveys related to this outcome. As such, results for this outcome were only collected from the 15 lab captains, not all participants. Screening tests were conducted by the 15 lab captains on behalf of participants from their respective labs.

Self-reported appropriateness of implementing POC screening program using the Intervention Appropriateness Measure (i.e., "Point of care testing seems appropriate."). Scale values: 1 (completely disagree) to 5 (completely agree).

Outcome measures

Outcome measures
Measure	PSOM Staff, Trainees, or Faculty Who Participate in the Point of Care Testing n=82 survey responses The cohort will be offered access to a self-administered saliva-based viral test is a small funnel and a tube in which participants will put their saliva into. When they are ready to self-collect their saliva sample, they will be instructed to not eat or drink for 30 minutes prior to collecting their saliva and to collect saliva in an isolated room. We will evaluate the implementation of this viral test. Self-administered saliva-based viral testing: Participants will be instructed on how to inactivate the virus and bring their sample to their laboratory's central PCR machine, where they will take an assay test. They will be instructed to collect saliva into a 1.5 milliliter (mL) collection tube containing inactivation buffer (TCEP and EDTA) using a small funnel and inactivate at 95°C for 10 minutes. Participants will then transfer 6ul of saliva into 2 PCR tubes containing amplification master mix and primers, put tubes in a heat block or PCR machine at 65°C for 45 minutes and assess fluorescence using a simple battery-powered fluorescence viewer. Once they assess their sample, they will be instructed to dispose of the saliva sample safely and in accordance with best laboratory practices. No saliva samples will be collected by the research team at any time as part of this study.
Appropriateness of Implementing a Voluntary COVID-19 Point of Care (POC) Screening Program	4.40 score on a scale Standard Deviation 0.72

PRIMARY outcome

Timeframe: fourteen weeks

Population: Only the 15 lab captains completed surveys related to this outcome. As such, results for this outcome were only collected from the 15 lab captains, not all participants. Screening tests were conducted by the 15 lab captains on behalf of participants from their respective labs.

Self-reported feasibility of implementing POC screening program using the Feasibility of Intervention Measure (i.e., "Point of care testing seems feasible."). Scale values: 1 (completely disagree) to 5 (completely agree).

Outcome measures

Outcome measures
Measure	PSOM Staff, Trainees, or Faculty Who Participate in the Point of Care Testing n=82 survey responses The cohort will be offered access to a self-administered saliva-based viral test is a small funnel and a tube in which participants will put their saliva into. When they are ready to self-collect their saliva sample, they will be instructed to not eat or drink for 30 minutes prior to collecting their saliva and to collect saliva in an isolated room. We will evaluate the implementation of this viral test. Self-administered saliva-based viral testing: Participants will be instructed on how to inactivate the virus and bring their sample to their laboratory's central PCR machine, where they will take an assay test. They will be instructed to collect saliva into a 1.5 milliliter (mL) collection tube containing inactivation buffer (TCEP and EDTA) using a small funnel and inactivate at 95°C for 10 minutes. Participants will then transfer 6ul of saliva into 2 PCR tubes containing amplification master mix and primers, put tubes in a heat block or PCR machine at 65°C for 45 minutes and assess fluorescence using a simple battery-powered fluorescence viewer. Once they assess their sample, they will be instructed to dispose of the saliva sample safely and in accordance with best laboratory practices. No saliva samples will be collected by the research team at any time as part of this study.
Feasibility of Implementing a Voluntary COVID-19 Point of Care (POC) Screening Program	4.29 score on a scale Standard Deviation 0.75

SECONDARY outcome

Timeframe: four weeks

Population: Given participant preferences to retain privacy, individual counts of positive tests were not tracked and self-reports of test results were not collected. However, when completing the survey on their colleagues' behalf, lab captains could note whether anyone in their labs received a positive test result, and they also had the option not to disclose results. The count for this measure refers to the number of labs which reported a positive test result during the study period.

Self-report of if participant received any positive test results from saliva-based viral test or Clinical Laboratory Improvement Amendments (CLIA) approved test

Outcome measures

Outcome measures
Measure	PSOM Staff, Trainees, or Faculty Who Participate in the Point of Care Testing n=82 survey responses The cohort will be offered access to a self-administered saliva-based viral test is a small funnel and a tube in which participants will put their saliva into. When they are ready to self-collect their saliva sample, they will be instructed to not eat or drink for 30 minutes prior to collecting their saliva and to collect saliva in an isolated room. We will evaluate the implementation of this viral test. Self-administered saliva-based viral testing: Participants will be instructed on how to inactivate the virus and bring their sample to their laboratory's central PCR machine, where they will take an assay test. They will be instructed to collect saliva into a 1.5 milliliter (mL) collection tube containing inactivation buffer (TCEP and EDTA) using a small funnel and inactivate at 95°C for 10 minutes. Participants will then transfer 6ul of saliva into 2 PCR tubes containing amplification master mix and primers, put tubes in a heat block or PCR machine at 65°C for 45 minutes and assess fluorescence using a simple battery-powered fluorescence viewer. Once they assess their sample, they will be instructed to dispose of the saliva sample safely and in accordance with best laboratory practices. No saliva samples will be collected by the research team at any time as part of this study.
Self Report of Test Results	1 laboratories

SECONDARY outcome

Timeframe: four weeks

Population: Based on engagement and participant feedback during the pilot phases of this study, follow-up surveys were minimized to reduce participant burden. This scale was not implemented for participants, and as such, the outcome cannot be reported.

Self report of program usability using the Intervention Usability Scale. Scale values: 1 (strongly disagree) to 5 (strongly agree).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: four weeks

Population: Based on engagement and participant feedback during the pilot phases of this study, follow-up surveys were minimized to reduce participant burden. This scale was not implemented for participants, and as such, the outcome cannot be reported.

self report of user burden using the User Burden Scale. Scale values: 0 (not at all) to 5 (extremely).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: four weeks

Population: Based on engagement and participant feedback during this study, follow-up questions were minimized to reduce participant burden. Participants had the opportunity to informally share qualitative feedback over the course of the study, but there was not a formal evaluation of participant experience at four weeks. As such, this outcome cannot be reported.

self report of participant's experience in program using open ended qualitative questions

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: four weeks

Population: Based on engagement and participant feedback during the pilot phases of this study, follow-up questions were minimized to reduce participant burden. Qualitative interviews were not implemented with participants, and as such, this outcome cannot be reported.

self report of ease of program using open ended qualitative questions

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: four weeks

Population: Based on engagement and participant feedback during the pilot phases of this study, follow-up surveys were minimized to reduce participant burden. This scale was not implemented for participants, and as such, the outcome cannot be reported.

self report of interest in program continuing using a Likert Scale. Scale values: 1 (strongly disagree) to 5 (strongly agree).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: four weeks

Population: Based on engagement and participant feedback during the pilot phases of this study, follow-up surveys were minimized to reduce participant burden. This scale was not implemented for participants, and as such, the outcome cannot be reported.

self report of interest in program being more widely available using a Likert Scale. Scale values: 1 (strongly disagree) to 5 (strongly agree).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one time interview after four weeks of intervention

Population: Based on engagement and participant feedback during this study, follow-up qualitative interviews were not conducted. As such, this outcome cannot be reported.

self report of perspectives of program implementation and change in behavior or decision-making using qualitative open ended questions

Outcome measures

Outcome data not reported

Adverse Events

PSOM Staff, Trainees, or Faculty Who Participate in the Point of Care Testing

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

Daniel Blumenthal

University of Pennsylvania

Phone: 215-746-7155

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place