Clinical trial NCT05105789: Safe and Healthy Schools
Official title: Safe and Healthy Schools
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sars-CoV-2 Infection
COVID-19
Keywords: testing
diagnosis
schools
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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:

1. Is 'at-home' BinaxNOW testing feasible for families?
2. 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:

1. Are lollipop swabs more acceptable to individuals when compared to nasal swabs?
2. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCR
timeFrame: up to 2 days
measure: Frequency Table of Gold-Standard Nasal Swab PCR vs Lollipop Swab PCR COVID-19 Test Results
timeFrame: up to 2 days
measure: Standard Diagnostic Test Outcomes for Lollipop Swab PCR Testing as Compared to Nasal Swab PCR
timeFrame: up to 2 days
measure: Number of Successfully Completed At-home Tests
timeFrame: up to 24 hours
measure: Percent of Participants Who Answer 'Yes' When Asked if Lollipop Swabs Are More Acceptable Than Nasal Swabs
timeFrame: up to 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Community Locations
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ellen R Wald, MD
role: PRINCIPAL_INVESTIGATOR
References: