ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals
Phase: NA
Conditions: Immunodeficiency, Immunosuppression, HIV Infections, Graft Versus Host Disease, Leukemia, Lymphoma, Cancer, Multiple Myeloma, Transplant, Age-Related Immunodeficiency
Sponsor: Scripps Translational Science Institute

 
ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of 
Immunocompromised Individuals 
______________________________________________________________________________ 
Study Protocol 
Submitted to IRB: May 14, 2024      
IRB Approved: August 20, 2024 
Version 1.8 
NCT05655546           
Sponsor: 
The Scripps Research Institute  
3344 N. Torrey Pines Court, Plaza Level 
La Jolla, CA 92037 
 
Collaborator: 
Cue Health 
4980 Carroll Canyon Road, Suite 100 
San Diego, CA 92121 
 
Study Principal Investigator: 
Eric Topol, MD and Julia Moore Vogel, PhD. 
 

Table of Contents 
Table of Contents 
Background​
4 
Purpose​
5 
Study Design​
5 
Table 1. Summary of Study Arms.......................................................................................................................6 
Figure 1: Participant Flow................................................................................................................................... 6 
Study Population​
7 
Study Interventions​
8 
Device Use and Procedures​
9 
Reimbursement​
11 
Surveys​
11 
Outreach​
12 
Risks and Benefits of Participation​
12 
Sample Size and Data Analysis​
13 
Table 2: Sample size (target)............................................................................................................................13 
Risk Management Procedures​
14 
Data Acquisition, Storage and Analysis​
15 
Subject Payment/Costs​
15 
Estimated Duration of Study​
15 
Consent Procedures​
16 
Data Security​
16 
Participant Withdrawal​
16 
Monitoring​
17 
Record Retention​
17 
Publication​
17 
Study Funding​
17 
References​
18 
Appendix 1: Documentation​
20 
Appendix 2: Compatible Devices​
20 
Appendix 3: Participant Surveys ​
21 
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Appendix 4: Outreach One Pager​
26 
Appendix 5: Invitation Email​
28 
Appendix 6: You’re Eligible Email​
29 
Appendix 7: You’re Not Eligible Email​
30 
Appendix 8: Consent Reminder Email​
31 
Appendix 9: Baseline Survey Reminder Email​
32 
Appendix 10: Monthly Survey Reminder Email 1​
33 
Appendix 11: Monthly Survey Reminder Email 2​
34 
Appendix 12: Your Gift Card is Ready To Claim Email ​
35 
Appendix 13: ImmunoCARE Landing Page​
36 
Appendix 14: MyDataHelps In-app Copy​
38 
Appendix 15: Notifications ​
51 
Appendix 16: Calls to Action (prompts for each study task)​
56 
Appendix 17: Marketing Materials​
57 
Appendix 18: Research Match​
59 
Appendix 19: Optum Specific Outreach One Pager​
62 
Appendix 20: Optum Specific Invitation Email​
67 
Appendix 21: ImmunoCARE Animated Explainer Video | Script​
68 
Appendix 22: End of Study Survey Reminder​
71 
Appendix 23: Upload your diagnosis confirmation​
72 
Appendix 24: Claims reimbursement email​
73 
Appendix 25: Outreach Talking Points​
74 
Appendix 26: Safety Alert Email​
76 
Appendix 27: Safety Alert Push Notification/SMS​
77 
Appendix 28: ImmunoCARE Study Closure​
77 
 
 
 
 
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Background 
Immunocompromised individuals around the world are at significantly higher risk of adverse 
outcomes and death from COVID-19 infection (Baek, Lee, Kim, Choi, & Jung, 2021). 
People over the age of 65 also face higher risk of adverse outcomes and hospitalization 
(Vo, La, Wu, 2022). Even with vaccination, these  populations remain at significantly higher 
risk of hospitalization and severe disease (Ryan, 2021; Sun et al., 2022). These factors 
impact quality of life (Amonoo et al., 2021) and pose a threat of significant financial burden 
when standard of care is indicated (Stephenson, 2021).  
The pandemic illuminated already existing gaps in our healthcare system and limitations in 
our ability to track and mitigate community transmission (Kliff & Sanger-Katz, 2020). To 
address this, in part, the FDA has granted emergency use authorization for dozens of home 
devices that can be used to diagnose COVID-19 (Rizk et al., 2021). Easy to access testing 
and diagnosis, combined with measures such as isolation and social distancing, are some 
of our strongest tools that positively mitigate community transmission (Manabe, Sharfstein, 
& Armstrong, 2020). Additionally, we know that early detection through frequent testing has 
a positive correlation with people at high risk getting the medication they need, like 
Paxlovid, within the short window at disease onset when it is most effective. (Petty & 
Malani, 2022; Smith et al., 2021) 
Cue Health is a San Diego, California based healthcare technology company that develops 
portable diagnostic tests for at-home use. Cue developed the first FDA-authorized 
COVID-19 diagnostic test that was used at home and available over the counter, without a 
prescription. Cue’s COVID-19 tests amplify and detect the genomic RNA of SARS-CoV-2. 
The testing system consists of a swab and cartridge that reads the user’s specimen, and an 
application that produces the results. The app also provides access to a mobile health 
dashboard to connect with on-demand telemedicine, proctoring, and prescription services 
(CueHealth, 2022).  
The Digital Trials Center (DTC) at the Scripps Research Translational Institute (Scripps 
Research) is a leader in large-scale decentralized research studies, which harnesses digital 
health technologies to address pressing health problems. The DTC portfolio includes the 
direct-to-participant experience of the All of Us Research Program, which has engaged 
over 100,000 individuals across the United States. 
The DTC is also home to advanced data analytics that incorporate machine learning and 
other artificial intelligence approaches. DTC has launched several IRB-approved digital 
studies that address diabetes (PROGRESS), maternal health (PowerMOM) and sleep 
(Refresh).  
In March 2020, Scripps launched the Digital Engagement & Tracking for Early Control, & 
Treatment (DETECT) study, an app-based research platform that allows for consented 
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participants to share their wearable device data, self-reported symptoms, test results, 
vaccine information, and to optionally connect electronic health record (EHR) data. 
DETECT builds from our team’s prior work utilizing wearable device data to monitor 
influenza-like-illnesses at a state level (Radin, Wineinger, Topol, & Steinhubl, 2020). 
DETECT aims to provide a deeper understanding of physiological and behavioral changes 
associated with viral illness, including COVID-19 with the goal of ultimately improving 
real-time digital disease detection. DETECT has enrolled over 40,000 participants from 
across the country. The observational data collected has led to several findings including 
the ability to discriminate between COVID-19 and other illnesses among symptomatic 
individuals (Quer, Radin, et al., 2021; Gadaleta et. al., 2021) and a prolonged deviation of 
daily resting heart rate (RHR) for SARS-CoV-2 positive individuals (Radin et al., 2021). 
Another analysis showed deviation in resting heart rate post-vaccination with observed 
differences between doses as well as between types of mRNA vaccines (Quer, Gadaleta, 
et al., 2022). Most recently, the DETECT team published and confirmed the utility of 
wearable device data in the early detection of COVID-19 and other acute respiratory 
infections (Radin et al., 2022). 
Scripps DTC and Cue Health, in a new collaborative partnership, will combine their 
expertise in portable COVID-19 testing and direct to participant research to address the 
needs of the immunocompromised community. 
 
Purpose 
To examine whether a combination of at-home nucleic acid amplification tests, on-demand 
telemedicine, and delivery of Paxlovid within hours of testing positive for COVID-19, can 
reduce severe outcomes and hospitalization of immunocompromised patients. We will also 
analyze whether these efforts lower the cost of care compared to standard of care. 
 
Study Design 
We plan to conduct a randomized control trial with 10,000 participants. Participation will last 
for a minimum of 4months and maximum of 8 months, depending upon COVID-19 case 
rates. Half of participants will be randomized to the control group and continue their existing 
testing and healthcare practices. The remaining participants will be randomized into the 
intervention arm. Participants in the intervention will receive one Cue Cartridge Reader for 
the duration of the study and up to 10 Cue COVID Molecular tests per month for their own 
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use and to share with others who could expose them to COVID-19 (e.g. close contacts). In 
the case that a Cue Flu+COVID Molecular Test is available through FDA EUA or other 
authorization, participants may be provided this multiplex test in lieu of the Cue COVID 
Molecular Test. 
Table 1. Summary of Study Arms 
Study Arm 
Number of participants 
COVID-testing practice 
Control 
5,000 
None within this study 
Intervention Arm  
5,000 
10 Cue tests per month to participants’ for 
self and close contact use. Option to utilize 
Cue’s telehealth and Rx delivery. 
 
All intervention participants will be asked to test themselves if they are exposed or when 
symptoms arise. The primary outcome will be the number of hospitalizations that will be 
assessed from survey and claims data. We will also compare infection rates, ICU 
admissions, ED visits, deaths and cost of care between the control and intervention group. 
Our hypothesis is that access to high sensitivity portable molecular testing and subsequent 
antiviral treatment will significantly decrease hospitalization and thereby the cost of care. 
 
Interested individuals will access the study via the MyDataHelps platform by web or app to 
complete the eligibility and informed consent process. Within the MyDataHelps experience, 
participants will complete study activities such as surveys and optional sharing of claims 
data. Participants who are randomized to the intervention group will have the option to use 
Cue Care should they test positive for COVID-19. In the case that the COVID Flu+COVID 
test is available, the intervention group will also have the option to use Cue Care should 
they test positive for Influenza. Cue Care contracts licensed Healthcare providers to deliver 
telemedicine and treatment for COVID-19.  
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Figure 1: Participant Flow 
 
      
 
 
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Study Population 
To meet our study objectives, participants who enroll will be considered moderately to 
severely immunocompromised, this can be due to several types of conditions and 
treatments. Participants will provide documentation from a medical provider confirming their 
diagnosis. We will also enroll those who are 65 years or older, with no immunosuppressive 
diagnosis, due to the risk of severe outcomes and hospitalization within this age group. 
Additionally, because Medicare is widely used in this population, connecting Medicare 
claims for those enrolling by age will be required. This portion of participants will make up 
no more than 25% of the study population. 
 
Inclusion Criteria 
●​ Living in the United States 
●​ 18 years or older 
●​ Can read and understand English 
●​ Use of compatible device (as described in Appendix B) 
●​ Vaccinated against COVID-19 (completed at least the initial course, e.g. at least 2 
doses of Moderna or Pfizer, one dose of J&J) 
●​ Willing and able to participate in study interventions including: 
○​ Use of smartphone, including camera and bluetooth 
○​ Upload verification of diagnosis, if needed 
○​ Completing Surveys 
○​ Use of Cue Health App 
○​ Use of MyDataHelps Web or App 
●​ Belonging to one of these two groups: 
○​ Immunocompromised due to disease or therapy, including: 
■​ Symptomatic HIV  
■​ Graft versus host disease 
■​ Immunoglobulin deficiency/Immunodeficiency  
■​ Immunosuppressive therapy  
■​ Leukemia 
■​ Lymphoma (Hodgkin or non-Hodgkin) 
■​ Metastatic Cancer 
■​ Multiple Myeloma 
■​ Solid organ malignancy 
■​ Transplant, hematopoietic stem cell 
■​ Transplant, solid organ 
○​ 65 years of age or older 
 
Confirmation of immunocompromised status or age will be performed in one of three ways. 
Participants will be able to 1) upload a document directly into the MyDataHelps app,  2) 
email it to a study coordinator, or 3) have their eligibility automatically verified via claims 
data, if connected. Methods 1 and 2 will require the study team to review and confirm 
diagnosis prior to prompting the participant to complete the next study activity. Participants 
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will be notified by push notification, email and/or SMS (depending on their notification 
preferences) that their diagnosis has been verified and they are eligible to move forward to 
participation. Method 3 will be automated back end verification of diagnosis and/or 
immunosuppressive medication history in MyDataHelps using the participants connected 
claims data for identification of qualifying ICD-10 diagnosis codes. 
Study Interventions 
All Groups (n=10,000) 
Baseline study activities for all groups include: verification of immunocompromised status, 
downloading MyDataHelps or using the web version, completion of digital informed 
consent, baseline survey completion, optional connection to claims data source, monthly 
survey completion and reimbursement for participation. 
 
