The Safer At School Early Alert HUB
Phase: NA
Conditions: COVID-19
Sponsor: University of California, San Diego

 
 
 
 
 
 
Safer at School Early Alert Hub 
Protocol ID: 1U01HD108787-01 
National Clinical Trial (NCT) Identified Number:  NCT05642000 
Principal Investigator: Rebecca Fielding-Miller 
Sponsor: University of California San Diego 
Funded by: NIH 
Version Number:  1 
September 19, 2022 
 

 
 
NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans 
CONFIDENTIALITY STATEMENT 
This document is confidential communication. Acceptance of this document constitutes agreement by the 
recipient that no unpublished information contained herein will be published or disclosed without prior 
approval of the Principal Investigator or other participating study leadership and as consistent with the 
NIH terms of award.  
 

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Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
INVESTIGATOR’S SIGNATURE .............................................................................................................................. 2 
1 
PROTOCOL SUMMARY ............................................................................................................................... 3 
1.1 
Synopsis ................................................................................................. Error! Bookmark not defined. 
1.2 
Schema ................................................................................................................................................. 4 
1.3 
Schedule of Activities .......................................................................................................................... 5 
2 
INTRODUCTION ............................................................................................................................................ 7 
2.1 
Study Rationale .................................................................................................................................... 7 
2.2 
Background ........................................................................................................................................... 7 
2.3 
Risk/Benefit Assessment .................................................................................................................... 8 
2.3.1 
Known Potential Risks ..................................................................................................... 8 
2.3.2 
Known Potential Benefits ................................................................................................ 8 
2.3.3 
Assessment of Potential Risks and Benefits ................................................................ 8 
3 
OBJECTIVES AND ENDPOINTS ................................................................................................................ 9 
4 
STUDY DESIGN ........................................................................................................................................... 10 
4.1 
Overall Design .................................................................................................................................... 10 
4.2 
Scientific Rationale for Study Design .............................................................................................. 14 
4.3 
Justification for Intervention ............................................................................................................. 15 
4.4 
End-of-Study Definition ..................................................................................................................... 15 
5 
STUDY POPULATION ................................................................................................................................ 15 
5.1 
Inclusion Criteria ................................................................................................................................ 15 
5.2 
Exclusion Criteria ............................................................................................................................... 16 
5.3 
Lifestyle Considerations .................................................................................................................... 16 
5.4 
Screen Failures .................................................................................................................................. 16 
5.5 
Strategies for Recruitment and Retention ...................................................................................... 16 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ............................................ 17 
6.1 
Study Intervention(s) or Experimental Manipulation(s) Administration ...................................... 17 
6.1.1 
Study Intervention or Experimental Manipulation Description ................................. 17 
6.1.2 
Administration and/or Dosing ....................................................................................... 17 
6.2 
Fidelity ................................................................................................................................................. 18 
6.2.1 
Interventionist Training and Tracking .......................................................................... 18 
6.3 
Measures to Minimize Bias: Randomization and Blinding ........................................................... 18 
6.4 
Study Intervention/Experimental Manipulation Adherence .......................................................... 18 
6.5 
Concomitant Therapy ........................................................................................................................ 18 
6.5.1 
Rescue Therapy ............................................................................................................. 19 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL ......................................................................................... 19 
7.1 
Discontinuation of Study Intervention/Experimental Manipulation ............................................. 19 
7.2 
Participant Discontinuation/Withdrawal from the Study ............................................................... 19 
7.3 
Lost to Follow-Up ............................................................................................................................... 19 
8 
STUDY ASSESSMENTS AND PROCEDURES ...................................................................................... 19 
8.1 
Endpoint and Other Non-Safety Assessments .............................................................................. 19 
8.2 
Safety Assessments .......................................................................................................................... 20 
8.3 
Adverse Events and Serious Adverse Events ............................................................................... 20 
8.3.1 
Definition of Adverse Events ........................................................................................ 20 
8.3.2 
Definition of Serious Adverse Events .......................................................................... 21 

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8.3.3 
Classification of an Adverse Event .............................................................................. 21 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 22 
8.3.5 
Adverse Event Reporting .............................................................................................. 22 
8.3.6 
Serious Adverse Event Reporting ............................................................................... 22 
8.3.7 
Reporting Events to Participants ................................................................................. 23 
8.3.8 
Events of Special Interest ............................................................................................. 23 
8.3.9 
Reporting of Pregnancy ................................................................................................ 23 
8.4 
Unanticipated Problems .................................................................................................................... 23 
8.4.1 
Definition of Unanticipated Problems .......................................................................... 23 
8.4.2 
Unanticipated Problems Reporting .............................................................................. 23 
8.4.3 
Reporting Unanticipated Problems to Participants ................................................... 24 
9 
STATISTICAL CONSIDERATIONS .......................................................................................................... 24 
9.1 
Statistical Hypotheses ....................................................................................................................... 24 
9.2 
Sample Size Determination .............................................................................................................. 24 
9.3 
Populations for Analyses .................................................................................................................. 25 
9.4 
Statistical Analyses ............................................................................................................................ 25 
9.4.1 
General Approach .......................................................................................................... 25 
9.4.2 
Analysis of the Primary Endpoint(s) ............................................................................ 25 
9.4.3 
Analysis of the Secondary Endpoint(s) .......................... Error! Bookmark not defined. 
9.4.4 
Safety Analyses .............................................................................................................. 26 
9.4.5 
Baseline Descriptive Statistics ..................................................................................... 26 
9.4.6 
Planned Interim Analyses ............................................................................................. 26 
9.4.7 
Sub-Group Analyses ..................................................................................................... 26 
9.4.8 
Tabulation of Individual Participant Data .................................................................... 26 
9.4.9 
Exploratory Analyses ..................................................................................................... 26 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 26 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 26 
10.1.1 
Informed Consent Process ........................................................................................... 27 
10.1.2 
Study Discontinuation and Closure ............................................................................. 27 
10.1.3 
Confidentiality and Privacy ........................................................................................... 27 
10.1.4 
Future Use of Stored Specimens and Data ............................................................... 29 
10.1.5 
Key Roles and Study Governance .............................................................................. 29 
10.1.6 
Safety Oversight ............................................................................................................. 29 
10.1.7 
Clinical Monitoring .......................................................................................................... 30 
10.1.8 
Quality Assurance and Quality Control ....................................................................... 30 
10.1.9 
Data Handling and Record Keeping ............................................................................ 30 
10.1.10 
Protocol Deviations ........................................................................................................ 31 
10.1.11 
Publication and Data Sharing Policy ........................................................................... 31 
10.1.12 
Conflict of Interest Policy .............................................................................................. 32 
10.2 
Additional Considerations ................................................................................................................. 32 
10.3 
Abbreviations and Special Terms ...................................................... Error! Bookmark not defined. 
10.4 
Protocol Amendment History ........................................................................................................... 33 
11 
REFERENCES ................................................................................................ Error! Bookmark not defined. 
 

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STATEMENT OF COMPLIANCE 
 
The trial will be carried out in accordance with International Council on Harmonisation Good Clinical 
Practice (ICH GCP) and the following:  
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812).  
 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have 
completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the IRB for review and approval. Approval of both the protocol and the consent 
form(s) must be obtained before any participant is consented. Any amendment to the protocol 
will require review and approval by the IRB before the changes are implemented to the study. All 
changes to the consent form(s) will be IRB approved; a determination will be made regarding 
whether a new consent needs to be obtained from participants who provided consent, using a 
previously approved consent form.] 
 
 

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INVESTIGATOR’S SIGNATURE 
The signature below constitutes the approval of this protocol and provides the necessary assurances 
that this study will be conducted according to all stipulations of the protocol, including all statements 
regarding confidentiality, and according to local legal and regulatory requirements and applicable US 
federal regulations and ICH guidelines, as described in the Statement of Compliance above. 
 
Principal Investigator or Clinical Site Investigator: 
Signed: 
 
Date: 
4/25/24 
 
Name: Rebecca Fielding-Miller 
 
Title:     Associate Adjunct Professor 
 
 
 
 
 
 
 

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1 
PROTOCOL SUMMARY 
 
Protocol Title 
Safer at School Early Alert Hub 
Principal Investigator 
Rebecca Fielding-Miller 
Study Sites 
University of California, San Diego 
Study Activation Date 
September 19, 2022 
Planned Accrual 
 Total number of participants - 971 
Planned Accrual Period 
September 19, 2022 to December 17, 2022 
 
Planned Duration 
Data collection period: September 19, 2022 to December 17, 2022  
Intervention period: October 3, 2022 to March, 2023 
Study Design 
Create the Safer at School Early Alert School Hub (SASEA Hub), a school-
based environmental surveillance dashboard and diagnostic testing 
resource hub with an accompanying toolkit for rapid community 
tailoring to improve COVID-19 testing uptake in vulnerable and 
underserved communities using a Community Based Participatory 
Research (CBPR) framework and the Consolidated Framework for 
Implementation Research (CFIR).  
We will evaluate the ability of the saseahub.org to increase child and 
household diagnostic testing uptake via a step-wedge trial, with schools 
rotated onto the intervention arm (i.e., given access to the 
saseahub.org) at 2-week intervals.  All schools will rotate into the 
intervention by the Thanksgiving holiday.   

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Study Objectives 
Aim 1: Create the SASEA Hub, a school-based environmental 
surveillance dashboard and diagnostic testing resource hub with an 
accompanying toolkit for rapid community tailoring to improve COVID-
19 testing uptake in vulnerable and underserved communities using a 
Community Based Participatory Research (CBPR) framework and the 
Consolidated Framework for Implementation Research (CFIR). 
Aim 2: Assess SASEA Hub’s (intervention’s) potential to increase 
diagnostic testing uptake and identify more asymptomatic cases than 
schools. We will assess this aim through a randomized stepped wedge 
cluster trial design. The primary outcome will be testing uptake within 
the past 14-day period, assessed through the SASEA bi-weekly 
community survey.  
Aim 3: Assess SASEA Hub’s ability to increase risk mitigation behaviors 
(masking, physical distancing, increased hand hygiene) when the Hub 
notifies schools of a change in county level COVID-19 case rates or 
county level wastewater levels  
Treatment Description 
Intervention – receive access to the community tailored SASEA Hub 
website 
Inclusion Criteria 
Parent of a child or staff member attending one of 26 SASEA 
participating schools 
Exclusion Criteria 
All non SASEA school participating individuals or students of SASEA 
participating schools 
Study Outcomes 
Primary outcome – The primary study endpoint will be student 
diagnostic testing uptake in the previous 14-days, measured using 
household surveys distributed at 2-week intervals. 
1.1 
SCHEMA  
 

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1.2 
SCHEDULE OF ACTIVITIES  
 
Our timetable is shown below. Our partner schools will be enrolled as of August 2022, and we will 
already be implementing SASEA by the time this project begins. We anticipate completing all data 
collection by the end of Year 1 and will then work with our Community Advisory Board to develop the 
toolkit, with anticipated dissemination by the next academic school year. Throughout Year 2 we will 
continue analyzing data related to Aim 4, prepare manuscripts, lay summaries of findings to share with 
community partners, and applications for next-step work.  
  
Y
1
Q
1 
Y
1
Q
2 
Y
1
Q
3 
Y
1
Q
4 
Y
2
Q
1 
Y
2
Q
2 
Y
2
Q
3 
Y
2
Q
4 
Formalize CAB, hire and train staff 
  
  
  
  
  
  
  
  
Key informant interviews for template design (n=5) 
  
  
  
  
  
  
  
  
Pilot data analysis and dashboard template design with 
CAB 
  
  
  
  
  
  
  
  
Stepped wedge trial with cluster-level dashboard tailoring 
  
  
  
  
  
  
  
  
Parent-child interviews (n=40) 
  
  
  
  
  
  
  
  
CFIR data analysis and tailoring toolkit development 
  
  
  
  
  
  
  
  
Community data dissemination 
  
  
  
  
  
  
  
  
Parent-child narrative analysis 
  
  
  
  
  
  
  
  
Manuscript writing and dissemination, prepare follow-up 
applications 
  
  
  
  
  
  
  
 
 

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2 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
 
The SARS-CoV-2 pandemic necessitated the closure of childcare and school sites around the world. 
Schools and childcare settings present a unique dilemma for epidemic abatement: As indoor settings 
where individuals who are not currently eligible for COVID-19 vaccines spend large amounts of time in 
close proximity to one another they can have very high potential for the virus to spread. Timely 
detection of asymptomatic infections in school settings is necessary to prevent outbreaks in school 
settings, particularly asymptomatic outbreaks that could lead to larger community outbreaks among the 
unvaccinated and/or the evolution of new variants of concern (VoCs) with increased vaccine escape 
potential. This project will create a unique public-facing dashboard and resource hub (SASEA Hub 
website) that provides school staff and parents immediate access to environmental testing results from 
their neighborhood with accompanying information about COVID-19 testing and other related 
resources. The project will also provide novel information about the potential impact of the dashboard 
and resource hub on testing practices among students, parents and the broader community. 
 
 
2.2 
BACKGROUND  
 
Public schools are often cornerstones of their community. In historically marginalized communities in 
particular, they are often trusted providers for a range of support. The tradeoff between these crucial 
benefits of in-person learning versus the risk of SARS-CoV-2 transmission resulting from in-person learning 
has been hotly debated throughout much of 2020 and 2021. The stakes are particularly high in historically 
marginalized communities which rely most heavily on school services but have also been hit the hardest 
by COVID-19. Individual diagnostic testing combined with contact tracing and behavioral risk mitigation 
(masking, hand hygiene, ventilation, distancing) is key to reducing SARS-CoV-2 transmission and ensuring 
safe in-person learning.   
  
The SASEA program was co-developed by the University of California, San Diego (UCSD), the County of 
San Diego, and 15 partner schools serving socially vulnerable students in 5 school districts. SASEA utilizes 
daily wastewater and surface (floor) environmental monitoring to detect asymptomatic SARS-CoV-2 
infections. Responsive diagnostic testing is immediately triggered by positive environmental samples. In 
our pilot, SASEA was significantly associated with increased testing uptake among students and staff, and 
75% of asymptomatic COVID-19 cases were preceded by a positive environmental sample.  
 
The SASEA Hub intervention offers key innovations in school-community-public health partnership, 
utilizing anonymous, aggregate, and low-cost environmental surveillance strategies to trigger diagnostic 
testing, and rapid genetic surveillance with high spatial resolution. Because public schools serve families 
that reside within a specific geographic catchment area, and because children are likely to have the lowest 
levels of vaccine uptake even when vaccines become available for children under 12, SASEA Hub schools 
will provide community sentinel surveillance sites with a high degree of geographic resolution.   

