Safe and Healthy Schools

NCT05105789 | Completed Results FDA Device

• 3 other identifiers: 2021-0790Protocol Version 5/8/22A536756
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sars-CoV-2 Infection; COVID-19

Keywords

testing; diagnosis; schools

Outcome Measures

Primary Outcomes (5)

• Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCR

  The primary diagnostic outcome measure will be the negative predictive value (NPV). The kappa values for sensitivity, specificity, positive predictive value (PPV) and NPV of the BinaxNOW at Home testing with respect to PCR nasal swab (gold standard) are reported here.

  up to 2 days

• Frequency Table of Gold-Standard Nasal Swab PCR vs Lollipop Swab PCR COVID-19 Test Results

  Counts of negative and positive Nasal Swab vs. Lollipop Swab PCR COVID-19 tests with kappa statistical value.

  up to 2 days

• Standard Diagnostic Test Outcomes for Lollipop Swab PCR Testing as Compared to Nasal Swab PCR

  The kappa values for sensitivity, specificity, positive predictive value (PPV) and NPV of the Lollipop Swab PCR with respect to PCR nasal swab (gold standard) are reported here.

  up to 2 days

• 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

Study Arms (1)

BinaxNOW Test + Lollipop PCR

EXPERIMENTAL

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; Diagnostic Test: "Lollipop" swab

Interventions

BinaxNOW Test DIAGNOSTIC_TEST

diagnostic test for SARS-CoV-2

Also known as: BinaxNOW COVID-19 Ag Card

BinaxNOW Test + Lollipop PCR

"Lollipop" swab DIAGNOSTIC_TEST

A lollipop swab, is an oral swab to collect saliva, sucked on like a lollipop for 20 seconds.

BinaxNOW Test + Lollipop PCR

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• received a positive COVID-19 test in the past 3 months
• 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.
• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

Community Locations

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

COVID-19; Disease

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Some limitations and caveats of this study include: * Difficulty enrolling participants because parents were not allowed into the school building for the informed consent procedure. * The outdoor consenting procedure became more difficult, and at times impossible, during extreme cold, or rainy weather days. * School holidays during COVID surges, and the COVID Clinic's proximity and lack of cooperation also created limitations.

Results Point of Contact

• Title: Ellen Wald, MD
• Organization: UW School of Medicine and Public Health

erwald@pediatrics.wisc.edu

(608) 263-8558

Study Officials

• Ellen R Wald, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 3, 2021
• Study Start: October 11, 2021
• Primary Completion: May 21, 2023
• Study Completion: May 21, 2023
• Last Updated: May 22, 2024
• Results First Posted: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)