Safe and Healthy Schools
Phase: NA
Conditions: Sars-CoV-2 Infection, COVID-19
Sponsor: University of Wisconsin, Madison

 
 
Safe & Healthy Schools 
Last IRB Protocol Approval 5/8/2022 
#NCT05105789 

PROTOCOL TITLE: SAFE AND HEALTHY SCHOOLS 
 
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PROTOCOL TITLE: 
Safe and Healthy Schools 
LEAD RESEARCHERS: 
Ellen Wald, MD 
Department of Pediatrics 
(608) 263-8558 
erwald@wisc.edu 
 
Shelby O’Connor, PhD 
Department of Pathology and Laboratory Medicine 
(608) 890-0843 
slfeinberg@wisc.edu  
 
Co-Investigators 
Joseph McBride, MA, MD, DTMH 
Department of Medicine 
jmcbride@medicine.wisc.edu 
 
Gregory DeMuri, MD 
Department of Pediatrics 
(608) 265-6050 
demuri@pediatrics.wisc.edu 
 
 
VERSION NUMBER/DATE: 
Version 8, May 2022. 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
2 
August 2021 
Change BinaxNOW interval from 3 days to 5 
days, add compensation, update details about 
data labeling and storage 
Yes 
3 
September 
2021 
Add 50 participants with positive at-school 
BinaxNOW, add option to consent prior to 
initial BinaxNOW testing, clarify process for 
Spanish translation, change eligibility to 
include all MMSD staff and students ages 4-14 
with at least one symptom who are getting at-
school PCR testing, clarify criteria that define 
Yes 

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who will be excluded from the final study 
sample, add questions to data collection form 
4 
October 2021 
Add back-up data collection method, add 
questions to data collection form, update 
follow-up guidance for positive at-home 
BinaxNOW 
 
5 
December 
2021 
Modify recruitment method to allow 
participants to directly contact or approach the 
study team, and also to allow the study team to 
gently approach potential participants; describe 
sharing of results for at-school antigen test; 
explain that all study participants will receive a 
BinaxNOW home testing kit, not just 
participants with negative at-school antigen 
tests 
Yes 
6 
January 2022 
Add option of study team collecting at-school 
BinaxNOW test if it isn’t already being 
collected, change child age range to 4-19, and 
add lollipop-only alternative if study team runs 
out of BinaxNOW tests 
Yes 
7 
April 2022 
Add Accelerated Clinical Laboratories (ACL) 
as a lab service provider, in addition to Exact 
Sciences Laboratories.  
Yes 
8 
May 2022 
Change lollipop sample labels from coded to 
fully identifiable. Update recruitment to 
explain ACL introducing the study. Make 
lollipop-only an option if a potential  
participant is unwilling or unable to do at-home 
BinaxNOW testing. Extending study 
timelines—completing enrollment in August 
instead of March.  
Yes 
 
 
 

PROTOCOL TITLE: SAFE AND HEALTHY SCHOOLS 
 
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Table of Contents 
1.0 
Study Summary .................................................................................................... 4 
2.0 
Background .......................................................................................................... 5 
3.0 
Study Objectives and Endpoints ............................................................................ 8 
4.0 
Number of Participants ......................................................................................... 9 
5.0 
Inclusion and Exclusion Criteria ......................................................................... 10 
6.0 
Special Populations ............................................................................................. 12 
7.0 
Recruitment Methods .......................................................................................... 12 
8.0 
Consent/Assent Process ...................................................................................... 15 
9.0 
Process to Document Consent in Writing ............................................................ 18 
10.0 Setting ................................................................................................................ 18 
11.0 Study Intervention .............................................................................................. 19 
12.0 Study Timelines .................................................................................................. 20 
13.0 Procedures Involved ........................................................................................... 20 
14.0 Comparison of usual care and study procedures .................................................. 25 
15.0 Withdrawal of Participants .................................................................................. 26 
16.0 Data Management and Confidentiality ................................................................ 26 
17.0 Provisions to Protect the Privacy Interests of Participants ................................... 28 
18.0 Sharing of Results ............................................................................................... 28 
19.0 Data and Specimen Banking ............................................................................... 29 
20.0 Study Analysis .................................................................................................... 29 
21.0 Potential Benefits to Participants......................................................................... 31 
22.0 Risks to Participants ........................................................................................... 31 
23.0 Provisions to Monitor the Data to Ensure the Safety of Participants .................... 32 
24.0 Economic Burden to Participants ........................................................................ 33 
25.0 Resources Available ........................................................................................... 33 
26.0 Multi-Site Research ............................................................................................ 34 
27.0 References .......................................................................................................... 34 
28.0 Appendices ......................................................................................................... 34 
 
 
 
 

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1.0 
Study Summary 
 
Study Title 
Safe and Healthy Schools 
Brief Summary 
This study will target Madison Metropolitan School District 
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 
PCR testing.  
Number of study sites 
1 
Study Design 
Community-based empirical research  
Primary Objective 
(1) Determine whether “at-home” BinaxNOW testing is 
feasible for families, (2) Evaluate whether serial “at-home” 
BinaxNOW testing is non-inferior to “at school” single PCR 
testing, (3) Compare the acceptability of lollipop swabs and 
nasal swabs, and (4) Compare the performance of lollipop 
swabs to nasal swabs with PCR-based testing.  
Secondary 
Objective(s) 
NA 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
NA 
Drugs/devices used on 
study (including any 
IND/IDE #)  
This study will evaluate the BinaxNOW COVID-19 Ag Card 
and the “lollipop” swab sample collection method 
Study Population 
Madison Metropolitan School District school children ages 
4-19 and staff 
Sample Size 
400 with negative at-school BinaxNOW and 50 with positive 
at-school BinaxNOW. Total n=450.  
Study Duration for 
individual 
participants 
Up to 5 days 
Study Specific 
Abbreviations/ 
Definitions  
PCR: polymerase chain reaction 
EUA: emergency use authorization 
 

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2.0 
Background 
2.1 Relevant prior experience and gaps in current knowledge: 
Current standards for COVID-19 diagnosis include nasopharyngeal 
(NP), nasal or saliva specimens to detect SARS-CoV-2 via 
polymerase chain reaction (PCR) test. Because NP swabs are 
cumbersome to perform, uncomfortable for the patient, require 
health providers in personal protective equipment, scare young 
children and are not practical for large groups or repeat testing, we 
have been exploring the use of “lollipop” swabs. A lollipop swab, is 
an oral swab, sucked on like a lollipop for 20 seconds. It is 
essentially a sample of saliva that is conveniently collected. A 
previous experience with the use of lollipop swabs for the detection 
of group A streptococcus in children with pharyngitis, prompted us 
to perform a pilot test to assess the sensitivity of the lollipop swab 
compared to a NP swab for the detection of SARS-CoV-2 in 
symptomatic individuals with PCR. 
Additionally, our group has extensive experience training and 
implementing testing for SARS-CoV-2 in K-12 schools. During the 
2020-2021 academic school year, we trained two elementary schools 
to perform SARS-CoV-2 reverse transcription-loop-mediated 
isothermal amplification (RT-LAMP) saliva-based testing in 
Madison, WI. More broadly, we visited more than a dozen schools 
and districts to train staff how to perform BinaxNOW antigen tests. 
We generated an online portal, complete with videos, training slides, 
and examples of consenting documents. Through these efforts, we 
provided more than 100 schools in Dane County with the tools 
needed to perform antigen tests in the spring of 2021. 
2.2 Relevant preliminary data: 
Our previous research showed that 25 symptomatic patients assessed 
within 7 days of onset of symptoms (and known to be infected with 
SARS-CoV-2) were all positive when a lollipop swab was used for 
collection. In addition, 5 asymptomatic patients known to be infected 
with SARS-CoV-2 also proved to be positive when evaluated with a 
lollipop swab. 
2.3 Significance: The prevalence of SARS-CoV-2 among school-aged 
children in the 2021-2022 academic year is unknown. Intense 
vaccination campaigns will reduce the number of cases, but 
vaccination uptake varies widely across Wisconsin. Children under 
the age of 12 years will likely not be eligible for vaccination until the 
late fall, leaving many children still susceptible to infection during 
part of the school year. With the large number of children 
simultaneously returning to school (with many extracurricular 
activities), and potentially decreased attention to mitigation 

