COV-IDD: Testing for COVID-19 in High Risk Children With Intellectual and Developmental Disabilities
Phase: NA
Conditions: Covid19
Sponsor: University of Rochester

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NCT04887129
PROTOCOL
Title: COV-IDD: Testing for COVID-19 in high risk children with intellectual and 
developmental disabilities
Principal Investigator:
John Foxe, PhD 
Department of Neuroscience

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1.3 STUDY DESIGN
Scientific Questions and Impact: School-aged children with intellectual & developmental disabilities (IDD) 
are at extreme risk for severe COVID-19. Many have compromised immunological and respiratory function, 
and their risk is compounded by high prevalence of communication disorders that can lead to impaired self-
reporting of illness, as well as cognitive impairment and mobility issues that lessen compliance with safety 
protocols (distancing, masking, and sanitization). While some of these children are served in public schools, 
many are in IDD-specialized schools that provide not only educational services, but also clinical services, 
speech and psychological interventions, nutritional needs and physical care. For parents or guardians, the 
burden of homecare is enormous, such that maintaining employment is often impossible when the child is 
out of school. It is therefore essential that schools re-open in a manner that is safe for students with IDD. 
This project proposes a holistic virological and serological testing strategy, augmented by a mobile testing 
unit, systems modeling, educational outreach to address vaccine and testing hesitancy, and a scalable, 
innovative outcomes assessment that addresses multiple health domains (including anxiety, depression 
and social functioning), to stand up, refine and understand the best strategies for returning this vulnerable 
population safely to school.  Our ultimate goal is to develop generalizable and scalable approaches that 
can be disseminated rapidly to facilitate school opening. 
Participants: Rochester’s Mary Cariola Center (MCC) serves moderate-to-severe IDD children (N=450) 
via a large professional and support staff (N=500). 70% of MCC students live in poverty, and 54% are from 
under-represented minority (URM) backgrounds. MCC is highly representative of similar settings across 
the nation. Here, we will build on the existing close partnership between MCC and the UR-IDDRC, to 
implement and evaluate innovative testing strategies in this community that will prevent, contain and 
mitigate virus outbreaks – and maximize safe school participation for these vulnerable students. 
Scientific Goals: We will use systems simulation modeling to develop an efficient virological and 
serological testing regime, and to optimize tracing and isolation processes. Longitudinal virological testing 
will track infection rates and serological testing will quantify durability of protective immunological 
responses, which may be shorter-lived in IDD populations. We will deploy an innovative mobile testing-unit 
for optimal testing flexibility. We will also address psychological barriers to full engagement with public 
health policies, including anxiety about COVID-19, as well as vaccine and testing hesitancy. To do this, we 
will develop effective support and educational outreach tools and strategies to mitigate these concerns. We 
will also establish a community-engaged leadership plan to direct this project, assure its sustainability, 
disseminate findings, and engage fully with all stakeholders (including the MCC community). We will work 
directly with the Coordination and Data Collection Center (CDCC) to facilitate full, accurate, rapid research 
data acquisition, curation and standardization, and deposit in the NIH RADx Data Hub. Our five goals are:
1) Virological Testing: We will establish a nasal-swab FDA-approved testing regimen to monitor and
identify disease outbreaks in a specialized school setting serving 450 children with moderate-to-severe IDD 
and the 500 staff supporting them, a setting at ultra-high risk for COVID-19 disease transmission. We will 
rapidly identify infections and develop approaches for isolating and contact-tracing to stem virus spread. 2) 
Serological Testing: Serology will establish background immunity levels in students and staff, from 
infection or vaccination, and will follow those who are antibody-positive longitudinally to quantify temporal 
decay of IgG and neutralizing antibody levels.  We will determine whether protective immunity in children 
with IDD, a population with prevalent immunological dysfunction, wanes at an accelerated rate compared 
to the population-at-large; by doing so we will address an important knowledge gap, and provide key data 
to inform public health policy. 3) Modeling to Optimize Testing: We will use network models and agent-
based simulation models (or hybrid approaches) to guide testing strategies and interventions at MCC. 
Simulations will be conducted interactively and iteratively, to assist in planning and implementation of 
testing procedures, exploring the dynamic interplay between school operations and personnel interactions, 
potential infection risks and disease dynamics (including variant strains), and implementation of control 
measures (e.g. quarantine, isolation, contact-tracing and vaccination rates). 4) Mobile Unit Testing: We 
build on our successful mobile approach to delivering mobile dental care to the IDD students of MCC (the 
SMILEmobile), by staffing, equipping and deploying a customized, disability-enabled, mobile testing unit 
equipped with a specialized HEPA-filter enabled HVAC system (UR Health in Testing - HIT Mobile). We 
will use this to directly deliver rapid flexible testing to MCC. 5) Overcoming Testing & Vaccine 

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Anxiety/Hesitancy: We will conduct focus group interviews at MCC to identify key community concerns, 
myths and misconceptions about vaccination, and we will then build on our success in reducing vaccine 
hesitancy among URMC staff, to create a multimodal educational campaign that addresses these concerns.  
Strategies will include a speakers’ bureau, group discussions, and “table talk” conversations, combined 
with innovative visual approaches that communicate complex information in a readily accessible manner 
(via graphic medicine) and that promote vaccine uptake (via narrative portraits of trusted peers and 
coworkers who have chosen to be vaccinated). Finally, we will assess the impact of this program by 
deploying a validated, electronic patient reported outcome scale (PROMIS-29) already in widespread use 
across the UR health system and at Rochester’s East High School, to collect longitudinal data from staff, 
parents/guardians and children (by proxy reporting) across multiple health domains (including anxiety, 
depression, sleep disturbance, and social functioning). This scalable approach will reveal the full impact of 
the 
interventions 
and 
approaches 
proposed, and is readily compatible with 
extension to other sites in the RADx 
network.
Testing 
Capacity: 
Our 
Clinical 
Microbiology laboratory began SARS-
CoV-2 molecular testing on 3/16/2020, 
and has now tested over 500,000 
specimens, with consistent turn-around times of 24-48 hrs. Current capacity is approximately 10,000 
tests/day High throughput SARS-CoV-2 molecular platforms include: COBAS 8800 (Roche), Panther 
(Hologic), GeneXpert (Cepheid), and Amplitude (Thermo-Fisher), among others. The lab has sufficient 
capacity to run all testing in-house and does not currently utilize reference testing (Table 1).  Serological 
testing (IgG) has been available since 6/20 on the Abbott Architect.  Available capacity greatly exceeds the 
needs of the present project; the project testing engine will be ready to start on day one of the project 
(i.e., as soon as the first participant is enrolled).
1.4 CENTRAL AIMS
Scientific Goal 1:  Establish a molecular testing program to monitor and identify COVID-19 
infections within a school community of individuals with IDD 
Overview and rationale: This program will focus on the students (n=450) and staff (n=500) of the MCC, 
who collectively form a community that is highly representative of other IDD school communities across the 
nation. We will establish testing across this difficult-to-test population, using a tailored and flexible approach 
to foster test uptake and to prevent and/or mitigate COVID-19 outbreaks. 
Establish a clinical molecular and serological COVID-19 testing program for the Mary Cariola 
Center:  The dynamics of viral spread are unknown in a school serving individuals with IDD such as the 
MCC.  Questions to be answered with molecular testing include: What is the incidence of asymptomatic 
COVID-19 infection, and how is this affected by rising vaccination rates?  How do activities within the school 
alter risk?   Serological testing will assess baseline prevalence of prior infection (anti-NP IgG), and changes 
over time, in response to infection (anti-NP IgG+) and vaccination (anti-S IgG+, anti-NP IgG-).
Molecular Testing: RT-PCR tests for SARS-CoV-2 with FDA EUA will deliver highly sensitive and specific 
clinical-grade results.  Respiratory samples will be obtained by mid-turbinate or nasal swabs, collected in a 
dedicated area with proper ventilation and PPE (see Mobile Unit testing plan below), and delivered to the 
URMC Central Laboratory for testing in a CLIA environment with 24-72h turnaround times. The testing plan 
includes two groups: those tested as part of scheduled surveillance and those tested for symptoms or 
exposure. 
Surveillance Screening and Exposure/Symptomatic Testing: Participants will be tested  every 5-14 days to 
increase likelihood of detecting infected but asymptomatic individuals.  Enrolled students and staff who 
report symptoms in the on-site screening will be tested on-site.  Symptomatic individuals will be tested 
separately from asymptomatic participants every 3 days for up to 10 days. Reported test results will be 
qualitative, although Ct (cycle threshold) values will also be captured for modeling purposes. 
Table 1: URMC COVID-19 Testing Capacity and Modalities
Platform
Test
Capacity: Tests/Day
Certification
Roche 8800
Molecular
2000
FDA-EUA
Cepheid
Molecular
500
FDA-EUA
Holologic
Molecular
500-1000
FDA-EUA
Abbot Architect
Serology
1000
FDA-EUA
TF Amplitude
Molecular
3000-6000
FDA_EUA-pending