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In addition to early warning data for students, staff, and parents, increased rates of environmental 
detection at a SASEA Hub neighborhood, even in the absence of diagnosed cases, can allow public health 
officials and community stakeholders to rapidly implement increased diagnostic testing and vaccine 
outreach, and to closely tailor these outreach efforts to the specific community. This project will create a 
unique public-facing dashboard and resource hub that provides school staff and parents immediate access 
to environmental testing results from their schools with accompanying information about COVID-19 
testing and other related resources. The project will also provide novel information about the potential 
impact of the dashboard and resource hub on testing practices among students, parents and the broader 
community. 
 
2.3 
RISK/BENEFIT ASSESSMENT  
 
There will be no risk in enrolling to receive text/email notifications for SASEA Hub website updates related 
to COVID-19 information.  
 
We anticipate that the surveys sent to school parents and staff will hold minimal risk. There is a chance 
that participants may become emotional, uncomfortable, or bored when completing the survey due to 
topics concerning COVID-19. There is a small risk that survey data confidentiality could be breached and 
sensitive information may be exposed. We will not ask for personally identifiable information in these 
surveys.   
  
2.3.1 KNOWN POTENTIAL RISKS  
 
There will be no risk in enrolling to receive text/email notifications for SASEA Hub website updates related 
to COVID-19 information.  
 
We anticipate that the surveys sent to school parents and staff will hold minimal immediate and long term 
risk. There is a chance that participants may become emotional, uncomfortable, or bored when 
completing the survey due to topics concerning COVID-19. There is a small risk that survey data 
confidentiality could be breached and sensitive information may be exposed. We will not ask for 
personally identifiable information in these surveys. No alternative procedures/methods have been 
considered as the surveys will hold minimal risk.  
 
2.3.2 KNOWN POTENTIAL BENEFITS  
 
Being part of a school enrolled in SASEA Hub will benefit school staff and parents by receiving 
environmental COVID-19 monitoring updates on their neighborhood along with additional COVID-19 
related information on vaccination and testing locations.  
 
ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
 

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There is minimal risk in participating in the intervention – being part of a school receiving the SASEA Hub 
website. The surveys sent to the school families also hold minimal risk. Being part of a school enrolled in 
SASEA Hub will benefit school staff and parents by receiving environmental COVID-19 monitoring updates 
on their neighborhood along with additional COVID-19 related information on vaccination and testing 
locations. 
 
OBJECTIVES AND ENDPOINTS  
 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
PUTATIVE 
MECHANISMS OF 
ACTION 
Primary 
 
 
 
 
The primary outcome will be 
testing uptake among 
children within the past 14-
day period, assessed through 
the SASEA bi-weekly 
community survey. 
 
 
COVID-19 testing 
in past 14 days 
among children 
only 
 
 
We will assess this aim 
through a randomized 
stepped wedge cluster trial 
design. The primary outcome 
will be testing uptake within 
the past 14-day period, 
assessed through the SASEA 
bi-weekly community survey. 
 
The SASEA Hub intervention 
offers key innovations in 
school-community-public 
health partnership, utilizing 
anonymous, aggregate, and 
low-cost environmental 
surveillance strategies to 
trigger diagnostic testing, and 
rapid genetic surveillance 
with high spatial resolution.  
  
  
  
In addition to early warning 
data for students, staff, and 
parents, increased rates of 
environmental detection at a 
SASEA Hub school, even in the 
absence of diagnosed cases, 
can allow public health 
officials and community 
stakeholders to rapidly 
implement increased 
 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
PUTATIVE 
MECHANISMS OF 
ACTION 
diagnostic testing and vaccine 
outreach, and to closely tailor 
these outreach efforts to the 
specific community (i.e., 
ensure properly translated 
materials, address testing 
barriers specific to the 
community as identified in 
Aim 1) 
 
STUDY DESIGN 
 
2.4 
OVERALL DESIGN 
This study uses a mixed-methods convergent participatory design27 (Figure 5). Prior to the stepped 
wedge trial we will work with our CAB to develop a dashboard and resource hub template. We will then 
utilize a 20-week randomized stepped wedged trial in 48 school sites with approximately 24,000 
students and staff to assess aims 2 and 3. During each 4-week step interval we will use key informant 
interviews and focus group discussions to tailor the dashboard template to each cluster’s specific needs, 
preferences, and available community resources.  
C.4 Aim 1: Create SASEA Hub, a school-based, public facing environmental surveillance dashboard and 
diagnostic testing resource hub, along with an accompanying toolkit for rapid community tailoring to 
improve access, acceptability, and implementation of COVID-19 testing in vulnerable and underserved 
communities using participatory action research to identify (1) core and (2) community-specific barriers 
to diagnostic testing within and across 4 low income and historically marginalized communities in San 
Diego County. 
Background 

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Formative research is necessary to ensure that COVID-19 diagnostic testing, prevention, contact tracing, 
and isolation strategies are appropriately tailored to the unique needs of underserved and/or socially 
vulnerable communities. The objective of Aim 1 is to develop an environmental results dashboard and 
resource hub that can be rapidly tailored for diverse contexts to address COVID-19 diagnostic testing 
access and acceptability. The toolkit will contain the following components: (1)A customizable 
dashboard, developed using ArcGIS, for reporting school environmental surveillance results 
(2)Templates for online and print resources for schools to share with their community that address 
barriers to diagnostic testing access as well as the potential implications of a positive test; and (3)A 
toolkit to tailor the dashboard resource hub to specific communities.  
C.4.1a Methods to create Product 1  

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Step 1: Dashboard Template Design 
 
After convening our CAB, we will host a participatory mixed methods data analysis workshop using data 
from 15 Focus Group Discussions (FGDs) in in English and Spanish with 49 parents and staff members 
from our pilot partner schools, as well as survey data collected from 299 parents and teachers in 
February of 2020. These data were collected during our pilot phase from November 2020 – March 2021. 
FGD domains included perceptions of diagnostic testing and contact tracing, barriers to testing access, 
and preferred strategies for notifications of environmental results. While our team has already reviewed 
these data internally and begun the process of preparing manuscripts for dissemination, a participatory 
workshop with our CAB will allow us to more fully incorporate community member insights, providing us 
with a richer understanding of the data that will support a more responsive public-facing dashboard 
template design. After the analysis workshop, we will conduct up to 5 additional key informant 
interviews with school administrators, parent leaders, and county leadership to ensure that our 
template is responsive to current district, county, and state guidelines. 
We will build the dashboard template using ESRI’s ArcGIS. This platform is easy to configure, can be 
embedded in a variety of websites (for example, school or district sites), and can provide real-time data 
updates on environmental monitoring results pulled from a central server maintained by our team at 
UCSD and/or the laboratory processing samples. We have already created a dashboard mockup, risk 
index, and a variety of printable resources as part of our pilot project (Figure 6). We will review and 
modify these with our CAB based on the data analysis workshop and current local and national 
guidelines. 
Step 2: Community Tailoring 
Once we have developed the initial template, we will tailor the dashboard to each school cluster in the 
3-4 weeks before a site rotates into the intervention (SASEA Hub) condition using rapid community 
needs and asset mapping based on the methods developed by Lazarus et al. We will conduct 4 focus 
group discussions (FGDs) of approximately 8 parents and staff in each cluster. Focus group participants 
will be asked to participate in a series of activities to identify community needs and assets related to 

