N/A N=61

COVID-19 Screening Program

COVID-19

Bottom Line

View on ClinicalTrials.gov: NCT05216627 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2024

Primary outcome: Primary: Use of a Voluntary COVID-19 Point of Care (POC) Screening Program — 238 total completed screening tests reported

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Self-administered saliva-based viral testing (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Pennsylvania
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Use of a Voluntary COVID-19 Point of Care (POC) Screening Program	238	—
PRIMARY Acceptability of Implementing a Voluntary COVID-19 Point of Care (POC) Screening Program	4.36	—
PRIMARY Appropriateness of Implementing a Voluntary COVID-19 Point of Care (POC) Screening Program	4.40	—
PRIMARY Feasibility of Implementing a Voluntary COVID-19 Point of Care (POC) Screening Program	4.29	—
SECONDARY Self Report of Test Results	1	—
SECONDARY Program Usability	—	—
SECONDARY User Burden	—	—
SECONDARY Participant Experience	—	—
SECONDARY Program Ease	—	—
SECONDARY Program Continuation	—	—
SECONDARY Program Availability	—	—
SECONDARY Participant Perspective of Program Implementation and Change in Behavior or Decision-making Process	—	—

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).

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05216627). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.