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strategies, there will be increased transmission of respiratory viruses 
among members of the school community.  
We expect there will be a surge in respiratory illnesses caused by 
enterovirus, rhinovirus, community coronaviruses, influenza, RSV, 
parainfluenza, human metapneumovirus and adenovirus as well as 
SARS-CoV-2 in the fall and winter of next year. When schools 
reopened post COVID-19 shutdowns in Hong Kong and the UK, 
there were rapid increases in the cases of rhinovirus. This anticipated 
rise of symptomatic children requires a comprehensive strategy to 
quickly distinguish between cases of SARS-CoV-2 and non-SARS-
CoV-2 infections and implement a policy to consistently enable a 
prompt return to school.  
In order to appreciate the nuances of testing for infections with 
SARS-CoV-2, it is necessary to briefly discuss clinical presentation 
and viral replication.  
Clinical presentation and viral replication: Since the beginning of 
the pandemic, it was recognized that children are infected with 
SARS-CoV-2 less often than adults and that their illness has been, in 
general, milder than in adults. Many children and adults are 
completely asymptomatic. However, when children are 
symptomatic, their symptoms take the form of a mild upper 
respiratory infection with nasal congestion, nasal discharge, sore 
throat or cough. 
The time from when a person is exposed to the SARS-CoV-2 virus 
to the time that they become infectious to others is called the 
incubation period. Just before the onset of symptoms, virus 
multiplication in the nose and throat accelerates and the infected 
individual becomes infectious to others. Infectivity of a given 
individual peaks in about the next 24 hours. They remain infectious 
for about 5 days, during which time the amount of virus in the nose 
and throat gradually decreases. 
Diagnostic Testing for SARS-CoV-2 – Nucleic acid detection: 
The gold standard for diagnostic testing has been detection of SARS-
CoV-2 nucleic acids by a polymerase chain reaction (PCR). The first 
tests to be developed were performed on a sample obtained from the 
nasopharynx. Eventually, these PCR assays were modified to be 
performed on other samples including either nasal mucosal swabs or 
samples of saliva collected in small receptacles. The transition to the 
use of other samples has been important since acquiring the 
nasopharyngeal (NP) sample requires trained personnel and is 
uncomfortable for the patient. Repeated NP tests are dreaded. 
Identifying the optimum sampling technique for children remains a 
challenge.  

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PCR tests are generally performed in hospital or commercial 
laboratories. They are expensive—usually costing $75 to $150 
dollars. They also take time to perform; although some tests are run 
in as short a time as an hour or two; others take 6 to 12 hours. 
Transportation from the collection site to a centralized testing facility 
significantly prolongs turnaround time ranging from 1-3 days. These 
delays limit the use of PCR as a tool for infection control.   
The PCR test will be negative during the incubation period because 
there is not enough virus present to give a positive reaction. Just as 
the individual is becoming symptomatic, the PCR becomes positive. 
As the titer of virus peaks during the next 24 to 48 hours, the PCR 
test stays positive and will remain positive for quite a few more days 
while the patient is symptomatic and infectious to others. Of 
importance, the PCR may even remain positive when the patient is 
no longer infectious to others, because the test detects the nucleic 
acids even though the virus is no longer capable of replication.  
Antigen testing: Instead of detecting viral nucleic acids, the target 
for antigen tests is the nucleoprotein (N) protein of the SARS-CoV-2 
virus. Antigen tests can be performed in a shorter time than PCR 
tests and are much less expensive. While antigen tests are less 
sensitive than PCR tests, they both detect individuals who are 
infectious. The Abbott company developed a very simple assay that 
has been commercialized for use both as point-of-care as well as an 
in-home test called the BinaxNOW-COVID-19 Antigen test 
(hereinafter call BinaxNOW). The test comes packaged within a card 
which is the size and shape of a credit card and which opens like a 
small book. In addition, there is a container of reagent. The reagent 
is delivered into a small hole in the card. A nasal swab is obtained 
from the patient by swirling the swab gently in the anterior nares 
several times. The swab is then inserted into the space where the 
reagent is located and turned several times. A positive test is 
indicated by the presence of 2 lines, very similar to home pregnancy 
tests. The testing time is 15 minutes. A positive swab can be detected 
within 5 to 8 minutes, but the test cannot be classified as negative 
until 15 minutes have elapsed. In addition, this test is CLIA-waived 
and can be performed by school health personnel in the school 
setting, eliminating the need for specimen transport and dramatically 
reducing turn-around-time and providing immediately actionable 
results for determining the need for exclusion from school.  
The BinaxNOW test is reported to be approximately 94% sensitive 
in patients with symptomatic COVID-19 infections. Accordingly, it 
would be anticipated that if an individual who was truly infected 
with SARS-CoV-2 tested negative with the BinaxNOW test, then 
another test would almost certainly become positive if repeated 
within 24 hours, as the climb in viral load is particularly steep once 

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symptoms have developed. On the other hand, if the symptomatic 
individual with a negative BinaxNOW test is not infected with 
SARS-CoV-2, the repeat BinaxNOW will be persistently negative.  
Testing in schools:  There are several instances in which testing 
individuals for SARS-CoV-2 infection in the school setting is useful. 
Children or teachers may arrive at school and suddenly notice 
symptoms, or they may become symptomatic during the day. For 
these scenarios, we want to determine if the individual is positive for 
SARS-CoV-2 so they can be isolated and contact tracing can be 
initiated. If the patient is not infected with SARS-CoV-2, then an 
individual will only need to remain at home until their symptoms 
have resolved.  
BinaxNOW tests are a valuable adjunct to PCR testing in 
symptomatic individuals because they are available, simple, and 
rapid. A positive result for a student or staff member can rapidly 
exclude the individual from the class and begin contact tracing. 
However, Wisconsin Department of Health Services (DHS) requires 
that a negative BinaxNOW test in a symptomatic individual be 
followed by a PCR. This requirement reflects the imperfect 
sensitivity of the BinaxNOW card at 94% rather than 100%. 
However, PCR tests are inconvenient for families and time 
consuming, so many families prefer to be isolated for 10 days, 
creating a situation in which school will be missed unnecessarily. 
DHS is attempting to improve adherence to PCR follow-up testing 
by providing nasal swab kits directly to schools. However, 
transporting these swabs to the testing facility is time-consuming for 
staff, thereby adding cost and decreasing accessibility.    
Given that mask use is likely to be less stringent in the future, the 
likelihood of an increase in community-acquired viral infections is 
very high. This will translate into a greater proportion of children 
and adults presenting with respiratory symptoms who will have a 
negative BinaxNOW because their infection is caused by a virus 
different from SARS-CoV-2. Accordingly, we need a less resource-
intensive approach to test symptomatic individuals for SARS-CoV-
2. 
 
3.0 
Study Objectives and Endpoints 
3.1 Aim 1: We 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, we 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. We will address two key questions: 

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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: We 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, we 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 DHS program. We will address the following 
two key questions: 
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? 
3.2 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.  
 
4.0 
Number of Participants 
4.1 Total number of participants to be accrued: 
We expect to enroll approximately 450 participants.  
4.2 Number of participants needed to complete the research procedures:  
To achieve adequate statistical power, 358 participants with negative 
at-school BinaxNOW tests need to complete the research procedures, 
including the at-home BinaxNOW test.  
An additional 50 participants with positive at-school BinaxNOW 
tests need to provide lollipop swabs.  
 