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COVID-19 diagnostic testing uptake and health disparities in their community. The final activities and 
focus group domains will be determined together with our CAB. Likely activities are shown in table 1.  
Table 1: Community mapping exercises 
Exercise 
Details 
1: Community mapping 
Participants draw maps of their community to 
identify needs and assets related to COVID-19 
diagnostic testing uptake and related health 
disparities 
2: Health and safety within the (school) 
community 
Participants identify key factors in their 
community that support or undermine diagnostic 
testing and/or contribute to related health 
disparities   
3: Contribution of school and community assets 
to (school) community health and diagnostic 
testing uptake. 
Participants synthesize needs, assets, and factors 
identified in exercises 1 and 2 to create a 
community needs and asset ranking matrix. 
4: Local action / resource creation 
Using the matrix developed in exercise 3, 
participants identify pre-existing resources that 
should be included in SASEA-HUB and/or 
resources that should be created by the CAB and 
study team (i.e., translations or summaries of key 
information.) 
Step3: SASEA Hub documentation and tailoring toolkit 
Throughout the study, we will collect formative process data by meeting regularly with our CAB. We will 
document the tailoring and academic-community collaboration process using the Consolidated 
Framework for Implementation Research (CFIR)29 and the Community Based Participatory Research 
(CBPR) model developed by Belone et al30 as shown in Table 2. Both models recommend regular team 
meetings and debriefings to reflect on the process of implementation. We will hold regular study team 
and CAB check-in meetings in which we will reflect on (1) the complexity and logistics of the process, (2) 
the potential cost of the project and sources for long-term funding (i.e., state grants) (3) the 
organizational capacity necessary to conduct tailoring data collection and implement the project, and (4) 
the climate of the project and whether all team members feel equally heard and valued. Similarly, the 
CBPR model advises study teams to systematically reflect on (1) context, (2) partnership process, and (3) 
processes and outputs of research. These CBPR and CFIR guided reflections will be recorded using a 
standardized data collection sheet.  
C.4.2.c Analyses for Product 1: We will analyze data for steps 1 and 2 in real time as part of the 
workshops and focus group discussions. Members of the study team will also record these conversations 
and take extensive notes throughout to verify any discrepancies that emerge later. After all 4 tailored 
dashboards (one per school cluster) have been deployed, we will conduct a second round of 
participatory data analysis workshops with our CAB to identify core similarities and key differences in 

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the 4 different community need and asset mapping exercises and use these to further refine the 
dashboard template. We will also analyze the data collected from team debriefings to create a shareable 
toolkit of best practices for dashboard tailoring.  
C.4.3 Expected outcomes and products of Aim 1: The dashboard template and toolkit we generate will 
be made available on our project website (www.SASEAsystem.org), which already hosts open access 
laboratory and project implementation protocols for school environmental monitoring.  
 C.4.4 Potential problems and contingency plans We 
recognize that school administrators, parents, and 
other key stakeholders are likely to have significant 
time constraints. We have very strong relationships 
with school districts across the county, as well as the 
San Diego County Health and Human Services Agency 
(see letters of support). However, if time constraints 
do not permit the opportunity for live IDIs, we will 
instead email our proposed toolkit and questions for 
written feedback. 
 
 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
Our conceptual framework is based on our pilot data 
and behavioral theory (figure 4)  
   
Drawing from both Social Cognitive Theory 
(SCT) and the Social Ecological Model (SEM), we 
assume that accessing a COVID-19 diagnostic 
test is affected by individual self-efficacy and 
desire to learn one’s COVID-19 status, as well as 
social and structural factors such as geographic 
access to a testing site, linguistic and cultural 
tailoring of health outreach efforts, and 
community level social vulnerabilities (including 
any local, state, or municipality regulations 
related to COVID-19 sick leave, unemployment 
insurance, or rent relief). Desire to test will also 
be influenced by the perceived implications of 
testing, whether a desire to know one’s status 
is to protect one’s own health and one’s 
community, or a fear of stigma and blame upon 
diagnosis. Testing implications are also directly 
related to perceived implications of a positive 
diagnosis – contact tracing has been linked to 
fears of data privacy, particularly for those who 
are undocumented or living in households with 
mixed documentation status – and tracking and 

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tracing efforts seem to echo previous alleged government surveillance efforts by the FBI for many ethnic 
minority Muslim communities. Similarly, a positive test implies the need to isolate with attendant 
concerns about lost wages, the ability to isolate safely, dependent care, and mental and emotional health 
during isolation.   
  
In addition to providing resources to address these social and structural factors (i.e., providing 
downloadable materials in a user’s preferred language, linking local to income-replacement or other 
economic support services) SASEA Hub is also designed to serve as a cue to action via environmental 
testing data. Environmental testing results and a community risk indicator that incorporates the 
percentage of students and staff who have consented to responsive testing will be part of the public facing 
dashboard.   
  
SASEA Hub posits that specific cues to test as a result of concrete risk information (i.e., higher 
concentrations of COVID-19 particles in wastewater), along with resources to address social and structural 
barriers to diagnostic testing, is more likely to result in diagnostic testing uptake than (1) offering routine 
diagnostic testing in the absence of environmental cues, and (2) environmental cues alone with no 
resources to offset structural barriers. 
 
JUSTIFICATION FOR INTERVENTION 
 
Formative research is necessary to ensure that COVID-19 diagnostic testing, prevention, contact tracing, 
and isolation strategies are appropriately tailored to the unique needs of underserved and/or socially 
vulnerable communities. The objective of Aim 1 is to develop an environmental results dashboard and 
resource hub that can be rapidly tailored for diverse contexts to address COVID-19 diagnostic testing 
access and acceptability. The toolkit will contain the following components: (1)A customizable dashboard, 
developed using ArcGIS, for reporting regional environmental surveillance results (2)Templates for online 
and print resources for schools to share with their community that address barriers to diagnostic testing 
access as well as the potential implications of a positive test; and (3)A toolkit to tailor the dashboard 
resource hub to specific communities. 
 
We will utilize a 20-week randomized stepped wedged trial in 48 school sites with approximately 24,000 
students and staff to assess aims 2 and 3. During each 4-week step interval we will use key informant 
interviews and focus group discussions to tailor the dashboard template to each cluster’s specific needs, 
preferences, and available community resources. The stepped wedged trial will allow all participants to 
eventually access this COVID-19 tool to help them assess their risk and choose mitigation strategies. It 
would be unethical to restrict information of this kind from some participants. 
 
END-OF-STUDY DEFINITION 
 
A participant is considered to have completed the study if she or he has completed the community survey. 
 
STUDY POPULATION 
INCLUSION CRITERIA 

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In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
1. Parent with children enrolled at any of the 50 schools across the San Diego County that 
participated in the study during the 2021-2022 school year. 
2. School staff working at any of the 50 schools across the San Diego County that participated in 
the study during the 2021-2022 school year.  
3. Provision of signed and dated informed consent form 
4. Access to necessary resources for participating in a technology-based intervention (i.e., 
computer, smartphone, internet access) 
 
 
EXCLUSION CRITERIA 
 
An individual who meets any of the following criteria will be excluded from participation in this study: 
1. Not affiliated with participating sites as parents or staff.  
2. No access to necessary resources for participating in a technology-based intervention (i.e, 
computer, smartphone, internet access) 
 
LIFESTYLE CONSIDERATIONS 
 
N/A 
 
SCREEN FAILURES 
 
N/A 
 
STRATEGIES FOR RECRUITMENT AND RETENTION 
 
This study will consist of a 20-week randomized stepped wedge cluster trial. Parents will be invited to 
participate in a 5–10-minute self-administered survey conducted at 4-week intervals. Prospective parent 
participants will be identified using a sampling frame provided by schools, at the beginning of the school 
year, consisting of classroom, classroom size, and grade level. etween 40 participating schools clustered 
and 8 childcare sites within 4 district clusters (approximately 12 sites per district cluster) will be enrolled 
during the study; for a total of 48 sites and 4 district clusters. The average size of school and childcare 
sites is 500. From the sampling frame, three classrooms within each school will be randomly selected.  
Within the randomly selected classroom, teachers will distribute a survey invitation to all students. 
Average class size is 25 and we anticipate a 25% response rate per class, resulting in approximately 20 
surveys per site or approximately 150 surveys per cluster. Random samples of classrooms will be 
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biostatistician. All parents will be notified of the study and the possibility of receiving a survey invitation 
by school administrators at the beginning of the school year, with periodic reminders.  
This is a one time survey that does not require participant retention. Participants who complete the 
survey will be entered into a 1 of 3 $250 raffle gift card as an incentive. 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION 
 
STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
 
Assess SASEA Hub’s potential to increase diagnostic testing uptake and identify more asymptomatic cases 
than schools with SASEA environmental and response testing alone (control); and  
  
Assess SASEA Hub’s ability to increase risk mitigation behaviors (masking/double masking, physical 
distancing, increased hand hygiene, enhanced ventilation) when a potential case is signaled but not 
identified.  
  
Intervention schools will have higher rates of diagnostic testing than control-arm schools. We will test this 
hypothesis using self-reported survey data 
  
Diagnostic testing among household members of students will be higher in the control arm. We will test 
this hypothesis using self-administered survey data. Survey participants will be asked if they (1) have 
learned of any positive cases at the school site in the previous 14 days, and (2) whether or not they and 
their household members accessed a diagnostic test as a result of that notification.  
  
School staff and families will use more behavioral risk mitigation strategies in the three days following a 
potential case signal compared to times when there is no signal. We will test this hypothesis using 
biweekly surveys and structured systematic observations at school sites. 
ADMINISTRATION AND/OR DOSING 
 
Forty-eight participating schools (approximately 24,000 student and staff) clustered within 4 geographic 
areas will be enrolled during the study. The average size of school/childcare site is 500. Implementation 
of the intervention (SASEA Hub) will be conducted using a cluster randomized stepped wedge design, 
where the schools will be randomized by the study biostatistician, Dr. Gaines, into 4 clusters (with 12 
schools per cluster). Clusters will receive the intervention in a randomized order over 4 successive waves 
(see Figure 5) during a 20-week period (from mid-January 2022 to beginning of June 2022).  
   
A random cross-sectional sample of parents and caregivers (hereafter referred to as “parents”) will be 
selected to participate in a 5–10-minute self-administered survey conducted at 4-week intervals (see 
Table 3). Prospective parent participants will be identified using a sampling frame provided by schools, at 
the beginning of the school year, consisting of classroom, classroom size, and grade level. From the 
sampling frame, three classrooms within each school will be randomly selected. Within the randomly 

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selected classroom, teachers will distribute a survey invitation to all students. Average class size is 25 and 
we anticipate a 15% response rate per class, resulting in approximately 12 surveys per school or 
approximately 144 surveys per cluster; equating to 2,880 parent surveys during the 20-week period. 
Random samples of classrooms will be selected every 4-weeks with replacement using a randomization 
schedule generated by the study biostatistician, Dr. Gaines. To increase generalizability, we will randomly 
select serial cross-sectional samples with replacement since serial samples will allow for greater 
representation given the likelihood of student absences on the day of recruitment (e.g., potential for 
individual students to be absent and/or classrooms to be quarantined due to COVID-19 exposure). All 
parents will be notified of the study and the possibility of receiving a survey invitation by school 
administrators at the beginning of the school year, with periodic reminders.   
  
The primary outcome, diagnostic testing before and after implementation of the SASEA Hub will be 
examined using a mixed effects logistic regression with fixed effects for Time, SASEA Hub, and the 
interaction of Time x SASEA Hub. The mixed effects model will include a random component for school-
level intercepts (to account for students nested within schools) and district-level intercepts (to account 
for schools nested in districts). Potential confounders will be controlled for in the model (e.g., baseline 
COVID-19 diagnostic testing and vaccination rates within communities encompassing schools, school size, 
race/ethnicity, % receiving free/reduced lunch).  
 
FIDELITY 
INTERVENTIONIST TRAINING AND TRACKING 
 
All schools will be receiving the same SASEA Hub website as the intervention with minimal modifications 
based on their region. Region specific wastewater results and vaccine locations will be provided.  
 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
 
Because of the stepped wedge trial, all schools will be receiving the intervention (SASEA HUB). There is no 
randomization occurring in intervention rollout. As schools do not receive the website before the 
intervention, schools will not be in communication with other schools and will not find out about the 
website before the intervention is introduced to their campus.  
 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
 
N/A 
 
CONCOMITANT THERAPY 
 
 
N/A 

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RESCUE THERAPY 
 
N/A 
 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
 
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
Because the website traffic and survey participation are voluntary, there will be no need to remove 
participants from the study.  
 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Participants are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue a participant from the study for the following reasons: 
 
• 
Significant study intervention non-compliance, unless varying compliance is an aspect of the study 
objectives  
• 
Lost-to-follow up; unable to contact subject (see Section 7.3, Lost to Follow-Up) 
• 
Any event or medical condition or situation occurs such that continued collection of follow-up  
study data would not be in the best interest of the participant or might require an additional 
treatment that would confound the interpretation of the study 
• 
The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation 
 
LOST TO FOLLOW-UP 
 
There will be no follow up in this study. Participants are completing a one-time survey. Participants may 
decide to discontinue the survey at any time. Participants receiving notifications to the SASEA Hub website 
may also choose to discontinue the notifications.  
 
STUDY ASSESSMENTS AND PROCEDURES 
 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
 
No safety end point procedure was provided to participants since there was minimal risk in participating 
in a SASEA Hub school and completing the surveys.  
 

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SAFETY ASSESSMENTS 
 
1. Physical risk management plan 
a. We do not anticipate any physical risks from participating in this study.  
2. Psychological risk management plan  
a. Adverse Emotional Reaction: Following administration of screeners or surveys, if 
discomfort is evident. Significant discomfort will be study PI, Dr. Fielding-Miller, or her 
designee, and recommendation for continued monitoring by staff or for referral, as 
appropriate, for further evaluation and treatment will be made.  
3. Social/political risk management plan 
a. Adverse Community/Social impact from publication of study results: Significant rates of 
COVID-19 as well as other risk behaviors and psychiatric disorders occur in most ethnic 
groups. The specifics of the rates of these disorders and behaviors, their relationship to 
risk, protective, and resilience factors, and the effects of individual and environmental 
intervention remain to be determined. However, it seems unlikely that specific rates or 
characteristics of these factors in historically marginalized school communities in San 
Diego County or differences as compared to other groups will lead to stigmatization. 
Nevertheless, we plan to take the following steps to minimize this risk:  
b. Ongoing community feedback to school communities about the nature, purposes, and 
results of the study. This will afford an opportunity for community feedback on issues 
that might represent potential risk of stigmatization prior to publication of results.  
4. Confidentiality risk management plan  
All identifiable PHI data will be stored on a secure REDCap server and shared with the CDCC 
using appropriate protocols. Paper documents and digital recorders containing names and other 
identifying information (i.e., paper consent forms, focus group transcripts) will be kept in a 
locked file drawer in a locked office. All digital files will be deleted after transcription. 
Transcripts will be de-identified and kept on a password protected computer. 
 