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Clinical Serological Testing:  Tests with FDA-EUA will be used to assess the presence of IgG antibodies 
to SARS-CoV-2 (Table 1) every 6 months. Our current Abbott Architect assay qualitatively assesses IgG 
binding to the SARS-CoV-2 nucleocapsid (NP) protein 
and we intend to offer the Architect anti-spike (S) semi-
quantitative assay when it is granted EUA (expected 
shortly).  Serum will be collected upon enrollment and 
then every 6 months for the duration of the 
study period.  Assuming 70% study enrollment, this will 
result in 1,680 staff and 1,330 student serological tests.  
Reporting and Result Handling: The ordering provider 
(Dr. Anne Francis) at the MCC and nursing staff will 
receive test results. Positive results will be reported to 
public health agencies via standard clinical 
protocols.  Both molecular and 
serological clinical results will be qualitative (Positive, 
Negative, Inconclusive). Upon the communication of a 
positive molecular test result, students and staff will be 
referred to their primary care providers (PCPs) or 
urgent care if lacking a PCP.  Enrolled study subjects 
who have been in close proximity to the positive 
individual will be immediately PCR tested.  Unenrolled, 
exposed individuals will be offered study enrollment or 
else referred to their PCP/urgent care for testing. RT-PCR positive students will be re-tested every two 
weeks to assess viral load kinetics. 
Research Serological Testing: Modeling requires continuous, quantitative data to estimate antibody 
persistence, and as a correlate of immunity.  We will test 200 subjects every 4 weeks for up to 36 months 
using a multiplex research assay that simultaneously measures IgG levels against the spike (S) and 
nucleocapsid (N) proteins of SARS-CoV-2 and human seasonal strains (OC43, HKU1, NL63, 229E); we 
will also measure antibodies directed against the receptor binding domain (RBD) of the S protein.  This 
assay provides absolute measures of serum IgG (ng/ml), and is currently in use in several NIH funded 
studies (see Fig 1).  We are also adding emerging SARS-CoV-2 variants (e.g. UK, South African).  
Samples will be collected by fingerstick and volumetric micro-sampling (VAMS) to collect 40µl of capillary 
blood.  A topical anesthetic cream can be used prior to collection.  Samples will be analyzed by batch in 
Dr. Zand’s lab.
Scientific Goal 2:  Serological Testing and Modeling
The dynamics of the immune response to SARS-CoV-2 are as yet unknown in children with IDD, a 
population with prevalent immunological dysfunction, who may show different COVID-related 
immunological profiles and latencies to those of the general population. Here, we longitudinally follow those 
with IDD identified as antibody-positive, from either infection or vaccination, to quantify the timing of 
reductions in IgG and neutralizing antibody levels. We will use a combination of the SARS-CoV-2 clinical 
serological assay (described above), and a research multiplex assay for anti-spike and nucleocapsid protein 
IgG and receptor binding domain (RBS) antibodies, against SARS CoV-2 (including emerging virus 
variants), and a panel of commonly circulating human coronaviruses.  This will provide serological data 
uniquely focused on the IDD population with clear implications for public health immunity strategies. 
Experimental Approach.  IgG responses to individual SARS-CoV-2 antigens (S, NP, RBD) in enrolled 
students and staff will be measured initially by clinical testing and fingerstick at baseline, and then every 
four weeks by fingerstick for up to 36 months.  Any large increase in anti-SARS-CoV-2 levels will be 
confirmed by clinical serology. Dynamics of anti-SARS-CoV-2 IgG will be assessed by fitting the anti-S, NP 
and RBD quantitative results to a modified power law model that accounts for long-term antibody 
persistence:  
, where  is the peak log IgG level,  is the decay rate,  
𝑓(𝑡) = 𝑘+ log [(1 ‒ )(𝑐+ 𝑡) ‒ 𝛼+  𝜆]
𝑘
𝛼
𝑐
is a constant, and  is the steady-state long-term IgG level.  We will fit the model using a mixed effects 
𝜆
Figure 1 – Serological Testing.  (A) Clinical analysis of 
persistence of anti-S, anti-NP, and anti-RBD binding IgG 
and PCR results from the URMC Clinical Laboratory.  Note 
the early decline of anti-NP IgG.  (B) Multiplex testing for 
IgG directed against S proteins for common circulating 
coronaviruses, including SARS-CoV-2 (SARS2), and prior 
SARS-CoV-1 and MERS (Middle East Respiratory Virus) 

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method, where  and  are subject specific random effects drawn from a bivariate normal distribution. This 
𝑘
𝛼
will allow comparison of decay rates (
 and steady state anti-SARS-CoV-2 IgG levels (
 across subjects.
𝛼)
𝜆)
Scientific Goal 3: Systems modeling to direct testing strategies   
Our aim here is (A) to model potential transmission routes of COVID-19 at MCC using a network 
approach which can then be used to guide testing, and (B) to develop agent-based simulations to aid in 
developing and testing strategies to reduce risk of COVID-19 spread.  We will pay particular attention to 
modeling how changes in vaccination rates and asymptomatic infection with low viral load (PCR cycle 
threshold – Ct) affect risk of transmission. These models will be used to define testing strategies and 
interventions to reduce the risk of COVID-19 spread in the Fall semester, and to explore the dynamic 
interplay between school operations, infection risks and control measures. Successful completion of this 
work will result in development and deployment of generalizable simulation models to guide COVID-19 
testing. 
Network modeling is ideally suited for analysis of risk of disease transmission in complex systems (1), and 
can account for symptom latency, changes in classroom group composition, and student mobility.  Agent 
based models (ABMs) developed from network models can be used to study time varying outcomes arising 
from changes in behavior (e.g. vaccine acceptance), immunity, and asymptomatic infection among 
students, teachers and staff.  This approach enables in silico evaluation of hypothetical testing strategies, 
simulation of infection dynamics, and assessment of alternative mitigation strategies. Dr. Zand has 
developed network models and analytics for risk of transmitted infection in a complex, high contact hospital 
environment (1), and Dr. Seplaki is currently creating ABMs that assess strategies to decrease COVID-19 
infection risk on the UR Undergraduate Campus. Analytic approaches based on our prior work (1-6), will 
be used to construct (1) a network model of who is in contact with whom, for how long and (2) a mobility 
model of individual’s travel between school locations and (3) agent based models of behavior, given data 
about anxiety, vaccine status, and adherence to guidelines. The contact network, will model testing 
strategies for surveillance for new infections in a mix of individuals with varying levels of immunity, vaccine 
acceptance, exposure, and new emerging viral strains. The mobility network will be used to model 
prevention strategies of changing staff and student classes/movement/interaction to decrease the risk 
COVID-19 transmission. Agent based models will test the effects of behaviors on school operations. The 
number of students and staff who remain on-site and in-school, will be key outcomes. Questions will include:  
How does the mixture of immunity, class/student scheduling, and vaccine acceptance create opportunities 
for COVID-19 spread (and control)?  Do asymptomatic individuals with positive PCR tests spread virus?
Network modeling – We will contrast both a contact network and a mobility 
network model (Fig 2).  Data used for modeling will include the instruction 
schedules of IDD-students, staff and class locations.  Each data record will 
contain the subject ID, activity, location, time, and duration.  Student and staff 
attributes will be stored in the secure BLIS informatics database system (see 
Facilities and Resources), which will also hold the COVID-19 PCR and serology 
testing results. We will also incorporate anxiety data from the PROMIS survey 
(Goal 5 below), and rates of prior infection/vaccination (derived from serology 
data).  We will use the schedule database to construct directed, bipartite graphs 
where the nodes represent two categories of individuals (students, staff), and 
the edges are weighted by the duration of contact (4, 6). A mobility network 
model (1, 2) (Fig. 2B) will capture the movement of students and staff between 
physical locations within the building. For both network models, we will 
characterize measures of network structure (density, diameter) (1, 4, 6), and 
identify individuals with high contagion centrality. We will simulate various 
testing frequencies of asymptomatic individuals (1).  For example, we will model 
outcomes for increasing testing for: (1) staff who contact many students to 
decrease transmission risk, (2) staff who connect groups of students to decrease between-group spread.  
Sensitivity analysis will assess how modification of parameters (e.g. vaccination proportion, asymptomatic 
viral load) affects the ability to detect infection. 
Figure 2 