Control Group (n=5,000) 
Participants in the control group will complete the baseline study activities, as described 
above. If symptoms arise or COVID-19 infection occurs, participants will test and seek care 
as they normally would. 
 
Intervention Arm  (n=5,000) 
Participants in this group will complete the 
baseline study activities, as described 
above. Additionally, participants will be 
instructed to create a Cue Health account 
and download the Cue Health App. Using 
the app and the 10 Cue Health COVID-19 
molecular tests that are provided (or Cue 
Health 
Flu+COVID 
molecular tests if 
available 
and 
FDA 
authorized), 
the 
participant will perform tests after exposure 
or 
if 
symptoms arise. Participants can also use the test for 
close contacts who are exposed to COVID-19 and/or 
have 
symptoms. 
If 
COVID-19 
infection 
occurs, 
participants will have access to telemedicine to discuss 
further with a healthcare professional. When clinically 
indicated, medication for the treatment of COVID-19 
(and/or Influenza in case of Cue Health Flu+COVID test 
availability) will be prescribed and delivered to the 
participants' delivery address. Participants can also seek 
care through other healthcare providers or not seek care, 
at their discretion. 
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Device Use and Procedures 
CareEvolution MyDataHelps Web or App 
MyDataHelps by CareEvolution is the app or website that participants will use for digital 
consent, surveys, optional connection of claims data and reimbursement. In-app content 
can be reviewed in the appendices. 
 
The Cue Health Monitoring System 
The Cue Health Monitoring System is a complete diagnostic tool for COVID-19 that uses 
Nucleic Acid Amplification and provides actionable results within 20 minutes. Within each 
system there is a USB Charging Cable Power Adaptor, The Cue Cartridge Reader, Quick 
Start Guide, User Manual, and the COVID-19 Cartridge Pack consisting of the collection 
wand and test cartridge. Participants will receive these items in the mail after ordering their 
Monitoring System within the Cue Health App. The Cue Health Monitoring System works 
with The Cue Health App to deliver results to the participant.  
 
The Cue Health App 
The Cue Health App will be downloaded by participants in the intervention arm. Once 
participants download the app they will set up their account using their email and a unique 
password. Participants will need to view and accept the End User License Agreement as 
well as the Cue Privacy Policy to complete account creation. Once the participants Cue 
account is created, users will verify their registration email. At this time participants will set 
up their profile within the Cue Health app. Not all information is required to be filled in to 
complete this process. Participants will also have the option to enable alerts and location 
services (location services data will not be used for research). Neither are required for use 
of the app. Next, participants will pair the Cue Cartridge Reader to their mobile device. 
 
Pairing the Cue Cartridge Reader to the Mobile Smart Device 
First, participants will connect their cartridge to the power source to allow the device to 
charge. Once charged, the user will scan the QR code on the bottom of the cartridge to 
connect the two. Once connected the device is ready to use for testing. 
 
Running the Cue COVID-19 Molecular Test 
On the home screen in the Cue Health App participants will click +Begin New Test. Next, 
participants will read the use and precautions statement to proceed. Next, participants will 
open the single use test cartridge and sample wand provided in their Cue Health Monitoring 
System. Participants will remove the test cartridge from the tray and insert it into the 
cartridge reader. At this point, the cartridge is preheating for use and users should not 
insert the sample swab or remove the cartridge from the reader. When the cartridge is 
ready, the app will prompt the participant to collect the nasal sample. Instructions are 
provided in the app. Once collected, the sample wand is inserted into the test cartridge and 
sample analysis begins. When the test is complete the app screen will automatically 
advance to the test results. Test results can also be viewed on the home screen or in the 
test center within the participants Cue Health profile.  
 
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If the Cue Flu+COVID molecular test is available and FDA authorized, the above 
instructions are the same except that on the results screen where both COVID and 
Influenza results will be shown. 
 
Cue Care 
Within the Cue Health App, Cue Care allows individuals to access telehealth services from 
third party medical groups. Medical Groups provide telehealth or other healthcare services, 
like prescriptions, through licensed providers who practice medicine and nursing. 
Participants who enroll in this study and are randomized to the treatment arm will have 
access to Cue Care. Using Cue Care is not a requirement of this study and participants 
always have the option to act on their test results with their own providers, or to not seek 
care at all.  
Reimbursement 
Participants will be reimbursed for their participation. Total reimbursement will be up to $2     
00 in Amazon gift cards. When the onboarding, informed consent, diagnosis verification, 
optional claims data sharing process, and baseline survey are complete, participants will be 
provided with a $20 Amazon gift card. Participants who do not share claims data will 
receive $10 after completing consent and the baseline survey, then $20 after completing 
the final survey. Throughout the study, participants will be provided with $10 Amazon gift 
cards on a monthly basis for up to 8 months. If the study period runs shorter than 8 months, 
participants will receive the remaining gift card balance, to total up to $100, at study 
closure. Participants who do not share claims data and do not complete all monthly surveys 
may be offered half of the compensation they missed from monthly surveys upon 
completion of the final survey. For example, if a participant does not complete three 
monthly surveys (which would have earned them $30 of compensation), they may be 
offered an additional $15 for completing their final survey. This is to incentivize participants 
to provide an account of their COVID experiences over the course of the study in the final 
survey, a crucial data point to achieve study objectives. 
Interim analysis for ImmunoCARE has that claims data is more balanced between the two 
arms than survey data. To collect more claims data     , an additional $100 Amazon gift card 
will be offered to enrollees for connection of available insurance claims data. 
Surveys 
Participants will take surveys throughout the course of this study. To determine eligibility, 
prospective participants will complete the eligibility survey. Once enrolled, participants will 
complete the baseline survey where we will collect demographic and health information, 
including comorbidities. Each month, participants will be asked to report on their COVID 
exposures, diagnoses, and/or hospitalizations. The ability to report the positive diagnosis of 
a close contact will be available on the participant dashboard at all times. Surveys can be 
reviewed in the appendices. In an effort toward complete data collection we will collect 
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phone numbers, secondary contacts, and birth dates from participants who cannot share 
their claims data. Participants and their secondary contacts will only be called at the end of 
the study, by a research coordinator, to ask participants to complete surveys and remind 
them about reimbursement opportunities. Participants will be considered lost to follow up 
after three phone calls. Birth dates will be used to search the national death index. 
 
 
 
Outreach 
Center for Equitable and Diverse Research (CEDR), a division of the Institute for Public 
Health at SDSU. CEDR will be involved in conducting in-person outreach and education, 
study recruitment, and technical assistance as needed to help participants in San Diego 
County complete study requirements including the 1) eligibility survey, 2) using and 
navigating the MyDataHelps Web or App including assistance in completing monthly 
questionnaires, 3) creating the CUE Health App account, 4) completion of the informed 
consent process, 5) confirmation of immunocompromised status or age and 5) navigation 
of the CUE Health app. 
 
CEDR will utilize a multi-strategy approach to study recruitment that will use the Community 
Health Worker/Promotores (CHW/P) model to conduct individual and group outreach and 
education activities with community members, community clinics, senior centers, and 
community organizations. Example activities include outreach at health fairs, community 
clinic waiting rooms, patient groups and senior centers; provider education to generate 
patient referrals; and partnerships with community-based organizations and advocacy 
groups to raise awareness with the community members they serve. During all outreach 
and education activities, prospective study participants will be asked for consent to 
voluntarily provide their contact information for follow-up calls and text messages to support 
enrollment and study retention. CEDR will share the IRB-approved outreach one-pager 
found in Appendix 4 with interested participants which will include the CEDR email address 
and phone number for those who have questions about the study. Talking points for use by 
outreach staff while speaking with participants about the study can be found in Appendix 
25. 
Risks and Benefits of Participation 
The risks of participating in this study are minimal.   
There may be a small risk for emotional or mental discomfort from concern about whether 
they may have an infectious illness or not.  It is also possible, despite guidance otherwise, 
that participants may avoid seeking routine care due to the availability of home testing. 
Participants who are randomized to the control group may be disappointed that they are not 
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receiving the Cue product. For those who use the Cue tests, there may be slight discomfort 
when the nasal swab is performed for sample collection, though this will be minimal. 
In spite of all the safety measures that will be used, we cannot guarantee that a 
participant’s identity will never become known. Consequently, it may be possible, in the 
unlikely setting of a data breach, that collected study information could be used to help 
identify the participant.  
If participants have any concerns, they will be able to contact a study team member by 
email.   
The benefits of this study include the opportunity to contribute to research that could benefit 
the immunocompromised population. For some, there is the added benefit of access to 
frequent and reliable COVID-19 testing with the option to seek treatment if they test 
positive. 
 
Sample Size and Data Analysis 
This study has been adapted to a maximum number of 10,000 participants. Participants will 
be divided into 2 groups, a Control Arm and an Intervention Arm. Sample sizes have been 
calculated for detecting a difference in number of hospitalizations in Control Arm versus 
Intervention Arm. The main assumptions used are:  
-​
The percentage of COVID-19 positive cases over 4 months in this group is 5.9% 
(based on historical reported case data). 
-​
We expect a reduction of 5% in number of COVID-19 infections for the Intervention 
Arm with respect to the Control Arm. 
-​
28% of COVID-19 cases among immunocompromised will require hospitalization 
(Singson et.al, 2022) and 10% among >65 years old non-immunocompromised. 
Given that the percentage of 65+ non-immunocompromised will be limited to 25%, 
we expect that 23.5% of participants with COVID-19 infection will be hospitalized. 
-​
We expect a relative reduction in the fraction of hospitalizations per positive case by 
at least 30% for the Intervention arm with respect to the Control arm. 
-​
Of the participants hospitalized, 38% will be admitted to the ICU. 
-​
The number of hospitalizations will be assessed based on survey data. We expect 
that at least 80% of participants will complete the FINAL SURVEY even if they have 
been hospitalized.  
-​
The experiment will be run for 4 to 8 months (depending on number of COVID 
cases), and we expect to have a similar number of COVID-19 cases per month.  
-​
Interim analyses on the number of events and progress towards achieving enough 
events for a well-powered statistical test significance may be run start at month 1 or 
later. Determination of ending the study timeline may be based on having sufficient 
number of COVID cases and/or hospitalization events to achieve statistical power. 
Importantly, we will utilize data on the total number of events to determine when to 
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end the experiment; we will not use information on the difference in the number of 
events between study arms.  
 
 
 
Table 2: Sample size (target) 
Sample size estimation 
Control Arm 
N=5000 
Intervention Arm  
N=5000 
Loss to follow-up / drop-out / 
failure 
5% 
5% 
Expected total number of 
COVID-19 positives 
540 
513 
Loss to report: expected ratio 
of individuals not reporting in 
survey 
20% 
20% 
Expected total number of 
COVID-19 positives correctly 
reported 
432 
410 
Expected total number of 
reported hospitalizations 
102 
68 
Expected total number 
reported in ICU 
39 
26 
Given the assumptions of above, we should reach a target of 900 confirmed COVID 
positive cases reported in the survey or claims (approximately 450 per arm), that we expect 
to reach in 8 months if the rate of infection remains stable. The statistical power of the test 
(alpha=0.05) is equal to 0.76, meaning that if all assumptions hold, we have a 76% chance 
of observing a statistically significant difference in the number of hospitalizations between 
Control and Intervention arms.  
The minimum target is to reach 800 confirmed COVID positive cases (approximately 400 
per arm). The corresponding statistical power of the test (alpha=0.05) in this case is less 
than 0.7, meaning that if all assumptions hold, we have less than a 70% chance of 
observing a statistically significant difference in the number of hospitalizations between 
Control and Intervention arms.   
The experiment will proceed for between 4 and 8 months. We will aim to meet the target 
number of COVID cases (900) before 8 months, however we may decide to end once the 
minimum number of cases is reached (800) if the national COVID case trends suggest that 
we will not reach the target number of cases within 8 months. The study length will be 
re-evaluated if the minimum number of cases is not met within 8 months. 
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As a secondary output, we will also consider the total cost for the individuals in the two 
study arms, based on claims data if available.  
 
