SCALE-UP Counts: A Health Information Technology Approach to Increasing COVID-19 Testing in Elementary and Middle Schools Serving Disadvantaged Communities
Phase: PHASE3
Conditions: COVID-19
Sponsor: University of Utah

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Scale Up Counts Protocol Summary 
7/18/2024 
Clinical Trial Registration: NCT05112900 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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SCALE-UP Counts: A health information technology 
approach to increasing COVID-19 testing in elementary 
and middle schools serving disadvantaged communities 
 
Protocol Summary 
 
 
 
IRB Approval 
Date of 
Current 
Version: 
9/18/2023 
University of 
Utah IRB #: 
IRB_00143340 
Sponsor: NIH NATIONAL INST CHILD HLTH & HUMAN DEV 
  
Principal 
Investigator: 
Yelena Wu 
Internal Staff 
and  Sub-
Investigators: 
Site Name 
Staff Names 
University of Utah Yelena Wu 
 
Neng Wan 
 
Emerson Borsato 
 
Guilherme Del Fiol 
 
Sarah DeSantis 
 
Adam Hersh 
 
Kelly Lundberg 
 
Jacey Jones 
 
Anthony Banks 
 
Kate Welch 
 
Brian Orleans 
 
Liberty Woodside 
 
Ryan Cornia 
 
Will Tanguy 
 
Lindsey Anderson 
 
Jiantao Bian 
 
Jonathan Chipman 
 
Tammy Stump 
 
Caroline Joung 
 
Tatyana Kuzmenko 
 
David Wetter 
 
Richard Nelson 

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Rick Bradshaw 
 
Leticia Stevens 
 
Minkyoung Yoo 
 
Samuel Hancock 
 
Lydia Altamiranda 
 
This document was created using the ERICA Online System at the University of Utah. The document is created 
from study information approved by the IRB on the date listed above.  Any alteration to the original content of this 
document may not be considered to represent the study as approved by the IRB.  
 
 

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Background and Introduction 
 
Racial/ethnic minority and low socioeconomic status (SES) populations suffer profound health 
inequities across a wide variety of conditions as well as a disproportionate burden of the 
negative health consequences of the COVID-19 pandemic. Latinos make up ~14% of the Utah 
population vs. ~21% of Utah’s COVID-19 cases (50% higher) and the case rate is over 3-fold 
higher in neighborhoods characterized by high vs. low deprivation. 
In the Utah 2020-2021 school year, there have been 36,484 school-associated cases of 
COVID-19. Our ongoing partnerships with the Utah Department of Health (UDOH) allows us 
to access real-time information on “hotspot schools” across the state. One of our Utah school 
district partners, Granite School District (n=85 schools), currently has the 3rd highest number 
of cases of COVID-19 and 45% of its schools have a student population with >50% eligible to 
receive free/reduced lunch and 60% have a student population that is >50% ethnic minority. 
Schools bear a large part of the burden of managing COVID-19 testing and communicating 
with parents about testing their children. Few schools in Utah have information technology 
systems in place to support systematic communication with parents about student COVID-19 
testing and tracking testing outcomes. 
Through an existing RADx-UP grant (UL1TR002538-03S4), our team developed a text 
messaging and health navigator infrastructure that is now deployed in federally-qualified 
health centers across Utah. We chose to use text messaging because it is widely available in 
underserved communities, with 97% of individuals with an annual income <$30,000 and 96% 
with educational attainment of high school or less having a phone that can text. 
  
Additionally, the grant application and ERICA application are consistent in terms of study 
objectives/purpose, study design, study interventions/procedures, and study population.  
 
 
 
Purpose and Objectives 
 
Overview to Proposed Program: 
  
This project will address key testing challenges in schools by building on our collaborations 
with public school districts, private schools, charter schools and with UDOH on COVID-19 
testing and existing infrastructure. While we are focused on COVID-19 testing, in the case that 
the COVID-19 vaccination becomes more relevant or is the priority of the school, we are able 
to focus our intervention on the vaccine as well. We will work closely with schools and the 
Utah public health system to implement and test a shovel-ready and scalable health 
information technology approach that delivers automated text messages (TMs) to students’ 
parents and faculty/staff members around COVID-19 testing. In addition, some students and 
faculty/staff will receive a health navigator (HN) follow-up to ensure that tests are completed. 

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HN will be community members who have been trained in case management. Families (both 
of students and faculty/staff members) will be offered the recently FDA-approved in-home 
serial testing approach if accessing in-person testing is a challenge. 
  
We will employ a Sequential Multiple Assignment Randomized Trial (SMART) design using 
short time frames (<1 month) and iterative evaluation cycles. The proposed trial will compare 
the efficacy of TM versus usual care as an initial intervention. Among participants randomized 
to the TM condition, during each 2-3 week cycle, participants who report COVID-19 
symptoms or contact with someone with COVID-19 will be evaluated and classified as 
compliant (if COVID-19 test completed) or non-compliant (if no COVID-19 test is completed 
or no response received). Non-compliant participants will then either continue receiving TM or 
additionally receive HN (TM+HN) for the remainder of that cycle, depending on the condition 
to which they were randomly assigned at the beginning of the study. 
Research Question #1: Impact of an information technology and health navigator 
intervention for COVID-19 testing for underserved and vulnerable populations: Does 
text messaging vs. text messaging plus health navigator differentially: 
(a) Increase the proportion of students and/or faculty and staff members tested out of those 
who meet criteria for testing? 
(b) Decrease missed school days? 
(c) Decrease parent-reported challenges obtaining COVID-19 testing for their child? 
Approach and Design #1:  
We will conduct a Sequential Multiple Assignment Randomized Trial (SMART) that 
compares TM versus usual care/control in a first randomization of the study. During each 
cycle of the study, we will evaluate compliance to the TM intervention. Non-compliant 
participants will then receive their Phase 2 condition of continued TM or TM+HN to test 
whether “stepping up” to HN improves outcomes for those not responding to the first-line 
intervention of TM. All randomizations will take place on the individual level at the beginning 
of the study; participants will be randomized to the initial intervention (TM vs. usual care; 
Phase 1 Randomization), and TM participants will also be randomized to the Phase 2 condition 
(TM or TM+HN) which they would receive during cycles during which they are non-
compliant. 
This project is a Sequential Multiple Assignment Randomized Trial (SMART) that will be 
conducted with approximately 20,000 staff, parent, and student participants across 30 schools.  
Research Question #2: Implementation outcomes: What implementation barriers and 
facilitators are identified, including by students, faculty/staff members, parents, schools, and 
health navigators 

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Approach and Design #2: We will conduct a mixed-methods evaluation to understand 
implementation effectiveness outcomes as well as characteristics of both schools and students/ 
families that may influence intervention effects and implementation outcomes. 
Research Question #3: Moderators of intervention effects: What are the student/family 
socio-demographic and school characteristic moderators of SCALE-UP Counts effects? 
 
 
 
Study Population 
 
Age of Participants: Participants of all ages 
 
Sample Size: 
At Utah: 
  
All Centers: 
approx. 20,000 
 
Inclusion Criteria: 
We will partner with up to 30 elementary, middle and high schools in several school districts 
including the ones outlined below (n=67 eligible schools; see Table 1) as well as private and 
charter schools in the surrounding area. We will focus primarily on elementary school 
students who currently are not recommended to receive the COVID-19 vaccine. 
Table 1. Example Participating Schools   
District 
# of Schools Meeting 
Underserved Criteria 
# of 
Students 
Student Characteristics 
Granite 
48 
26,420 
• ~60% eligible for free/reduced lun
• ~64% are ethnic minorities 
Salt Lake City 
19 
7,828 
• ~77% eligible for free/reduced lun
• ~76% are ethnic minorities 
Students 
- Attends school at any of the participating elementary, middle, or high schools from the 
districts, charters, or private schools the research team is working with.  
Parents  
- Legal guardian/parent of the student. 
- Has a functioning cellular phone that can receive calls and text messages. 
School Staff 

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- Works at any of the participating elementary or middle schools from the districts, charters, 
or private schools the research team is working with.  
 
 
Exclusion Criteria: 
None 
 
 
Design  
 
Randomized Trial 
Prospective Social/Behavioral Intervention or Experiment 
 
 
 
 
Study Procedures 
 
Recruitment/Participant Identification Process: 
The proposed study will partner with elementary and middle schools from Utah school 
districts including the Granite School District and Salt Lake City School District, as well as 
private and charter schools in the surrounding area. The administration of the partnering 
schools and schools districts will have the option to follow an "opt-in" or "opt-out" enrollment 
procedure as outlined below: 
"Opt-out" Enrollment Procedure: 
The research team anticipates that SCALE-UP Counts will receive a waiver of documentation 
of consent from the IRB. All students who attend partnering schools will be enrolled, with 
parents/guardians provided with a website link to view a study information with details about 
the study and information on compensation (up to $25 per completed survey) and how to opt 
out.  Staff at the participating schools/districts who wish to participate will also be enrolled 
and receive the same information for the website study information letter and opt-out 
information. Informational flyers with contact information will be available at schools in 
English and Spanish. A social media posting will be made available to all participating schools 
to share on their social media accounts. The social media post directs people to the study 
website, similar to the informational flyers. All parents/guardians who meet criteria (i.e., have 
a functioning cellular phone that can receive calls and text messages) will be eligible to be 
randomized to text messaging (TM) or usual care groups. Participants who are randomized to 
text messaging and who are deemed non-compliant will be randomized again to text 
messaging (TM) or text messaging and health navigator (TM + HN). Participants who stop 
attending an enrolled school will be removed from the intervention but will continue to receive 
follow-up surveys. These participants will have the option to opt out by emailing the study 
team. The study team's email will be provided in the REDCap surveys.  
"Opt-In" Enrollment Procedure: 

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For those partnering schools and districts who wish to follow the “opt-in” enrollment 
procedure, the district administration will send a survey to parents/guardians and school staff 
via e-mail or other communication method with the same study information outlined above 
(i.e. website link, study information letter, social media post etc.) and the option to opt-in to 
the study. Upon survey completion, contact information of those parents/guardians and school 
staff who are willing to participate will be send directly to the study team. 
The proposed study will also partner with Utah Department of Health (UDOH) to obtain lists 
of schools and districts in Utah that request free COVID-19 home test kits from UDOH. The 
study team will reach out to these schools and districts in an effort to pair the study with the 
schools' test kit distribution. The study team will not provide the district/school with COVID-
19 home test kits unless requested. Schools/districts will utilize COVID-19 home test kits 
provided to them by UDOH and the proposed study will work in parallel with these efforts. 
Districts/schools recruited in partnership with UDOH will still need to meet the criteria and 
will be provided with the same website link, opt-out options, and flyers as described above. 
 
 
Informed Consent: 
Description of location(s) where consent will be obtained:  
For schools implementing the "opt-out" enrollment procedure, students will be sent home with 
the study flyer (attached) to inform their parents/guardians about the study procedures. Study 
flyers will also be distributed to faculty/staff of the participating schools. The study website 
will act as the study cover letter and will provide information on study procedures and opt out 
options. The website link will be provided to every potential participant through a text 
message. For schools implementing the “opt-in” enrollment procedure, district administration 
will send a survey containing study information to parents/guardians and school staff with the 
option to “opt-in” to the study. Contact information for parents/guardians and school staff who 
have opted-in to the study will be provided to the study team via REDCap. For research 
question #1: n/a waiver of documentation of consent requested for parents/guardians, school 
staff, and health navigators who are invited to participate in the study will have an opportunity 
to opt in or out of the study. For research question #2: n/a waiver of documentation of consent 
requested for parents/guardians, school staff, and health navigators who are invited to 
participate in qualitative interviews (research question #2) and to complete further 
questionnaires about their experience with SCALE-UP Counts, they will provide verbal 
consent prior to the interview and questionnaire completion. This will be completed over the 
phone and/or electronically.  
 
Description of the consent process(es), including the timing of consent:  
Informed Consent and Assent Procedures for research question #1: Prior to study activities, all 
potential participants and their parents/guardians will receive the relevant study information 
website link to review and/or a survey link from district administration with relevant study 
information. The study information website link provided will cover the basic elements of 
consent. Faculty/staff members and parents/guardians of students (if the student is <18 years 
of age) will have the opportunity of opting their child/themselves into or out of participating in 
the current study. Parents/guardians of students will receive a study cover letter website link 
with information about participation. Upon reviewing the website/cover letter, 

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parents/guardians will have an opportunity to opt-in or -out of participation. Those who are 
participating will receive the consent and parental permission cover letter/website, which are 
within the same document. Children who are 8 years of age or older will receive the assent 
cover letter.. A waiver of consent/assent has been similarly granted for our other studies, 
including one led by MPI Wu of a cluster-randomized trial in Utah schools. Informed Consent 
and Assent Procedures for research question #2: For students, parents/guardians, school staff, 
and health navigators who are invited to participate in qualitative interviews and to complete 
further questionnaires about their experience with SCALE-UP Counts, they will provide 
verbal consent prior to interview and questionnaire completion. See interview guide 
documents for verbal consent wording. We will use the NIH RADx-UP Tier 1 CDEs and/or 
modify them for use with pediatric populations to assess socio-demographics, housing, 
employment, and insurance, testing, and symptoms. We have the capacity to accommodate 
data harmonization and sharing with the RADx CDCC, including through infrastructure 
established through our currently-funded RADx-UP grant (UL1TR002538-03S4). We will 
also use items assessing social determinants of health from the PhenX Toolkit (e.g., family 
income, birthplace, access to health services, health literacy, concentrated poverty) and 
COVID-19 specific constructs (e.g., vulnerability and exposure to COVID-19, COVID-19 
knowledge, attitudes, and avoidant behaviors). No personal identifiers are collected which is 
why we applied for a waiver of documentation of consent to achieve this research aim. 
Personal identifiers are asked when completing the RADx-UP Tier 1 Common Data Elements 
surveys. Prior to completing RADx-UP questionnaires, staff and parents/guardians will be 
provided with detailed consent information specifically pertaining to the collection and sharing 
of the data collected on these questionnaire with the Duke Clinical Research Institute. 
Participants determine the level of PHI they wish to provide and they are not required to 
provide PHI to complete surveys. Participants are asked if they consent to collecting 
identifiable information to be shared with the Duke Clinical Research Institute including (but 
not limited to) name, date of birth, address, social security number, sociodemographic 
information and if they wish to be contacted about future research which is why we applied for 
a waiver of documentation of consent to achieve this research aim. See RADx-UP ICF 
document for consent language. Informed Consent and Assent Procedures for COVID-19 test 
results provided by Ellume at-home test application: Users who download and utilize the app 
for testing/test result purposes agree to privacy policy and terms prior to testing within the 
Ellume app. 
 
Procedures: 
Enrollment/waiver of documentation of consent:  For partnering schools implementing the 
"opt-out" enrollment procedure, all students who attend partnering schools will be enrolled, 
with parents/guardians provided with a study information through a website link with details 
about the study and information on compensation (up to $25 per completed survey) and how 
to opt out.  Staff at these participating schools/districts who wish to participate will also be 
enrolled and receive the same website link for study information and opt-out information. All 
parents/guardians who meet criteria (i.e., have a functioning cellular phone that can receive 
calls and text messages) will be eligible to be randomized to text messaging (TM) or usual 
care groups. Participants who are randomized to text messaging and that are deemed non-
compliant will additionally receive a health navigator (TM + HN) if randomized to that 
condition. 

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For those partnering schools and districts who wish to follow the “opt-in” enrollment 
procedure, the district administration will send a survey to parents/guardians and school staff 
via e-mail or other communication method with the same study information outlined above 
(i.e. website link, study information letter, etc.) and the option to opt-in to the study. Upon 
completion of the survey, the contact information of those parents/guardians and school staff 
who are willing to participate will be sent directly to the study team. All parents/guardians 
and who meet criteria (i.e., have a functioning cellular phone that can receive calls and text 
messages) will be eligible to be randomized to text messaging (TM) or usual care groups. 
Participants who are randomized to text messaging and that are deemed non-compliant will 
additionally receive a health navigator (TM + HN) if randomized to that condition. 
Procedures for research question #1: Does text messaging vs. text messaging plus health 
navigator differentially: 
Interventions to Promote COVID-19 Testing: TMs will be used to screen students and staff 
and direct families to testing resources. HN will address motivation (both parental and 
individual for faculty/staff) for testing, logistics and barriers to testing, and support tracking of 
their own and students’ outcomes over time. Test kits provided by the study team will come 
with a reminder flyer to follow test kit instructions closely and review recommendations by 
the test kit company for serial testing. Participants who pick up test kits will also receive a 
flyer with a QR code that links to a form for reporting test outcomes and reminders to 
complete the study surveys. While we are focused on COVID-19 testing for students and 
school staff, in the case that the COVID-19 vaccination becomes more relevant or is the 
priority of the school, we are able to focus our intervention on the vaccine as well. 
Text Messages (TMs): We will send HIPAA-compliant bidirectional texts to students’ 
parents or legal guardians (termed “parents” throughout this application) and school staff. 
Priority groups will be identified in collaboration with partners based on criteria set by the 
Centers for Disease Control and Prevention (CDC), local public health officials, and school 
priorities. TMs can be tailored based on the closest testing options. A first TM will screen for 
reported symptoms or COVID-19 exposure to know if the student, staff member or household 
member should get tested. Individuals who reply “yes” will receive additional TMs with a 
recommendation to be tested, testing locations/hours/phone and/or information on home 
testing options, and resources about what to do if they test positive. We will evaluate 
compliance to the TM intervention. Non-compliant participants will then receive their Phase 2 
condition of continued TM or TM+HN to test whether “stepping up” to HN improves 
outcomes for those not responding to the first-line intervention of TM only. 
All participants assigned to TM or TM + HN and respond "yes" will be asked through text 
message to self-report the number of COVID-19 home test kits taken. Participants will also be 
asked to self-report through text message the number of (and names of) their enrolled 
child(ren) that tested positive. 
Individuals who reply “no” will be instructed to respond back to the text message at any time 
should they begin experiencing symptoms or have a new COVID-19 exposure. We will adapt 
TM targets and content to account for changes such as the status of the pandemic, testing 
criteria and logistics, and school outbreaks. Our existing TM infrastructure, which can 

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automatically determine the language in which to send messages, allows us to program and 
deploy new TMs in a matter of minutes to hours depending on the extent of the adaptations. 
TMs will be repeated as frequently as needed (e.g., weekly) to continuously screen for 
COVID-19 testing eligibility, to provide updates, and to assess test completion per parent-
report. 
Health Navigator (HN): 
Some parents and/or school staff members may be reluctant to get tested themselves or to test 
their children due to knowledge gaps or other concerns or barriers. However, practical advice 
from navigators can educate and overcome engagement logistics, transportation, and expense 
barriers. Navigators will be community members who completed case management training 
through University Neighborhood Partners. Navigators will be taught an empirically validated 
behavior change approach (Motivation And Problem Solving; MAPS). MAPS is based on 20 
years of extensive feedback on structure and content from low SES, predominantly minority 
populations, and has been demonstrated to be effective in increasing enrollment and enhancing 
and maintaining behavior change. We are using MAPS in multiple studies including in 
SCALE-UP Utah. MAPS is a holistic, dynamic approach to behavior change that integrates 
two empirically validated approaches (motivational interviewing and practical problem 
solving) with demonstrated efficacy for helping patients engage in target behaviors. 
Importantly, MAPS addresses the social determinants of health, and provides practical advice 
and connections to services, including addressing testing (and, if relevant, vaccine) concerns 
(e.g., worries about repercussions of a positive test, infecting family members, quarantining). 
All navigators will receive ~20 hours of training. 
Individuals who receive a TM recommending a COVID-19 test but who did not report 
completing a test will be contacted by a navigator if they were randomized to that phase 2 
condition (as opposed to continued TM). The navigator will address testing (and, if relevant, 
vaccine) barriers, connect them to a testing site, and discuss implications of a potential 
positive result. Navigators will provide in-home testing kits to families unable to travel to test 
sites. We will offer testing to students’ and staff members' family members who live in the 
same household, due to feedback from our school partners that a significant barrier to testing 
among their families is when other family members, including parents, are also experiencing 
symptoms. In-school testing will be provided through existing test kits and protocols paid for 
by UDOH. To manage navigator work queues, we will provide them with access to a 
dashboard with real-time reports for tracking TM responses that has been implemented 
through our current RADx-UP project. Navigators will be able to see a list of parents and staff 
members to call and document outcomes. 
Staff: 
Contact information for staff who have opted-in (or not opted-out) of the study will be 
provided to the study team via REDCap. Information provided will include staff name, cell 
phone number, email address, home address, and role at the school. Schools will also provide 
the study team with data on the number and timing of missed days of work for enrolled staff 
which will be used as a secondary measure of intervention effects. The contact information 
will be used to send text messages informing staff about the study. This message will include 

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the option to opt-out of participation. Those who do not opt out are randomized. In the first 
randomization, participants will be randomized to either text messaging or control. The control 
group assignment consists of typical or usual care for COVID-19 in that school/district, such 
as following school procedures for state (e.g., Utah Department of Health) recommendations 
on testing. The second randomization is also participant-level randomization to text messaging 
+ health navigator (HN) coaching versus continued text messaging among participants who 
are non-compliant by not testing or not responding to testing recommendation follow up. 
  
Randomization: 
Randomization of staff participants will consist of two phases, both taking placed upon 
enrollment in the study. Phase 1 will consist of assigning participates to text messaging or to 
usual care groups. The Phase 2 randomization will take place among participants in the TM 
condition. They will be assigned a Phase 2 condition of continued text messages or text 
messages + health navigator (HN), which they will receive during intervention cycles in which 
they are evaluated as non-compliant. 
Phase 1 Randomization: 
Participants included in Phase 1 are those who did not opt-out of the study. Participants 
eligible for Phase 1 Randomization will either be assigned to 1). usual care (control, 
approximately 20% of participants) or 2). receive text messages (TM, approximately 80% of 
participants).  
• TM consists of a text message prompt asking if a participant has COVID-19 symptoms 
or if a participant has been exposed to a person that has tested positive for COVID-19. 
If a participant responds yes, they will receive a TM prompt for immediate testing and 
to re-test. Participants will be provided with information on testing options. After 24 
hours, the participant will be asked if they tested and what their results are. After 3 
days, participants will be prompted to re-test. At the end of the cycle, participants will 
be asked through text message to state the number of home test kits picked up, number 
of household members who tested, number of household members who tested 
positive, as well as the number of (and names of) their enrolled child(ren) that tested 
positive. 
• Usual Care- Participants will only receive public service announcement-type 
messaging on COVID-19 testing every 3 weeks (e.g., recommendation to obtain 
COVID-19 testing if exposed or experience symptoms; information on testing options 
through the school or district). 
Phase 2 Randomization: 
For participants in the TM condition, the Phase 2 condition will be randomly assigned upon 
enrollment. Participants will receive their Phase 2 condition if they are non-compliant with the 
TM intervention. Participants will be evaluated as non-compliant if they had reported 
symptoms or contact and then stop responding to text messages or respond that they did not 

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test. Participants will be randomized to 1.) continued TM or 2.)continued TM plus health 
navigator (TM+HN). 
• TM will continue to consist of prompts and reminders on COVID-19 testing 
options. At the end of the cycle, participants will be asked through text message to 
state the number of home test kits picked up, number of household members who 
tested, number of household members who tested positive, as well as the number of 
(and names of) their enrolled child(ren) that tested positive. 
• TM+HN consists of continued text messages about COVID-19 testing options with the 
addition of a brief telephone call from a health navigator (HN). These calls will be 
conducted using Motivation and Problem Solving (MAPS). MAPS is an empirically 
validated proactive coaching approach used to address barriers and motivate 
participants to utilize testing options if they are experiencing COVID-19 symptoms or 
have been exposed to someone that has tested positive for COVID-19. At the end of 
the cycle, participants will be asked through text message to state the number of home 
test kits picked up, number of household members who tested, number of household 
members who tested positive, as well as the number of (and names of) their enrolled 
child(ren) that tested positive. 
Parents/Students: 
Contact information for students’ parents/guardians who have opted into the study will be 
provided via REDCap. Information provided will include the parent/guardian's name, cell 
phone number, parent/guardian's email, home address, students name, student identification 
number, and student’s school name. Schools will also provide the study team with data on the 
number of missed school days for enrolled students which will be used as a secondary measure 
of intervention effects. The contact information will be used to send text messages informing 
parents/guardians about the study. This message will include the option to opt-out of 
participation. Those who do not opt out are randomized. In the first randomization, 
participants will be randomized to either text messaging or control. The control group 
assignment consists of typical or usual care for COVID-19 in that school/district such as 
following school procedures for state (e.g., Utah Department of Health) recommendations on 
testing.. The second randomization is participant-level randomization to text messaging + 
health navigator (HN) coaching versus continued text messaging among participants who are 
non-compliant by not testing or not responding to testing recommendation follow up. 
Randomization: 
Randomization of parent/student participants will consist of two phases, both taking 
place upon enrollment in the study. Phase 1 will consist of assigning participants to text 
messaging or to usual care groups. The Phase 2 randomization will take place among 
participants in the TM condition. They will be assigned a Phase 2 condition of continued text 
messages (TM) or text messages + health navigator (HN), which they will received during 
intervention cycles in which they are evaluated as non-compliant. 
Phase 1 Randomization: 

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Participants included in Phase 1 are those who did not opt-out of the study. Participants 
eligible for Phase 1 Randomization will either be assigned to 1). usual care (control, 
approximately 50% of participants) or 2). receive text messages (TM, approximately 50% of 
participants).  
• TM consists of a text message prompt asking if a participant has COVID-19 symptoms 
or if a participant has been exposed to a person that has tested positive for COVID-19. 
If a participant responds yes, they will receive a TM prompt for immediate testing and 
to re-test. Participants will be provided with information on testing options for 
COVID-19. After 24 hours, the participant will be asked if they tested and what their 
results are. After 3 days, participants will be prompted to re-test. At the end of the 
cycle, participants will be asked through text message to state the number of home test 
kits picked up, number of household members who tested, number of household 
members who tested positive, as well as the number of (and names of) their enrolled 
child(ren) that tested positive. 
• Usual Care- Participants will only receive public service announcement-
type  messaging on COVID-19 testing every 3 weeks (e.g., recommendation to obtain 
COVID-19 testing if exposed or experience symptoms; information on testing options 
through the school or district). 
Phase 2 Randomization: 
For participants in the TM condition, the Phase 2 condition will be randomly assigned upon 
enrollment. Participants will receive their Phase 2 condition if they are non-compliant with the 
TM intervention. Participants will be evaluated as non-compliant if they had reported 
symptoms or contact and then stop responding to text messages or respond that they did not 
test. Participants will be randomized to 1.) continued TM or 2.) continued TM plus health 
navigator (TM+HN). 
• TM will continue to consist of prompts and reminders on COVID-19 testing 
options. At the end of the cycle, participants will be asked through text message to 
state the number of home test kits picked up, number of household members who 
tested, number of household members who tested positive, as well as the number of 
(and names of) their enrolled child(ren) that tested positive. 
• TM+HN consists of continued text messages about COVID-19 testing options with the 
addition of a brief telephone call from a health navigator (HN). These calls will be 
conducted using Motivation and Problem Solving (MAPS). MAPS is an empirically 
validated proactive coaching approach used to address barriers and motivate 
participants to utilize testing options if they are experiencing COVID-19 symptoms or 
have been exposed to someone that has tested positive for COVID-19. At the end of 
the cycle, participants will be asked through text message to state the number of home 
test kits picked up, number of household members who tested, number of household 
members who tested positive, as well as the number of (and names of) their enrolled 
child(ren) that tested positive.  