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Agent-based modeling - ABMs are well-suited to dynamically characterize complex and difficult-to-
measure mechanisms driving infectious disease transmission (7, 8). They are also used to design and 
evaluate interventions to reduce infection risks by simulation of "what-if" scenarios.  MCC is an ideal 
setting for agent-based modeling as it is a circumscribed physical location with well-defined populations 
(i.e. students, staff), movement and interaction patterns. It is worth emphasizing that MCC is highly 
characteristic of the many similar school settings that provide services to children with IDD nationwide, 
and as such, provides an excellent test population form which to derive generalizable models.  Agents will 
be individually characterized with fundamental attributes (e.g., movement rules, contacts with other 
agents, infection-susceptibility) that are abstract reflections of key variables (e.g. contact time, 
asymptomatic viral load, vaccine status). A wide range of use cases will be simulated including support 
for planning and deployment of testing procedures, exploring hypothetical testing or screening strategies, 
simulation of virus transmission dynamics, and assessment of alternative prevention or mitigation 
strategies.   We will leverage guidance from administrators on student and staff activity schedules to 
study density and space in order to understand how they relate to possible patterns of infection.  
Simulations will examine the numbers of people in given rooms contemporaneously and the potential 
mixing of vulnerable and asymptomatically infected subjects. These efforts can inform the network models 
(see above) to guide decisions about when and who to test.  The ABM models will be used to identify 
strategies to prevent negative impact of asymptomatic infected individuals, with logistical and/or financial 
constraints.
Contingency Plans: During COVID, MCC has had to respond to immediate changes in requirements 
from DOH and the NYS Governor.  The process to “pivot” will be replicated, as it has worked well within 
the organization structure.  Upon notification of a change, this will be broadly communicated to the project 
team, with same day conference established to evaluate and implement required changes.  We anticipate 
during the course of this study that vaccinations will be approved for children under 16.  This opportunity 
will be incorporated into educational initiatives, and will be recorded for study participants. Our scientific 
goals as outlined herein have built in contingencies around the expected introduction of vaccines in this 
population. We will also work with NIH program to revise the research and testing program in response to 
major changes in policy. The modeling goal described above is specifically designed to react to changing 
infection/vaccination landscapes. 
Community Partnerships and Engagement: Our goal is to enroll 70% of eligible students and staff at 
MCC.  This enrollment projection is based on past local experience of Dr. Foxe and the MCC leadership, 
and the high motivation level of MCC parents/guardians and staff. To increase participant engagement and 
interest in the project we will modify our proposed student recruitment and retention approaches based on 
key input and feedback from MCC leaders and a convenience sample of parents/guardians (9, 10).  Our 
approach will start with an Introduction Phase followed by an Engagement phase, concluding with a 
Consent phase that includes baseline (and follow-up) surveys to characterize the participants, their 
households and community of residence.  The UR Clinical and Translational Science Institute (directed by 
MPI Zand) will assist, and has extensive experience in community engagement, recruitment and retention 
of special populations. The IDDRC Human Phenotyping and Recruitment (HPR) Core will also be leveraged 
for their expertise including recruiter training and retention strategies.
Involvement of Community Stakeholders: We will develop a full partnership with the MCC community 
that results in sustained community engagement across project activities, and also after the current project 
ends. In this context, the term ‘community’ includes: all students, their family members (including 
guardians), and all staff, affiliated with MCC. To do this, we have established the Community Advisory 
Board (CAB) to provide broad input on project design, implementation and iteration (see Goal 1).
Strategies to Improve Testing and Vaccine Uptake; Communication Approach: See Goal 5.
Scientific Goal 4:  Mobile Unit Testing:  We will staff, equip and deploy a customized, disability-
enabled, mobile unit (UR Health in Testing - HIT Mobile) to bring testing directly to the MCC community.

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Overview and Rationale: We have built a robust and trusting relationship with MCC, its leadership, staff, 
parents and students. A flagship component of this relationship is our UR-SMILEmobile, which provides 
specialized dental services to the IDD community. In 2020, the SMILEmobile provided 280 visits and 927 
treatments to MCC children – thereby providing greater access to needed care. 
The same considerations behind the creation of the SMILEmobile also apply to testing for COVID-19 
(including access/mobility issues, limited agency and intellectual disability). The innovation of bringing care 
directly to MCC students has proven to be efficient, effective, and appreciated by MCC students, their 
parents, and the MCC staff. A mobile COVID testing unit will add flexibility and scalability to testing at MCC, 
and will also enable testing at other remote locations. For instance, if there were several positive test results 
in a nearby school or town, the mobile unit could be deployed to quickly test large numbers of students and 
staff in situ. This rapid response ‘hotspot’ testing will help identify people who are positive and reduce 
spread allowing schools to remain open without risking additional contamination. Positive subjects will be 
offered enrollment into the study to track dynamics and immunity.  
Approach: We will staff, equip and deploy a customized, disability-enabled, mobile testing unit equipped 
with a specialized HEPA-filter enabled HVAC system (UR Health in Testing - HIT Mobile) that will directly 
deliver virological and serological testing to MCC students and staff on their campus.  To do this, we will 
procure a customized van, designed to incorporate a wheel chair lift and seating for the driver, a nurse 
practitioner and a research assistant. The HIT Mobile will be smaller, simpler and more agile than the 
already successfully deployed SMILEmobile, since it does not require dental chairs or complex equipment, 
but will be designed for sufficient space to carry out testing. We have already sourced a number of vendors 
and solicited initial designs. A simpler design using a standard van and a pop-up medical tent (E-Z UP 
EMC100) will be implemented at study startup. This will permit initiation of the mobile testing unit approach 
within the first month after project approval. The custom van conversion will require several months to 
complete (anticipated in August 2021). The process will be initiated immediately upon project approval, in 
order to put a sustainable approach in place for the fall and winter months.
Testing strategy: We will use a blended approach to testing start-up, setting up initial testing in a dedicated 
room within the MCC building complex, but we will transition to outdoor testing using the on-site van and 
pop-up tent as available.  We project that the mobile unit should be able to administer tests every 5-10 
minutes for staff, and every 10-15 minutes for students, allowing between 40-80 tests/day.
Evaluation: The goal of the mobile testing strategy is to demonstrate the generalizable value and utility of 
bringing testing directly to the IDD community, using an innovative, mobile approach.  We hypothesize that 
this approach will increase engagement and uptake by the IDD community and school staff. We will assess 
attitudes towards testing, use of the bus, and differences in testing turn-around/adoption between the in-
school testing and the mobile unit as part of our program evaluation efforts.
Dissemination of Findings: Mobile units will expand services beyond MCC and can be replicated in other 
locations.  They are sustainable and easy to maintain compared to on-site footprints which are often 
difficult to acquire, expensive and disruptive to existing workflows/classrooms. We will disseminate our 
findings in a methods paper and will also present them to the NYS 853 and 4410 Coalition of Schools.
Scientific Goal 5: Overcoming Testing & Vaccine Hesitancy; Measuring Impact: Major barriers to 
return-to-school efforts are driven by (mis)perceptions of risks related to virus infection, testing and 
vaccination by parents, guardians, and staff.  Anxiety, stress and medical mistrust further add to testing 
and vaccine hesitancy, which is a particular concern in a setting where many of our at-risk children meet 
diagnostic criteria for autism spectrum disease (ASD).  To address these issues, we will leverage our 
recent success in reducing vaccine hesitancy in our URMC staff, to design and implement educational 
and intervention strategies that mitigate these issues in the MCC community by addressing common 
myths, misconceptions and concerns about vaccination, testing and virus infection. Initial surveys of 
URMC staff in late 2020 (reflecting over 10,000 responses) revealed a 
disappointing 40% level of vaccine hesitancy.  We addressed this with a 
major targeted educational outreach effort, tailored to specific staff 
populations.  The result was an 85% uptake rate of the vaccine among 
the 20,000 plus URMC staff eligible to receive it in early 2021 – i.e., a 

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60% reduction in the rate of vaccine hesitancy.  We will take a similar approach in the MCC 
community, as follows:
1)
Conduct focus group interviews via zoom with priority populations to understand the nuances of 
COVID-related anxiety and vaccine hesitancy, and the locations/context that encourage greater 
vaccine acceptance. 
2)
Develop and deploy targeted strategies to increase understanding of the COVID-19 vaccine, that help 
individuals and communities make informed decisions about whether or not to receive the vaccine.  
This will require building and mobilizing a network of community partners, leaders and influencers, 
maximizing opportunities to build trust and share information. 
3)
Develop effective communication tools and platforms, including the preparation of materials in 
multiple languages, and the development of specifically targeted messaging for the MCC sub-
communities and populations most impacted by COVID. Examples of these tools are: educational 
videos, testimonials, posters, digital and social media, web pages and public relations efforts.
4)
Deliver on-the-ground education, including an educational speakers’ bureau, accessible by online 
request, which will send speakers to community groups (via Zoom or other virtual platforms). Even 
more targeted activities in the form of individualized “table talk” conversations will be developed for 
families and other small groups to discuss the vaccine in trusted settings.  
5)
Create innovative visual media and art, in collaboration with the URMC’s Artist in Residence.  
Specifically, we will use graphic medicine to address common myths, misconceptions and concerns 
about vaccines, as well as humanizing portraiture that creates visual narratives in which trusted peers 
and coworkers share their reasons for choosing to become vaccinated.
Measuring Impact: We will assess the impact of this program by deploying a validated, electronic 
outcome reporting scale that is already in widespread use across the UR health system (11), and at 
Rochester’s East High School (12), to collect longitudinal data from staff, children (by proxy reporting) and 
parents/guardians across multiple health domains - including anxiety, depression, sleep disturbance, and 
social functioning (13).  Specifically, we will customize the standard, short form Patient-Reported 
Outcomes Measurement Information System (PROMIS®-29) survey, by adding an additional domain to 
evaluate COVID-specific anxiety and vaccine hesitancy in our parent and school worker communities, 
based on concerns identified in our URMC staff baseline survey (see above) and in our initial MCC focus 
group interviews. We will then deploy the enhanced PROMIS-29 scale in electronic form within the MCC 
community, via two user-friendly approaches: (1) iPad/tablets at MCC (our standard approach in UR’s 
ambulatory health clinics), and (2) mobile devices.  We expect the latter approach to substantially 
increase survey participation, particularly among parents/children who have elected not to attend school, 
due to severe underlying health concerns, high levels of anxiety or other considerations.  
Data collection takes < 5 mins with these approaches. All data will be stored on a secure, redundant, 
HIPPA-compliant server located behind the URMC’s firewall. Participants will be sampled monthly using 
methods from our prior work at East High School (12) and the UR medical system (11). Each participant 
will receive a survey invitation unique to their email address or cell phone number, and surveys will be 
delivered in a self-report format (for MCC staff and parents) or in a proxy-report format (for children with 
IDD). In addition to the custom COVID-related survey domain, PROMIS-29 domains that we expect to be 
most informative will include the following: A) Anxiety, B) Depression, C) Sleep Disturbance and D) Social 
Functioning. We are especially interested in the relationship between generalized anxiety, COVID-specific 
anxiety and vaccine hesitancy – and how these parameters are influenced by the educational, 
interpersonal and art-based interventions that we will deploy.  We are also interested in measuring the 
impact of in-person school attendance by MCC school children, on all of these domain areas (this will be 
analyzed by comparing the two cohorts of MCC school children who are currently attending the school in 
person, to the cohort who are participating in school programs on a 100% virtual/distance basis).
Our goal is to use the enhanced PROMIS-29 scale to determine if a highly effective COVID testing and 
containment/prevention program, based on cutting-edge data-driven modeling approaches, and 
combined with innovative educational outreach efforts, not only enables sustainable in-person school 
attendance, but also results in broad improvements in health outcomes for children and their families.  
Finally, in proposing to adapt and enhance the PROMIS-29 scale to this specific use case, and to develop 
generalizable models and educational interventions, we also intend to develop a scalable approach that 
can be readily disseminated and adapted to schools across the country. 

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Confidentiality of Testing and other Data: Identified data will be reported from the laboratory to the 
ordering provider (Dr. Francis at MCC) via secure fax.  MCC will report results clinically, to the State via 
secure electronic channels, and to the county DOH for the purposes of guiding contact tracing and post-
exposure testing.  Individuals who are selected for post-exposure testing will NOT be informed of the 
identity of the individual to whom they may have been exposed. At UR, individual-level data will be made 
available only to a very limited number of persons in the modeling and intervention team, who will use the 
information exclusively to inform their modeling and infection control efforts.
2. CHARACTERISTICS OF THE RESEARCH POPULATION
2.1 Subject Characteristics  
All staff and students at Mary Cariola Center (MCC) are eligible for this study
a) Number of Subjects – There are 500 on-site staff and 450 students. Up to 950 people 
may enroll, although we expect around 70% enrollment
b) Gender and age of subjects – Among MCC employees, approximately 75% are female. We 
expect at least 50% to consent to testing and another 30% to complete the baseline survey. 
Among students under age 18, approximately 30% are female, consistent with the national IDD 
population. We expect 70% to enroll. Unless our enrollment trends show otherwise we do not anticipate 
any unique messaging or additional outreach to achieve our enrollment target. There are also Mary 
Cariola students age 18-21 approximately 30% female.
There are no exclusions by age however we are limited by the ages of those attending or residing in 
MCC  and the age range of employees.
MCC students are included in this study as the main participants as the study seeks to understand 
testing and transmission patterns among individuals with IDD in school and residential settings including 
modeling. Most of the students in the school setting are under age 18; The youngest student is age 3. 
There are also about 60 students at the school between the ages of 18-21. Approximately one third of 
these students have legally authorized representatives (guardians).
Age distribution of students is:
3-5
20%
6-10
28%
11-14
25%
15-17
19%
18-21
8%
We will track early enrollment to determine if rates are lower than expected or if there are under-
represented age groups (based on the age distribution of MCC students). This will warrant revising of 
recruitment strategies and tactics within the research team and the CAB. 
MCC Staff range in age from 18 to 75. 

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Efforts to enroll employees will be informed by the CAB. We will track early enrollment to determine if 
rates are lower than expected or if there are under-represented age groups. Lower than anticipated 
enrollment will warrant revising of recruitment strategies and tactics within the research team and 
informed by the CAB.
c) Racial and Ethnic Origins
Underrepresented minorities in the local community are Black and Hispanic. The minority 
participation in this research among students is based on the distribution of races and ethnicities 
at Mary Cariola. Thus approximately 43% will be a racial minority (Blacks representing 76%) and 
11% will be Hispanic. Materials will be available in Spanish. As part of our vetting process we will 
assure that the messaging, photos and other representations include minority images and 
language that reflect health equity. 
Among MCC Staff, approximately 30% are Black and 3% are Hispanic. 
d) Vulnerable Subjects 
This study, by design, involves a vulnerable population, children under age 18. The 
importance of this study is provided in the application and in the NOSI itself given the risks 
associated with COVID-19 among this population. The benefits of undergoing testing and the 
proposed modeling in this group of children considered at high risk for illness and hospitalization 
due to COVID-19 exposure will be both direct and indirect. First, children will have access to 
testing not readily available to them. Second, indirect benefits would be the information provided 
to MCC to modify procedures to mitigate or minimize transmission at the children’s residential 
and school facilities. The proposed testing regime will also help define what pattern of testing is 
warranted for individuals with IDD.  Given the high risk nature of COVID-19 among this 
population, and the potential for local and national impact, the risks to subjects (primarily 
discomfort with testing) are reasonable in relation to the importance of the knowledge that 
reasonably may be expected to result.
e) Spanish-speaking Staff and Parents of students
There are staff at Mary Cariola whose primary language is Spanish. To enroll these 
participants we will use consent documents and questionnaires translated into Spanish. 
Additionally, Spanish-speaking members of the study team will consent these participants in 
Spanish or if necessary we will have translators on-site to facilitate consent in Spanish. Some 
parents of Mary Cariola students may also have Spanish as their primary language and we will 
get permission using Spanish and permission and questionnaires translated into Spanish. 
2.2 Inclusion and Exclusion Criteria
Criteria are presented below in a table for each of the three groups involved in 
the study: MCC students, MCC Staff and parent/guardian decision makers. 
Inclusion and Exclusion Criteria 
Cohort
Study Procedure
Inclusion Criteria
Exclusion Criteria
IDD Students

COVID-19 RT-PCR 
Testing

IDD Student of the Mary 
Cariola Center

Age 3 – 21

Contraindication to 
nasal swab

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
Anti-SARS-CoV-2 
Antibody Testing 

Have a parent/guardian 
who can give informed 
consent

In the judgement of the 
Mary Cariola Medical Staff 
will be able to safely 
participate in the study 
procedures (nasal swab, 
phlebotomy) 

Contraindication to 
phlebotomy (e.g. 
anticoagulated, 
bleeding diathesis)
Mary Cariola 
Center Staff

COVID-19 RT-PCR 
Testing

Anti-SARS-CoV-2 
Antibody Testing

Age 18 – 72

Able give informed 
consent

Anticipated duration of 
remaining employment 
less than 1 month (e.g. 
retiring)

