NCT05105789

Safe and Healthy Schools

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 4 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sars-CoV-2 Infection
• COVID-19

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	BinaxNOW Test	diagnostic test for SARS-CoV-2
DIAGNOSTIC_TEST	"Lollipop" swab	A lollipop swab, is an oral swab to collect saliva, sucked on like a lollipop for 20 seconds.

Timeline

• Start date: 2021-10-11
• Primary completion: 2023-05-21
• Completion: 2023-05-21
• First posted: 2021-11-03
• Last updated: 2024-05-22
• Results posted: 2024-05-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study