COVID-19 Screening Program

Study Overview
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Brief Summary
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In view of the recent COVID surge and difficulties in obtaining testing, we aim to increase Point of Care (POC) testing, whereby University of Pennsylvania (Penn) faculty, staff, and trainees who are working in person at Perelman School of Medicine (PSOM) laboratories can self-test. The purpose of this study is to evaluate the implementation of this POC testing program. We will not be collecting any samples as part of this study. This will ensure that individuals can rapidly identify if they have COVID-19 while balancing use, acceptability, appropriateness, and feasibility. We will start with a pilot phase whereby we will evaluate the implementation of a POC version of COVID-19 screening program that will coordinate several existing systems at the University of Pennsylvania including voluntary, self-administered saliva-based viral testing. We will pilot this program to a small cohort of PSOM labs and then test implementation of the self-testing of the POC version of COVID-19 screening across all PSOM labs for those who wish to participate. All results will be self-reported and will not be used to validate any tests or support any future approval from the FDA. No data from this study will go into the participants' Electronic Medical Record (EMR).

Detailed Description
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Background: The coronavirus disease (COVID-19) pandemic has resulted in close to 300,000,000 reported cases worldwide, including more than 58,000,000 reported cases and 800,000 deaths in the United States [1,2]. Initial efforts to address the COVID-19 pandemic were aimed at testing symptomatic individuals, implementing stay-in-place orders, and at increasing hospital capacity to meet surge demands [3]. Currently, we are going through an unprecedented surge in the total number of cases - mostly due to the spread of the Omicron variant. While we continue to confront the current crisis, a complete lockdown as seen in 2020 is not desirable or being planned. We must address the current issue and also plan for the future by putting in place tools to enhance our ability to conduct effective screening, containment, and case management. Future variants may cause similar delays in testing availability. Widespread COVID-19 testing is needed to safely and effectively operate schools, workplaces, and businesses across the US. However, currently approved clinical testing options require reagents that are limited in supply and expensive quantitative polymerase chain reaction (qPCR) machines, severely hindering scalability [4] coupled with acute shortage of person-power. In response to limited clinical testing options, rapid antigen tests that are available to purchase over-the-counter and can be self-administered have become recently a popular testing approach; however, these tests are expensive, in short supply, and may not be as sensitive in detecting Omicron variant compared to polymerase chain reaction (PCR) tests [5]. Emerging evidence indicates that saliva testing with the option of self-administration of testing can accurately identify COVID-19 viral infection [6]. Moreover, this approach provides an option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor's office, hospital, or testing site. Point of care testing (i.e. using saliva-based self-collection to administer screening for COVID-19 in one's own laboratory setting) utilizes testing equipment that is readily available to our workforce, leverages their existing training, and benefits from existing institutional health and safety infrastructure. Self-administration of saliva testing also reduces exposure of health care workers to the virus and preserves limited personal protective equipment [7]. Additional diagnostic testing options will continue to increase staff access. For these reasons, we propose to evaluate the implementation of a COVID-19 POC screening program that uses saliva-based self-testing and to pilot test approaches to improve program enrollment. Objective: The primary objective of the study is to evaluate the use, acceptability, appropriateness, and feasibility of implementing a voluntary COVID-19 Point of Care (POC) screening program with Penn faculty, staff, and trainees that uses saliva-based self-collection followed by testing in their own PSOM laboratories. A secondary objective is to learn about self-reported test results, program usability, user burden, participant experience, program ease, program continuation and availability. Another secondary objective is to learn about individual's perspectives about the program. Study Design: This is an implementation clinical trial that we anticipate lasting up to two months. In the first phase, we will pilot the approach with four PSOM laboratories. We plan to enroll up to 50 people across these labs during the pilot phase. Labs will be located on Penn campus. We will pilot test the best manner to distribute saliva collection test kits and assay tests to participants and elicit rapid feedback for one week. We will apply feedback in real time to improve the distribution method. In the second phase, we will roll out the clinical trial more broadly across all interested PSOM laboratories. We anticipate enrolling up to 500 participants across all PSOM laboratories. All participants will be Penn employees (faculty, staff, and trainees) who work in a PSOM laboratory. All participants will be required to provide informed consent and watch a training video before self-collecting their first saliva sample. All participants will be told they can collect saliva samples as much or as little as they want - but no more than daily for up to four weeks. They will also be asked to complete online surveys weekly for up to four weeks. These surveys are expected to take about 15 minutes to complete. See below for table of survey measures and frequency. A subset of participants will also be asked to participate in a one-time qualitative interview after the point of care testing program is over. This interview is expected to take about 30 minutes.

Official Title
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COVID SAFE 2.0: COVID-19 Screening Program

Conditions
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COVID-19

Intervention / Treatment
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* Diagnostic Test: Self-administered saliva-based viral testing


Participation Criteria
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Eligibility Criteria
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To be eligible, participants must: Be 18 years or older Be University of Pennsylvania staff, faculty or trainee who is working in person on campus at a PSOM laboratory Have knowledge of safe practices in and access to a biological safety cabinet Have knowledge and access to pipet and PCR machine

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PSOM staff, trainees, or faculty who participate in the point of care testing<br>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. | Diagnostic Test: Self-administered saliva-based viral testing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of a voluntary COVID-19 Point of Care (POC) screening program | How often they use the POC screening program | four weeks | 
| acceptability of implementing a voluntary COVID-19 Point of Care (POC) screening program | Self-reported acceptability of implementing POC screening program using the Acceptability of Intervention Measure. Scale values: 1 (completely disagree) to 5 (completely agree). | four weeks | 
| appropriateness of implementing a voluntary COVID-19 Point of Care (POC) screening program | Self-reported appropriateness of implementing POC screening program using the Intervention Appropriateness Measure. Scale values: 1 (completely disagree) to 5 (completely agree). | four weeks | 
| feasibility of implementing a voluntary COVID-19 Point of Care (POC) screening program | Self-reported feasibility of implementing POC screening program using the Feasibility of Intervention Measure. Scale values: 1 (completely disagree) to 5 (completely agree). | four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self report of test results | Self-report of if participant received any positive test results from saliva-based viral test or Clinical Laboratory Improvement Amendments (CLIA) approved test | four weeks | 
| program usability | Self report of program usability using the Intervention Usability Scale. Scale values: 1 (strongly disagree) to 5 (strongly agree). | four weeks | 
| user burden | self report of user burden using the User Burden Scale. Scale values: 0 (not at all) to 5 (extremely). | four weeks | 
| participant experience | self report of participant's experience in program using open ended qualitative questions | four weeks | 
| program ease | self report of ease of program using open ended qualitative questions | four weeks | 
| program continuation | self report of interest in program continuing using a Likert Scale. Scale values: 1 (strongly disagree) to 5 (strongly agree). | four weeks | 
| program availability | self report of interest in program being more widely available using a Likert Scale. Scale values: 1 (strongly disagree) to 5 (strongly agree). | four weeks | 
| Participant perspective of program implementation and change in behavior or decision-making process | self report of perspectives of program implementation and change in behavior or decision-making using qualitative open ended questions | one time interview after four weeks of intervention |