Must be willing to 
participate in RT-PCR and 
antibody testing

Contraindication to 
nasal swab

Contraindication to 
phlebotomy (e.g. 
anticoagulated, 
bleeding diathesis)
3. SUBJECT IDENTIFICATION, RECRUITMENT, AND CONSENT
3.1 Method of Subject Identification and Recruitment
Participants will be assigned de-identified code numbers to maintain confidentiality. This code 
will be used to label all de-identified documents and data files relating to the subject.
Selection will occur as a function of the criteria above.
3.2 Process of Consent
Consent is an on-going process that starts when you first inform potential subjects about the 
study and ends when the subject’s study participation is completed. 
a) Written informed consent will be obtained by standard procedures approved by the University 
of Rochester Medical Center Research Subjects Review Board (RSRB). Consent form will be e-
mailed or sent via letter or fax to the subject (if an adult) or to the subject’s parent/guardian for 
their review at least 24 hours before their scheduled appointment. Informed consent will be 
obtained in person by one of the study investigators prior to any study-related activities, typically 
as the first line of action when a subject comes in for the experiment they are participating in. 
The consent form will be reviewed and the participant or guardian will be given as much time as 
they desire to decide. If they would like to take more time to seek input from other individuals 
before deciding about participation, this will be allowed and the visit rescheduled. The 
participant or guardian will again be given the opportunity to ask any questions before signing 
the consent form. The study will again be explained in detail by a study investigator and the 
participant or guardian will be given the opportunity to ask questions and will be reminded of 
their right to discontinue the study at any time. Participants or guardians will be given copies of 

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their written consent to participate. The original signed consent form will be stored in a locked 
file cabinet in the study coordinator’s office for future reference. 
b) This study includes children, a vulnerable population, and these MCC students have 
moderate to severe IDDs. We will administer an age/ developmentally-appropriate assent form 
in conjunction with guardian permission. There may be participants with IDDs that are unable to 
be assented due to cognitive and language limitations. We will consult MCC personnel when 
determining the cognitive abilities of the students. The study staff will still explain the procedures 
to the individual and attempt to determine their level of understanding. If determined that they 
cannot provide informed assent we will document this on an assent form (there is a check box 
on the assent forms to indicate subject’s ability to provide informed assent)  and proceed only 
with parent/guardian permission. For these participants, the staff will also use a low threshold 
for any indication a participant wishes to stop their participation.
c) Consent for participants with Spanish as a primary or sole or preferred language. Mary 
Cariola Staff whose primary and preferred language is Spanish will be consented using our 
Spanish Consent forms, by study personnel who speak fluent Spanish or by translators from the 
URMC. Two study team members are fluent in Spanish. Questionnaires have been translated 
into Spanish and are built into RedCap forms sent to participants based on the language used 
to consent them. Email contact with the link to surveys is also in Spanish. All questionnaire data 
on both English and Spanish forms are coded and transmitted to the data team as coded 
information  without information about the language of the data collection form – this prevents 
identification of participants based on language of consent. Parents of students whose 
primary/preferred language is Spanish will be given the Spanish permission forms and work with 
one of the Spanish speaking study team members. Students at Mary Cariola are fluent English 
speakers and all classes are taught in English. We will use English Assent forms with students.
 d) Alternately, the patient will be given the choice to utilize the Electronic Informed Consent 
(eConsent) process to provide consent remotely. This platform involves a computer based 
consent form accessed on personal electronic devices (e.g., computers, portable tablets, smart 
telephone), rather than traditional paper documentation created using a REDCap-based 
electronic consent form. The IRB-approved consent form will be developed in REDCap, a 
secure, web-based, HIPAA compliant, data collection platform with a user management system 
allowing project owners to grant and control varying levels of access to data collection 
instruments and data (e.g. read only, de-identified-only data views) for other users.  
If the patient chooses to eConsent, a member of research team will request verbal 
permission to send the eConsent via email or text. The request will state: “Because URMC can’t 
control the security of email or text messages once we send them, we need your permission to 
text or email you. Do you want to receive the link to the eConsent via email or text?”  The 
permission will be documented.  The email or text will not include PHI. 
•
The patient will be contacted by the research coordinator via telephone and/or 
video conference to ensure that the subject or legally authorized representative has full 
understanding of the study and has had ample opportunity to ask questions.  
•
In order to authenticate the identity of the subject or legally authorized 
representative signing the consent, an agreed passcode is communicated between the 
subject and the research coordinator.  This passcode is saved as part of the subject’s 
record for verification use later. The subject or legally authorized representative, at the 

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time of accessing the survey/eConsent, must then enter the passcode which is 
compared with the stored version entered by the research coordinator. 
•
Subject or legally authorized representative signatures will be obtained using a 
typed signature.  
•
Once the consent form is signed and submitted, subjects will be able to receive a 
print out of the paper copy, download a PDF, and/or receive an email with a PDF 
attachment of the signed document.  The original consent form will be placed in the 
research record.  Prospective subjects will be given the opportunity to consent to future 
use of information and consent to re-contact in the future.
e) Some students at Mary Cariola School are age 18 or older (up to 21) and have legally 
authorized representatives (LARs). We will use our adult consent documents and have the LAR 
consent to participation of the student in the study. We will also get signed assent directly from 
the student when they are developmentally capable of providing informed assent. There may be 
participants with IDDs that are unable to be assented due to cognitive and language limitations. 
We will consult Mary Cariola personnel when determining the cognitive abilities of the students. 
If determined that they cannot provide informed assent we will document this on an assent form 
(there is a check box on the assent forms to indicate subject’s ability to provide informed assent)  
and proceed only with consent of the LAR. For these participants, the staff will also use a low 
threshold for any indication a participant wishes to stop their participation.
4. METHODS AND STUDY PROCEDURES
4.1 Study Procedures and Assessments
Funding of study elements: A grant to the University of Rochester from the National Institutes of 
Health RADx-UP program is providing funding for all aspects of the study procedures with the 
exception of the fingerstick blood draw and analysis of these blood samples. The fingerstick test 
for COVID-19 antigens is not an FDA approved test – it is solely for research purposes.  
Funding for this aspect of the project comes from a separate grant from the National Institutes of 
Health as a supplement to the University of Rochester Intellectual and Developmental 
Disabilities research Center.
Questionnaire: Staff or parents of students will be sent a unique link to a RedCap form for 
them to fill out. We will arrange to send this to them via email or provide them with an 
opportunity to fill this out on-site using a study iPad. The questionnaires are designed to collect 
information about the household of the subject, demographics information, attitudes and 
opinions regarding COVID-19 risk and testing, and vaccines. Also asked are questions about 
medical history, health status, drug/alcohol use.   
A second link to the questionnaire will be sent all current participants to collect a cross-section 
of responses at a single time point – beginning mid May 2022. The questionnaires will be 
identical to the initial questions presented to each participant at the time of their enrollment.
Asymptomatic Testing – 
Nasal Swab: Participating individuals (students and employees) will be tested for COVID-19 
(RT-PCR) using a specimen collected using a mid-turbinate swab. This asymptomatic testing 

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regime starts on or after (if scheduling testing requires this to begin on a different day) 
enrollment and is repeated every 5-14 days for up to 36 months. Anyone testing positive is 
followed up as described below for symptomatic individuals. 
Saliva Sample:  For those participants (students only) that are unable to tolerate the nasal swab 
(mid-turbinate) test, we will use the Spectrum Solutions™ SDNA-1000 Molecular Diagnostic 
Saliva Collection Device. This is a self-contained, EUA authorized saliva collection system. It 
requires filling a small tube with saliva.
Blood Samples:  Participating asymptomatic individuals (students and employees) will be tested 
for antibodies using the fingerstick upon scheduling first sampling visit and monthly thereafter 
for up to 36 months. This first blood sampling will be using a fingerstick and 1-2 drops of blood 
will be collected in a curette for serology testing. Possible complications include pain from the 
fingerstick, and a low risk of infection. The rationale for this intervention is to measure serum 
antibodies against SARS-CoV-2 using standard FDA approved testing methods.
A second method for blood sampling using venipuncture will be carried upon enrollment 
or upon scheduling the first sampling visit and subsequently, every six months for up to 
36 months. In addition this method will be used for additional blood collection for MBC 
and DNA analyses.  This  second method will use venipuncture to collect ~6-10 cc of whole 
blood (except in students younger than 5 years in whom we will collect between 3-5cc). The 
possible complications of phlebotomy/venipuncture include pain, small local hematoma 
formation, bleeding and infection. However, this method of blood collection and testing is widely 
used by millions individuals daily in the United States with minimal complications, including IDD 
subjects. Phlebotomy will be conducted by a team specially trained in working with IDD subjects 
to minimize risk. 
Symptomatic Testing. Those presenting with symptoms will be also tested for COVID-19 (RT-
PCR). Those with negative test results will return to the asymptomatic testing protocol. Those 
with positive tests will follow NY State guidelines for quarantine/isolation. Upon return to 
work/school they will continue with PCR and antibody testing as described above 
Additional Study Procedures
The below are not accomplished using FDA approved tests and are for research use only.
Blood Sample - Analysis of memory B cell recall responses. Memory B-cell (mBC) recall 
responses are key to generating new antibodies against highly homologous antigenic epitopes 
after vaccination. Dr. Zand and Wang have demonstrated that IgG secreted by in vitro mBC 
after SARS-CoV-2 infection and vaccination contain IgG recall reactivity that includes new 
pathogen-specific epitope specificities2, 3, 6. We will compare the mBC recall specificities for 
SARS-CoV-2 in vaccinated and unvaccinated subjects. Peripheral blood mBC in one tube (one 
tube – 6-10ml) of heparinized blood will be stimulated to form antibody secreting cells (ASCs) 
by 6 days in vitro culture with a combination of pokeweed mitogen, Staphylococcus aureus 
protein A, CpG ODN-2006, and IL-10. IgG secreted by ASCs in vitro will be analyzed by 
mPLEX-CoV3, 4, 6. Antigen-specific and total IgG ASCs in the cell pellet will be enumerated by 
ELISpot. Antigen-specific IgG ASCs as a percentage of total IgG ASCs will quantify antigen-
specific IgG mBC as a proportion of total IgG mBC 8.

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Genetic Research Procedures
Banking of DNA samples for mRNA vaccine response and IgG level decay targeted genotyping:
Blood Sample - One tube (one tube – 6-10ml) of blood will be collected from up to 200 
neurotypical staff and 50 IDD students and stored for later DNA isolation and targeted genomic 
analysis. This is genomic research and NOT genetic testing. It will be carried out for research 
purposes only and no information about genetics will be disseminated to participants. After all 
testing is completed samples will be destroyed. 
Population 
(Minor vs. Adults) 
Blood Draw 
Procedure 
(COVID 
antibodies, 
MBC, or 
DNA) 
Amount 
of 
Blood 
Frequency of 
Blood Draw  
Fingerstick 
or 
Venipuncture 
Adults 
COVID anti
1-2 
drops
monthly
fingerstick
Minors
COVID anti 
1-2 
drops
monthly
fingerstick
Adults
COVID
6-10 cc
Every 6 months 
(completed)
Veni.
Minors
COVID
6-10cc 
(unless 
under 
age 5 
(then 3-
5cc)
Every 6 months 
(completed)
Veni.
Adults
MBC
6-10 cc
Once only
Veni.
Minors
MBC
6-10cc 
(unless 
under 
age 5 
(then 3-
5cc)
Once only
Veni.
Adults
DNA
6-10cc
Once only
Veni.
Minors
DNA
6-10cc 
(unless 
under 
age 5 
(then 3-
5cc)
Once only
Veni.

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Mandated COVID-19 testing for Mary Cariola Staff: In response to the New York State 
vaccine mandate Mary Cariola Center policy requires staff who are not vaccinated to be 
tested weekly for COVID-19. One method for meeting this policy requirement is enrollment in 
this study. Staff who are enrolled will be tested weekly and results reported to Mary Cariola 
personnel. For all unvaccinated staff enrolled in the study missing the scheduled weekly 
COVID test  will be reported to Mary Cariola administrative personnel in accordance with Mary 
Cariola Center policy.   
Other data. MCC will also provide student and staff schedules (i.e. what room they are in) for 
use in the modeling
Multisite collection procedures:
All data will be collected by the URMC team in the Rochester area. The primary data collection 
location will be the Mary Cariola Center. Some home visits for testing of MCC students or staff 
will also be accomplished using our mobile test unit.
4.2 Future Use Data/Samples
We provide subjects with the option of participating in future research studies on all 
our consent forms. If they consent, we store their data in a de-identified fashion indefinitely. 
We offer to destroy their records at any time upon their request to withdraw from future 
studies. If this request is made, we will permanently delete all stored data recorded with that 
participant during the study.
Data will be encrypted and electronically sent to Duke Clinical Research Institute at Duke 
University. They are serving as the NIH-funded Coordination and Data Collection Center 
(CDCC).  Data sent to DCRI include all questionnaire data, results of COVID-19 tests and 
results of serology tests. Biosamples will NOT be sent. Results of the tests WILL be 
transmitted electronically to the CDCC. Blood samples will be securely stored until the end of 
the study when they will be destroyed.
The Duke Clinical Research Institute (DCRI) is a research group chosen by the National 
Institute of Health (NIH) to combine the data collected from everyone taking part in RADx-UP 
studies. The DCRI will build two RADx-UP  The first database will only hold identifiable 
information 
These data will be kept at the DCRI. The DCRI will not share these data with the NIH.
These data can be linked with information from other sources, such as the Centers for 
Medicare and Medicaid Services and electronic health record, among others if parent 
permission or participant consent is provided
The DCRI will keep identifiable information to contact participants for future research studies 
only if parents/participants provide permission/consent to be contacted.
Identifiable data will be password-protected and only staff responsible for maintaining the 
security of the data at the DCRI have access. 
The second database will contain de-identified data. Only data that parent has given 
permission or participant has consented to maintain.   
De-identified data will be kept in a secure database for COVID19 research at the NIH. Other 
researchers may use these data for studies, other than the ones stated in this consent form.

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Blood drawn for B-cell analysis and for future genomic testing will be maintained solely at 
the University of Rochester.  These samples and data derived from them will NOT be 
transmitted to DCRI. Data will be integrated and managed in REDCap and CABIN 
servers. All biological samples will be obtained specifically and solely for research 
purposes. De-identified residual blood and extracted DNA will be stored in locked -80C 
freezers and saved for future analysis.
4.3 Costs to the Subject
There are no costs for participation
4.4 Payment for Participation
Mary Cariola staff will be paid $25 gift card after the first visit and $10 at their monthly visits that 
involve fingerstick for the duration of their enrollment.
Mary Cariola students (children ages 3-17) will get $25 for enrolling in the study and an additional 
$10 at each monthly fingerstick visit, 
Mary Cariola students (age 18 and over) will be paid $25 gift card after the first visit and $10 at 
their monthly visits that involve fingerstick for the duration of their enrollment.
Students and Staff participants will get an additional payment of $25 for completing the second 
set of questionnaires (CDE/PROMIS)
4.5 Return of Individual Research Results
Subjects (and/or their parent/guardian) will be informed if there is a positive COVID-19 test.
5. SUBJECT WITHDRAWALS
If a subject wishes to self-withdraw from this study, there are no impediments or consequences. 
The participant will be paid what is owed for participation to that point. This is outlined in the 
consent form. A minor or vulnerable participant may be withdrawn by the researcher if they are 
identified as distressed by study procedures. Minor subjects can withdrawal by withdrawing 
assent either explicitly or implicitly (by being non-compliant during study procedures). The 
parent/guardian can withdrawal permission at any time without consequences. The participant 
will be paid what is owed for participation to that point. This is outlined in the consent form.
6. RISK/BENEFIT ASSESSMENT
6.1 Risks to Subjects
 Potential Risks and Benefits for Participants 
This study, by design, involves a vulnerable population, children under age 18. The importance 
of this study is provided in the application and in the NOSI itself given the risks associated with 
COVID-19 among this population. The benefits of undergoing testing and the proposed 
modeling in this group of children considered at high risk for illness and hospitalization due to 
COVID-19 exposure will be both direct and indirect. First, children will have access to testing not 
readily available to them. Second, indirect benefits would be the information provided to MCC to 
modify procedures to mitigate or minimize transmission at the children’s residential and school 
facilities. The proposed testing regime will also help define what pattern of testing is warranted 

