ReSET Aim 1a: Restarting Safe Education and Testing for Children With Medical Complexity - Feasibility of In-home Cohort SARS-CoV-2 Testing Strategies, and Associations With CMC Parent Perceptions About In-person School Attendance
Phase: NA
Conditions: COVID-19, Children With Medical Complexity (CMC)
Sponsor: University of Wisconsin, Madison

Yr 2 ReSET Aim 1a v. 11.21.22 
 
 
 
 
 
 
 
 
Title: 
Year 2 ReSET Aim 1a: Restarting Safe Education and Testing for Children with 
Medical Complexity - Feasibility of in-home cohort SARS-CoV-2 testing 
strategies, and associations with CMC parent perceptions about in-person 
school attendance 
 
 
Short Title:  
 
 
Yr 2 ReSET Aim 1a (in-home cohort) 
 
 
Principal Investigator:  
Ryan Coller, MD, MPH 
Division of Hospital Medicine 
Department of Pediatrics 
University of Wisconsin School of Medicine and Public Health 
600 Highland Ave H6/570 
Madison, WI  53792-4108 
 
 
 
 
PH: 608-263-9408 
 
  
rcoller@pediatrics.wisc.edu 
 
Co-PI:  
 
  
Gregory P. DeMuri M.D. F.A.A.P. 
Division of Pediatric Infectious Diseases 
Department of Pediatrics 
University of Wisconsin School of Medicine and Public Health 
600 Highland Ave H6/570 
Madison, WI. 53792-4108 
PH: 608-265-6050 
demuri@pediatrics.wisc.edu 
 
 
 
 
 
 
 
 
 
 
 
 

Yr 2 ReSET Aim 1a v. 11/21/22 
 
 
Page 2 of 11 
 
 
BACKGROUND INFORMATION 
The Coronavirus Disease 2019 (COVID-19), caused by the SARS-CoV-2 virus, is a worldwide pandemic that has resulted in 
large-scale quarantines in cities, states, and countries throughout the world. SARS-CoV-2 is a respiratory virus that is 
most commonly spread via contact with infective respiratory droplets and aerosols produced by coughing, sneezing, 
talking, and singing.  
 
Children with medical complexity (CMC), i.e., children with multiple severe chronic conditions, high resource use, severe 
functional limitations, and substantial family-identified service needs, are a medically vulnerable population for the 
development of severe COVID-19. An illustrative CMC is born months premature with quadriplegic cerebral palsy, 
seizures, feeding and breathing tubes, 12 medications, and 8 specialists. Our research illustrates CMC as a socially 
vulnerable population in the US with over half living in poverty, 17% in rundown housing, and 14% food insecure - all 
substantially higher than non-CMC. CMC are also disproportionately from communities of color. CMC account for 1-5% 
of children, but > 1/3rd total child health spending, the majority being for hospital care. Medical fragility puts CMC at 
high risk for severe COVID-19 disease, including hospitalization and death.  
 
Deciding to send CMC to school poses a major dilemma to families wanting to minimize severe COVID-19 risk. CMC 
require a mean of 52 hours/week for direct care, and even three feet of physical distancing is not possible with most 
daily needs, e.g., enteral tube nutrition and medications, respiratory medications, diapering/toileting, and direct 
mobility assistance (pushing a wheelchair).  Our year 1 data indicated many families opted to place CMC in virtual 
learning environments when offered by their school district.  By the beginning of the Fall 2021 school year, many CMC 
returned to in-person schooling when virtual learning was discontinued.  Parents’ perception of risk with in-person 
school attendance remained high suggesting they were forced to return their CMC to in-person schooling despite 
concern for insufficient mitigation strategies, such as masking, physical distancing and contact tracing. 
 
Achieving in-person school attendance is critical for CMC.  In year 2 of this grant, we will continue to identify parental 
opinions concerning in-school attendance, track parental attitudes toward testing and vaccination, and use our findings 
to inform policy recommendations. 
 
STUDY OBJECTIVE 
The study objective is to promote safe in-person school attendance for CMC by 1) evaluating the feasibility of home-
based testing strategies for CMC and 2) identifying parental perceptions of testing and school attendance.   
 