Assessment of adverse events. PI, Rebecca Fielding-Miller, PhD MSPH, or her designees, who will 
constitute the committee responsible for monitoring the safety of this study, executing the Data and 
Safety Monitoring Plan (DSMP), and complying with the reporting requirements. All Serious Adverse 
Events will be reported to the UCSD IRB and to NIH within two business days.   
 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
DEFINITION OF ADVERSE EVENTS 
 

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Mild adverse event (AE is transient and usually self-limited, requires no more than minimal intervention, 
monitoring, or treatment, does not interfere with the participant's daily activities, usually does not require 
discontinuation from the study).   
  
Moderate adverse event (AE may or may not be transient and self-limited, requires more than minimal 
intervention, monitoring, or treatment, interferes with daily activities, usually does not require 
discontinuation from the study).   
DEFINITION OF SERIOUS ADVERSE EVENTS 
 
Severe adverse event (AE usually not transient and self-limited, requires significant intervention, 
monitoring, or treatment, any AE resulting in hospitalization, prolongation of existing hospitalization, or 
significant disability/incapacity).   
  
Life-threatening adverse event, persistently disabling adverse event, or a congenital anomaly/birth defect.   
  
Fatal adverse event.   
CLASSIFICATION OF AN ADVERSE EVENT 
N/A 
2.4.1.1 SEVERITY OF EVENT 
 
Mild adverse event (AE is transient and usually self-limited, requires no more than minimal intervention, 
monitoring, or treatment, does not interfere with the participant's daily activities, usually does not require 
discontinuation from the study).   
  
 
Moderate adverse event (AE may or may not be transient and self-limited, requires more than minimal 
intervention, monitoring, or treatment, interferes with daily activities, usually does not require 
discontinuation from the study).   
 
Severe adverse event (AE usually not transient and self-limited, requires significant intervention, 
monitoring, or treatment, any AE resulting in hospitalization, prolongation of existing hospitalization, or 
significant disability/incapacity).   
  
Life-threatening adverse event, persistently disabling adverse event, or a congenital anomaly/birth defect.   
  
Fatal adverse event.   
 
2.4.1.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
Related – The AE is known to occur with the study procedures, there is a reasonable possibility that the 
study procedures caused the AE, or there is a temporal relationship between the study procedures and 

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the event. Reasonable possibility means that there is evidence to suggest a causal relationship between 
the study procedures and the AE. 
 
Not Related – There is not a reasonable possibility that the study procedures caused the event, there is 
no temporal relationship between the study procedures and event onset, or an alternate etiology has 
been established. 
 
EXPECTEDNESS  
 
The likelihood of the incidence of the occurrence of each adverse event during a participant's involvement 
in the study is estimated using the following categories:   
  
Likely: incidence equal to or greater than 10%   
  
Less Likely: incidence equal to or greater than 1% to less than 10%   
  
Rare: incidence less than 1%   
  
1. Physical Risk: rare, no biological samples will be collected from human subjects in this study   
2. Psychological Risk: Adverse emotional reaction to the information collected in screeners or 
surveys. This includes an adverse emotional reaction to reporting substance use, related 
morbidity, or other associated problems (mild, rare).    
3. Social/Political Risk: Adverse community/social impact from publication of study findings 
(moderate, rare).   
4. Legal Risk: Lawsuits arising from the testing intervention (moderate, rare).   
5. Confidentiality Risk: Loss of confidentiality in any of the studies, but particularly those obtaining 
Identified PHI (private health information) (moderate, rare).   
6. Other Risks: None   
 
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
Rebecca Fielding-Miller, PhD MSPH, or her designees, who will constitute the committee responsible for 
monitoring the safety of this study, executing the Data and Safety Monitoring Plan (DSMP), and 
complying with the reporting requirements. All Serious Adverse Events will be reported to the UCSD IRB 
and to NIH within two business days.   
2.4.2 ADVERSE EVENT REPORTING  
Rebecca Fielding-Miller, PhD MSPH, or her designees, who will constitute the committee responsible for 
monitoring the safety of this study, executing the Data and Safety Monitoring Plan (DSMP), and 
complying with the reporting requirements. All Serious Adverse Events will be reported to the UCSD IRB 
and to NIH within two business days.   
2.4.3 SERIOUS ADVERSE EVENT REPORTING  
  

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Rebecca Fielding-Miller, PhD MSPH, or her designees, who will constitute the committee responsible for 
monitoring the safety of this study, executing the Data and Safety Monitoring Plan (DSMP), and complying 
with the reporting requirements. All Serious Adverse Events will be reported to the UCSD IRB and to NIH 
within two business days. 
 
2.4.4 REPORTING EVENTS TO PARTICIPANTS  
 
N/A 
2.4.5 EVENTS OF SPECIAL INTEREST  
N/A 
 
2.4.6 REPORTING OF PREGNANCY  
N/A 
 
2.5 
UNANTICIPATED PROBLEMS 
 
2.5.1 DEFINITION OF UNANTICIPATED PROBLEMS 
 
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human Research 
Protections (OHRP).  OHRP considers unanticipated problems involving risks to participants or others to 
include, in general, any incident, experience, or outcome that meets all of the following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
participant population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized. 
 
2.5.2  UNANTICIPATED PROBLEMS REPORTING  
 
[The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB) and to the Data Coordinating Center (DCC)/lead principal investigator (PI). The UP report will include 
the following information: 
 
Rebecca Fielding-Miller, PhD MSPH, or her designees, who will constitute the committee responsible for 
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with the reporting requirements. All Serious Adverse Events will be reported to the UCSD IRB and to NIH 
within two business days. 
2.5.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
 
N/A 
 
3 
STATISTICAL CONSIDERATIONS  
 
 
3.1 
STATISTICAL HYPOTHESES 
 
• 
Primary Endpoint(s):  
For the primary outcome, we hypothesize that diagnostic testing among household members of 
students will be higher in the control arm. We will test this hypothesis using self-administered survey 
data. Survey participants will be asked if they (1)have learned of any positive cases at the school site 
in the previous 14 days, and (2)whether or not they and their household members accessed a 
diagnostic test as a result of that notification. 
 