4.3 Replacing enrolled participants: 
If participants with negative at-school BinaxNOW test results do not 
complete the procedures within the target window, i.e., do not 
successfully completing the at-home BinaxNOW test within 72 
hours, they will be replaced. We will continue enrolling until 358 

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participants have completed the research procedures within the target 
timeframe. 
We will continue enrolling participants with positive at-school 
BinaxNOW test results until 50 participants have nasal and lollipop 
PCR results.  
5.0 
Inclusion and Exclusion Criteria 
5.1 Eligibility Screening: 
This study will enroll MMSD school children ages 4-19 and MMSD 
staff who currently have at least one symptom of COVID-19, have 
not had a positive COVID test within the past 3 months, and will 
undergo nasal PCR testing at an MMSD elementary school.  
If symptomatic MMSD school children or staff intend to have nasal 
swab PCR tests at school, then school-approved personnel may 
inform adults—staff or children’s parents—of our research study. 
The staff will either provide a flyer or verbally let them know it 
involves a lollipop test at that time, and if the at-school BinaxNOW 
is negative, it will also involve the performance of an at-home 
BinaxNOW test in approximately 24 hours. If the school does not 
conduct a BinaxNOW test, then the study team will collect a nasal 
swab for the “at-school” BinaxNOW test.  
If the study team does not have any BinaxNOW tests due to a supply 
shortage, the at-school and at-home BinaxNOW tests will be 
dropped and participants will be recruited for a Lollipop Only 
alternative. Additionally, if a potential participant expresses interest 
in the study but is unwilling or unable to do at-home BinaxNOW 
testing, then the study coordinator will offer them the Lollipop Only 
alternative.  
School-approved personnel will also let potential participants know 
that they would not be eligible to participate if they have had a 
previous positive COVID-19 test in the past 3 months, either 
verbally or by providing a flyer. The staff will ask if the adult is 
interested in speaking to a study coordinator to learn more about the 
study. If yes, the staff will either direct the potential participant to 
the study coordinator or they will inform the study coordinator that a 
potential participant is interested in speaking with them, and they 
will connect the coordinator to the potential participant, either on the 
phone or in person.  
Alternatively, the study team may gently approach potential 
participants near the at-school testing locations. Potential 
participants may also directly contact the study team in response to 
poster and flyer advertisements.  

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Once an interested participant is identified, the study coordinator 
will review eligibility criteria and explain more details about what is 
involved. They will let them know what the exclusion criteria are 
and tell them that prior to enrolling in the study, they do not need to 
disclose whether they have received a positive COVID-19 test. The 
coordinator will ask, after the potential participant has learned more 
about the study and had a chance to ask questions, whether they are 
eligible and interested in participating. If they decline, the study 
coordinator will not ask for more details about why they do not wish 
to participate. In other words, study coordinators will be careful not 
to probe about COVID-19 diagnoses prior to enrollment. If a 
potential participant indicates that they are interested in participating 
but are unable or unwilling to complete the at-home BinaxNOW 
testing, then the study coordinator will present the Lollipop Only 
alternative. They will also have this conversation in a setting that is 
as private as possible. If the potential participant says that they are 
eligible and interested in participating, the study coordinator will 
conduct verbal consent with the adult and assent with the child, 
when applicable. The study coordinator will record the participant’s 
name and information after consent and assent are complete. This 
study will not track information or explanations from participants 
who decline enrollment.   
5.2 Criteria that define who will be included in the final study sample: 
For Aim 1, 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 will include participants who provide a lollipop swab that is 
successfully resulted at Exact Sciences or ACL.  
5.3 Criteria that define who will be excluded from the final study 
sample: 
If certain samples do not provide a result—such as if samples are 
missing, compromised, or invalid—the subject will not be included 
in analyses for one or both of the study aims. Criteria for exclusion 
from analyses are as follows: 
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 

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6.0 
Special Populations 
6.1  
☒ Children/Minors (HRP-416 - CHECKLIST - Children) 
 
☐ Pregnant persons / fetuses (HRP-412 - CHECKLIST - Pregnant Women; 
HRP-413 - CHECKLIST - Non-Viable Neonates; HRP-414 - CHECKLIST 
- Neonates of Uncertain Viability) 
☐ Prisoners (HRP-415 - CHECKLIST - Prisoners) 
☐ Participants with impaired decision-making capacity (HRP-417 - 
CHECKLIST - Adults with Impaired Decision-Making Capacity) 
 
 
 
This study will enroll MMSD students ages 4-19, staff and teachers. This 
research involves no greater than minimal risk to individuals, including 
children. It is necessary to enroll children in this study to determine what 
types of tests are optimal in school settings. Verbal assent will be obtained 
from all children enrolled in the study after their parent or legal guardian 
provides consent.  
 
6.2 ☒ Non-English speaking participants  
☐ Illiterate or Low Literacy participants 
☐ Participants with visual or hearing impairments 
☐ Status Relationship: Individuals with a status relationship with the PI or 
other study team members (e.g., employees, students, family members) 
 
This study will enroll Spanish-speaking participants. Ideally, the 
study team member conducting the consent/assent process and study 
procedures will be fluent in Spanish. If not, they will utilize a 
translator employed by the school district, school-approved 
personnel who are fluent in Spanish, or UW-Madison or UW Health 
interpreter services.  
 
6.3  
☐ Individuals who are receiving inpatient or outpatient services for mental 
illness, developmental disability, or alcohol and other drug abuse (AODA) 
☐ Individuals who are protectively placed by a court in a treatment facility 
☐ Veterans/Military Personnel 
☐ Emancipated minors 
☐ Anyone especially vulnerable to manipulation or inducements for 
participation as a result of their illness or socioeconomic condition 
 
 
 
This study will not include any of the populations listed above.  
 
7.0 
Recruitment Methods 
7.1 Recruitment Source: 

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Participants will be recruited by nursing staff at Madison 
Metropolitan School District elementary schools.   
 
7.2 Methods to Identify Potential Participants:  
Potential participants may learn about the study from the school 
nurse, nurse’s assistant, or whichever school-approved personnel are 
coordinating or administering COVID-19 testing. The school nursing 
staff may recommend at-school COVID-19 testing if staff or 
students become symptomatic while they are at school. Additionally, 
MMSD sends COVID-19 Student Screening emails to parents every 
weekday morning. If parents indicate that one or more of their 
children have symptoms, they are prompted to take a screening 
survey, then school nurses review the survey. Nurses may talk with 
parents on the phone and recommend that they bring their child(ren) 
to school for testing. If parents agree to at-school testing, the nursing 
staff may inform the parent of the study. Additionally, if a parent has 
a symptomatic child who attends a different MMSD school (e.g., a 
child who attends middle or high school), the nursing staff may also 
recommend at-school testing for them, as well. If parents agree to at-
school testing for any of their children ages 4-19, the nursing staff 
may inform them about the study. The nursing staff will ask whether 
a potential participant is interested in talking with a study 
coordinator.  
There will also be a sign at the schools near the location where 
COVID-19 testing is taking place. The sign will ask if people are 
symptomatic and getting tested, and if yes, they may be eligible to 
participate in a study. It instructs people to “call the study 
coordinator now” if they would like more information. When they 
call the number provided, the study coordinator would talk with the 
potential participant or parent on the phone or in person to provide 
more information about study details and eligibility. The study 
coordinator will also be wearing a UW badge, so if they are in close 
vicinity of the sign, participants may also walk up to them to ask 
about the study. Additionally, the study team may gently approach 
potential participants to see if they are interested in learning more 
about the study.  
 