STUDY DESIGN 
This is a single site study taking place over 12 months (June 2022-June 2023) and involving (51) caregivers and their 
children who were previously enrolled in IRB #2022-0462.  Year 2 study design and procedures are similar to the 
activities in Year 1, the primary difference being a switch to symptom and exposure only testing in Year 2 (no longer 
doing any surveillance testing). 
 
COVID-19 TESTING DEVICE 
BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative 
detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are 
built into the testing system and results are available in 15 minutes. To collect a nasal swab sample, the entire absorbent 
tip of the swab (usually ½ to ¾ inch) is carefully inserted into both nostrils. Swabs are then placed in the supplied card 
and extraction reagent is added. After 15 minutes, the results are read as the presence or absence of a blue line as 
compared to the control line. Test kits will be stored in study offices and shipped to families by UPS or given in person if 
the family is in clinic or hospital.  The test procedure itself (swabbing the nose) poses no significant safety risk.  Subjects 
were trained on the proper administration of the test during year 1 of the study.   
 

Yr 2 ReSET Aim 1a v. 11/21/22 
 
 
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Abbott’s ABT BinaxNOW COVID-19 Ag Self Test is covered under the FDA’s Emergency Use Authorization (EUA) for over-
the-counter, non-prescription, and symptomatic or asymptomatic use.  The test can be used with children two years and 
older with sample collection performed by an adult, and can be self-administered for all people aged 15 years or more.  
In this study, adult caregivers will be performing the tests on their child.  Use of the BinaxNOW COVID-19 Ag Self Test 
in this study is consistent with the FDA’s EUA recommendations. 
 
The results of BinaxNOW tests performed at home will NOT be reported to the Wisconsin Department of Health Services 
as this is not required per state statutes §252.05.  However, any confirmatory PCR results triggered by in-home study 
testing will be reported to the Wisconsin Department of Health Services using the Wisconsin Electronic Disease 
Surveillance System (WEDSS) by the party who performed the PCR. WEDSS is a secure, web-based system designed to 
facilitate reporting, investigation, and surveillance of communicable diseases in Wisconsin. It is designed for public 
health staff, infection control practitioners, clinical laboratories, clinics, and other disease reporters. 
 
POTENTIAL RISKS AND BENEFITS 
 
Potential Risks 
Dislike of the nasal testing procedure. There is a small risk that some caregivers and children may find the nasal swab 
testing procedure unpleasant, burdensome, and/or anxiety-provoking.  To address this issue, participants will be 
reminded that study participation is completely voluntary and they may choose to refuse nasal testing.  If nasal testing is 
refused, participants may choose to stay in study but not participate in testing.  Additionally, participants may consent 
to all or a portion of the study (e.g., weekly study staff contact and surveys but not testing, and vice versa).   
 
The PCR confirmatory test (performed following a positive BinaxNOW system test in a clinic or hospital) is typically done 
with a swab that goes deep into the nostril.  The child may experience discomfort during this procedure but the test only 
takes a few seconds. 
 
Distress if the test is positive.  Some participants may become distressed upon hearing their child or family member has 
tested positive for the virus.  The study team will guide families in finding the most appropriate plan of care in the event 
they become ill.  Likewise, the study team will suggest where family members can seek care for COVID related-illness.  
They will also give guidance on how best to avoid spreading the illness to other members of your household and the 
community.   
 
Ignoring COVID precautions with negative results. It is possible for the nasal swab test to give a false negative result.  
This may lead the family to stop following measures they would otherwise take to protect themselves from COVID-19 
(i.e., frequent handwashing, mask-wearing, or social distancing), thus making them more likely to be exposed to COVID-
19 or to expose someone else.  Study staff will remind participants of the importance of following public health 
recommendations no matter what the results of the test show. 
 
Distress experienced during or after completing research surveys/interviews.  Some participants may find the 
completion of study surveys distressing.  To protect against this distress, participants will be made aware that 
participation in the research study is entirely optional, has no effect on their children’s medical care, that they may 
choose not to answer certain questions, and that they may end their participation at any time.  If a participant expresses 
distress, the study staff will notify Dr. Coller.  Participants will also be given the phone number (in the informed consent 
process) to contact Dr. Coller. 
 
Detection of previously undisclosed dangerous or potentially dangerous situations or occurrences. It is possible that 
families may disclose information to our study staff that indicates they have been or may be subject to dangerous 
situations.  Situations or occurrences that might be disclosed to or observed by the study staff and would require the 
staff to complete an incident report include but are not limited to child abuse, imminent threat to self, and imminent 
threat to others (even though our questionnaires will not specifically ask about these issues).  General procedures we 

Yr 2 ReSET Aim 1a v. 11/21/22 
 
 
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will take in these situations follow.  Specifically, any suspected child abuse must immediately be reported to the 
Wisconsin Department of Child Protective Services (CPS) and, if any immediate danger is possible to the child, family or 
another individual, to the local Police Department.  The social worker on call will be notified immediately if a participant 
discloses suicidal ideation or domestic violence.  In any adverse situation possibly related to the research study, Dr. 
Coller and the IRB will also be notified. 
 
Accidental disclosure of confidential material.  It is possible that despite careful procedures to protect private 
information, there could be accidental disclosure of confidential information.  To protect against accidental disclosure, 
study staff will store all electronic data on UW-maintained servers and UW-issued computers; paper data will be kept in 
locked cabinets in locked staff offices with access restricted to authorized study staff.  Data containing identifiable 
information will be deidentified as soon as possible, and staff will use ID numbers on study materials when possible.  In 
the event of a breach of confidentiality, we will notify the participant, Dr. Coller, and the IRB.   
 
Potential Benefits 
The results of the study may help researchers advance their understanding of in-home testing strategies for children 
with medical complexity. 
 
STUDY RECRUITMENT AND WITHDRAWAL 
 
Subject Identification 
The 51 caregivers and children who participated in the first year of this study will be invited to participate in Year 2.  
These families were recruited from the Pediatric Complex Care Program (PCCP) of the American Family Children’s 
Hospital and Specialties Clinics.  Families who drop out of the study will not be replaced. 
 
Subject Inclusion Criteria 
In order to be eligible to participate in this study, the caregiver/child must meet the following criteria: 
1. The caregiver agrees to comply with all study procedures and expects to be available for the duration of the 
study. 
2. The caregiver continues to self-identify as the primary caregiver (parent, foster parent, legal guardian) of the 
CMC enrolled in Year 1 of the study. 
3. The caregiver is currently providing care on an ongoing basis to their CMC. The child may not be housed in a 
skilled nursing facility, an acute care or transitional facility, a rehabilitative hospital, a medical group home or in 
a foster home (unless the primary caregiver for the study is the foster parent).  
4. Caregiver and child are residents of Wisconsin.   
5. The caregiver provides a written informed consent form. 
 
Subject Exclusion Criteria 
1. Failure to meet all inclusion criteria. 
 
NOTE: Age and school attendance status are not criteria for the year 2 study protocol. All children participating in year 1 
were 16 years of age or less (so none will turn 18 in year 2), and a child may participate regardless of type of school 
attendance (home-schooled, in-person, or hybrid). 
 
Subject Recruitment 
Caregivers will be sent a memo by email inviting them to participate in Year 2 of the study.  The memo will contain a 
summary of the changes from Year 1 to Year 2, as well as the informed consent form (as an attached document).  In 
addition, caregivers will be mailed a hardcopy of the memo and consent form.  The memo will be sent to current study 
participants in mid to late May, prior to end of Year 1 activities.  It is anticipated that very few or no Year 1 participants 
will choose to discontinue from the study because study compliance and appreciation for access to in-home testing kits 
has been very high.   
 
 

Yr 2 ReSET Aim 1a v. 11/21/22 
 
 
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Subject Withdrawal 
Subjects are free to withdraw from the study at any time.  An investigator may terminate a study subject’s participation 
in the study if: 
• 
The caregiver is no longer providing care to a CMC. 
• 
The caregiver’s CMC disenrolls from Pediatric Complex Care Program. 
• 
The caregiver or child no longer meets the study inclusion criterion and this precludes further study 
participation. 
 
Study staff will attempt to contact subjects by phone to inform them they have been terminated from the study and to 
make arrangements for any honorarium that is due.  Failure or refusal to participate in COVID-19 testing, weekly 
communication with the study staff, or the quarterly surveys will not result in study termination. 
 
STUDY ENROLLMENT 
 
Enrollment 
Caregivers will be sent a memo inviting them to continue into Year 2 of the study.  They will receive this material by 
email and United States Postal Service.  They can choose to consent to participate in Year 2 in one of two ways: 
 
1) Print the consent form from the email memo, review and sign consent form, photograph the signed document, 
and email back to the study staff.  If they wish to speak to research staff prior to signing consent form, staff will 
contact them by phone to discuss questions or concerns. 
 
2) Receive the consent form and memo in the mail, review and sign consent form, photograph the signed 
document, and email back to the study staff.  If they wish to speak to research staff prior to signing consent 
form, staff will contact them by phone to discuss questions or concerns. 
 
A week following the mailing of the memos and consent forms, study staff will begin contacting subjects who have not 
sent in their consent form.  Staff will inquire whether they received the memo and ask if they are interested in 
participating in year 2 of the study.  If interested in participating, staff will provide instructions on how to consent to 
year 2.   
 
The caregiver providing consent will be a parent or legally authorized guardian of the child, and only a single 
parent/guardian signed consent will be obtained. 
 
Like year 1, a waiver of assent will be sought based on the impairments associated with this population of children.  The 
children in this study will be enrolled from the Pediatric Complex Care Program.  To qualify for this program, children 
must have at least 3 organ systems affected by chronic disease, regularly see at least 3 clinical specialists, and have high 
utilization of the healthcare system (≥10 clinic visits or ≥5 hospital days in the prior year). The vast majority of the 
children in the program have moderate to severe cognitive impairment (impaired decision-making capacity) and are 
nonverbal. Many of the children have visual and hearing impairments. Children who express discomfort or intolerance for 
nasal swabbing may continue to participate even if all methods of testing are refused. Given the lack of assent capacity in 
the targeted subject population, and the potential for ‘dissent’ and excusal from nasal swabbing, assent will not be 
obtained. 
  
 
 
 

Yr 2 ReSET Aim 1a v. 11/21/22 
 
 
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STUDY ACTIVITIES 
Year 2 participation will involve 1) quarterly surveys by REDCap survey link, 2) in-home testing, and 3) completing a 
weekly testing log (send photo to reset@pediatrics.wisc.edu email OR complete REDCap survey).   
 
Quarterly surveys 
Approximately every 3 months (August ‘22, November ‘22, January ‘23, April ‘23) the caregiver will be asked to complete 
a survey regarding their perceptions about testing and school attendance (see Quarterly Survey).  This survey, 
administered on REDCap, will take approximately 15 minutes to complete and will be self-administered online. 
 
In-home Testing and Weekly Testing Log 
Like year 1, caregivers will be provided with BinaxNOW Rapid Antigen tests by the study team and asked to perform 
tests on their child when they are symptomatic or have had a known exposure to COVID-19.  Unlike year 1, participants 
will not have the option to perform surveillance testing (testing twice weekly regardless of symptoms or exposure).  This 
change will be clearly conveyed to participants in the invitation memo and the consent form.  As they have done in Year 
1, caregivers will be asked to document their testing activities, results, and any possible COVID-19 symptoms on the 
Weekly Testing Log.  This log will be collected by email or e-survey. 
 
Caregivers will be given the following instruction with regard to testing: 
 
• 
If your child is symptomatic and the initial test is negative, test again using a Binax NOW test in 48 hours over 3 
days.  Report the test results in your weekly log. 
 
• 
If your child is not symptomatic and the initial test is negative, test 2 more times using Binax NOW test kits at 
least 48 hours apart over 5 days.  Report the test results in your weekly log. 
 
• 
If your child is symptomatic and the initial test is positive, no need to repeat Binax Now test.  Arrange to obtain a 
PCR test within 48 hours to confirm whether the in-home test was accurate.  Report the test results on your 
weekly log. 
 
• 
If your child is not symptomatic and the initial test is positive, no need to repeat Binax NOW testing.  Arrange to 
obtain a PCR test within 48 hours to confirm whether the in-home test was accurate.  Report the test results on 
your weekly log. 
 
While false negative tests are possible with asymptomatic individuals, there will be no change in standard mitigation 
measures based on the test results (mandatory masks in school, social distancing, hand hygiene, etc.).  If testing 
produces a positive result, the caregiver will be instructed to contact the study team immediately and then obtain a PCR 
(polymerase chain reaction) test within 48 hours.  If needed, the study staff will assist the caregiver in making 
arrangements for this test.  Study staff will not be performing PCRs.  If the PCR returns as positive, the caregiver will be 
instructed to keep the child at home per public health guidelines and pause in-home testing for 21 days.  In the event of 
a positive PCR, the study team will recommend that the participant not perform another PCR for 90 days.  Study staff 
will be in close communication with Dr. Coller and Dr. DeMuri regarding families who test positive and/or are 
symptomatic. 
 
Last study contact 
On the day of their last weekly staff communication, caregivers will be asked to complete their last quarterly survey.  
Study staff will instruct them to keep any remaining testing supplies. 
 
SUBJECT PAYMENT 

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Caregivers will receive a stipend of $200 five times over the course of the year-long study (approximately every 2-3 
months).  Participants who complete the entire study will receive a total of $1000.  Payment to subjects who complete a 
portion of the study will be prorated.  Children will not receive compensation for their participation in the study. 
 
STUDY EVALUATIONS AND DATA TRANSFER/STORAGE 
 
Subject ID assignment 
Participants will have the same subject IDs as they had in Year 1.   
 
Study Surveys and Trackers  
Study surveys will be administered using UW-Madison REDCap.  Study survey questions contain items derived from 
previously validated and published instruments.  The year 1 Enrollment Tracker will continue to be maintained 
containing subject names, study IDs, addresses, telephone numbers, email addresses, and individual study activity 
progress across study milestones.  The enrollment tracker will be housed in a secure UWBox folder, accessible to only 
those research staff with need to have access.  Data collected on paper, such as the consent form should a participant 
choose not sign electronically, will be stored in a locked file cabinet in study staff locked offices until destroyed.  Only 
study staff will have access to study data and access will be limited to only what is needed by study staff to perform their 
study role.   
 
Collected data, such as test results and study surveys, will be coded to protect confidentiality.  Codes to the direct 
identifiers, such as child and caregiver names, will be stored in a spreadsheet on the Department of Pediatrics HIPAA 
compliant secure file storage server with access limited to the PI and research manager. 
 
As this is an NIH-funded study, a Certificate of Confidentiality applies, minimizing informational risks and confidentiality 
issues. 
 
Following data analysis and study conclusion, server data will be de-identified and remain housed on the Department of 
Pediatrics server or on UW-Madison Box. Note that UW Cybersecurity will set up and approve the Box account to be 
used for data storage. 
 
A summary table of the data elements, collection, transfer, and storage follow.   
 
Collected 
Entered/Transferred 
Stored/Access rights 
Destruction 
Subject ID Master List 
Spreadsheet on staff computer 
Stored in secure folder on UWBox; 
access restricted to authorized study 
staff. 
List with identifiable data will be 
destroyed once study analyses are 
completed.  De-identified data stored 
on UWBox indefinitely. 
Consent forms 
If subject signs on paper, copy 
will be retained in locked staff 
office. 
Hardcopy consents will be kept in 
locked cabinet in locked staff office 
with access restricted to authorized 
study staff. 
Hardcopy consents will be stored and 
retained for at least 7 years after the 
completion of the study.  Emailed 
photographs will be deleted once 
printed. 
Study surveys 
Entered on-line in REDCap 
Stored in REDCap (maintained by UW-
Madison IT staff on campus 
infrastructure).  Access restricted to 
authorized study staff. 
De-identified data set stored 
indefinitely 
Study Staff Weekly 
Communication Log 
Spreadsheet on staff computer 
Stored on UWBox; access restricted to 
authorized study staff. 
List with identifiable data will be 
destroyed once study analyses are 
completed.  De-identified data stored 
on UWBox indefinitely.  
Positive PCR results – 
verbal report from 
parent 
Recorded on study staff log 
Documented in REDCap and in 
enrollment tracker on secure Box. 
• Study staff’s Log: identifiable data 
will be destroyed once study analyses 

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are completed.  De-identified data 
stored on UWBox indefinitely.  
 