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for individuals with IDD. Given the high risk nature of COVID-19 among this population, and the 
potential for local and national impact, the risks to subjects (primarily discomfort with testing) are 
reasonable in relation to the importance of the knowledge that reasonably may be expected to 
result. 
Potential Risks: 
Nasal Swab: The nasal swab will be used to collect the samples for FDA approved RT-PCR. 
Potential risks include slight discomfort or irritation of the nasal area being swabbed, anxiety 
and agitation in an IDD child. While unlikely since a mid-turbinate (rather than a nasal 
pharyngeal) swab is used, it is possible that the nasal mucosa could be damaged while 
obtaining the specimen. Those collecting specimens will have special training that is specific to 
specimen collection in an IDD population This is generally a minimal risk procedure, and we 
have specifically chosen to use nasal swabs, and not deep nasal pharyngeal swab method 
sample collection, for this reason. 
Saliva test:  The saliva test (ThermoFisher SDNA-1000 Saliva Collection Device) uses a small 
tube to collect a saliva sample for testing for presence of COVID-19. This tube contains a viral 
stabilization fluid to prevent deterioration of the sample until testing can occur. This test will be 
offered for use when your child refuses to have the nasal swab test. There are risks of this new 
test. The tube itself is a choking hazard. The fluid inside the tube can cause harm if ingested. 
The fluid in the tube should not get on skin or in eyes.  To prevent these risks the collection tube 
is designed to prevent any of this fluid from exiting the tube using a ‘spill-proof’ design. In 
addition, the study coordinators will securely hold the tube at all times and your child will not be 
able to ingest either the tube or the fluid. 
Phlebotomy: Two methods will be used to collect blood samples. The first will be using a 
fngerstick and 1-2 drops of blood will be collected in a curette for serology testing. Possible 
complications include pain from the fingerstick, and a low risk of infection. The rationale for this 
intervention is to measure serum antibodies against SARS-CoV-2 using standard FDA 
approved testing methods. In the  second method phlebotomy will collect ~4-8 cc of whole blood 
(except in students younger than 5 years in whom we will collect between 3-5cc). The possible 
complications of phlebotomy include pain, small local hematoma formation, bleeding and 
infection. However, this method of blood collection and testing is widely used by millions 
individuals daily in the United States with minimal complications, including IDD subjects. 
Phlebotomy will be conducted by a team specially trained in working with IDD subjects to 
minimize risk. 
Monitoring Risk: Data from the virological and serological surveillance testing will be used to 
inform models of how surveillance testing in a school for IDD children, with parent/guardian 
consent, can be used to improve surveillance and minimize infection, given the scarce resource 
of COVID-19 testing reagents currently in the US. First, there is currently no NYS DOH or CDC 
recommended or mandated COVID-19 testing surveillance plan for such schools, and thus we 
do not know what the optimal testing plan is. Given this clinical/epidemiological equipoise, it is 
possible that the changes in testing patterns will improve detection of COVID-19 in this 
community. It may also be possible that such changes will not improve detection or, although 
we think that this possibility is very small, worsen detection rates. Given that surveillance testing 
is currently not standard of care for students, it is hard to conceive of how regular surveillance 
testing would worsen COVID-19 detection rates, especially in asymptomatic individuals. 

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Genetic Information Risk: While the controlled-access databases used to store data from this 
project will not contain information that is traditionally used to identify participants, such as 
name, address, and telephone number, people may develop ways in the future that would allow 
someone to link genetic or medical information in these databases back to. For example, 
someone could compare information in our databases with
information from participants (or a blood relative) in another database and be able to
identify them (or a blood relative). Individuals who request access to these data will have to 
agree not to try to identify participants or any relatives, or to contact participants or relatives. 
However, there is a small possibility that in the future an unauthorized attempt to identify a 
participant in the study could succeed. Some genetic variations can help predict the future 
health problems participants or their relatives. Patterns of genetic variation can be used by law 
enforcement agencies to identify a person or their blood relatives. Therefore, participant’s 
genetic information potentially could be used in ways that could cause them or their family 
distress, such as by revealing that a participant (or a blood relative) carries a genetic disease. 
There also may be other privacy risks that we have not foreseen.
A Federal law, called the Genetic Information Nondiscrimination Act (GINA), makes it illegal 
for health insurance companies, group health plans, and most employers to
discriminate based on genetic information. This law generally will protect participants in the 
following ways:
• Health insurance companies and group health plans may not request your genetic
information that we get from this research.
• Health insurance companies and group health plans may not use your genetic
information when making decisions regarding your eligibility or premiums.
• This Federal law does not protect participants against genetic discrimination by
companies that sell life insurance, disability insurance, or long-term care insurance.
6.2 Benefits to Subjects
 Potential benefits to the subjects. This research seeks to develop new methods of adjusting 
surveillance testing for SARS-CoV-2 infection the prevalence of antibodies against SARS2 in a 
high risk and vulnerable population using FDA approved clinical tests. There are several direct 
benefits to research subjects and their families, including regular monitoring for asymptomatic 
COVID-19 infection at no charge, potential prevention of spread or infection to the Mary Cariola 
School and community and participants families. 
Another possible benefit is the increased sense of well-being and psychological satisfaction of 
altruistic participation in a study to further the our understanding of, and potentially improving 
our understanding of COVID-19. Such motivation, and the personal satisfaction that comes with 
contributing altruistically to medical research, which does not directly benefit the participant, has 
been described in cancer and HIV trials, with similar descriptions for bone marrow donation. We 
will also provide each subject and their parent/guardian with their test results (if positive), and an 
explanation of what this means.
Definition, Collection and Reporting of Adverse Events (AEs), Serious Adverse Events 
(SAEs) and Unanticipated Problems (UPs) 
Identification of Adverse Events and Serious Adverse Events 
Athough this study is not testing a drug, device or biologic, and all testing methods are NYS 
and/or FDA approved, we will adhere to the Food and Drug Administration definition of adverse 

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events, serious adverse events, and unanticipated problems. In addition, we will adhere to the 
Office of Human Subjects Research Protections (OHRP) reporting requirements. 
 Adverse Event Definition: An AE will be defined as “Any untoward medical occurrence in a 
participant, which does not necessarily have a causal relationship with the study intervention.” 
Examples of adverse events in this study could include bruising or bleeding at a phlebotomy 
site, phlebotomy site infection, bleeding from a nasal swab, mild injury due to subject agitation 
during the study procedures (e.g. bruise on a leg from increased agitation). In addition, in our 
experience during previous studies, the use of specially trained personnel to perform such 
minimal risk procedures results in phlebotomy and similar minimal risk procedures being 
extremely well tolerated by IDD children. 
 Serious Adverse Event Definition: An SAE will be defined as “Any adverse event that results 
in death, immediately life threatening conditions, hospitalization, persistent or significant 
disability or incapacity.” The study procedures in this proposal are generally classified as 
minimal risk , and thus we do not anticipate serious adverse events. In the IDD population, 
examples of possible SAEs could include unexpected death or hospitalization in a study 
participant. 
 COVID events – This is a surveillance study, and it is expected that some subjects will 
become COVID-19 positive. This rate may be high depending on the local indicence of new 
COVID-19 cases. Thus, we will use the following schema for defining COVID-19 AEs and SAEs 
o COVID-19 PCR positive No Adverse Event – asymptomatic, resulting in only quarantine. This 
will not be reported as an AE or SAE. 
o COVID-19 PCR positive Adverse Event – resulting in changes in medical therapy, COVID-19 
specific outpatient therapy, prolonged interval with positive test results (>30 days after initial test 
or symptoms). 
o COVID-19 PCR positive Serious Adverse Event – resulting in hospitalization, life threating 
conditions (e.g. hypoxia, intubation), significant new disability or incapacity (e.g. new lower 
functional status with no recovery, new oxygen requirement), or death. 
o Unanticipated Problems Definition: We define UPs as any event that meets all of the 
following criteria: (1) It is unexpected (in terms of nature, severity, or frequency) given (a) the 
research procedures in the protocol documents, such as the RSRB-approved research protocol 
and informed consent document; and (b) the characteristics of the subject population being 
studied; (2) It is 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 (3) suggests that the research 
protocol places subjects or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
Reporting of Adverse Events: 
Adverse Events and Unanticipated Problems will be reported as follows: 
 Responsibility for Reporting Events: The PIs will be responsible for reporting any AE, SAE, or 
UP to the University of Rochester Humans Subjects Review Board and the COV-IDD Data 
Safety Monitoring Board within 5 days of the event. They will be assisted by the study 
coordinators. Any SAE must be reported to the RSRB within 24 hours. 
 Reporting to the NIH Study Sponsor: Dr. Foxe, as the Communicating PI, will be responsible 
for timely reporting of any AE, SAE or UP to the National Institutes of Health through the 
Program Officer, and any other required governmental reporting 