7.3 Where, When and How Participants will be Recruited:  
If an MMSD student, teacher or staff member develops one or more 
symptoms consistent with COVID-19, either at home or at school, 
they may confer with the school nursing staff. The staff may 
recommend COVID-19 testing at the school. If a symptomatic 
individual (or their parent, in the case of children) agrees to a nasal 

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swab PCR test at the school, then staff will inform them about the 
opportunity to participate in research. School-approved personnel 
will ask if they are interested in speaking with a study coordinator, 
and if yes, they will connect them with a study coordinator. The 
study coordinator will provide more information, and if the potential 
participants indicate that they are eligible and interested in 
participating, they will complete the consenting process. When 
possible, this initial information discussion and the consenting 
process will be conducted in person. If school personnel talk to 
parents on the phone, then the study coordinator may also talk with 
parents on the phone. This may be necessary in certain situations, 
such as when a parent intends to have someone who is not a legal 
guardian pick their child up from school, such as an older sibling or 
grandparent. When needed, the school personnel will connect the 
parent and the study coordinator over the phone for the initial 
discussion and consenting process. There will also be a sign near the 
location where the COVID-19 testing is taking place that will 
instruct people to call the study coordinator at the time of testing.  
There are times when symptomatic adults and children may come to 
the school for testing without first talking with school personnel. In 
these cases, school personnel would not be available to introduce the 
study. School-approved personnel, such as Accelerated Clinical 
Laboratories staff collecting the BinaxNOW and nasal PCR swabs, 
may also introduce the study to adults. Additionally, people getting 
tested may see the sign and call the study coordinator to learn more 
about the study. Or, if study team members are in the close vicinity 
of the sign, wearing a UW badge, then participants may walk up to 
the study coordinator to ask them about the study.  
With the presence of a sign near the testing location, the study team 
members may also gently approach potential participants. For 
example, the study team may ask whether they have questions about 
the sign or are interested in learning more about the study. The study 
team will be careful to be respectful, rather than intrusive, in their 
approach.  
7.4 Recruitment Materials: 
Flyers describing the study are available in both English and 
Spanish. Schools could use the flyer, at their discretion, to inform the 
school community about the study that is taking place. School-
approved personnel, such as ACL staff, could also use the flyer to 
inform potential participants about the study at the time they are 
eligible.  
A sign describing the study will be placed near the location where 
COVID-19 testing is taking place. It instructs people to call the study 
coordinator if they are experiencing symptoms and getting tested.  

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If the study team does not have a supply of BinaxNOW tests, the 
Lollipop Only flyer and poster will be used for recruitment. 
7.5 Compensation:  
All participants will be offered a small prize, such as a sticker or 
small toy, for completing the lollipop swab. All participants who 
complete an at-school BinaxNOW test will also be given a 
BinaxNOW COVID-19 Ag Card Home Test kit, which includes two 
tests and instructions in both English and Spanish. These test kits 
cost approximately $20 at local retailers. Participants with a negative 
at-school antigen test will need to use one of the two tests to 
complete study procedures. Remaining tests may be used at 
participants’ discretion.  
For participants who have a negative at-school BinaxNOW test and 
therefore complete the at-home BinaxNOW test, this study will 
provide subjects or their parent/legal guardian, in the case of 
children, with a $10 gift card. The gift card will be given to adults 
after completing the at-home BinaxNOW test. It is possible for 
people to participate in this research study more than once—they 
may be eligible each time they get a BinaxNOW test and nasal PCR 
at school, if they have not had a positive COVID-19 test in the past 3 
months. Therefore, participants will be re-consented and 
compensated each time they participate in the study. If participants 
do not complete the virtual/home visit, they will not receive a gift 
card.  
 
8.0 
Consent/Assent Process 
 
8.1 A trained study team member will obtain informed consent from all 
adult participants and all parent/legal guardians of child participants. 
The trained study team member will also obtain assent from all 
children. If a parent or legal guardian chooses to enroll more than 
one child in the study, the consent and assent process will be 
completed for each child enrolled. Children ages 4-14 will be 
assented using the Assent Script. Children ages 15-17 will be 
assented using the Consent Script. There will be minor differences in 
assent discussions depending on children’s ages, as study team 
members will use age-appropriate language.  
 
If the study team does not have a supply of BinaxNOW tests, or if a 
potential participant is unwilling or unable to complete at-home 
BinaxNOW testing, the Lollipop Only consent and assent will be 
used. 
 

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The consent process will occur in person whenever possible. When 
needed, the consent may occur over the phone. The assent process 
will always occur in person, at the school, after the parent or legal 
guardian has provided consent.  
 
The consent process will be conducted face to face whenever  
possible. If needed, it may be conducted with parents or legal 
guardians over the phone. The consent informs participants that 
email is generally not a secure way to communicate, as there are 
many ways for unauthorized users to access email. It instructs 
participants to avoid sending sensitive, detailed personal information 
by email. It also says that subjects may participate in the study even 
if they do not consent to email communication. At this time during 
the consent process, study staff will ask and record on the data 
collection form whether or not the parent or legal guardian consents 
to email communication. Consent scripts will be provided in person, 
by mail, or by email, per the participant or parent’s preference.  
There will not be any waiting period between informing the 
prospective participant and obtaining the consent. Study team 
members will ensure that parents and legal guardians will not feel 
pressured to participate. When initially approaching subjects about 
the research participation opportunity, the study team will emphasize 
that there is no penalty for choosing not to participate. If parents or 
legal guardians indicate that they feel rushed, do not have time to 
fully consider the decision, or they can’t ask all their questions, then 
study team members will encourage them not to enroll. Assent will 
be sought after obtaining consent from a parent or legal guardian.  
A trained study team member will ask questions about key elements 
of the consent and assent to ensure the potential participant is 
understanding. Based on their responses to the questions, the study 
team member will determine whether a potential participant 
understands the information.  
At the beginning of the virtual or at-home study visit for BinaxNOW 
testing, the study team member conducting the visit will remind the 
participant and their parent (in the case of children) that participation 
in research is voluntary. Virtual visits will be conducted using a 
UW-approved videoconferencing platform.  
We will be following HRP-090 – SOP – Informed Consent Process 
for Research. In accordance with the SOP, the consent script used for 
this study is the same as the consent form used for the long form of 
consent documentation, except the signature block has been 
removed.  

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Consent scripts and information sheets for adult participants and for 
parents or legal guardians of children participants are uploaded in 
ARROW. An assent script is also uploaded.  
 
8.2 This research involves no greater than minimal risk to adults or 
children, and it involves no procedures for which written 
documentation of consent is normally required outside of the 
research context. Therefore, we are requesting a waiver of written 
consent and assent documentation. We will use consent and assent 
scripts to obtain verbal consent and assent, and we will provide an 
information sheet to the consenting guardian in person and/or via 
email or mail. We will document in the study’s secure database that 
verbal consent and assent occurred prior to any study procedures. 
We anticipate that parents or legal guardians may have someone else 
pick their child up from schools, such as a grandparent or older 
sibling. Therefore, the ability to obtain consent verbally over the 
telephone is essential to be able to conduct this study. To keep in-
person and phone consent processes consistent by using a script, we 
request a waiver of written consent and assent documentation for all 
participants.  
 
Non-English-Speaking Participants 
We will enroll Spanish-speaking families. The consent script has 
been translated into Spanish by a translator employed by UW Health 
Translation Services. Ideally, the study coordinator will be fluent in 
Spanish so that they can read the consent and assent scripts, solicit 
and answer any questions, and directly obtain verbal consent and 
assent. If the study coordinator is not fluent in Spanish, they will use 
the services of a translator. In that case, the study coordinator would 
conduct the consenting discussion and solicit questions in English, 
and the translator would relay this information to the participant in 
Spanish. In other words, the questions would be translated to English 
for the study coordinator, and the study coordinator’s responses 
would be translated back to Spanish. If this process is conducted 
with a parent or legal guardian over the phone and a translator is 
required, the process would occur as described above.  
Participants who are not yet adults (children) 
We will obtain assent from all children who enroll in this study. If 
they do not assent, we will not enroll them. The study coordinator 
conducting assent will have sufficient experience and/or training in 
working with children in this age range. They will use age-
appropriate language to inform children that participating in research 

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studies is voluntary, meaning it is entirely up to them if they want to 
be in the study. They will be told that no one on the study team will 
be upset or disappointed if they do not wish to participate. The child 
will be asked directly if they would like to participate, and they will 
need to verbally answer in the affirmative. Passive resignation will 
not be considered assent. Study coordinators will receive training 
from experienced study staff in recognizing and responding to 
children’s dissent. 
Individuals under the age of 18 are considered “children” for the 
purposes of this study. We will enroll students 4 to 19 years old.  
Since no greater than minimal risk to children is presented by this 
study, we will obtain permission from one parent or legal guardian, 
even if another parent is alive, known, competent, reasonably 
available, and shares legal responsibility for the care and custody of 
the child.  
Permission will be obtained from legal guardians, as determined by 
the school.   
Assent will be obtained from all children enrolled in the study.  
Assent will be obtained using a verbal script. The Assent Script will 
be used for children ages 4-14, and the Consent Script will be used 
for children ages 15-17. If children choose to participate, their verbal 
assent will be documented in the study’s secure database.  
 