Risk Management Procedures 
Loss of privacy 
Participants will be identified by a 10-digit, randomly assigned alphanumeric study ID.  Only 
the investigators and research staff will have access to the patient’s fully identified medical 
information.  The information that matches the code to the identifying information will be 
kept in a safeguarded database that is password protected.   
Adverse Events 
We do not expect any adverse events to  occur. However, unless otherwise required by 
local regulations, the sponsor (Scripps Research Translational Institute) is responsible for 
complying with required timelines for any safety reporting obligation to Health Authority 
(HA), IRB and to any participating (co or sub) investigators, as defined in applicable laws 
and regulations. The safety reporting responsibilities to HA and IRB are defined in the 
collaborative research support agreement.  
 
Data Acquisition, Storage and Analysis 
All study data will be integrated by CareEvolution via the study app and the Cue Health app 
and securely transferred to Scripps Research where it will be stored on servers secured 
with two-factor authentication.  
Future research 
Participant information will be kept for up to 6 years after completion of this study for future 
research that has not yet been planned. Individual information after the removal of 
identifiers such as names, emails or zip codes will be kept indefinitely for future research 
studies at Scripps Research Translational Institute. 
 
Subject Payment/Costs 
There is no cost to the subject for study participation.  Reimbursement of up to $200      will 
be redeemable through Amazon gift cards. 
 
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Estimated Duration of Study 
We had initially planned for each participant to be part of the study for up to 8 months. 
However, due to the FDA issuing a warning letter regarding Cue Health’s COVID-19 test 
accuracy and calling for discontinuing use of the device in May 2024, we have decided to 
end the study early. We plan to analyze the data primarily to characterize the effect of the 
COVID-19 pandemic on the study population. If connected, claims data collection will 
persist for about three months after participation ends, and data analysis will continue for 
one to two years following the completion of data collection. 
Consent Procedures 
Study purpose, methods, materials, risks, benefits, and alternatives will be provided in a 
detailed onboarding process as well as in the long form consent, both within the 
MyDataHelps app. Participants will have the ability to reach the study team by phone or 
email with anything they may need. Those individuals who were recruited by CDER can 
reach out to the CDER team for technical assistance as needed. Informed consent will be 
obtained in the app with a digital signature. Participants will be given a copy of their signed 
consent form. 
 
Data Security 
The collection and processing of personal data from participants enrolled in this study will 
be limited to the data needed to investigate this study’s hypothesis and the clinical data 
typically used as covariates in the analysis of clinical studies. Access to data will be limited 
to those authorized by Principal Investigators, including CareEvolution and CueHealth. 
Privacy policies and user agreements 
Scripps Research Translational Institute affirms the participant’s right to protection against 
invasion of privacy.  Data files are stored on a password-protected computer/database and 
will be accessible only to the above-listed investigators and research staff.  Only the 
research staff will have the link that can match the code to traditional identifying 
information.  The data sets used for analysis will be coded and not contain information that 
could be used to identify the patient.  
 
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Participant Withdrawal 
Participation is voluntary and the participant can discontinue participation at any time 
without loss of benefits or penalty.  A participant who wishes to withdraw consent can make 
a request through the app during the study period.  Any data that has been entered in the 
database will be included in the analysis of the study. All study activities and data collection 
will stop at the time of withdrawal.  
 
Monitoring 
Scripps Research Translational Institute will monitor the study and study investigators will 
be responsible for notifying the IRB with any deviations or adverse events as required by 
the local laws and regulations.   Source documents will be reviewed to ensure all subjects 
have properly signed and dated the informed consent and any HIPAA-related 
documentation required for data sharing.  
 
Record Retention 
Research records with participant identification will be kept for 6 years after study 
completion. The collected data and related health information, after removal of identifiers 
like name, email or zip codes, will be kept indefinitely.  Record retention will comply with the 
specific requirements of the IRB.  
 
Publication 
The results of this research will be presented at conferences, shared publicly, and/or in 
publications. Scripps will provide a report or update to the CHWs, partner organizations and 
other interested parties (i.e. government and public officials, community leaders, etc.) 
 
 
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Study Funding 
Funding for this study is provided by Cue Health, who is also a scientific collaborator on the 
study.  
 
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References 
Amonoo, H. L., Topping, C. E. W., Clay, M. A., Reynolds, M. J., Rice, J., Harnedy, L. E., . . . 
El-Jawahri, A. (2021). Distress in a Pandemic: Association of the Coronavirus Disease-2019 
Pandemic with Distress and Quality of Life in Hematopoietic Stem Cell Transplantation. 
Transplant Cell Ther, 27(12), 1015 e1011-1015 e1017. doi:10.1016/j.jtct.2021.09.001 
Baek, M. S., Lee, M. T., Kim, W. Y., Choi, J. C., & Jung, S. Y. (2021). COVID-19-related outcomes 
in immunocompromised patients: A nationwide study in Korea. PLoS One, 16(10), 
e0257641. doi:10.1371/journal.pone.0257641 
Ryan, L. (2021). Vaccinated but Not Protected—Living Immunocompromised During the Pandemic. 
JAMA, 325(24), 2443-2444. doi:10.1001/jama.2021.9321 
Stephenson, J. (2021). As COVID-19 Hospitalizations of Unvaccinated Patients Soar, Private 
Insurers No Longer Waiving Out-of-Pocket Costs. JAMA Health Forum, 2(8), 
e213263-e213263. doi:10.1001/jamahealthforum.2021.3263 
Sun, J., Zheng, Q., Madhira, V., Olex, A. L., Anzalone, A. J., Vinson, A., . . . National, C. C. C. C. 
(2022). Association Between Immune Dysfunction and COVID-19 Breakthrough Infection 
After SARS-CoV-2 Vaccination in the US. JAMA Intern Med, 182(2), 153-162. 
doi:10.1001/jamainternmed.2021.7024 
Kliff, S., & Sanger-Katz, M. (2020). Bottleneck for US coronavirus response: the fax machine. New 
York Times.  
Manabe, Y. C., Sharfstein, J. S., & Armstrong, K. (2020). The Need for More and Better Testing for 
COVID-19. JAMA, 324(21), 2153-2154. doi:10.1001/jama.2020.21694 
Petty, L. A., & Malani, P. N. (2022). Oral Antiviral Medications for COVID-19. JAMA, 327(24), 
2464-2464. doi:10.1001/jama.2022.6876 
Rizk, J. G., Forthal, D. N., Kalantar-Zadeh, K., Mehra, M. R., Lavie, C. J., Rizk, Y., . . . Lewin, J. C. 
(2021). Expanded Access Programs, compassionate drug use, and Emergency Use 
Authorizations during the COVID-19 pandemic. Drug Discov Today, 26(2), 593-603. 
doi:10.1016/j.drudis.2020.11.025 
Smith, R. L., Gibson, L. L., Martinez, P. P., Ke, R., Mirza, A., Conte, M., . . . Brooke, C. B. (2021). 
Longitudinal Assessment of Diagnostic Test Performance Over the Course of Acute 
SARS-CoV-2 Infection. The Journal of Infectious Diseases, 224(6), 976-982. 
doi:10.1093/infdis/jiab337 
CueHealth. (2022). Retrieved from cuehealth.com 
 
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Quer, G., Gadaleta, M., Radin, J. M., Andersen, K. G., Baca-Motes, K., Ramos, E., . . . 
Steinhubl, S. R. (2021). The Physiologic Response to COVID-19 Vaccination. medRxiv. 
doi:10.1101/2021.05.03.21256482 
 
Quer, G., Radin, J. M., Gadaleta, M., Baca-Motes, K., Ariniello, L., Ramos, E., . . . 
Steinhubl, S. R. (2021). Wearable sensor data and self-reported symptoms for COVID-19 
detection. Nat Med, 27(1), 73-77. doi:10.1038/s41591-020-1123-x 
 
Radin, J. M., Quer, G., Pandit, J. A., Gadaleta, M., Baca-Motes, K., Ramos, E., . . . Topol, E. 
J. (2022). Sensor-based surveillance for digitising real-time COVID-19 tracking in the USA 
(DETECT): a multivariable, population-based, modelling study. Lancet Digit Health. 
doi:10.1016/S2589-7500(22)00156-X 
 
Radin, J. M., Quer, G., Ramos, E., Baca-Motes, K., Gadaleta, M., Topol, E. J., & Steinhubl, 
S. R. (2021). Assessment of Prolonged Physiological and Behavioral Changes Associated 
With 
COVID-19 
Infection. 
JAMA 
Netw 
Open, 
4(7), 
e2115959. 
doi:10.1001/jamanetworkopen.2021.15959 
 
Radin, J. M., Wineinger, N. E., Topol, E. J., & Steinhubl, S. R. (2020). Harnessing wearable 
device data to improve state-level real-time surveillance of influenza-like illness in the USA: 
a 
population-based 
study. 
Lancet 
Digit 
Health, 
2(2), 
e85-e93. 
doi:10.1016/S2589-7500(19)30222-5 
Singson JR, Kirley PD, Pham H, et al. Factors Associated with Severe Outcomes Among 
Immunocompromised Adults Hospitalized for COVID-19 — COVID-NET, 10 States, March 
2020–February 2022. MMWR Morb Mortal Wkly Rep 2022;71:878–884. DOI: 
http://dx.doi.org/10.15585/mmwr.mm7127a3 
Gadaleta, M., Radin, J.M., Baca-Motes, K. et al. Passive detection of COVID-19 with 
wearable sensors and explainable machine learning algorithms. npj Digit. Med. 4, 166 
(2021). https://doi.org/10.1038/s41746-021-00533-1 
 
Vo AD, La J, Wu JT, et al. Factors Associated With Severe COVID-19 Among Vaccinated 
Adults Treated in US Veterans Affairs Hospitals. JAMA Netw Open. 2022;5(10):e2240037. 
doi:10.1001/jamanetworkopen.2022.40037 
 
 
 
 
 
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Appendix 1: Documentation 
Cue Health Privacy Policy 
Cue Health Terms of Use and End User License Agreement 
FDA Emergency Use Authorization Letter 
Cue COVID-19 Test Instructions for Use 
Cue Health Monitoring System Quick Start Guide 
Cue Health Monitoring System User Manual  
CareEvolution MyDataHelps Privacy and Use Policy 
Cue Care Terms of Use 
 
Appendix 2: Compatible Devices 
●​ Apple® 
○​ Apple® iPhone® 8 Plus or later with iOS® 13 or higher 
○​ Apple® iPad® models with iPadOS® version 13.0 or higher with Bluetooth® 
Standard 4.2 or later (Bluetooth® 5.0 preferred) 
■​ iPad 6th generation or later 
■​ iPad Air® 3rd generation or later 
■​ iPad mini® 5th generation or later 
■​ iPad Pro® 2nd generation or later 
●​ Android™ 
○​ Smartphone models with OS 9.0 (API level 28) or higher; display size 5.5’’ or 
higher; Bluetooth® Standard 4.2 or later (Bluetooth 5.0 preferred); Wi-Fi® 
dual-band 2.4GHz and 5 GHz (5 GHz preferred). 
○​ Any Android™ smartphone device which meets the above minimum 
requirements may be used. The following are recommended devices that 
meet these requirements: 
■​ Google Pixel™ 4, 4a, 5, 6 
■​ Samsung Galaxy® A21, A71 5G unlocked, S8/S8+/S8 Note and later 
■​ Motorola® Moto G fast 
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Appendix 3: Participant Surveys  
Note: Email is being collected at the time of screening and will be used to contact 
participants if there are changes in their eligibility status. 
 
Eligibility Survey 
Please complete the following survey to determine your eligibility for participation in this 
study. 
 
1.​ Can you read and understand English? (Yes/No) 
2.​ Are you over the age of 18? (Yes/No) 
3.​ Are you 65 years or older? (Yes/No) 
4.​ Do you live in the United States? (Yes/No) 
5.​ Do you have a smartphone with a recent operating system installed (Android: OS 
9.0 or higher, Apple: iOS 13.0 or higher)? (Yes/No) 
6.​ Are you willing to connect your health insurance claims to the study app? (Yes/No) 
Tap the info icon for a list of health plan providers. 
a.​ List that appears if the info icon is tapped: 
b.​ Medicare 
c.​ Medicaid 
d.​ Anthem BlueCross and BlueShield 
e.​ Anthem BlueCross 
f.​ Empire BlueCross BlueShield 
g.​ Empire BlueCross 
h.​ Wellpoint 
i.​ Carelon 
j.​ Unicare 
k.​ Simply Healthcare Plans 
l.​ National Government Services, Inc. 
m.​MMM 
n.​ Health Sun 
o.​ HealthLink 
p.​ Amerigroup 
q.​ None of these 
7.​ Are you immunocompromised? (Yes/No) 
 
7a. If Yes → Please classify your diagnosis. (Select all that apply.) 
●​ Symptomatic HIV 
●​ Graft versus host disease 
●​ Immunoglobulin deficiency/Immunodeficiency  
●​ Immunosuppressive therapy  
●​ Leukemia 
●​ Lymphoma (Hodgkin or non-Hodgkin) 
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       Page 22 of 77 
 

●​ Metastatic Cancer 
●​ Multiple Myeloma 
●​ Solid organ malignancy, with immunosuppression 
●​ Transplant, hematopoietic stem cell 
●​ Transplant, solid organ 
●​ None of these 
8.​ Are you able to upload verification of your immunocompromised status, if 
necessary? This can be a screenshot of an EMR (electronic medical record), 
diagnosis list, or a doctor’s note. (Yes/No) 
9.​ Have you completed a COVID-19 vaccine primary series? (Yes/No) 
a.​ If you have a medical exemption for COVID-19 vaccination, please email the 
study team at ImmunoCARE@scripps.edu 
10.​One more thing, will you share your email or phone number? We will contact you if 
there is a change to your eligibility status. This is optional at this point. 
a.​ What is your phone number or email address? 
 
If 1, 2, 4, and 5 are YES and either 
1. 3 is yes, 6 is yes, and 6a is not “None of these” 
2. 7 is yes and 7a is not “None of these” 
then: 
If 1 through 8 are YES and 6a is not “None of these”: Thank you! You are eligible to 
participate. Please continue to learn more about our study.  
 
Otherwise: Thank you for your interest in participating in the ImmunoCARE Study. 
Unfortunately, you did not meet the study’s eligibility requirements at this time. 
 
 
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Baseline Survey 
Thank you for consenting to participate in this study. Please complete this baseline survey. 
1.​ What is your date of birth? 
2.​ What is your phone number? 
3.​ In case we cannot contact you, please provide the telephone number of a relative or 
friend who would know where you can be reached. This is optional. 
4.​ What terms best express how you describe your gender identity? (Check all that 
apply) 
○​ Man 
○​ Woman 
○​ Transgender 
○​ Non Binary 
○​ Other (please specify) 
○​ Prefer not to answer 
5.​ Which categories describe you? Select all that apply. Note, you may select more 
than one group 
○​ American Indian or Alaskan Native 
○​ Asian 
○​ Black, African American, African 
○​ Hispanic, Latino, or Spanish 
○​ Middle Eastern or Northern African 
○​ Native Hawaiian or other Pacific Islander 
○​ White 
○​ None of these fully describe me (please specify) 
○​ Prefer not to answer 
6.​ What is your annual household income from all sources? 
○​ $25,000 or less 
○​ More than $25,000 
7.​ What is your zip code?  
8.​ Please indicate if you have any of the following chronic conditions 
○​ Diabetes 
○​ High blood pressure 
○​ Asthma 
○​ COPD  
○​ Emphysema 
○​ Chronic Bronchitis 
○​ Heart Failure 
○​ Chronic Kidney Disease 
○​ Other (please specify) 
9.​ How many doses of the COVID-19 vaccine have you received? 
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If none: please confirm your medical exemption from COVID-19 vaccination was 
reviewed by the study team. 
10.​For your [nth] dose, please indicate: 
○​ Date 
○​ Type:​ ​
[ ] Full dose​   [ ] Booster 
○​ Manufacturer:  
[ ] Pfizer 
[ ] Moderna 
[ ] Janssen (Johnson & Johnson) 
[ ] Novavax 
[ ] Other (if you received it abroad) 
[Repeats for the number of doses reported in 7.] 
11.​Over the last month have you: 
○​ Been exposed to a close contact with COVID-19?​
​
[ ] Yes   [ ]  No 
○​ Contracted COVID-19?​
​
​
​
​
​
[ ] Yes   [ ]  No 
○​ Been prescribed medication for COVID-19?​
​
​
[ ] Yes   [ ]  No 
○​ Been to Urgent Care due to COVID-19?​​
​
​
[ ] Yes   [ ]  No 
○​ Been to the Emergency Room due to COVID-19?​
​
[ ] Yes   [ ]  No 
○​ Been admitted to the hospital for COVID-19?​
​
​
[ ] Yes   [ ]  No 
○​ Been in the Intensive Care Unit due to COVID-19?​
​
[ ] Yes   [ ]  No 
○​ Needed additional health care (e.g. dialysis, CT scan, MRI) as a result of 
COVID-19? 
​
​
[ ] Yes   [ ]  No 
 
Is there any context you would like to share about the responses above? 
(open text box) 
 
 
Monthly Survey 
Thank you for your continued participation in the ImmunoCARE study. This survey is 
intended to capture information about how you have been feeling and any COVID-19 
exposures and infections you have had since we last checked in. Once you complete this 
survey you will earn a $10 Amazon gift card to thank you for your time. 
1.​ Since we last checked in, have you: 
○​ Been exposed to a close contact with COVID-19?​
​
[ ] Yes   [ ]  No 
○​ Contracted COVID-19?​
​
​
​
​
​
[ ] Yes   [ ]  No 
○​ Been prescribed medication for COVID-19?​
​
​
[ ] Yes   [ ]  No 
○​ Been to Urgent Care due to COVID-19?​​
​
​
[ ] Yes   [ ]  No 
○​ Been to the Emergency Room due to COVID-19?​
​
[ ] Yes   [ ]  No 
○​ Been admitted to the hospital for COVID-19?​
​
​
[ ] Yes   [ ]  No 
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○​ Been in the Intensive Care Unit due to COVID-19?​
​
[ ] Yes   [ ]  No 
○​ Needed additional health care (e.g. dialysis, CT scan, MRI) as a result of 
COVID-19? 
​
​
[ ] Yes   [ ]  No 
○​ ​
 
Is there any context you would like to share about your previous responses? (open 
text box) 
 
Thank you for sharing this information with the study team. Your Amazon gift card is now 
available.  
 
If No → Thank you for confirming you have not had COVID-19 since we last 
checked in. Your Amazon gift card is now available. 
 
 
End of Study Survey 
Thank you for your participation in the ImmunoCARE study. This survey is intended to 
capture information about how you have been feeling and any COVID-19 exposures and 
infections you have had since enrolling in ImmunoCARE. Once you complete this survey 
you will earn an Amazon gift card to thank you for your time. 
     Since you enrolled in ImmunoCARE, have you: 
○​ Been exposed to a close contact with COVID-19?​
​
[ ] Yes   [ ]  No 
○​ Contracted COVID-19?​
​
​
​
​
​
[ ] Yes   [ ]  No 
○​ Been prescribed medication for COVID-19?​
​
​
[ ] Yes   [ ]  No 
○​ Been to Urgent Care due to COVID-19?​​
​
​
[ ] Yes   [ ]  No 
○​ Been to the Emergency Room due to COVID-19?​
​
[ ] Yes   [ ]  No 
○​ Been admitted to the hospital for COVID-19?​
​
​
[ ] Yes   [ ]  No 
○​ Been in the Intensive Care Unit due to COVID-19?​
​
[ ] Yes   [ ]  No 
○​ Needed additional health care (e.g. dialysis, CT scan, MRI) as a result of 
COVID-19? 
​
​
[ ] Yes   [ ]  No 
Is there any context you would like to share about your previous responses? (open 
text box) 
 
Thank you for sharing this information with the study team. Your Amazon gift card is now 
available.  
 
If No → Thank you for confirming you have not had COVID-19 since we last 
checked in. Your Amazon gift card is now available. 
 
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Appendix 4: Outreach One Pager 
HEADING 
ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of 
Immunocompromised Individuals 
INTRO 
Are you at high risk of hospitalization from COVID-19 infection due to age or a compromised 
immune system? The ImmunoCare study aims to reduce that risk. Scripps Research – a 
renowned biomedical research institute – and Cue Health, a leading health care technology 
company that develops portable diagnostic tests for at-home use, are launching the ImmunoCARE 
Study. 
SUBHEADING 
More on The ImmunoCARE Study 
ImmunoCARE is an innovative research project to study whether repeated at-home tests, 
on-demand telemedicine, and quick delivery of medication for those who test positive for COVID-19 
can reduce COVID-19 severity in immunocompromised people and those over 65. 
ImmunoCARE will enroll 10,000 participants. Half of participants will test for COVID-19 and seek 
care as they normally would; the other half will receive 10 at-home COVID-19 tests per month from 
Cue Health for themselves and others in their household. All participants will be asked to complete 
monthly surveys about COVID-19 exposure, infection, and hospitalization.  
Who can enroll 
ImmunoCARE is available to individuals who are moderately to severely immunocompromised or 
are 65 and older. Participants will provide documentation from health claims data confirming their 
diagnosis and age. Additional criteria for enrollment can be found at immunocare.scripps.edu or 
scan the QR code. the link below. 
Our thanks to you 
As our thanks for your participation, all eligible participants will receive a series of Amazon gift cards 
as compensation throughout the study.  
Questions? 
If you have any questions about the study, feel free to reach out to the study team at 
immunocare@scripps.edu.CEDR@sdsu.edu or leave a message at 619-594-2922.
 
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Appendix 5: Invitation Email 
SUBJECT LINE: 
Immunocompromised and concerned about COVID-19? 
PREHEADER: 
Join The ImmunoCARE study which aims to reduce hospitalizations 
BODY: 
Dear [FIRST NAME], 
Are you at high risk of hospitalization from COVID-19 infection due to a compromised immune 
system or age? The ImmunoCare study aims to reduce that risk. Scripps Research – a 
renowned biomedical research institute – and Cue Health, a leading health care technology 
company that develops portable diagnostic tests for at-home use, are launching the ImmunoCARE 
Study. 
ImmunoCARE is an innovative research project designed to examine whether a combination of 
repeated at-home tests, on-demand telemedicine, and quick delivery of Paxlovid after testing 
positive for COVID-19 can reduce severe outcomes and hospitalization of people just like you. 
We can only succeed in this research with your help. Eligible participants will take part in a 4- to 
8-month study and may receive at-home diagnostic tests free of charge.  
Learn more and take our eligibility survey today. 
CTA 
LEARN MORE 
Take Care, 
The ImmunoCARE Study Team 
Questions? Reach out to us at Immunocare@scripps.edu 
 
 
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Appendix 6: You’re Eligible Email 
SUBJECT LINE:  
Welcome to the ImmunoCARE 
PREHEADER:  
Download the study app today!  
BODY COPY:  
Dear [FIRST NAME], 
Thank you for your interest in participating in the ImmunoCARE Study. We are pleased to 
inform you that you’ve met all of the eligibility criteria!  
The first step is to download the study app, MyDataHelps. Once you do, you will create a new 
account and provide your consent to participate. After that, you will be on your way to helping 
researchers learn more about how to keep people safe from severe COVID-19 infection.  
Get started today!  
CTA:  
DOWNLOAD APP  
Take Care, 
The ImmunoCARE Study Team 
Questions? Reach out to us at Immunocare@scripps.edu 
 
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Appendix 7: You’re Not Eligible Email 
SUBJECT LINE:  
Thank you for your interest in ImmunoCARE 
PREHEADER:  
We appreciate your willingness to join our study  
BODY COPY:  
Dear [FIRST NAME],  
Thank you for your interest in participating in the ImmunoCARE Study. Unfortunately, you did 
not meet the study’s eligibility requirements at this time. 
We greatly appreciate your time and commitment to advancing research to improve COVID-19 
outcomes.  
Take Care, 
The ImmunoCARE Study Team 
Questions? Reach out to us at Immunocare@scripps.edu 
 
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Appendix 8: Consent Reminder Email 
SUBJECT LINE:  
Your ImmunoCARE registration is incomplete  
PREHEADER:  
Please complete your ImmunoCARE consent  
BODY COPY:  
Dear [FIRST NAME], 
Thank you for your interest in the ImmunoCARE Study. We appreciate your willingness to help 
advance research on reducing COVID-19 hospitalizations for immunocompromised individuals. 
You are still eligible to participate! 
Your consent is required to proceed with participation in this research study. To access the 
ImmunoCARE consent, open your MyDataHelps app.  
If you have any questions about the consent process, you may contact us at 
Immunocare@scripps.edu.  
Thank you again for your participation in this critical research study to reduce COVID-19 
hospitalizations.  
Take Care, 
The ImmunoCARE Study Team 
If you have any questions, please reach out to the study team at Immunocare@scripps.edu 
 
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Appendix 9: Baseline Survey Reminder Email 
SUBJECT LINE:  
Reminder: Your ImmunoCARE survey is waiting!  
Alternate subject line: Don’t forget to complete your first survey 
PREHEADER:  
Take the survey today!  
BODY COPY:  
Dear [FIRST NAME],  
Thank you for joining the ImmunoCARE Study. The next step is to complete the Baseline 
Survey, which asks questions about your demographic information and health conditions. This 
survey will help researchers understand where you are starting the study from and how the 
study progresses.  
This survey should only take a few minutes. Once you complete this survey, you will earn a $20 
Amazon gift card to thank you for your time. 
Thank you again for your participation.  
Take Care, 
The ImmunoCARE Study Team 
Questions? Reach out to us at Immunocare@scripps.edu 
 
 
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Appendix 10: Monthly Survey Reminder Email 1 
SUBJECT LINE:  
It’s time for your monthly ImmunoCARE survey  
PREHEADER:  
Take the survey today!  
BODY COPY:  
Dear [FIRST NAME],  
As a valued participant in the ImmunoCARE Study, your survey responses are of critical 
importance to researchers.  
It’s time to take this month’s survey to share whether you have had any COVID-19 exposures 
or infections since we last heard from you.  
The survey should only take a few minutes of your time, and you will receive an Amazon gift 
card for answering.  
Thank you again for your time and participation in ImmunoCARE.   
Take Care, 
The ImmunoCARE Study Team 
Questions? Reach out to us at Immunocare@scripps.edu 
 
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Appendix 11: Monthly Survey Reminder Email 2 
SUBJECT LINE:  
Do you have a minute for ImmunoCARE?  
PREHEADER:  
Your monthly survey only takes a few minutes  
BODY COPY:  
Dear [FIRST NAME],  
Do you have a minute? A minute or two is all it takes to complete this month’s ImmunoCARE 
survey.  
By letting us know if you’ve been exposed to, infected with, or hospitalized from COVID-19 in 
the past month, you’re helping advance research on reducing hospitalizations and improving 
outcomes for immunocompromised individuals.  
Once you complete your survey, you will receive a code for your Amazon gift card as our 
thanks to you.  
Thank you again for your time and participation in ImmunoCARE.   
Take Care, 
The ImmunoCARE Study Team 
Questions? Reach out to us at Immunocare@scripps.edu 
 
 
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Appendix 12: Your Gift Card is Ready To Claim 
Email  
SUBJECT LINE:  
Our gift to you for participating in ImmunoCARE  
PREHEADER:  
Your Amazon gift card code is ready  
BODY COPY:  
Dear [FIRST NAME],  
We are grateful for your participation in the ImmunoCARE Study. To thank you, we are pleased 
to give you an Amazon gift card for completing a series of steps throughout the study.  
Your gift card for [INSERT AMOUNT] is ready to use. Login to your My Data Helps account to 
access your Amazon gift card code.  
Thank you again for your valued participation in ImmunoCARE.  
Take Care, 
The ImmunoCARE Study Team 
Questions? Reach out to us at Immunocare@scripps.edu 
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       Page 35 of 77 
 

Appendix 13: ImmunoCARE Landing Page 
The ImmunoCARE Study:  
Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised 
Individuals 
About the study 
The risks associated with COVID-19 infection is higher for immunocompromised individuals and 
people over 65 than the general public. ImmunoCARE is an innovative research project to study 
whether repeated at-home tests, on-demand telemedicine, and quick delivery of medication for 
those who test positive for COVID-19 can reduce COVID-19 severity in immunocompromised 
people. 
ImmunoCARE is a joint research project from Scripps Research – a renowned biomedical research 
organization – and Cue Health, a leading health care technology company that develops portable 
diagnostic tests for at-home use. 
Who can enroll 
ImmunoCARE is available to individuals who are moderately to severely immunocompromised. 
Participants will provide documentation from a medical provider confirming their diagnosis.  
Additional inclusion criteria includes:  
●​ Living in the United States 
●​ 18 years or older 
●​ Vaccinated against COVID-19  
●​ Willing and able to participate in study interventions including: 
○​ Use of a compatible smartphone, including camera and bluetooth 
○​ Willing and able to share health insurance claims data from Medicaid, Medicare, or 
an Anthem plan if over 65 and not otherwise immunocompromised 
○​ Completing Surveys 
○​ Use of Cue Health App and tests 
○​ Use of MyDataHelps by Web or App 
●​ Immunocompromised, including 
○​ Symptomatic HIV 
○​ Graft versus host disease 
○​ Immunoglobulin deficiency/Immunodeficiency  
○​ Immunosuppressive therapy  
○​ Leukemia 
○​ Lymphoma (Hodgkin or non-Hodgkin) 
○​ Metastatic Cancer 
○​ Multiple Myeloma 
○​ Solid organ malignancy 
○​ Transplant, hematopoietic stem cell 
○​ Transplant, solid organ 
○​ 65 years or older 
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What we will ask you to do 
ImmunoCARE will enroll 10,000 participants. Half of participants will test for COVID-19 and seek 
care as they normally would; the other half will receive at-home COVID-19 tests from Cue Health for 
themselves and others in their household. All participants will be asked to complete monthly 
surveys about COVID-19 exposure, infection, and hospitalization.  
Our thanks to you 
As our thanks for your participation, all eligible participants will receive a series of Amazon gift cards  
as compensation for time throughout the study.  
Join today  
Interested in helping advance research on COVID-19 outcomes for immunocompromised 
individuals? Click below to see if you are eligible to participate!  
CTA: Let’s Go 
Questions? Reach out to us at ImmunoCARE@scripps.edu 
[LINK TO MDH web and app stores]  
 
 
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Appendix 14: MyDataHelps In-app Copy 
 
Heading: 
Welcome to the ImmunoCARE Study 
 
Body: 
ImmunoCARE is an innovative research project to study whether repeated at-home tests, 
on-demand telemedicine, and quick delivery of medication for those who test positive for 
COVID-19 can reduce COVID-19 severity in immunocompromised people and those over 
65. 
 
Please complete the following survey to determine whether you are eligible for this study. If 
eligible, you will learn more about our study and decide whether you would like to enroll. 
 
Button Text: 
Next 
 
[Eligibility Survey questions here; see Appendix 3] 
 
Heading: 
What is the ImmunoCARE study? 
 
Body: 
You are being invited to participate in the ImmunoCARE. This is a cohort study, meaning 
you will be randomized into one of two groups.  
Half of the participants will receive Cue Health products to see if they decrease COVID-19 
cases and hospitalizations. The other half will continue their normal behaviors, without Cue 
products. This helps us measure if having access to Cue products decreases the number 
of COVID-19 infections and severity. 
 
Participants have no obligation to use all the features of the Cue Care product. Consent for 
this study and all study activities is completely voluntary. You do not have to participate if 
you do not want to. If you join and change your mind, you can drop out at any time. 
 
To thank you for your time, you may be eligible to receive electronic Amazon gift cards for 
your time throughout the study. 
 
If you have questions about the study, please ask us by emailing 
ImmunoCARE@scripps.edu. 
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       Page 38 of 77 
 

 
Button Text: 
Next 
 
Heading: 
The ImmunoCARE Study 
 
Body: 
Our commitment 
●​ Keeping your information private is our top priority. 
●​ You will be guided throughout the study. 
●​ We deeply respect your time. 
●​ We will let you know what we are learning. 
Your rights 
●​ You can leave the study whenever you want. 
●​ You can choose which tasks to complete. 
●​ There is no cost to participate. 
 
This study is led by Scripps Research Translational Institute, a non-profit academic 
institution in La Jolla, California and funded by Cue Health. 
 
Button Text: 
Next 
 
Heading: 
The ImmunoCARE Study 
 
Body: 
Expectations & Requirements 
●​ Share your health insurance claims data 
●​ Take surveys each month 
●​ If needed, upload confirmation of your immunocompromised status 
●​ If randomized to a treatment group, use Cue Health tests 
The next couple screens ask you about the State you live in and provide comprehensive 
information to help you make an informed decision about joining ImmunoCARE.  
 
If you have any questions, email us at ImmunoCARE@scripps.edu 
 
Button Text: 
Next 
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       Page 39 of 77 
 

 
 
Heading: 
State of Residence 
 
Body: 
What state do you live in? [Dropdown with list of states] 
 
Button Text: 
Next 
 
Pre-conditions:  
California residency indicated 
 
Heading: 
California Experimental Subject's Bill of Rights 
 
Body: 
[Contents of the California Bill of Rights] 
 
Button Text: 
Next 
 
Heading: 
Consent to Participate in Research 
 
Body: 
[Contents of Long Form Consent] 
 
Button Text: 
Next 
 
Heading: 
Participant Agreement 
 
Body: 
I have read and understood the explanation of the study. I have had a chance to ask 
questions and have them answered to my satisfaction. I agree to take part in this study. I 
have not been forced or made to feel obligated to take part. I am free to withdraw my 
consent at any time. 
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       Page 40 of 77 
 

 
If I want to participate, I must sign this consent form. If I would like a copy of this document, 
I am able to save it and keep it for my records. 
 
By providing my name below and continuing to the next screen, I am authorizing this 
document and agreeing to participate in this study. 
 
First Name:  [input field] 
Last Name: [input field] 
 
Button Text: 
Yes/No 
 
Heading: 
Signature 
 
Body: 
Please sign using your finger on the line below. 
 
[Touch area for signature] 
 
Button Text: 
Next 
 
Heading: 
Thank you 
 
Body: 
Thank you for joining the ImmunoCARE study! Your signed consent form is available in the 
Settings tab under Documents.  
 
Continue to the following screen to connect your health plan and share your claims data 
with us or upload an image to confirm your eligibility We will verify your diagnosis and 
monitor your health outcomes at the conclusion of the study. 
 
If you decide to share your claims data, please share access to your data for 1 year when 
prompted.  
 
Button Text: 
Next 
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       Page 41 of 77 
 

 
 
Heading (claims): 
Diagnosis Confirmation 
 
Body: 
The claims data from your health plan indicate a previously diagnosed condition that we 
need to learn more about for the purposes of this study. 
 
Please upload a document confirming your diagnosis on the next screen. This can be a 
doctor's note, a screenshot of your EHR diagnosis list, lab work, test results or medication 
list. 
 
Accepted file types are [list of file types]. If your document is another type, please email it to 
the study team at ImmunoCARE@scripps.edu 
 
Button Text: 
Next 
 
Heading (no claims): 
Diagnosis Confirmation 
 
Body: 
Thank you for your participation! 
 
Please upload a document confirming your diagnosis or age on the next screen. This can 
be a doctor's note, a screenshot of your EHR diagnosis list, lab work, test results or 
medication list. 
 
Accepted file types are [list of file types]. If your document is another type, please email it to 
the study team at ImmunoCARE@scripps.edu 
 
Button Text: 
Next 
 
Heading: 
[None] 
 
Body: 
[None] 
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       Page 42 of 77 
 

 
Button Text: 
Capture or Upload Image 
 
Heading: 
Thank you 
 
Body: 
Thank you for confirming your medical information. We will be reviewing the document you 
uploaded and will notify you when we are ready for you to continue with the study. 
 
Button Text: 
Done 
 
Heading: 
Document Review 
 
Body: 
Our research coordinator iscurrently reviewing the document you uploaded confirming 
your diagnosis or age. This process can take a few business  days, we appreciate your 
patience.  
 
No further action is required on your part. We will notify you once we complete our review 
so you can continue with the study. 
 
Button Text: 
Done 
 
Heading: 
Baseline survey 
 
Body: 
Help us learn about other diagnoses and understand any differences between demographic 
groups, such as income, race, ethnicity, and age. 
 
Button Text: 
Next 
 
[Baseline survey questions here; see Appendix 3] 
 
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       Page 43 of 77 
 

Pre-conditions:  
Participant randomized into treatment arm 
 
Heading: 
Thank you 
 
Body: 
Thank you for sharing this information with the study team.  
 
You have been randomized to the treatment group.  
 
As such, the next step is to register an account with Cue Health and download their app on 
your smartphone. You will also order your testing kit through the mobile app. 
 
Continue to the next task for additional instructions. 
 
Button Text: 
Done 
 
Pre-conditions:  
Participant randomized into control arm 
 
Heading: 
Thank you 
 
Body: 
Thank you for completing all of the onboarding activities. 
 
You have been randomized to the control group. 
 
This means you will come back to this app monthly to tell us how things are going and 
answer a few questions. Your $20 Amazon gift card for completing onboarding will be 
available shortly. In the future, you will receive a $10 Amazon gift card for each monthly 
survey you complete. 
 
Button Text: 
Done 
 
Pre-conditions:  
Participant randomized into intervention arm 
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       Page 44 of 77 
 

 
Heading: 
Cue+ Membership 
 
Body: 
To begin, you must create an account with Cue Health using the link we will give you next. 
This link is unique to you and must not be shared with anyone else. 
 
As a participant in our study, you have access to 10 Cue Health tests per month for free. 
 
When creating your Cue account, you must use the email address you previously gave us 
to ensure you receive your testing kit at no cost. Make sure it appears below correctly. If 
you need to change it, exit this survey and go to the Account tab. 
 
Email: [read-only, pre populated input field] 
 
Button Text: 
Next 
 
 
 
Heading: 
Create Cue Health account 
 
Body: 
Create an account with Cue Health using the link below. 
 
You will be placing the order for $0. 
 
Cue Health [link to Cue+ order page on Cue Health website] 
 
Remember to use the email address we have on file. 
 
 
Button Text: 
Next 
 
Heading: 
[None] 
 
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       Page 45 of 77 
 

Body: 
Now that you have created an account with Cue Health, you may download the app on 
your smartphone. 
 
Search for Cue Health on your smartphone’s app store. It should look like one of the two 
screenshots below depending on your device.  
 
Once you’ve found it, proceed to installing it and sign in. 
 
[Two cropped screenshots showing Cue Health logo and app name] 
 
Button Text: 
Next 
 
Heading: 
[None] 
 
Body: 
Have you successfully installed the Cue Health app and signed in? 
 
[ ] Yes 
[ ] No 
 
Button Text: 
Next 
 
Heading: 
Order a Cue test kit 
 
Body: 
Great! You may now order your testing kit. 
 
In the Cue Health app, order the 10 COVID-19 Tests & Cue Reader. Since you are a study 
participant, you should see $0 as the price for the package. 
 
Button Text: 
Next 
 
Heading: 
[None] 
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       Page 46 of 77 
 

 
Body: 
Have you successfully placed an order for the testing kit? 
 
[ ] Yes 
[ ] No 
 
Button Text: 
Next 
 
Heading: 
Thank you 
 
Body: 
Thank you for completing this task. 
 
Once you receive the testing kit, return to the app and let us know. You’ll get familiarized 
with the kit at that point and take your first test. 
 
Button Text: 
Done 
 
Heading: 
Take test 
 
Body: 
Open your testing kit package and get familiarized with its contents. Proceed to take a 
baseline COVID-19 test with this device. 
 
Button Text: 
Next 
 
Heading: 
[None] 
 
Body: 
Have you taken your first test with the Cue Health kit? 
 
[ ] Yes 
[ ] No 
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       Page 47 of 77 
 

 
Button Text: 
Next 
 
Heading: 
Thank you 
 
Body: 
Thank you for completing this task. 
 
Please remember to take a Cue COVID-19 test when you may have been exposed or are 
experiencing symptoms. If someone in your household may have been exposed to 
COVID-19 or is symptomatic, give them a test to use. Please set up profiles in the Cue App 
for each person who uses Cue tests. 
 
We’ll also notify you next month when it’s time for your check-in. 
 
Button Text: 
Done 
 
Heading: 
Monthly check-in 
 
Body: 
Thank you for your continued participation in this study. 
 
This survey is intended to capture information about how you have been feeling and any 
COVID-19 exposures and infections you have had since we last checked in. 
 
Once you complete this survey, you will earn a $10 Amazon gift card to thank you for your 
time. 
 
Button Text: 
Done 
 
[Monthly check-in survey questions here; see Appendix 3] 
 
Heading: 
Thank you 
 
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       Page 48 of 77 
 

Body: 
Thank you for sharing this information with the study team. Your Amazon gift card is now 
available. 
 
Please remember to take a Cue COVID-19 test when you may have been exposed or are 
experiencing symptoms. If someone in your household may have been exposed to 
COVID-19 or is symptomatic, give them one test to use. You can set up a profile for them in 
your Cue App. 
 
Button Text: 
Done 
 
Heading: 
Amazon Gift Card 
 
Body: 
You are now eligible for a [$20 | $10] Amazon gift card.  
 
[Gift card code] 
 
In order to use your gift card, add it to your Amazon.com account.  
 
 
Button Text: 
Done 
 
Heading: 
[None] 
 
Body: 
Have you taken your first test with the Cue Health kit? 
 
[ ] Yes 
[ ] No 
 
Button Text: 
Done 
 
Heading: 
When to test 
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Body: 
You should use your Cue Health Molecular COVID-19 test if you may have been exposed 
to COVID-19 or notice any of the following symptoms, or think you might be getting sick: 
 
●​ Fever 
●​ Chills 
●​ Congested or runny nose 
●​ Cough 
●​ Sore throat 
●​ Congestion 
●​ Stomachache 
●​ Headaches  
●​ Body aches 
●​ Fatigue 
●​ Neck pain 
●​ Shortness of breath 
●​ Chest tightness 
●​ Sneezing  
●​ Wheezing 
●​ Weakness 
 
If someone in your household may have been exposed to COVID-19 or is experiencing any 
of these symptoms, you can set up a Cue profile for them in your Cue account and provide 
them with a test. 
 
Button Text: 
Done 
 
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Appendix 15: Notifications  
 
Theme 
Trigger 
Title 
Push and SMS copy 
Note: All SMS copy will 
include a link to log in to 
the participant portal. 
Consent 
completion 
5 hours after account 
creation, if consent has 
not been completed 
Are you ready to 
join? 
To take part in the 
ImmunoCARE study, 
please complete 
consent. 
Reminder 1: 
Consent 
completion  
3 days after account 
creation, if consent has 
not been completed 
Next step: 
complete 
consent 
To learn how you can 
help the study of 
COVID-19 outcomes in 
immunocompromised 
individuals, review 
consent materials. 
Reminder 2: 
Consent 
completion  
7 days after account 
creation, if consent has 
not been completed 
Questions about 
ImmunoCARE? 
If you have any 
questions before you 
join, feel free to email us 
at 
ImmunoCARE@scripps.
edu 
Share 
diagnosis info 
 
 
5 hours consent 
completion (for 
conditions that cannot 
be verified by claims or 
for those who did not 
connect their claims 
data.) 
Verify your 
diagnosis 
Please upload 
confirmation of your 
immunocompromised 
status 
Reminder 1: 
Share 
diagnosis info 
3 days after consent 
completion (for 
conditions that cannot 
be verified by claims or 
for those who did not 
connect their claims 
data.); requested 
information will vary by 
diagnosis  
Next step: share 
diagnosis info 
To verify your eligibility, 
please upload a 
document showing your 
diagnosis [alternate: 
medication list, lab 
results, test results]. 
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       Page 51 of 77 
 

Reminder 2: 
Share 
diagnosis info 
7 days after consent 
completion (for 
conditions that cannot 
be verified by claims or 
for those who did not 
connect their claims 
data.) 
Last reminder: 
confirm 
diagnosis 
To move forward, please 
share a document 
showing your diagnosis. 
[alternate: medication 
list, lab results, test 
results]. 
Connect 
health plan 
claims data 
(post consent) 
5 hours consent 
completion 
Connect your 
health claims 
data 
Please search for your 
health insurance 
provider to share. 
Reminder 1: 
Connect 
health plan 
claim (post 
consent) 
3 days after consent 
completion 
 
Ready to share 
your claims 
data? 
You need to share 
claims data to move 
forward. 
Reminder 2: 
Connect 
health plan 
claim (post 
consent) 
7 days after consent 
completion 
Last reminder: 
share your 
claims data 
Please search for your 
health insurance 
provider to share and 
continue participating. 
Baseline 
survey 
5 hours after eligible for 
baseline survey 
Next step: 
baseline survey 
Please share information 
to help us learn about 
you. 
Reminder 1: 
Baseline 
survey 
3 days after eligible for 
baseline survey 
Do you have 
time for a 5 min 
survey? 
Click to complete 
baseline survey 
Reminder 2: 
Baseline 
survey 
7 days after eligible for 
baseline survey 
Last reminder: 
Baseline survey 
Your baseline survey is 
waiting. 
Ready to order 
first kit 
Upon being assigned to 
test arm and Cue 
verifying their email 
address for account 
creation 
You are eligible 
for free COVID 
tests 
Download the Cue 
Health app to create 
your account and order 
Reminder 1: 
Ready to order 
first kit 
3 days after first 
invitation to order tests, 
if Cue confirms they 
have not ordered 
Time to order a 
test kit 
Click here to get 
instructions 
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       Page 52 of 77 
 