RADx optional component 
The funding for this grant is part of a larger NIH funding project called RADX-Up.  In accepting the grant, Dr. Coller and 
his team agreed to ask permission of subjects for the sharing of certain data with NIH and their contracted research 
group, the Duke Clinical Research Institute.  The researchers hope to use this data to learn more about COVID-19 and 
other diseases and conditions.  Permission to share this data is voluntary and requires additional consent.   If the 
caregiver does not consent to the sharing of data with the NIH, their responses to study surveys and testing data will be 
provided to NIH in an aggregated fashion (no identifiable data will be shared).  If the caregiver consents to sharing their 
individual, identifiable data with the NIH, their name, date of birth, address, phone numbers, and email addresses will be 
shared with the NIH with their individual responses to their study surveys and testing data. 
 
Parents will be presented with the following explanation of this data collection and asked whether they give consent to 
participate: 
 
OPTIONAL STUDY ACTIVITIES - Consent to Share Your Re-SET Data with the National Institutes of Health 
 
The following study activities are optional.  You may still take part in this study if you say no to any or all of these 
optional activities.  Participating in any of these activities will not help you or your child directly.    
 
Dr. Coller and his research team received funding for the ReSET COVID testing study from the National Institutes of 
Health which funds a larger program called RADX-UP.  The researchers overseeing RADX-UP are asking for your 
permission for us to share your Re-SET study data with NIH so they can learn more about COVID-19 and other 
diseases and conditions.  The following consent form asks for your permission for us to share this study 
information.  This is an optional, additional request.  If you decline sharing your information with the NIH, your 
participation in the Re-SET study will not be affected. 
 
What is the NIH and RADX-UP? 
The NIH stands for the National Institutes of Health. The NIH is part of the United States Department of Health and 
Human Services. The NIH’s purpose is to find new knowledge that will lead to better health for everyone. The NIH 
funded (provided support) for the RADx-UP program.  
 
RADx-UP stands for Rapid Acceleration in Diagnostics (in) Underserved Populations. RADx-UP is a health research 
program to learn more about COVID-19 disease. If you join RADx-UP, we will gather some data (information) about 
you. We will combine these with data from other people who join RADx-UP. We will study the data from all who 
join to understand how to help more people at risk for or with COVID-19.  
 
What will you ask of me? 
If you decide to join this study, we will gather data (information) about you and your child. If you choose to 
participate in this data sharing, Dr. Coller and his team will share the information collected in the study surveys 
with the NIH/RADX-UP team.  Examples of the information that we may collect from your study surveys are, but 
not limited to: 
• 
basic information about you and your child such as name, date of birth, address, contact information, race, 
ethnicity, gender, language, health insurance status, disability, job, and household information including 
address history 
• 
information about COVID-19 related to you and your child, including information about any symptoms and 
test results. If you had a positive COVID-19 test, we will ask information about contact tracing (people who 
may have come in contact with you while you had COVID-19). We will ask about your child’s medical 
history and if they have or have not had vaccines and why.  
• 
information about you and your child’s health, education, family, home, relationships, and social life, among 
others. 

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What will you do with my data? 
We will keep your data securely (which means with extra protection), along with the data from all the other people 
who take part in the RADx-UP program. Researchers will use the data to learn more about COVID-19 or other 
diseases and conditions.  
 
The Duke Clinical Research Institute (DCRI) is a research group chosen by the National Institute of Health (NIH) to 
combine the data collected from everyone taking part in RADx-UP studies.  
 
The DCRI will build two RADx-UP databases (systems that hold electronic information).  
 
The first database will only hold information that can identify you (called identifiable information). Examples are 
your name, address, email, and date of birth.  
• 
These data will be kept at the DCRI. The DCRI will not share these data with the NIH.  
• 
Only if you agree, by initialing below, the DCRI will keep information that can identify you in order to 
contact you for future research studies. If you do not agree, this information will stay with your study team, 
as applicable. 
• 
These data will stay in a password-protected secure electronic system and only staff responsible for 
maintaining the security of your data at the DCRI will be able to see this information.  
• 
This database will contain the following identifiable information: name, date of birth, address, phone 
numbers, and email addresses of you and your child.  This information will be paired with your responses 
to the study survey questions.  Survey questions include information about your child’s medical conditions, 
school attendance, health insurance type(s), vaccination status of you and your child, COVID testing history, 
your opinions about vaccinations and testing, household income, race, ethnicity, gender, your educational 
background, employment status, and marital status.   
 