• 
Secondary Endpoint(s): 
 
N/A 
 
3.2 
SAMPLE SIZE DETERMINATION 
 
Power was computed for a randomized stepped wedge design with 48 schools, 4 clusters (12 schools per 
cluster), and 5 steps with 1 cluster per step (or 4-week interval) based on diagnostic testing uptake in 
response to a positive environmental signal (see 1, responsive testing). Power is based on the primary 
outcome, on-site COVID-19 diagnostic testing uptake in response to a positive environmental signal in 
schools (see section A.4.1 and C.5.2). Published studies on the uptake of COVID-19 diagnostic testing 
among school-aged children and their household members in the presence of environmental surveillance 
are non-existent. We relied on testing rates observed in San Diego County schools during the latter half 
of the 2020-2021 academic year. Assuming a baseline COVID-19 testing rate of 2%, intra-class correlation 
ICC=0.10, Type I error rate of 0.05, and an average of 500 staff/students per school, we will have more 
than 80% power to detect a minimal difference of 0.06% in weekly testing uptake (2.0% pre SASEA-SNAP 
vs. 2.6% post SASE-SNAP). Using similar assumptions for the secondary outcome, COVID-19 diagnostic 
testing uptake within household members of students, we will have over 80% power to identify a minimal 
detectable difference of 2.8% in testing uptake with a serial cross-sectional sample of 2,880 parents (2.0% 
pre SASEA-SNAP vs. 4.8% post SASEA-SNAP). Power was calculated in STATA 16.1 using a method 
described by Hemming and Girling 
 

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3.3 
POPULATIONS FOR ANALYSES 
 
A random cross-sectional sample of parents and caregivers will be selected to participate in a 5–10-minute 
self-administered survey conducted at 4-week intervals (see Table 3). Prospective parent participants will 
be identified using a sampling frame provided by schools, at the beginning of the school year, consisting 
of classroom, classroom size, and grade level. From the sampling frame, three classrooms within each 
school will be randomly selected. Within the randomly selected classroom, teachers will distribute a 
survey invitation to all students. Average class size is 25 and we anticipate a 15% response rate per class, 
resulting in approximately 12 surveys per school or approximately 144 surveys per cluster; equating to 
2,880 parent surveys during the 20-week period. Random samples of classrooms will be selected every 4-
weeks with replacement using a randomization schedule generated by the study biostatistician, Dr. 
Gaines. To increase generalizability, we will randomly select serial cross-sectional samples with 
replacement since serial samples will allow for greater representation given the likelihood of student 
absences on the day of recruitment (e.g., potential for individual students to be absent and/or classrooms 
to be quarantined due to COVID-19 exposure). 
 
3.4 
STATISTICAL ANALYSES 
 
3.4.1 GENERAL APPROACH 
As a guide, the following should be addressed, as appropriate: 
 
• 
For descriptive statistics, describe how categorical and continuous data will be presented (e.g., 
percentages, means with standard deviations, median, range.  
• 
For qualitative research, describe how procedural and interpretive rigor will be monitored and 
maintained 
• 
For inferential tests, indicate the p-value and confidence intervals for statistical significance (Type 
I error) and whether one or two-tailed 
• 
Indicate whether covariates will be pre-specified in the sections below or later in a SAP 
• 
State whether checks of assumptions (e.g., normality) underlying statistical procedures will be 
performed and whether any corrective procedures will be applied (e.g., transformation or 
nonparametric tests) 
 
<Insert text> 
 
3.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
Descriptive statistics will be calculated for all primary outcomes, which will be assessed through the 
collection of weekly diagnostic testing surveillance data (provided by SDHHSA) and serial cross-sectional 
parent surveys. The primary outcome, diagnostic testing before and after implementation of the SASEA 
program will be examined using a mixed effects logistic regression with fixed effects for Time, SASEA 
program, and the interaction of Time x SASEA program. The mixed effects model will include a random 
component for school-level intercepts (to account for students nested within schools) and district-level 
intercepts (to account for schools nested in districts). Potential confounders will be controlled for in the 

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model (e.g., baseline COVID-19 diagnostic testing and vaccination rates within communities 
encompassing schools, school size, race/ethnicity, % receiving free/reduced lunch).    
 
3.4.3 SAFETY ANALYSES 
 
N/A 
 
3.4.4 BASELINE DESCRIPTIVE STATISTICS 
Include content in this section if applicable, otherwise note as “N/A.” 
 
Intervention groups should be compared on baseline characteristics (e.g., demographics, laboratory 
measurements, behavioral characteristics) using descriptive statistics. Discuss planned baseline descriptive 
statistics, and indicate whether inferential statistics will be used. 
 
<Insert text> 
 
3.4.5 PLANNED INTERIM ANALYSES  
 
N/A 
3.4.6 SUB-GROUP ANALYSES 
 
N/A 
 
 
3.4.7 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
State whether individual participant data will be listed by measure and time point. 
 
N/A 
 
3.4.8 EXPLORATORY ANALYSES 
All planned exploratory analyses should be specified in the protocol. 
 
<Insert text> 
 
4 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
4.1 
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 

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4.1.1 INFORMED CONSENT PROCESS 
 
4.1.1.1 CONSENT/ASSENT 
AND 
OTHER 
INFORMATIONAL 
DOCUMENTS 
PROVIDED 
TO 
PARTICIPANTS 
 
 
Any consent forms will be approved by the IRB prior to research activity onset. Consent forms describing 
in detail the study intervention, study procedures, and risks will be given to the participant and written 
documentation of informed consent will be completed prior to starting the study intervention.  The 
following consent materials are submitted with this protocol: consent form for community survey.  
 
4.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
Consent forms will be required to be completed prior to starting the community survey. Consent forms 
will be available in English and Spanish. An email address and phone number will be provided if individuals 
have questions.  
 
STUDY DISCONTINUATION AND CLOSURE 
 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be provided 
by the suspending or terminating party to study participants, investigator, funding agency, and regulatory 
authorities. If the study is prematurely terminated or suspended, the Principal Investigator (PI) will 
promptly inform study participants, the Institutional Review Board (IRB), and sponsor/funding agency and 
will provide the reason(s) for the termination or suspension. Study participants will be contacted, as 
applicable, and be informed of changes to study visit schedule. 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Demonstration of efficacy that would warrant stopping    
• 
Insufficient compliance of study staff to the protocol   (ie, significant protocol violations) 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
 
The study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the funding agency and IRB 
 
4.1.2 CONFIDENTIALITY AND PRIVACY  
 

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Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, 
the safety and oversight monitor(s), and the sponsor(s) and funding agency. This confidentiality is 
extended to the data being collected as part of this study. Data that could be used to identify a specific 
study participant will be held in strict confidence within the research team. No personally-identifiable 
information from the study will be released to any unauthorized third party without prior written approval 
of the sponsor/funding agency.  
 
All research activities will be conducted in as private a setting as possible. 
 
There will be no medical records collected for this study.  
 
The study participant’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the reviewing IRB, Institutional policies, or sponsor/funding agency 
requirements. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be transmitted to and stored on a secure server at UCSD. This will not include the participant’s contact or 
identifying information. Rather, individual participants and their research data will be identified by a 
unique study identification number. The study data entry and study management systems used by UCSD 
research staff will be secured and password protected. At the end of the study, all study databases will be 
de-identified and archived at Redcap.  
 
Measures Taken to Ensure Confidentiality of Data Shared per the NIH Data Sharing Policies  
 
It is NIH policy that the results and accomplishments of the activities that it funds should be made available 
to the public (see https://grants.nih.gov/policy/sharing.htm). The PI will ensure all mechanisms used to 
share data will include proper plans and safeguards for the protection of privacy, confidentiality, and 
security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be 
traceable to a specific study participant). Plans for archiving and long-term preservation of the data will 
be implemented, as appropriate.  
 