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Procedures for research question #2: What implementation barriers and facilitators are 
identified, including by students, parents, schools, and health navigators? 
We will conduct a mixed-methods evaluation to understand implementation effectiveness 
outcomes as well as characteristics of both schools and students, faculty/staff members and 
families that may influence intervention effects and implementation outcomes. We will 
collect survey data from  students, staff members and parents , including items from the NIH 
RADx-UP Tier 1Common Data Elements (CDE). The surveys will assess perceived barriers 
to participating in SCALE-UP Counts (e.g., lack of interest or need, logistical barriers), 
facilitators to participating (e.g., receiving ongoing support around COVID-19 testing (and if 
relevant vaccination), HN), and targets of the intervention (e.g., self-efficacy related to 
attaining COVID-19 testing). We will collect COVID-19 test results of participants through 
self-report as well as through results reported to the Ellume testing app. We will also collect 
implementation predictors from HNs and school nurses, staff, and leaders at each school and 
district. School staff/leaders and health navigators will complete brief online assessments 
before and after implementing the interventions. Prior to implementation, school staff and 
leaders will be surveyed on Implementation Readiness, including priorities, available 
resources, and access to information using questions adapted from the Organizational 
Readiness to Change Assessment. We will also assess school setting characteristics 
(e.g.,leadership engagement, implementation climate) using measures that have been tested for 
validity and reliability. The post-implementation assessments will measure changes in 
determinants such as outcome expectations and organizational capabilities targeted by the 
interventions (e.g., capacity to use information technology systems). Throughout the trial, we 
will also assess school, district, and local characteristics that are dynamic and influence 
implementation throughout the project duration (e.g., school/district priorities, policy 
initiatives, local COVID rates). Adaptation to interventions will be assessed using structured 
surveys administered to school/district staff and classified using the adaptation framework 
proposed by Stirman and colleagues. 
We will conduct stakeholder interviews to understand students’, participating staff members' 
and parents’ experiences receiving the SCALE-UP Counts interventions and feedback on ways 
to improve the interventions to better meet their needs and preferences. With school nurses, 
other school/district staff and leaders, and health navigators, we will conduct interviews to 
understand their experiences implementing and managing the interventions and to ascertain 
their recommendations on modifications that are needed to increase the feasibility of 
implementation, uptake, and effectiveness. 
  
NIH RADx-UP Tier 1 Common Data Elements 
NIH RADx-UP Tier 1 Common Data Elements are a common set of questionnaires that NIH 
has asked investigators (that are funded through the RADx-UP program) to use as part of their 
studies and to be sent to the Duke Clinical Research Institute (DCRI). Eventually those data 
can be merged into a single dataset for analysis. Each project is different in terms of the 
interventions delivered and primary outcomes, so this study does not qualify as a multi-site 

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study. Individuals are not required to answer the Common Data Element questionnaires to 
participate in the study. 
Participants (staff, parents, and students) who choose to answer the RADx-UP questionnaires 
will be provided with consent information from the RADx-UP program that details how their 
information will be used and stored. This consent is provided prior to the completion of every 
RADx-UP questionnaire participants are asked to complete. Participants will only be asked for 
identifiable information if they choose to participate in the RADx-UP questionnaires. 
Common Data Element questions that are shared with the Duke Clinical Research Institute 
include (but not limited to) personal identifiers such as name, address, contact information, 
social security number, and date of birth in addition to sociodemographic, housing, and health 
status questions. Participants are not required to provide this information to complete the 
questionnaires. A detailed explanation that providing personal identifiers is not required to 
participate is provided to participants before RADx-UP consent information is asked.  If a 
participant decides to withdraw from the study, only participant data collected to that point 
would be used.  
Participants will be asked to complete the RADx-UP questionnaires at baseline, month 1, 
month 6, month 9, and month 12. Participants who are enrolled in the intervention but did not 
complete the baseline survey or other follow up questionnaires (non-responsive participants) 
may receive a brief survey designed to collect pertinent information related to the study's 
outcomes (e.g., demographics, COVID-19 testing and vaccine history). This survey consist of 
a subset of important questions that have already been approved in the current questionnaires. 
This survey will be sent electronically through REDCap notification and/or through postal 
mail that includes an insert with a QR code to access the survey. Participants who are no 
longer enrolled in a participating school will be removed from the intervention but will 
continue to receive follow up surveys through month 12 from their enrolled school date. These 
participants will have the opportunity to opt-out of receiving surveys by emailing the study 
team.  
Questionnaires will be sent via text message through REDCap. RADx-UP questionnaire data 
will be stored on password protected computers. All data that will be transferred outside of the 
institution to the Duke Clinical Research Institute will be encrypted. Data will be sent to the 
Duke Clinical Research Institute monthly. This study has a Data Transfer Agreement with 
Granite School District. The Data Transfer Agreement with RADx-UP/the Duke Clinical 
Research Institute is pending IRB Approval. Duke Clinical Research Institute will store 
identifiable information in a secured data base. Duke Clinical Research Institute will use a 
second secured data base to store and send de-identified data to the NIH.  
Procedures for research question #3:  What are the student/family socio-demographic and 
school characteristic moderators of SCALE-UP Counts effects? 
We will gather data on student, staff member and family socio-demographic characteristics 
(e.g., race/ethnicity, household income, primary language spoken) and school characteristics 
(e.g., number of students, percent of students eligible for free and reduced lunch, percent of 
students who identify as an ethnic minority). These data will lead to a new understanding of 

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what students and schools benefit most from the interventions and to guide future intervention 
tailoring to maximize efficacy across settings and for underserved groups. 
 