9.0 
Process to Document Consent in Writing 
 
9.1 We will not document consent in writing. However, we will 
document that both consent and assent, when applicable, occurred 
prior to study procedures in the Data Collection Form in in the ICTR 
version of REDCap.  
 
9.2 This research involves no greater than minimal risk to adults or 
children, and it involves no procedures for which written 
documentation of consent is normally required outside of the 
research context. Therefore, we are requesting a waiver of written 
consent and assent documentation. Consent and assent scripts have 
been uploaded in ARROW.  
 
 
10.0 Setting 
 

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10.1 Research procedures will be performed at elementary schools and 
virtually. We have received approval from the Madison Metropolitan 
School District. If enrollment targets are not met, we will seek 
approval from additional area school districts. If a participant is 
unable to complete a virtual visit, the study procedures will take 
place in person, at the participants’ homes. Study team members will 
be in private, quiet locations whenever conducting virtual study 
visits.  
Since we are conducting research in elementary schools, we will 
seek approval from school districts. We will submit documentation 
from an appropriate authority at each school or district granting 
permission to conduct the human subjects research. We will contact 
each school or district to obtain this permission and meet the 
requirements each site may have for conducting human subjects 
research.  
11.0 Study Intervention 
 
11.1 The “lollipop” swab collection method and the BinaxNOW COVID-19 Ag 
Card Home Test are being evaluated. The PCR testing method, the COVID-
Flu Multiplex Assay, may also be included in this study. This test provides 
results for COVID-19, Influenza A, and Influenza B.  
11.2 Study team members will store, handle, and guide administration of 
the “lollipop” collection swab. They will instruct participants to suck 
on the swab for 20 seconds, as they would suck on a lollipop. The 
study team member will closely oversee that the participant is 
following instructions.  
Study team members will provide all participants who consent to at-
home antigen testing with a BinaxNOW COVID-19 Ag Card Home 
Test kit, which includes two tests and instructions in both English 
and Spanish. A trained study team member will supervise the test via 
video chat or in person. For Spanish-speaking participants/parents, 
the study team member supervising the test will either be fluent in 
Spanish, or they will use the services of a translator.  
11.3 The “lollipop” collection swab is a non-significant risk device. It 
does not meet the definition of “significant risk,” which is a device 
that presents a potential for serious risk to health, safety or welfare of 
subjects.  
The saliva sample collected from the “lollipop” will be analyzed by Exact 
Sciences Laboratories using the COVID-Flu Multiplex Assay. The FDA 
approved this assay for use with nasal swabs under the Emergency Use 
Authorization (EUA) only. The saliva samples collected from the “lollipop” 
may also be analyzed by ACL using either their standard process for 
COVID-19 PCR testing or a multiplex assay.  

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The BinaxNOW COVID-19 Ag Card Home Test received EUA from the 
FDA. The test is authorized for prescription home use with self-collected 
observed direct anterior nasal swab samples from individuals aged 15 years 
or older who are suspected of COVID-19 by their healthcare provider within 
the first seven days of symptom onset or adult-collected nasal swab samples 
from individuals aged four years or older who are suspected of COVID-19 
by their healthcare provider within the first seven days of symptom onset. 
The BinaxNOW COVID-19 Ag Card Home Test is to be performed only 
with the supervision of a telehealth proctor. Documentation of the EUA, 
including an updated Letter of Authorization, have been submitted to the 
IRB.  
 
 
12.0 Study Timelines 
12.1 Participation in the study will typically last from 12-72 hours, 
depending on when the at-home BinaxNOW test virtual visit is 
completed. When scheduling virtual visits, we will try to schedule as 
close as possible to 24 hours after the initial in-school test. The target 
window is no sooner than 12 hours and no later than 72 hours after 
the in-school test. If it is not completed within 72 hours, the study 
team will ask the participant to schedule a time to complete the at-
home test as soon as possible. If the participant is not able to 
complete the at-home test within 5 days of enrollment, they will be 
withdrawn from the study.  
We anticipate enrolling all study participants by August, 2022. We 
intend to complete primary analyses by October, 2022.  
 
13.0 Procedures Involved 
13.1 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 virtual visit.  
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 study team does not have any BinaxNOW tests due to a supply 
shortage, or if a potential participant is unwilling or unable to 
complete at-home BinaxNOW testing, the BinaxNOW procedures 
will be dropped and only the lollipop swab will be collected.  
 

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13.2 Schedule of Study Procedures 
 
Study Activity  
At school or by 
phone* 
At school 
Virtual or 
Home Visit**  
Informed Consent 
X  
 
Assent 
 
X 
Collect Basic Information  
X  
 
BinaxNOW test 
X*** 
 
Lollipop swab  
  
X 
 
BinaxNOW test  
 
X*** 
Adverse Event 
Assessment  
X 
X***  
*All adult study participants will provide informed consent and basic information 
at school. For children participants, the parent or legal guardian may provide 
consent and basic information either over the phone or in person.  
**Only participants who have a negative at-school BinaxNOW test will be asked 
to do an at-home BinaxNOW test.  
***If the study team runs out of BinaxNOW tests, or if a participant is unwilling 
or unable to complete at-home BinaxNOW testing, these study procedures will 
not be performed. Participants will be consented for the Lollipop-Only alternative.  
13.3 Immediately after consent/assent, the study coordinator will collect 
information about the participant (name, date of birth, gender, race, 
and ethnicity), as well as the parent or legal guardian’s name, in the 
case of children. The study coordinator will also collect the 
participant’s physical and mailing addresses, phone number, and 
email address. If participants provide their email address, the study 
coordinator will ask if they are willing to be contacted about this 
study in the future. The study coordinator will verbally ask questions 
and record responses via real-time electronic data capture in ICTR 
REDCap.  
If the study coordinator is unable to collect data directly in REDCap, such as 
if there is no internet connection or ICTR REDCap is down, then the study 
team will enter data according to an emergency back-up protocol. For this 
protocol, the study team may record answers electronically in a PDF version 
of the data collection form. They may temporarily store PDF files locally on 
an encrypted laptop computer managed by UW-Madison Department of 
Pediatrics Computer Services. As soon as possible, study team members 
would enter data and upload the PDF into REDCap, then immediately delete 
the file from local storage. The local laptop storage will serve as a transfer 
proxy, rather than a storage location. Whenever this emergency protocol for 
data collection is followed, the study team will also follow a sanitation 
protocol to ensure that the PDF is stored only in REDCap. For sanitation, 
the PDF will be permanently deleted by the end of the following business 
day, once the primary data collection method becomes available. The PDF 
files will be stored locally in a folder specifically set up to be excluded from 