Certificate of Confidentiality  
 
To further protect the privacy of study participants, the Secretary, Health and Human Services (HHS), has 
issued a Certificate of Confidentiality (CoC) to all researchers engaged in biomedical, behavioral, clinical 
or other human subjects research funded wholly or in part by the federal government.  Recipients of NIH 
funding for human subjects research are required to protect identifiable research information from forced 
disclosure per the terms of the NIH Policy (see https://humansubjects.nih.gov/coc/index). As set forth 
in 45 CFR Part 75.303(a) and NIHGPS Chapter 8.3, recipients conducting NIH-supported research covered 
by this Policy are required to establish and maintain effective internal controls (e.g., policies and 
procedures) that provide reasonable assurance that the award is managed in compliance with Federal 

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statutes, regulations, and the terms and conditions of award. It is the NIH policy that investigators and 
others who have access to research records will not disclose identifying information except when the 
participant consents or in certain instances when federal, state, or local law or regulation requires 
disclosure. NIH expects investigators to inform research participants of the protections and the limits to 
protections provided by a Certificate issued by this Policy.] 
 
Survey data will be securely stored in UCSD’s REDCap database. Study personnel accessing the data will 
be required to access UCSD’s VPN and Active Directory log in to enter REDCap. We take care to ensure 
that participants cannot be identified on the basis of a combination of metadata values (e.g zip code). 
Qualitative data transcripts will be stored in UCSD’s Microsoft One Drive.   
   
4.1.3 FUTURE USE OF STORED SPECIMENS AND DATA  
 
Survey data collected for this study will be analyzed and stored at Duke University using the RADxUp 
database. After the study is completed, the de-identified, archived data will be transmitted to and stored 
at the RADxUp database, for use by other researchers including those outside of the study. Permission to 
transmit data to the RADxUp database will be included in the informed consent.  
 
When the study is completed, access to study data will be provided through the RADxUp database 
managed by Duke University. There will be no specimens collected for this study.  
 
4.1.4 KEY ROLES AND STUDY GOVERNANCE 
Principal Investigator 
Rebecca Fielding Miller, PHD, 
Professor 
University of California San Diego 
9500 Gilman Drive, La Jolla CA 
92093 
(858) 534-2230 
rfieldingmiller@health.ucsd.edu 
 
Rebecca Fielding-Miller, PhD MSPH, or her designees, who will constitute the committee responsible for 
monitoring the safety of this study, executing the Data and Safety Monitoring Plan (DSMP), and complying 
with the reporting requirements.  
 
4.1.5 SAFETY OVERSIGHT 
 
 
As required by the FOA, Dr. Fielding-Miller, PhD, MSPH, PI of the study, will establish a Data and Safety 
Monitoring Board (DSMB) to monitor data and oversee participant safety. Members of the DSMB who 
have expressed their willingness to participate include Dr. Natasha Martin, DPhil, Dr. Nanda Ramchandar, 
MD, and Dr. Laramie Smith, PhD. At the first meeting, the DSMB will review the study's protocol. 
Thereafter, the DSMB will monitor and review recruitment, adverse events, data quality, outcome data, 

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and overall awardee performance. The DSMB has the responsibility to review interim data and final data, 
and recommend whether the protocol should be modified, and, at each meeting, whether the study 
should be continued or should be terminated early. The significance of the DSMB's ethical responsibilities, 
to the participants as well as to the integrity of the study, are of paramount importance to individual 
members of the proposed research alliance of UCSD, SDCOE, our school district partners, and to the 
National Institutes of Health.  
 
4.1.6 CLINICAL MONITORING 
The study is collecting survey data, there is no clinical monitoring  
 
4.1.7 QUALITY ASSURANCE AND QUALITY CONTROL 
 
Quality control (QC) procedures will be implemented as follows: 
 
Informed consent --- Study staff will review both the documentation of the consenting process as well as 
a percentage of the completed consent documents.  This review will evaluate compliance with GCP, 
accuracy, and completeness.  Feedback will be provided to the study team to ensure proper consenting 
procedures are followed.  
 
Source documents and the electronic data --- Data will be initially captured on source documents (see 
Section 10.1.9, Data Handling and Record Keeping) and will ultimately be entered into the study 
database.  To ensure accuracy site staff will compare a representative sample of source data against the 
database, targeting key data points in that review. 
 
Intervention Fidelity — Consistent delivery of the study interventions will be monitored throughout the 
intervention phase of the study. Procedures for ensuring fidelity of intervention delivery are described in 
Section 6.2.1, Interventionist Training and Tracking.  
 
Protocol Deviations – The study team will review protocol deviations on an ongoing basis and will 
implement corrective actions when the quantity or nature of deviations are deemed to be at a level of 
concern. 
 
Should independent monitoring become necessary, the PI will provide direct access to all trial related 
sites, source data/documents, and reports for the purpose of monitoring and auditing by the 
sponsor/funding agency, and inspection by local and regulatory authorities. 
4.1.8 DATA HANDLING AND RECORD KEEPING  
 
4.1.8.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
 

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Data collection will be the responsibility of the stepped-wedged study staff under the principal 
investigator's supervision. The investigator will be responsible for ensuring the accuracy, completeness, 
legibility, and timeliness of the data reported. 
 
All source documents will be completed in a neat, legible manner to ensure accurate interpretation of 
data. 
 
Survey data will be collected through REDCap, and entered into RADxUp database. The data system 
includes password protection and internal quality checks, such as automatic range checks, to identify data 
that appear inconsistent, incomplete, or inaccurate.   
 
4.1.8.2 STUDY RECORDS RETENTION  
 
Study documents will be retained for a minimum of 3 years. No records will be destroyed without the 
written consent of the sponsor/funding agency, if applicable. It is the responsibility of the sponsor/funding 
agency to inform the investigator when these documents no longer need to be retained. 
4.1.9 PROTOCOL DEVIATIONS   
 
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol, 
International Council on Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) 
requirements. The noncompliance may be either on the part of the participant, the investigator, or the 
study site staff. As a result of deviations, corrective actions will be developed by the site and implemented 
promptly.  
 
These practices are consistent with ICH GCP:  
• 
Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3  
• 
Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1  
• 
Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2.  
 
It will be the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations within days of identification of the protocol deviation. All deviations will be addressed in study 
source documents, reported to the NIH. Protocol deviations will be sent to the reviewing Institutional 
Review Board (IRB) per their policies. The site investigator will be responsible for knowing and adhering 
to the reviewing IRB requirements.  
 
4.1.10 PUBLICATION AND DATA SHARING POLICY  
 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 

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National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed 
journals. Data from this study may be requested from other researchers 3 years after the completion of 
the primary endpoint by contacting Duke University RADxUP database.  Considerations for ensuring 
confidentiality of these shared data are described in Section 10.1.3. 
 
4.1.11 CONFLICT OF INTEREST POLICY 
 
The independence of this study from any actual or perceived influence is critical. Therefore, any actual 
conflict of interest of persons who have a role in the design, conduct, analysis, publication, or any aspect 
of this trial will be disclosed and managed. Furthermore, persons who have a perceived conflict of interest 
will be required to have such conflicts managed in a way that is appropriate to their participation in the 
design and conduct of this trial. The study leadership in conjunction with the RADxUp has established 
policies and procedures for all study group members to disclose all conflicts of interest and will establish 
a mechanism for the management of all reported dualities of interest. 
 
4.2 
ADDITIONAL CONSIDERATIONS 
 
N/A 
 
 

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4.3 
PROTOCOL AMENDMENT HISTORY 
N/A. 1 protocol write up version