COVID-19 Screening Program

Completed

Conditions: COVID-19

Interventions: Diagnostic Test: Self-administered saliva-based viral testing

Registration Number: NCT05216627

Lead Sponsor: University of Pennsylvania

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 61

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PSOM staff, trainees, or faculty who participate in the point of care testing	Self-administered saliva-based viral 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.

Primary Outcome Measures

Name	Time	Method
Use of a Voluntary COVID-19 Point of Care (POC) Screening Program	fourteen weeks	How often they use the POC screening program
Feasibility of Implementing a Voluntary COVID-19 Point of Care (POC) Screening Program	fourteen weeks	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).
Appropriateness of Implementing a Voluntary COVID-19 Point of Care (POC) Screening Program	fourteen weeks	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).
Acceptability of Implementing a Voluntary COVID-19 Point of Care (POC) Screening Program	fourteen weeks	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).

Secondary Outcome Measures

Name	Time	Method
Self Report of Test Results	four weeks	Self-report of if participant received any positive test results from saliva-based viral test or Clinical Laboratory Improvement Amendments (CLIA) approved test
Program Continuation	four weeks	self report of interest in program continuing using a Likert Scale. Scale values: 1 (strongly disagree) to 5 (strongly agree).
Program Availability	four weeks	self report of interest in program being more widely available using a Likert Scale. Scale values: 1 (strongly disagree) to 5 (strongly agree).
Participant Experience	four weeks	self report of participant's experience in program using open ended qualitative questions
Program Usability	four weeks	Self report of program usability using the Intervention Usability Scale. Scale values: 1 (strongly disagree) to 5 (strongly agree).
User Burden	four weeks	self report of user burden using the User Burden Scale. Scale values: 0 (not at all) to 5 (extremely).
Program Ease	four weeks	self report of ease of program using open ended qualitative questions
Participant Perspective of Program Implementation and Change in Behavior or Decision-making Process	one time interview after four weeks of intervention	self report of perspectives of program implementation and change in behavior or decision-making using qualitative open ended questions