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the client’s backup routine. If files are accidentally backed up, they will be 
manually removed from the backup and deleted permanently from all 
locations except REDCap. Additionally, the SMPH VPN via the Palo Alto 
Global Protect client, configured and available for use on all DOP 
endpoints, will be enabled and connected by the end-user on data collection 
endpoints whenever study data is being accessed or transferred.  
The study team will make every effort to enter data directly into REDCap in 
real time. The study team will use a wireless hotspot for reliable internet 
connectivity, rather than relying solely on the school’s Wi-Fi connection, to 
minimize the need for this emergency data collection protocol. 
After this basic information is collected, the study coordinator will 
begin testing. If the participant did not already receive an at-school 
BinaxNOW test, then the study coordinator will collect the nasal 
swab for and administer the BinaxNOW test. When study staff 
collect the nasal swab for the BinaxNOW test, they may encourage 
parents/legal guardians to comfort their child. Participants under the 
age of 18 will only receive nasal swabs when their parent or legal 
guardian is physically present. If a potential participant is unwilling 
to have the study team collect a nasal swab, they will not be enrolled 
in the study. 
Next, the study coordinator will guide the participant through 
completing a “lollipop” swab at school. The lollipop swab is 
obtained by having the participant suck on a swab for 20 seconds in 
the same way that they would suck on a lollipop. The study 
coordinator will ask whether they prefer the PCR nasal swab or 
lollipop collection method. The study coordinator will provide the 
lollipop swab to Exact Sciences or ACL for analysis. For Exact 
Sciences, it will be labeled with the study ID and date of collection. 
For ACL, lollipop samples will have a label and accompanying 
requisition form that will both contain the subject’s full name, date 
of birth, and the date and time of collection.  
If the study team does not have any BinaxNOW tests due to a supply 
shortage, study participation will end after the lollipop swab is 
collected. If BinaxNOW tests are available and the participant 
intends to do the at-home antigen testing, then the at-school antigen 
testing is required.  
If a 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 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.  
 

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If a participant is unwilling or unable to complete an at-home 
BinaxNOW test, then their study participation is complete after 
providing the lollipop swab for PCR testing.  
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.  
The study coordinator will send participants a confirmation email 
with a unique link to a secure video chat platform, such as Microsoft 
Teams, Cisco WebEx, or HIPAA-Secure Zoom. They will also send 
instructions about how to join the meeting link. During the virtual 
visit, the study coordinator will instruct the family to read the 
instructions in the BinaxNOW box, do their best to do the test 
accurately, and ask questions as needed. The study coordinator will 
also ask if the participant understands and feels comfortable with the 
instructions, and the study coordinator will offer to demonstrate the 
steps of the test. The study team member will use the video to 
observe sample collection and offer tips or suggestions, as needed, to 
ensure proper collection. They will also ensure that participants take 
time and care to read the test results accurately, and they will answer 
any questions that participants may have. The participant or their 
parent will verbally provide the test results to the study team, and the 
study team will record the result in REDCap. The completed test 
card will be observed and the results verified by the study 
coordinator. 
If a participant is unable or unwilling to do a virtual visit for at-home 
testing, such as they do not have access to technology or do not wish 
to provide an email address, they will be offered an in-person home 
visit. The procedures would be the same. If participants are not able 
to complete the test during the virtual visit, such as inability to 
collect the sample or accidental tampering with the test card, the 
study team member will also provide the option of a home visit. At 
home visits, if participants are unable or unwilling to collect the 
nasal swab sample themselves, the study coordinator may collect the 
sample.  
After recording the result of the BinaxNOW test, the study 
coordinator will ask the participant if they think they would have 
been able to accurately do this test on their own or if help was 
necessary. The study coordinator will record their response in 
REDCap. They will also note what type of help was needed, if any. 
Furthermore, the study coordinator will ask if the adult thinks they 
would be able to accurately do the test on their own in the future.  
The BinaxNOW test kit contains two tests. The second test will be 
used as a back up, in case the first test is compromised in some way. 

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If the second test is not used during the study, the participant may 
keep it and use it in the future if they feel confident doing so. If a 
participant says that they do not think that they could accurately do 
the test on their own, the study coordinator would advise them to 
seek assistance from a medical provider.  
To accomplish the aims of this study, the study team will also need 
access to the results from the nasal swab antigen and PCR tests 
collected by the school. Parents will learn the results of the antigen 
test, and they will share the results with the study coordinator. If the 
samples are processed at Exact Sciences Laboratories, they will 
share the test results of the nasal swab and lollipop PCR tests with 
the study team via Exact Science’s instance of HIPAA-secure Box. 
If the samples are processed by ACL, then the study team will share 
the results of the nasal swab and lollipop PCR tests with the study 
team via a UW-Madison Cybersecurity-approved data sharing tool.  
 
13.4 A data collection form is uploaded in ARROW. Below is a list of 
data elements. Note that all data elements will be collected from 
participants who complete the at-home BinaxNOW test—those 
whose initial at-school BinaxNOW test was negative. The data 
elements related to at-home BinaxNOW testing will not be collected 
from participants whose initial at-school BinaxNOW test was 
positive, as they will not complete the at-home test virtual visit.  
• Administrative information 
o Dates and locations (i.e., virtual or in-person) of study 
activities 
o Times of data collection and study activities 
o Confirmation of consent and assent 
• Participant information collected verbally and recorded in 
REDCap 
o Participant’s first and last name 
o Participant’s parent or legal guardian (in the case of 
children) 
o Address 
o Phone Number 
o Email Address 
o Questions about participant’s opinions on data 
collection methods 
• Biosample Collection Date/Time 
o At-school BinaxNOW (collected by school or study 
team) 
o Nasal swab for PCR testing (collected by school) 
o Lollipop swab 
o BinaxNOW test (administered by participant/family) 
• Biosample Results 

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o Results of at-school BinaxNOW 
o Results of nasal swab PCR collected by school 
personnel—COVID-19 and, whenever these tests are 
ordered by the schools, also Influenza A, Influenza B, 
and cycle threshold (CT) value 
o Results of lollipop swab PCR testing—COVID-19, 
Influenza A, Influenza B, and CT value 
o At-home BinaxNOW test result 
 
Source records that will be used to collect data about participants:  
☐ UW Health medical or billing records via ICTR’s Clinical 
Research Data Service (CRDS) 
☐ UW Health HealthLink Records (study team will directly 
access) 
☐ Data from departmental QA or QI database 
☐ Data from UW Health Enterprise Data Warehouse (EDW) 
☐ Data from PACS (Picture Archiving and Communication 
System);  
☐ Data from Center for Medicare/Medicaid Services 
☐ Data from publicly available datasets (e.g., U.S. census data) 
☐ Data from outside institutions or organizations (specify: 
______________) 
X Other (specify: _Data from Exact Sciences, accessed via Exact 
Sciences’ HIPAA-secure Box, and Data from ACL, exchanged 
via UW-Madison Cybersecurity-approved data sharing tool__) 
13.5 The “lollipop” collection swab is a non-significant risk device. It 
does not meet the definition of “significant risk,” which is a device 
that presents a potential for serious risk to health, safety or welfare 
of subjects. 
The FDA granted Emergency Use Authorization for the BinaxNOW 
test.  
 
14.0 Comparison of usual care and study procedures 
14.1 If individuals want additional testing for COVID-19, they could obtain 
PCR testing at a variety of locations, such as a local testing center, 
pharmacy, or their child’s PCP’s office. The parent could also choose to 
purchase and administer their own BinaxNOW test from a supplier, such as 
Walgreens or CVS. They may also seek out an alternative type of testing. 
Cost, convenience, and parent and child willingness are all factors that 
influence which types of testing may or may not be selected.  
 
14.2 UW Health guidance about COVID-19 testing is described at 
https://coronavirus.uwhealth.org/COVID-19-testing/. Individuals who are 

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experiencing symptoms of COVID-19 are encouraged to contact their health 
care providers. The typical guidance for symptomatic patients is to get PCR 
testing done.  
 
14.3 Standard of care at UW Health for children experiencing one or more 
symptoms of COVID-19 is a nasal PCR test. Elementary schools are 
offering nasal PCR tests, so the school’s procedures overlap with standard 
of care at UW Health. The “lollipop” and BinaxNOW testing procedures in 
this protocol do not overlap with standard clinical care.  
 
