Safe and Healthy Schools

Study Overview
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Brief Summary
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This study will target Madison Metropolitan School District (MMSD) school children ages 4-19 and staff who have not had a previous positive COVID-19 test within the past 3 months. It will enroll children and adults for 1-3 days to explore whether serial at-home BinaxNOW testing is feasible and non-inferior to at school single PCR testing for the evaluation of symptomatic individuals with a negative initial BinaxNOW. It will also explore whether lollipop swabs are more acceptable and perform as well as nasal swabs with polymerase chain reaction (PCR) testing.

Detailed Description
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Study Design: This is a quantitative community-based study, conducted in the K-12 setting with school children 4-19 years old, teachers, and staff. If a participant's initial at-school BinaxNOW test is positive, then they will only complete the lollipop swab for PCR testing. They will NOT do the at-home BinaxNOW test. If a participant's initial at-school BinaxNOW test is negative, then they will complete both the lollipop swab for PCR testing AND an at-home BinaxNOW test approximately 24 hours later. If the participant is unwilling or unable to complete the at-home test, they will be presented with a lollipop swab only option. Aim 1: The investigators will test the hypothesis that serial at-home BinaxNOW testing will be feasible and non-inferior to the single at-school PCR testing program. To do this, the investigators will distribute over-the-counter BinaxNOW antigen tests to volunteer families, and create a protocol to ensure families can perform and report test results accurately to the school. Two key questions will be addressed: Is 'at-home' BinaxNOW testing feasible for families? Is serial 'at-home' BinaxNOW testing non-inferior to 'at-school' single PCR testing? Aim 2: The investigators will test the hypothesis that lollipop swabs are more acceptable to individuals and PCR testing is non-inferior to performing PCR on nasal swabs. To test this hypothesis, the investigators will work with MMSD schools to incorporate a lollipop swab for PCR at the time a symptomatic student or staff receives a nasal swab for PCR that is part of the Department of Health Services (DHS) program. Two key questions will be addressed: Are lollipop swabs more acceptable to individuals when compared to nasal swabs? Will lollipop swabs perform as well as nasal swabs with PCR-based testing? Hypotheses to be tested: Aim 1.1: At-home BinaxNOW testing will be feasible for families. Aim 1.2: Serial at-home BinaxNOW testing is non-inferior to at school single PCR testing. Aim 2.1: Lollipop swabs are more acceptable to individuals than nasal swabs. Aim 2.2: Lollipop swabs will perform as well as nasal swabs with PCR-based testing. Protocol Amendment 2/4/22 to expand the upper eligible age for children from 14 to 19 years and to recognize the potential supply chain limitations of BinaxNOW tests. If the study team does not have any BinaxNOW tests due to a supply shortage, the BinaxNOW procedures will be dropped and only the lollipop swab will be collected. Protocol Amendment 5/16/22 extends the study timeline and adds a lollipop swab only option.

Official Title
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Safe and Healthy Schools

Conditions
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Sars-CoV-2 Infection, COVID-19

Intervention / Treatment
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* Diagnostic Test: BinaxNOW Test
* Diagnostic Test: Lollipop swab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: school children ages 4-19 MMSD staff have at least one symptom of COVID-19 have not had a positive COVID-19 test in the past 3 months will undergo nasal PCR testing at an MMSD elementary school Exclusion Criteria: received a positive COVID-19 test in the past 3 months Criteria for inclusion in the final study sample: Aim 1. Symptomatic participants with a negative at-school BinaxNOW test and nasal PCR results who complete both the lollipop PCR and at-home BinaxNOW tests within 72 hours will be included in the final study sample. Aim 2. Symptomatic participants who provide a lollipop swab that is successfully resulted. Criteria for exclusion in the final study sample: Aim 1 Missing nasal PCR result Do not successfully complete an at-home BinaxNOW test within 72 hours of the at-school BinaxNOW test Aim 2 Missing nasal PCR result Missing lollipop PCR result

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BinaxNOW Test + Lollipop PCR<br>If a symptomatic participant's initial at-school BinaxNOW test was positive, then their study participation is complete after providing the lollipop swab for PCR testing. If a symptomatic participant's initial at-school BinaxNOW test was negative, then they will be asked to complete an at-home BinaxNOW test approximately 24 hours later. For the at-home BinaxNOW testing, the participant will schedule a follow-up virtual visit with the study coordinator. If they are unable to complete a virtual visit, they will schedule an in-person home visit. They will also be sent home with a BinaxNOW testing kit. | Diagnostic Test: BinaxNOW Test<br>* diagnostic test for SARS-CoV-2<br>* Other names: BinaxNOW COVID-19 Ag Card;Diagnostic Test: Lollipop swab<br>* A lollipop swab, is an oral swab to collect saliva, sucked on like a lollipop for 20 seconds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative Predictive Value (NPV) of BinaxNOW | The primary diagnostic outcome measure will be the negative predictive value (NPV). The NPV of BinaxNow is  91% in symptomatic subjects. The null hypothesis is that the negative predictive value of BinaxNOW is at least 91% (which is the reported rate in symptomatic subjects after a single test) versus the alternative hypothesis that the NPV is greater than 91%. | up to 2 days | 
| Tabulated Results from Nasal vs Lollipop Swab-based PCR tests | The hypothesis is that the lollipop swab test will be non-inferior to the gold-standard PCR testing of nasal swabs. Concordance between the PCR test results will be evaluated by calculating the Kappa statistic which will be reported along with corresponding two-sided 95% confidence interval. The nonparametric bootstrap technique will be used to construct the confidence interval. A kappa statistic of >0.95 will be considered as sufficient to define lollipop swab test non-inferior to the gold standard PCR testing of nasal swabs. | up to 1 day | 
| Number of successfully completed at-home tests | Feasibility of 'at-home' BinaxNOW testing will be determined by number of successfully completed at-home tests. At-home test taking will be monitored by study team remotely (via zoom or similar). | up to 24 hours | 
| Percent of participants who answer 'yes' when asked if lollipop swabs are more acceptable than nasal swabs | To address the acceptability of lollipop swabs vs nasal swabs, the study team will ask participants a binary question: Are lollipop swabs more acceptable to participants when compared to nasal swabs? Yes/No. | up to 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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testing, diagnosis, schools