Reminder 2: 
Ready to order 
first kit 
7 days after first 
invitation to order tests, 
if Cue confirms they 
have not ordered 
You’ve been 
selected! 
Download an app to 
order a testing kit 
Take first test 
7 days after eligible for 
ordering or 5 days after 
Cue confirmed 
participant placed first 
order and has not taken 
test 
Take your first 
Cue test 
When you receive your 
Cue tests, please take 
one to try it out. 
Reminder 1: 
Take first test 
10 days after eligible for 
ordering or 8 days after 
Cue confirmed 
participant placed first 
order and has not take 
test 
Did you take 
your first Cue 
test? 
If you have your Cue 
tests, please try it out. 
Reminder 2: 
Take first test 
14 days after eligible for 
ordering or 12 days after 
Cue confirmed 
participant placed first 
order and has note 
taken test 
Final reminder: 
take first Cue 
test 
Get to know Cue tests 
before you need them. 
Test reorder 
reminder 
30 days after last tests 
received or presumed 
order date 
Order more Cue 
tests 
If you have fewer than 6 
tests, we recommend 
you reorder in the Cue 
app. 
Alt 1: Test 
reorder 
reminder 
30 days after last tests 
received or presumed 
order date 
Time to reorder 
Cue tests 
Don’t run out - order 
more Cue tests in the 
Cue app today. 
Alt 2: Test 
reorder 
reminder 
30 days after last tests 
received or presumed 
order date 
You are eligible 
to order more 
Cue tests 
Open the Cue app to 
order more tests when 
you’re ready. 
Monthly 
survey is 
ready v1 
30 days have passed 
since previous survey 
was completed 
Your monthly 
survey is ready  
Complete this 1-2 minute 
survey and earn a $10 
Amazon gift card. 
Monthly 
survey is 
ready v2 
30 days have passed 
since previous survey 
was completed 
Your monthly 
Survey is 
waiting for you  
Complete this 1-2 minute 
survey and earn a $10 
Amazon gift card. 
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Monthly 
survey is 
ready v3 
30 days have passed 
since previous survey 
was completed 
Don’t forget! 
Complete this 1-2 minute 
survey and earn a $10 
Amazon gift card. 
Monthly 
survey is 
ready v4 
30 days have passed 
since previous survey 
was completed 
Do you have 
time for a 5 min 
survey? 
Complete this 1-2 minute 
survey and earn a $10 
Amazon gift card. 
Reminder: 
monthly 
survey v1 
30 days have passed 
since previous survey 
was completed 
Survey time!  
Let us know about any 
COVID exposures and 
infections and earn a 
$10 Amazon gift card. 
Reminder: 
monthly 
survey v2 
30 days have passed 
since previous survey 
was completed 
Reminder: 
monthly survey 
Let us know about any 
COVID exposures and 
infections and earn a 
$10 Amazon gift card. 
Reminder: 
monthly 
survey v3 
30 days have passed 
since previous survey 
was completed 
How are you? 
Let us know about any 
COVID exposures and 
infections and earn a 
$10 Amazon gift card. 
Reminder: 
monthly 
survey v4 
30 days have passed 
since previous survey 
was completed 
Keep us 
updated on how 
you are feeling! 
Let us know about any 
COVID exposures and 
infections and earn a 
$10 Amazon gift card. 
Gift card is 
ready 
5 hours after gift card 
becomes available, if 
they haven’t viewed the 
gift card screen 
Your gift card is 
ready 
Log in to claim your $10 
Amazon gift card. 
Study 
conclusion 
After completion of final 
survey or 1 month after 
sending the end of study 
survey. 
The 
ImmunoCARE 
study is over 
Thank you for everything 
you’ve done in the past 
[number of months] 
months. We’ll share 
study results when 
they’re ready. 
EOS Survey 
At the end of the data 
collection period 
(between 4 and 8 
months) 
Most important 
survey to date 
Thank you for everything 
you’ve done. Take your 
last survey to finish out 
your participation and 
earn your gift card. 
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EOS Survey 
At the end of the data 
collection period 
(between 4 and 8 
months) + 5 days 
Earn gift cards 
for Surveys you 
missed! 
Take the end of study 
survey. 
 
 
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Appendix 16: Calls to Action (prompts for each 
study task) 
These calls to action and descriptive text may be used in the app to launch tasks. 
 
Connect your health plan 
We’ll receive claims data to learn more about your health. If you cannot or do not want to 
share your claims, please let us know by opting out. 
 
Confirm your diagnosis 
We need additional documentation regarding your diagnosis 
 
Diagnosis verified 
Complete your next survey 
 
Baseline survey 
Tell us more about yourself 
 
Create your Cue Health account 
You’ll be able to register and order your testing kit at no cost 
 
Take the COVID-19 test 
Complete this task once you have received the Cue testing kit 
 
Monthly check-in 
Let us know if you’ve been exposed to or treated for COVID-19 
 
alt: Let us know whether you’ve been exposed to or treated for COVID-19 
 
Report symptoms or exposure 
Let us know if you’re having symptoms or have been exposed to COVID-19 
 
Claim your gift card 
You have received a gift card for completing a task 
 
When to use a Cue test 
See the list of symptoms to look out for 
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Appendix 17: Marketing Materials 
Below are example designs of marketing materials. Images may vary. 
 
 
 
 
 
 
 
 
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Appendix 18: Research Match 
 
Background: 
ResearchMatch.org will be utilized as a recruitment tool for this protocol.  ResearchMatch.org is a 
national electronic, web-based recruitment tool that was created through the Clinical & Translational 
Science Awards Consortium in 2009 and is maintained at Vanderbilt University as an IRB-approved 
data repository. 
 Preface: ResearchMatch aims to serve as an effective, relevant, and complementary recruitment tool 
that will help connect willing volunteers with researchers who are searching for appropriate 
volunteers to be placed in their clinical and other health related research studies. For more 
information visitwww.researchmatch.org 
Email copy to use via researchmatch.org: 
A research team with The Scripps Research Institute in La Jolla, CA, believes you might be a good 
match for the following study: 
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The ImmunoCARE Study 
Are you at high risk of hospitalization from COVID-19 infection due to a compromised immune 
system or age? The ImmunoCare study aims to reduce that risk. Scripps Research – a renowned 
biomedical research institute – and Cue Health, a leading health care technology company that 
develops portable diagnostic tests for at-home use, are launching the ImmunoCARE Study. 
ImmunoCARE is an innovative research project designed to examine whether a combination of 
repeated at-home tests, on-demand telemedicine, and quick delivery of Paxlovid after testing 
positive for COVID-19 can reduce severe outcomes and hospitalization in immunocompromised 
people and those over 65. 
We can only succeed in this research with your help. Eligible participants will take part in a 4- to 
8-month study and may receive at-home diagnostic tests free of charge.  
Additional inclusion criteria includes:  
●​ Living in the United States 
●​ 18 years or older 
●​ Vaccinated against COVID-19  
●​ Willing and able to participate in study interventions including: 
○​ Use of a compatible smartphone, including camera and bluetooth 
○​ Willing and able to share health insurance claims data from Medicaid, Medicare, or 
an Anthem plan if over 65 and not otherwise immunocompromised 
○​ Completing Surveys 
○​ Use of Cue Health App and tests 
○​ Use of MyDataHelps by Web or App 
●​ Immunocompromised, including 
○​ Symptomatic HIV 
○​ Graft versus host disease 
○​ Immunoglobulin deficiency/Immunodeficiency  
○​ Immunosuppressive therapy  
○​ Leukemia 
○​ Lymphoma (Hodgkin or non-Hodgkin) 
○​ Metastatic Cancer 
○​ Multiple Myeloma 
○​ Solid organ malignancy 
○​ Transplant, hematopoietic stem cell 
○​ Transplant, solid organ 
○​ 65 years or older 
 
Participation in the study is voluntary and does include compensation. 
 
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Yes, I'm interested! 
 
No, thanks. 
 
Note: Potential participants who click Yes, I am interested will show up within the researcher’s 
ResearchMatch portal. The message below will be sent to interested participants.  Potential 
Participants who click No, thanks are directed back to researchmatch.org and the following 
link:https://www.researchmatch.org/recruitmentresponse?cn=2&id=5401753265359&guid=4464672
1865.921&gid=18598032.0513 
Response Email: 
Dear XXX, 
Thank you for your interest in participating in The ImmunoCARE Study. To learn more about the 
study, please visit Immunocare.scripps.edu for more information and next steps. 
If you have any questions, please let us know.  
Best, 
The ImmunoCARE Study Team 
 
 
 
 
 
 
 
 
 
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Appendix 19: Optum Specific Outreach One Pager 
Optum Option One 
HEADING 
ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised 
Individuals 
INTRO 
Are you at high risk of hospitalization from COVID-19 infection due to age or a compromised 
immune system? The ImmunoCare study aims to reduce that risk. Scripps Research – a renowned 
biomedical research institute – and Cue Health, a leading health care technology company that 
develops portable diagnostic tests for at-home use, are partnering with your Optum Physician to 
launch the ImmunoCARE Study. 
SUBHEADING 
More on The ImmunoCARE Study 
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ImmunoCARE is an innovative research project to study whether repeated at-home tests, on-demand 
telemedicine, and quick delivery of medication for those who test positive for COVID-19 can reduce 
COVID-19 severity in immunocompromised people and those over 65. 
ImmunoCARE will enroll 10,000 participants. Half of participants will test for COVID-19 and seek 
care as they normally would; the other half will receive 10 at-home COVID-19 tests per month from 
Cue Health for themselves and others in their household. All participants will be asked to complete 
monthly surveys about COVID-19 exposure, infection, and hospitalization.  
Who can enroll 
ImmunoCARE is available to individuals who are moderately to severely immunocompromised or 
are 65 and older. Participants will have the option to provide documentation from health claims data 
confirming their diagnosis and age. Additional criteria for enrollment can be found at 
immunocare.scripps.edu or scan the QR code. the link below. 
Our thanks to you 
As our thanks for your participation, all eligible participants will receive a series of Amazon gift 
cards as compensation throughout the study.  
Questions? 
If you have any questions about the study, feel free to reach out to the study team at      
immunocare@scripps.edu. 
 
Optum Option two: 
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[Optum logo] 
[Participant address] 
[QR Code] Find out if you qualify and learn more. 
Optum.com/ImmunoCARE 
 
Join the ImmunoCARE study 
 
What is the ImmunoCARE study? 
This study will look at COVID-19 and people with weak (compromised) immune systems. 
People with weak immune systems can’t fight germs well. They can become sick more often. 
COVID-19 can be especially dangerous for them. This study will look to find better ways to 
protect them from COVID-19. 
 
Will I be paid for participating in the study? 
If you qualify, you’ll receive an Amazon gift card when you sign up and complete some 
information. After that, you’ll receive an Amazon gift card each month for up to 8 months. 
There’s no cost for you to take part in the study. 
 
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Who is running the ImmunoCARE study? 
For the study, your Optum doctor will partner with: 
• Scripps Research, a renowned biomedical research institute 
• Cue Health, a leading health care technology company that makes home C0VID-19 tests 
 
What will I need to do in the study? 
People who join the study will be assigned to one of two groups. (You will be put into a group 
randomly. You won’t be able to choose your group.) The first group will test for COVID-19 
and seek care as they normally would. 
 
The other group will get tools and services to find, and care for, COVID-19 quickly at home. 
This will include: 
• Special COVID-19 test kits. The kits are designed to find COVID-19 early. 
• Virtual care, on demand. If a test shows you have COVID-19, you can see a doctor by video 
right away. 
• Quick delivery of a COVID-19 medicine, PaxlovidTM. If your doctor orders Paxlovid for you 
as part of your regular medical care, you’ll get it delivered the same day as long as it is ordered 
early enough in the day. 
 