14.4 Research participation would not affect standard clinical care.  
 
15.0 Withdrawal of Participants 
15.1 If a participant with a negative at-school BinaxNOW test result does 
not complete the BinaxNOW at-home test within 5 days (120 hours) 
of the initial test, they will be withdrawn from the serial antigen 
testing portion of the study without their consent.  
15.2 For orderly termination, a study team member will notify the 
participant that their study participation is complete.  
15.3 If a participant asked to complete the at-home BinaxNOW test fails 
to do so, we will still use their lollipop swab results and results of the 
nasal swabs collected at school to explore Aim 1.  
 
16.0 Data Management and Confidentiality 
16.1 Procedures that will be used for quality control of collected data: 
A study team member will watch participants conduct the at-home 
BinaxNOW test to ensure quality of sample collection and test 
administration. The result of the test will be verified by the 
coordinator.  
16.2  Steps the researchers will take to secure the data: 
X Data will be coded, and the “key” linking identities to codes will 
be kept separately from the data. (applies to lollipop swabs 
processed by Exact Sciences Laboratories) 
☐ Data will be coded, and the “key” linking identities to codes will 
be kept on paper only. The study data will be stored electronically 
and labeled only with codes. 
☐ Only those listed as key personnel will have access to the “key.” 
☐ Access to the “key” will be limited to the following person (e.g., 
Database Administrator): ________________________________ 
☐ This study is funded by the National Institutes of Health 
and is covered by a Certificate of Confidentiality. 

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☐ This study is NOT funded by the National Institutes of 
Health but because it will collect sensitive information, the 
research team will apply for a Certificate of Confidentiality 
to protect data from being requested without the subject’s 
consent as part of a legal proceeding. 
X Other: _Data will be stored in REDCap, and all fields containing 
PHI will be labeled as such. Granting study team member’s permission 
to export data containing PHI will be limited to a need-only basis.___ 
16.3 How and where data and/or specimens will be stored and maintained: 
☐ Online Collaborative Research Environment (OnCore) 
Biospecimen Management 
X Research Electronic Data Capture (REDCap) Specify which 
instance you will be using (e.g., ICTR’s, Department of 
Medicine’s): _ICTR______________________________ 
X Other software option that will be stored on departmental 
server. Specify the department: 
_Pediatrics_____________________ 
X Locked filing cabinet or drawer inside a locked room. 
Specify the building: __800 University Bay Drive________ 
X Other (describe): _Lollipop specimens will be provided to 
Exact Sciences Laboratories or ACL for analysis after 
collection by the end of the day. Lollipop test results will be 
provided to the study team using Exact Sciences’ instance of 
HIPAA-Secure Box or using a UW-Madison Cybersecurity-
approved data sharing tool. ACL, adult participants, or parents 
of child participants will verbally share the results of the at-
school antigen test with the study team.   
☐ Data will not be stored or accessed on portable devices. 
X Portable devices will be used to access secure web-based 
data collection sites such as ICTR’s REDCap.  
☐ Data stored on portable devices will be coded with the key 
stored separately. No identifiers will be stored on portable 
devices. 
X Data stored on portable devices and therefore only 
encrypted devices will be used. 
 
16.4 Management of Identifiers: 
☐ Identifiers will be destroyed after all data has been 
collected. 
X Identifiers will be destroyed at study closure. 
☐ Identifiers will be destroyed at study closure or at the time 
of publication. 
 
16.5 Plans for sharing of data and/or specimens outside the study team / 
institution: 

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Exact Sciences or ACL will provide us with the results of the nasal 
swab PCR test collected by the school. The study team will provide 
lollipop collection swabs to Exact Sciences or ACL for analysis.  
 
To obtain the nasal swab PCR test results from Exact Sciences, the 
study team will send Exact Sciences a result pull request with the 
participant’s name, date of birth, and collection date. We will do this 
by uploading information to Exact Sciences’ HIPAA-secure Box for 
sharing with Exact. The lollipop collection swabs will be labeled 
with the participant’s study ID and date of collection.  
 
To obtain the nasal swab PCR test results from ACL, the study team 
will include information on the lollipop swab label and 
accompanying requisition form, including the participant’s name, 
date of birth, and date and time of collection. ACL will match this 
information to a nasal swab and provide PCR test results for both the 
lollipop and nasal swab.  
 
The results of the nasal swab and lollipop PCR tests will be sent via 
Exact Sciences’ HIPAA-secure Box or a UW-Madison 
Cybersecurity-approved data sharing tool.  
 
A study team member will deliver the lollipop swabs from the school 
to Exact Sciences or ACL.  
 
17.0 Provisions to Protect the Privacy Interests of Participants 
17.1 Steps that will be taken to protect participants’ privacy interests: 
☐ Procedures will be performed in a private area where others 
cannot see the procedures being performed or overhear the 
conversation between subjects and researchers. 
X All members of the study team are up to date on their institutional 
HIPAA training. 
X The study is not collecting information that could pose 
legal or reputational risks to participants. 
17.2 To conduct research on COVID-19 testing methods, it is necessary 
to collect participant’s communicable disease status, which is 
considered sensitive information.  
17.3 Study team members will be experienced and/or trained in how to 
work with children and help them feel at ease during research 
procedures. Study team members will explain study procedures to 
participants in advance using age-appropriate language, and they will 
take time to answer any questions that participants may have.  
18.0 Sharing of Results  

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18.1 Since the lollipop PCR test is investigational, the results will not be 
shared with participants or others. If the at-home BinaxNOW test is 
positive, the study team member will encourage the participants to 
follow up with their primary care provider. The school will receive 
the results of the nasal PCR from Exact Sciences or ACL, and that 
result will govern whether the child is permitted to return to school 
when symptoms resolve (if PCR is negative) or is required to stay at 
home for 10 days (if PCR is positive). As the resulting lab, Exact 
Sciences and ACL are responsible for reporting the nasal PCR 
results to Dane County Department of Health Services. Since the 
lollipop swab is investigational, results do not need to be reported to 
health officials.  
For overall care management and recommendations, the study team 
is deferring to the school, which conducts and receives results of the 
nasal swab PCR result. Since this is the clinical test, the investigators 
would not recommend changing care management based on the 
exploratory test results in this study (lollipop swab and BinaxNOW). 
Any time an at-home BinaxNOW test is positive, the study team will 
encourage participants to follow up with the school and/or their PCP 
for recommendations. In short, the overall care plan will be based on 
the nasal swab PCR and managed by the school.  
18.2 The results of this study will be published and accessible to the 
public.  
19.0 Data and Specimen Banking 
19.1 The lollipop swabs and assays will be destroyed after results are 
recorded. Participants will be instructed to dispose of BinaxNOW 
test cards after the test is completed. There will be no biospecimen 
banking in this study. All data for this study will be stored in Exact 
Sciences’ HIPAA-Secure Box, a UW-Madison Cybersecurity-
approved data sharing tool, Department of Pediatrics Secure Server, 
and REDCap, and only approved study team members will have 
access to the REDCap project.  
19.2 At the end of this study, participant names and contact information 
(phone, address, email) will be destroyed. All other study data will 
be banked.  
19.3 Only de-identified data will be shared with external researchers.  
19.4 Data will be fully anonymized prior to banking, so participants may 
not withdraw their banked data from future research use.  
 
20.0 Study Analysis 
20.1 Statistical Hypotheses: 
Aim 1: The null hypothesis is that the negative predictive value of 
BinaxNOW is at least 91% (which is the reported rate in symptomatic 

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subjects after a single test) versus the alternative hypothesis that the NPV is 
greater than 91%.  
Aim 2: The lollipop swab test will be non-inferior to the gold-standard PCR 
testing of nasal swabs.  
 