The second database will not hold information to identify you. It will hold all the nonidentifiable information you 
agree to give. 
• 
You will be assigned a study code and you will only be identified in this database by this study code. 
• 
It will not contain your name or other information that could easily identify you. 
• 
We plan to transfer and keep these non-identifiable data in a secure database for COVID19 research at the 
NIH. Other researchers may use these data for studies, other than the ones stated in this consent form. 
• 
When using the data from this second database, researchers will only have access to your non-identifiable 
data and cannot link the data back to you. 
• 
Because the data cannot be linked back to you, we will not contact you to inform you or ask your 
permission before sharing the data with researchers.  
• 
This database will contain the nonidentifiable information that you provide on the study surveys. 
 
How will you protect my privacy? 
Your privacy is very important to us. We will take great care to protect your privacy. However, there is always a 
chance that, even with our best efforts, your identity and/or information collected during this study may be 
accidentally released or seen by unauthorized persons. Here are a few steps we will take: 
• 
Data will be stored on protected, secure computer systems. We will limit and keep track of who can see 
these data. 
• 
Anyone who can see these data will have to use a password. 
• 
We will take steps to protect your information from others that should not be able to see it. 
• 
When your data are shared with other researchers, they will not have information that can identify you.  
• 
This project has a Certificate of Confidentiality from the United States government. Certificates of 
Confidentiality protect your privacy by blocking the release of identifiable, sensitive research information 
to anyone not connected to the research except when you agree, or in a few other specific situations. 
 
Optional:  

Yr 2 ReSET Aim 1a v. 11/21/22 
 
 
Page 10 of 11 
I agree to let Duke Clinical Research Institute (DCRI) collect the following identifiable information: name, address, 
contact information, and date of birth, as stated above. 
 
Yes, initials ________ 
No, initials ________ 
 
I agree to let the DCRI collect only my zip code and no other identifiable information as stated above. 
 
Yes, initials ________ 
No, initials ________ 
 
I agree to be contacted for future research as stated above. 
 
Yes, initials ________ 
 
No, initials ________ 
 
 
 
 

Yr 2 ReSET Aim 1a v. 11/21/22 
 
 
Page 11 of 11 
DATA ANALYSIS 
In primary analyses, feasibility and school perception measures will be summarized with descriptive statistics. 
Differences by race/ethnicity and urban/rural category will be identified with t-tests or Wilcoxon rank-sum tests 
(continuous variables) and Chi-squared or Fisher’s exact tests (categorical variables). Aim 1’s design will allow us to 
conduct a couple of comparative analyses:  
(1) We will evaluate whether statistically significant differences in feasibility or perceptions exist for in-home 
compared to school-based cohorts (see IRB ReSET Aim 1b)  
(2) We will explore differences in perceptions associated with changes in community spread.  
 
We anticipate the relatively small number of subjects and low COVID-19 rates will make sensitivity and specificity 
determination of BinaxNOW tests difficult; however, we will measure the number of positive and negative tests during 
the study period as well as the concordance of positive tests with PCR testing. 
 
UNANTICIPATED PROBLEMS OR COMPLICATIONS 
Study staff will report any unanticipated problems or complications to the principal investigator promptly. Weekly team 
meetings will review study issues such as any deviations from the protocol, subject complaints or questions, and positive 
test results. The principal investigator will provide guidance on these issues and determine whether such events are to be 
reported to the IRB in accordance with posted guidance. Should urgent issues arise, study staff will have access to 
principal investigator and/or research manager guidance at all times via email, texting and phone. 
 
INSTITUTIONAL REVIEW BOARD 
The UW-Madison Health Sciences Institutional Review Board (IRB) will serve as the IRB for this study. 
 
PROJECT FUNDING 
This project is funded by the National Institutes for Health.