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 COVID-19 Infection Reporting: Dr. Nicole Pecora will report any positive COVID-19 RT-PCR 
testing to the NYS Department of Health. As these tests are clinical tests, this reporting is 
mandated and occurs automatically 4 time daily. 
6.3 Alternatives to Participation
7. CONFIDENTIALITY OF DATA AND INFORMATION STORAGE
There is a well-established secure data management approach using LabKey that links to 
REDCap as described in the application. Access to identifiable data will be limited to selected 
members of the study team
 Participant identities will be kept confidential unless safety concerns necessitate 
unmasking some or all data.
We employ a state-of-the-art data management system (BLIS) (Figure 1) that is ideally suited to 
managing and integrating clinical study data with biospecimen records and customized modules 
for high-throughput assays data (primary and derived results). BLIS is a customized instance of 
the open-source LabKey Server an application developed to integrate, analyze, and share 
biomedical research data, including Luminex®, ELISpot, rt-PCR and specimen inventory. 
Specific scientific applications and workflows are added on top of the basic platform and 
leverage a data processing pipeline, managing raw experiment files and derived datasets 
generated from computational tools.
REDCap (Research Electronic Data Capture): REDCap is a secure, web-based platform for 
structured data capture providing real time validation rules (with automated data type and range 
checks) at the time of data entry with complete transaction audit logs.6 It has tools for sending 
notifications to study team members when a patient has completed a study visit which improves 
communication between the clinical site and the labs. The proposed COV-IDD data 
management team has in depth experience utilizing REDCap to design and implement 
customized electronic data capture (EDC) solutions. REDCap servers are housed in the 
University’s Primary Data Center and all web-based information transmission is encrypted. 
REDCap is available free of charge to the UR CTSI through the REDCap Consortium and is 
widely used for research studies and trials. Currently, over 3100 institutional consortium 
partners from 126 countries use REDCap.
Ripple (RippleScience.com): Ripple is a participant recruitment and management software 
initially developed at the University of Michigan to serve the needs of academic investigators. It 
closes a gap left by existing tools by providing investigators a centralized web interface to 
manage all aspect of recruitment and post-enrollment tracking of participants for clinical, 
translational, and social science studies. Its toolset includes multi-study calendaring and 
protocol event tracking, automated reminders and recruitment metrics. Ripple is HIPAA-
compliant through a BAA with the University of Rochester.
Data Analysis and High-Performance Computing
In order to enable High Performance Computing (HPC) and Data Analysis, the COV-IDD 
systems and researchers integrate with the Center for Integrated Research Computing (CIRC) 

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BHWARD. BHWARD is a specialized, FISMA compliant, HIPAA secure, high-performance 
computing environment designed and built to work with legally restricted data.  All research data 
is kept quarantined from different projects through controlled resource allocation methods. All 
project data are kept segregated through independent tablespace allocations, appropriate 
access rights, and encryption.
Long-term Data Storage and Archival
To enable the long-term storage and archival of large-file data, the COV-IDD has partnered with 
the Research & Academic IT group for use and expansion of SMD-NAS, a Dell-EMC Isilon 
scale-out storage system which is detailed in the Administrative Core DMP.
Research & Academic IT provides a broad range of IT services and is committed to meeting the 
technology needs of the University of Rochester community including desktop support, 
application management, and Information Security for the University of Rochester School of 
Medicine and Dentistry including other affiliated organizations.
Due to the provision of these systems, no long-term data storage or archival is necessary within 
individual cores or labs. This provides additional safeguards from the need for diverging 
management procedures and ensures proper backup, encryption and security methods are 
inherited without additional effort.
Data will be encrypted and electronically sent to Duke Clinical Research Institute at Duke 
University. They are serving as the NIH-funded Coordination and Data Collection Center (CDCC). 
Data Security and Safety
All systems across the University, including instruments, require user authentication against the 
URMC-managed Active Directory. External users, including sponsors gain access to these 
systems via creation of URMC guest accounts obtained from University IT. The COV-IDD Data 
Management Committee, will setup templates for study team user roles and permissions which 
can then be implemented by the Protocol PI and the study delegation log as detailed in the 
Administrative Core DMP.
The University also has an extensive intrusion detection, firewall and centralized logging 
system. External collaborators that require access to specific data paths have their access and 
systems assessed to ensure the encryption both in-transit and at-rest and safe handling of any 
data they may have access to.
8. RESEARCH INFORMATION IN MEDICAL RECORDS
No research data will be included in the subject’s medical record for this study.
9. DATA ANALYSIS AND DATA MONITORING
Data Safety Monitoring 
The Principal Investigator (PI) will be responsible for ensuring participants’ safety on a daily 
basis and for reporting Serious Adverse Events and Unanticipated Problems to his or her 
Institutional Review Board (IRB), the NIH Program Officer and the Data Safety Monitoring Board 

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as required. The study coordinator and the statistician (Dr. Dongmei Li) prepares reports that list 
adverse events, serious adverse events, deaths, and disease- specific events required for 
monitoring body review in order to ensure good clinical care and identify any emerging trends. 
The Data Safety Monitoring Board (DSMB) will act in an advisory capacity to to monitor 
participant safety, evaluate the progress of the study, to review procedures for maintaining the 
confidentiality of data, the quality of data collection, management, and analyses. 
Frequency of Data and Safety Monitoring 
The PI will be informed of serious adverse events as soon as they occur by the study 
coordinator and will notify the RSRB, NIH Program Officer, and the Data Safety Monitoring 
Board (DSMB) within 48 hours of becoming aware of the event. The PI will report the Serious 
Adverse Events and Unanticipated Problems the RSRB within 5 business days of becoming 
aware of the event, according to local RSRB requirement. Specific triggers for an ad hoc review 
or initiation of the process of an ad hoc review will occur if there are unforeseen deaths or the 
threshold for SAE has been met. 
Safety reports are sent to the Data Safety Monitoring Board twice a year and will include a 
detailed analysis of study progress, data and safety issues. 
Content of Data and Safety Monitoring Report 
The study report will contain the following documents and tables: 
 Actual versus expected enrollment table, including a CONSORT diagram. 
 Table of testing results, including number of tests per student or staff member, testing 
outcome (positive, negative) for both Serology and RT-PCR 
 Table of aggregate adverse events, deaths, and unanticipated problems 
 Demographic data will include sex, ethnicity, race, education and age and will be stratified by 
site. 
 Table of expected and missing visits, time points, and tests 
 Table of protocol deviations 
Monitoring Body Membership and Affiliation 
The following individual(s) has/have accepted position(s) as part of the Data Safety Monitoring 
Body (DSMB). DSMB membership will be reviewed and approved by the University of 
Rochester Research Subjects Review Board (RSRB). Should there be any questions regarding 
the independence of the DSMB it will be addressed and corrected if necessary. 
Michael Keefer MD (Chair) 
Chief – Division of Infectious Diseases 
University of Rochester Medical Center 
Ann Francis MD 
Chief Medical Officer 
Mary Cariola Center 
Nancy Bennett MD MPH 
Director – Center for Community Health and Prevention 
University of Rochester Medical Center 
Brenda Tesini MD 
Associate Hospital Epidemiologist - URMC Adult and Pediatric Division of Infectious Diseases 
University of Rochester Medical Center 

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The Independent Monitors for this study, Dr. Michael Keefer (Infectious diseases, clinical trials, 
vaccine studies), Dr. Ann Francis (pediatrics), and Dr. Nancy Bennett (epidemiology infectious 
diseases expertise) are not associated with this research project and thus work independently of 
the PIs, Dr. Foxe, Dr. Pecora, and Dr. Dewhurst. They not a part of the key personnel involved 
in this grant, and are qualified to review the patient safety data generated by this study because 
their unique expertise in the area of infectious diseases, epidemiology, and pediatrics. Dr. Tesini 
is the hospital epidemiologist and will be advising on infection control issues. 
Conflict of Interest for the DSMB Members 
Monitoring body members should have no direct involvement with the study investigators or 
intervention. Each member will sign a University of Rochester Conflict of Interest Statement 
which includes current affiliations, if any, with any steering committees or advisory councils 
associated with the study, pharmaceutical and biotechnology companies (e.g., stockholder, 
consultant), and any other relationship that could be perceived as a conflict of interest related to 
the study and/or associated with commercial or non-commercial interests pertinent to study 
objectives.
Protection of Confidentiality 
Only deidentified and/or masked data will be presented during the open sessions of the DSMB. 
All data, whether in a report or discussed during a DSMB meeting are confidential. Participant 
identities will be kept confidential unless safety concerns necessitate unmasking some or all 
data. 
Monitoring Entity Responsibilities 
The responsibility of the Monitoring Board will include: 
 Reviewing the research protocol, Data and Safety Monitoring Plan (DSMP), and informed 
consent documents, proposed revisions. 
 Evaluating the progress of the study on an ongoing basis including periodic assessments of 
data quality, participant recruitment, accrual and retention, participant risk versus benefit, and 
other factors that can affect the outcome. 
 Considering the impact of factors external to the study when new information, such as 
scientific or diagnostic developments becomes available that may affect safety of participants, 
their willingness to participate in the study or the ethics and conduct of the study. 
 Reviewing Unanticipated Problems, Serious Adverse Event. 
 Reporting any problems with study conduct or performance to the UR Research Study 
Review Board. 
 Ensuring the measures to ensure the confidentiality of study data and results are appropriate. 
 Reviewing and evaluating requests for protocol modifications/amendments. 
 Reviewing before study initiation the stopping rules and plans for interim analyses presented 
in the protocol. These plans outline the conditions under which a study may be stopped (e.g., 
difficulties in recruitment, retention, obtaining outcome measures or other issues). 
 Reviewing the interim analyses and/or accumulating data at the specified interval(s), and as 
appropriate and make a recommendation to continue, terminate or modify the study based on 
observed benefit or harm in accordance with the planned stopping rules. 

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