20.2 Sample Size Justification:  
 
For Aim 1, it is anticipated that the majority of initial BinaxNOW tests will 
be negative. It is hypothesized that the proposed two-day serial testing 
procedure using BinaxNOW tests in participants with an initial negative test 
will identify true negatives in >95% of participants. The primary diagnostic 
outcome measure will be the negative predictive value (NPV). The NPV of 
BinaxNow is ~91% in symptomatic subjects. For the proposed study, the 
NPV after the second test (24 hours after the first negative results), is 
assumed to be substantially higher than 91% since the first test was already 
negative. In order to detect a true NPV after the second test of at least 95% 
with 90% power at the one-sided 0.05 significance level, a sample size of 
N=358 participants with an initial negative test is required. To reach a 
sample size of N=358 participants with an initial negative test, BinaxNOW 
kits will be administrated to 400 participants. We intend to continue 
enrolling until we reach the target sample size of N=358 completing the at-
home BinaxNOW test.  
 
20.3 Participant Population for Analysis: 
For Aim 1, we will include all participants who complete the at-home 
BinaxNOW test within 72 hours (N=358) and have nasal PCR results. For 
Aim2, we will include all participants who have both nasal and lollipop PCR 
results.  
 
20.4 Statistical Methods:  
 
Aim 1. Sensitivity, specificity, positive predictive value (PPV) and NPV of 
the proposed BinaxNOW testing procedure for symptomatic subjects will be 
calculated and reported along with the corresponding two-sided 95% 
confidence interval. Formal non-inferiority testing of the BinaxN0W testing 
procedure with PCR will be conducted with respect to sensitivity and 
specificity with a non-inferiority margin of δ=5% and a 
sensitivity/specificity of PCR of 99%.    
 
Aim 2. Results obtained from nasal and lollipop swab-based PCR testing 
will be summarized in tabular format. 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. Furthermore, standard diagnostic test outcomes, i.e., sensitivity, 
specificity, NPV and PPV will be calculated (using the nasal swab-based 

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testing as gold standard), and reported along with the corresponding two-
sided 95% confidence intervals. Formal non-inferiority testing of the 
lollipop swab test with PCR will be conducted with respect to sensitivity 
and specificity with a non-inferiority margin of δ=5% and a 
sensitivity/specificity of PCR of 99%. Statistical analyses will be conducted 
using SAS software (SAS Institute, Cary NC), version 9.4 or greater. 
 
20.6 Handling of Missing Data: The primary analysis for evaluating the 
diagnostic utility of the BinaxNOW testing procedure will be based on the 
complete case principle. Since the analyses of this study won’t involve any 
formal multivariate or longitudinal statistical modeling, no imputation-based 
analyses will be conducted.  
 
21.0 Potential Benefits to Participants 
21.1 
For participants who only participate in the lollipop PCR portion of the 
study, there is no immediate benefit. 
 
Through doing the at-home BinaxNOW testing under the observation of a 
trained study team member, participants and their families may learn about how 
to accurately conduct this type of at-home test for COVID-19. Through asking 
questions and/or receiving confirmation that they are conducting the test 
correctly, individuals and families may feel more confident conducting at-home 
tests in the future. If the second test in the BinaxNOW kit is not used as a back-up 
during the study, the participant may keep the test and use it later if they feel 
comfortable doing so. The BinaxNOW tests are also readily available to families 
at local retailers, such as Walgreens. Therefore, if a family member is 
symptomatic in the future, they may feel more comfortable doing at-home testing 
independently.  
 
The results of the BinaxNOW test, along with other information, can help 
participants’ healthcare providers make informed recommendations about their 
care. For example, in the case that the original BinaxNOW and nasal swab PCR 
tests were negative and the delayed, at-home BinaxNOW test is positive, that 
would be helpful information for a participant’s primary care provider. That 
information will need to be integrated with the results of the nasal PCR that was 
also performed. The probability that the delayed, at-home BinaxNOW test will be 
positive is less than 5%.  
 
If the results of the at-home BinaxNOW test are negative, that may help 
individuals and families feel more confident in the initial results they received.  
 
The results of the at-home BinaxNOW test in this study, or any future at-home 
BinaxNOW tests that families may conduct, may help limit the spread of COVID-
19 to participants’ families and others in their community.  
 
22.0 Risks to Participants 

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22.1 There are no known or anticipated risks of the lollipop swab 
collection method. Our study team implemented a similar testing 
method in a previous study (2017-1425), and it was well tolerated by 
participants.  
Potential risks of the BinaxNOW at-home test include possible 
discomfort or other complications that can happen during sample 
collection. Since study coordinators will observe sample collection 
and correct or support as needed, the probability of this risk is very 
small.  
Another potential risk of the BinaxNOW test is a possible incorrect 
test result. However, the definitive test result which will govern 
management of care is the nasal PCR.   
There is a risk of a breach of confidentiality.  
22.2 The lollipop swab collection method, although investigational, has 
no associated risks. The performance of the BinaxNOW test will be 
supervised, therefore avoiding risks other than not obtaining the 
nasal swab correctly.  
22.3 Study procedures do not pose risks to an embryo or fetus should a 
participant be or become pregnant.  
22.4 For child participants, a parent or guardian will collect the nasal 
swab sample from the child. To do so, the adult will need to be in 
close proximity to the symptomatic child. Hand washing and 
masking by the parent or guardian will protect them from becoming 
infected.  
Since this study collects the names of parents or legal guardians, 
there is also a risk of breach of confidentiality for them.    
22.5 Consistent with guidance in the EUA, the BinaxNOW test conducted 
at home for purposes of this study will be performed only with the 
supervision of a telehealth proctor. Or if telehealth supervision is not 
possible, a study team member will supervise the test in person, at 
the participant’s home.   
 
23.0 Provisions to Monitor the Data to Ensure the Safety of 
Participants 
 
23.1 The study team will build, run, and regularly review reports in 
REDCap to monitor study progress and identify potential problems.  
Regularly reviewed reports will include data elements essential to 
the study’s aims, as well as information about potentially reportable 
events.  

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Study team members will enter information about any potential 
reportable events, including adverse events, protocol deviations, 
and/or participant complaints into REDCap. Information will be 
reviewed by a principal investigator.  
Information about potentially reportable events will be recorded at 
each participant interaction.  
The principal investigators will review potentially reportable events 
in a timely manner.  
Cumulative data will be reviewed every two months after enrollment 
commences.  
We do not anticipate any conditions that would trigger an immediate 
suspension of the research.  
24.0 Economic Burden to Participants 
24.1 Participants will not be responsible for any costs because of 
participation in the research.  
25.0 Resources Available 
 
Will the research be conducted outside 
School of Medicine and Public Health 
or UW Hospitals and Clinics (e.g. the 
researcher does not have an SMPH 
research feasibility attestation for this 
study)?    
X YES (complete 25.1) 
☐ NO (remove text below, but retain this 
section) 
 
25.1 We received approval from the Madison Metropolitan School 
District (MMSD) to recruit participants at local elementary schools. 
Based on data from schools reopening post COVID-19 shutdowns in 
other countries, infectious disease experts on the study team 
anticipate that there will be a surge in respiratory illnesses caused by 
enterovirus, rhinovirus, community coronaviruses, influenza, RSV, 
parainfluenza, human metapneumovirus and adenovirus, as well as 
SARS-CoV-2, in the fall and winter of 2021-2022. Therefore, we 
expect that several elementary school children, teachers, and/or staff 
will become symptomatic each school day, and we will be able to 
reach our target enrollment numbers. If we are unable to enroll at our 
target recruitment rate in MMSD schools alone, we will pursue 
approval with other local school districts.  
 
At least one full-time study coordinator will be assigned to conduct 
and complete this project.  

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This study will be conducted at elementary schools, via virtual visits 
by staff in a private, quiet location, and at participant homes.  
 
If participants receive a positive at-home BinaxNOW test, we will 
refer them to their healthcare provider. We will also verify the 
results of the nasal PCR which will govern the management of return 
to school.  
 
Study team members will meet and/or communicate regularly to 
ensure that all persons assisting with the research are adequately 
informed throughout the study about the currently approved 
protocol, the research procedures, and their duties and functions. 
Any changes to the protocol and/or consent/assent will be 
communicated via email to all study team members conducting study 
activities.  
 
26.0 Multi-Site Research 
NA 
 
27.0 References 
NA 
 
28.0 Appendices 
NA