 
Procedures performed for research purposes only:  
 
 
Statistical Methods, Data Analysis and Interpretation 
 
Statistical Analysis and Power for research question #1: We expect to enroll >50% of 
students and staff members from each of 30 schools (average of >250 students/school). The 
overall type I error will be split evenly (0.025) for the two co-primary outcomes: percent tested 
and difference in missed school days. Our primary power assessment is conservatively based 
on the assumption that students and staff are missing 15% of school days, that the testing rate 
is 50%, and that the intra-class correlation (ICC) is 0.02. The anticipated ICC of 0.02 is 
consistent with prior school-level association after adjusting for school factors from meta-
analyses. Based upon a 2-sample comparison of proportions and using normality 
approximations, we are 80% powered to detect an improvement of 6.1% fewer missed days of 
school (missed school days at 8.9% or less) and at least a 9.2% improvement in testing (testing 
of at least 59.2%) bet. The primary analysis for each primary outcome will entail fitting a 
linear mixed effects logistic regression model; regressing the outcome upon treatment (TM vs. 
usual care) and adjusting for fixed effects of school level, percent receiving free/reduced 
lunch, and percent ethnic minority and for random effects of student, staff member, school, 
and school nurse. 
  
Analysis for research question #2: We will test whether the quantitative measures of 
barriers, facilitators, and implementation targets at the student (or staff member) and school 
level predict testing uptake and missed school days. For each measure, we will fit a mixed 
effects logistic regression to predict outcomes adjusting for the same fixed and random effects 
as in Research Question 1. The study is 80% powered to identify student- and staff-level 
predictors associated with an odds ratio (OR) of 1.10 per standard deviation (SD) of the 
predictor for missing school days and an OR of 1.07 per standard deviation of the predictor for 
testing in univariate analyses or multivariable analyses. For school-level predictors, assuming 
an ICC for schools of 0.02, the study is 80% powered to identify predictors associated with an 
OR of 1.27 per SD of the predictor for missed school days and an odds ratio of 1.19 per SD of 
the predictor for testing, in univariate or multivariable analyses. In secondary analyses, we will 
use random forests to build a prediction model across quantitative measures at the student and 
school levels. We will estimate generalizable predictive performance of these models via 10-
fold cross-validation and summarize impacts of predictors on outcomes via partial dependency 
plots. Interview data will be transcribed by the research assistant and subjected to content 
analysis to identify the primary themes related to barriers and facilitators to intervention 
receipt, effectiveness, and implementation, and intervention changes recommended. We will 

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employ recommended methods to integrate the quantitative and qualitative data collected 
through narrative descriptions and joint displays of the quantitative and qualitative data. 
  
Statistical Analysis and Power for research question #3:  
Primary Hypotheses. The 2-phase SMART design provides the opportunity to test multiple 
hypotheses. Our primary hypotheses (see Significance) address the effects of the interventions 
on COVID-19 testing rates and missed days of work/school: 1) Is the TM intervention superior 
to usual care? 2) Among those who are non-compliant to TM, is TM+HN superior to 
continued TM? 
Primary Analyses. Student, staff member and family socio-demographic effect modifiers will 
be tested using a linear mixed effects logistic regression model; regressing the outcome on 
treatment (i.e., TM vs. usual care; TM vs. TM+HN) and adjusting for fixed effects of school 
level, income (qualifies for free/reduced lunch), ethnic minority status, English spoken as 
primary language, and the interaction between treatment and the aforementioned effect 
modifier of interest. Random effects will include the student/staff member, school, and school 
nurse. School level modifiers will be modeled similarly, with school-level characteristics 
constant over all students within each school. Analyses will account for clustering by school. 
We will use linear contrasts to estimate main effects of TM vs. use on usual care and (among 
the participants assigned to TM) the effect of TM+HN vs. continued TM at each post-baseline 
timepoint. 
Power 
At the student- and staff- level, assuming 15% school days missed and accounting for unequal 
allocation of the modifiers, the study is 80% powered to detect a differential effect of 4.7% 
missed days among students eligible for free/reduced lunches and among ethnic minorities; 
and the study is 80% powered to detect a differential effect of 7.2% of COVID-19 testing. At 
the school level, an ICC of 0.02 is assumed and modifiers will be dichotomized at their 
median. We are 80% powered to detect an effect modifier of 7.5% in days missed school and 
of 11.9% of COVID-19 testing.