They will also be asked to: 
• Use the CUE Health app. It’s needed to use the test kit and get virtual care. 
• Complete a survey once a month. 
 
The goal of the study is to learn if fast testing and care can: 
• Stop COVID-19 early or keep it from getting so severe that you need hospital care 
• Lower the cost of care compared to standard care 
 
How long will the study last? 
The study will last 4 to 8 months. 
 
Who can join the study? 
You may qualify for this study if you have: 
• HIV with or without symptoms (like fever, chills, rash) 
• Graft versus host disease (when a bone marrow transplant attacks the body) 
• Immunoglobulin deficiency or immunodeficiency (when the immune system is missing a key 
part for fighting germs) 
• Immunosuppressive drugs (medicine that keeps the body from rejecting a bone marrow or 
organ transplant); exception: steroids 
• Cancers of the immune system, like leukemia, multiple myeloma or lymphoma (Hodgkin or 
non-Hodgkin) 
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• Metastatic cancer (any cancer that has spread) 
• Solid organ cancer (examples: breast, lung, colon) 
• Bone marrow transplant 
• Solid organ transplant (examples: heart, lung, kidney) 
 
Will my medical information be shared? 
If you join the study, you will be given a random study ID number to identify you. We will not 
share your personal health information with anyone outside of this study. 
 
Any person depicted in the stock image is a model. 
Optum is a registered trademark of Optum, Inc. in the U.S. and other jurisdictions. All other 
brand or 
product names are the property of their respective owners. Because we are continuously 
improving 
our products and services, Optum reserves the right to change specifications without prior 
notice. 
Optum is an equal opportunity employer. 
© 2023 Optum, Inc. All rights reserved. 10291862 228531-042023 
 
     
 
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Appendix 20: Optum Specific Invitation Email 
SUBJECT LINE: 
Immunocompromised and concerned about COVID-19? 
PREHEADER: 
Join The ImmunoCARE study which aims to reduce hospitalizations 
BODY: 
Dear [FIRST NAME], 
Are you at high risk of hospitalization from COVID-19 infection due to a compromised immune 
system or age? The ImmunoCare study aims to reduce that risk. Scripps Research – a renowned 
biomedical research institute – and Cue Health, a leading health care technology company that 
develops portable diagnostic tests for at-home use, are partnering with your Optum Physician to 
launch the ImmunoCARE Study. 
ImmunoCARE is an innovative research project designed to examine whether a combination of 
repeated at-home tests, on-demand telemedicine, and quick delivery of Paxlovid after testing 
positive for COVID-19 can reduce severe outcomes and hospitalization of people just like you. 
We can only succeed in this research with your help. Eligible participants will take part in a 4- to 
8-month study and may receive at-home diagnostic tests free of charge.  
Learn more and take our eligibility survey today. 
CTA 
LEARN MORE 
Take Care, 
The ImmunoCARE Study Team 
Questions? Reach out to us at Immunocare@scripps.edu 
 
 
 
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Appendix 21: ImmunoCARE Animated Explainer 
Video | Script 
 
INTRO & INCENTIVE​
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·  ​
People who are immunocompromised or over the age of 65 are still at high risk of 
developing severe disease from COVID-19, but a new study could help reduce that risk.  ​
​
 
·  ​
The ImmunoCARE study is enrolling 10,000 participants nationwide and is providing 
some participants with free highly sensitive at-home COVID tests, access to telemedicine 
and delivery of antiviral medications. All participants will get Amazon gift cards as a thank 
you for taking part.​
​
 
·  ​
Interested? Keep watching to learn more, or head to immunocare.scripps.edu to get 
started.​
​
 
·  ​
Scientists at the Scripps Research Digital Trials Center are investigating if early 
detection and rapid treatment can reduce COVID-19 hospitalizations among 
immunocompromised people and those over 65. 
 
·  ​
The study is fully remote, meaning you won’t need to visit a clinic or have in-person 
consultations. 
 
ELIGIBILITY & ACCOUNT SET UP 
 
·  ​
To find out if you are eligible to participate, you’ll need to visit the study website and 
complete a brief survey. 
 
o   TEXT ON SCREEN (NOT PART OF SCRIPT): 
§  Live in the United States 
§  18 years or older 
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§  Access to smartphone 
§  Vaccinated against COVID-19 
§  Diagnosed as moderately to severely immunocompromised, or be 65 years 
or older 
§  Willing to participate in all study activities 
 
·  ​
If you are eligible to participate, you will be prompted to create an account on the 
study web app, complete the informed consent process and fill out a short baseline survey. 
 
SYNCING HEALTH PLAN 
 
·  ​
Next, you will also be asked to connect to your health plan. This allows scientists to 
verify your immunocompromised status or age and study any medical care you received 
through your plan related to COVID-19. We use strict privacy practices. 
 
·  ​
If it cannot be verified through your health plan data, you will need to provide proof 
of your immunocompromised status or age by sharing a document directly with the study 
team. 
 
INTERVENTION 
 
·  ​
Once your status is verified, you will be randomly assigned to either the control arm 
or the intervention arm. It is important to have participants in both of these groups so 
scientists can accurately determine whether the intervention is working. 
 
·  ​
Those assigned to the control arm will complete a monthly survey about any 
COVID-19 exposures and diagnosis. If they develop symptoms, they will test and seek care 
as they normally would. 
 
·  ​
Those assigned to the intervention arm will also complete a monthly survey and 
create an account on the Cue Health mobile app. These participants will receive 10 Cue 
Health COVID-19 molecular at-home tests each month. Participants will perform tests after 
exposure or if symptoms arise. The tests can also be used for members of the same 
household, who have been exposed to COVID-19 or have symptoms. 
 
·  ​
These nucleic acid amplification tests detect the genomic RNA of SARS-CoV-2, the 
virus that causes COVID-19, and are much more sensitive than more common rapid antigen 
tests. 
 
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·  ​
If a test is positive, participants can consult with a healthcare professional through the 
Cue Health app. When clinically indicated, medication for the treatment of COVID-19 will 
be prescribed and delivered to the participant’s home. Participants can also seek care through 
their own healthcare provider, or not seek care at their discretion. 
 
OUTRO 
 
·  ​
The scientists expect the study to run for up to 8 months. Participation is voluntary 
and you can withdraw at any time.​
​
 
·  ​
Help us support those who are still at high risk of severe outcomes from COVID-19. 
 
·  ​
For more information, visit immunocare.scripps.edu 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Appendix 22: End of Study Survey Reminder 
SUBJECT LINE:  
End of Study Survey 
PREHEADER:  
Your end of study survey only takes a few minutes  
BODY COPY:  
Dear [FIRST NAME],  
Do you have a minute? A minute or two is all it takes to complete this end of study survey, it’s the 
most important survey yet! 
By letting us know if you’ve been exposed to, infected with, or hospitalized from COVID-19 in the 
past month, you’re helping advance research on reducing hospitalizations and improving outcomes 
for immunocompromised individuals.  
Once you complete your survey, you will receive a code for your  Amazon gift card as our thanks to 
you.  
Thank you again for your time and participation in ImmunoCARE.   
Take Care, 
The ImmunoCARE Study Team 
Questions? Reach out to us at Immunocare@scripps.edu 
 
 
 
 
 
 
 
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Appendix 23: Upload your diagnosis 
confirmation 
SUBJECT LINE:  
Confirm your diagnosis 
PREHEADER:  
Upload confirmation of your diagnosis  
BODY COPY:  
Dear [FIRST NAME],  
Please take a moment to upload confirmation of your diagnosis.      
Once you complete this step, you can move forward with your participation in ImmunoCARE.  
Thank you again for your time and participation in ImmunoCARE.   
Take Care, 
The ImmunoCARE Study Team 
Questions? Reach out to us at Immunocare@scripps.edu 
 
 
 
 
 
 
 
 
 
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Appendix 24: Claims reimbursement email 
SUBJECT LINE:  
Share your data and receive an Amazon Gift Card 
PREHEADER:  
Connect your health claims data and receive a $30 Amazon Gift Card 
BODY COPY:  
Dear [FIRST NAME],  
We are grateful for your participation in the ImmunoCARE Study. Preliminary analysis of the 
ImmunoCARE data is revealing the research value of claims data.           Would you consider 
connecting yours? This will help ImmunoCARE get a more complete data set prior to study 
close out. Participants who agree to connect their health claims data will receive a $30 Amazon 
gift card as a thank you, while supplies last. 
Login to your My Data Helps account to connect to your insurance claims. If you have any 
questions or trouble connecting your claims data, feel free to reach out to us at 
ImmunoCARE@scripps.edu. 
[Optional: button with text “Log in to share”] 
Thank you again for your valued participation in ImmunoCARE.  
Take Care, 
The ImmunoCARE Study Team 
Questions? Reach out to us at Immunocare@scripps.edu 
 
 
 
 
 
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Appendix 25: Outreach Talking Points 
Introduction: 
●​ Briefly introduce yourself and express gratitude for the person's time. 
●​ Mention that you'd like to share information about a valuable opportunity called the 
ImmunoCARE Study, which does not involve any treatment. 
Study Purpose: 
●​ Explain that the ImmunoCARE Study is a collaboration between Scripps Research and 
Cue Health. 
●​ Explain that the study aims to understand and improve COVID-19 outcomes specifically 
for immunocompromised individuals and those aged 65 and above. 
●​ Emphasize the study does not involve treatment. 
Target Population: 
●​ Highlight the increased risk for severe outcomes from COVID-19 in individuals with 
compromised immune systems or over the age of 65. 
●​ Mention the specific conditions that make someone eligible, such as Symptomatic HIV, 
Graft versus host disease, Immunoglobulin deficiency, etc. 
Study Activities: 
●​ Explain the two groups within the study: one group continues normal testing and 
care-seeking, while the other receives at-home COVID-19 tests and additional support. 
●​ Emphasize that all participants, regardless of group, will be asked to complete monthly 
surveys about COVID-19 exposure, infection, and hospitalization. 
Innovative Approaches: 
●​ Discuss the innovative aspects of the study, including at-home testing, telemedicine 
consultations, and rapid medication delivery. 
●​ Stress the importance of finding practical and effective ways to support individuals in 
managing COVID-19. 
Participant Appreciation: 
●​ Express gratitude for the participant's potential contribution to the research. 
●​ Mention that eligible participants will receive compensation in the form of Amazon gift 
cards as a token of appreciation for their time throughout the study. 
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Joining the Study: 
●​ Share the official study website link: https://immunocare.scripps.edu/ 
●​ Provide information on how individuals can check their eligibility and sign up for the 
study. 
Impact of Participation: 
●​ Stress the potential impact of their involvement, highlighting that their contribution could 
significantly influence our understanding and management of COVID-19 in vulnerable 
populations. 
Questions and Concerns: 
●​ Encourage participants to ask any questions they may have about the study. 
●​ Provide referrals for health and social services when participants describe barriers to 
participation related to social determinants of health. 
●​ Provide your contact information (email or phone number) or direct them to the study 
website or email address (ImmunoCARE@scripps.edu) for more detailed information. 
Closing: 
●​ Thank them for considering participation in the ImmunoCARE Study. 
●​ Reiterate the importance of their potential role in advancing crucial research efforts. 
 
 
 
 
 
 
 
 
 
 
 
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Appendix 26: FDA Alert Email 
SUBJECT LINE: 
Do Not Use Cue Health Device 
PREHEADER: 
Cue Health’s COVID-19 Tests Have a Risk of False Results 
BODY COPY: 
Dear [FIRST NAME], 
This is an alert regarding the ImmunoCARE Study. The U.S. Food and Drug Administration 
(FDA) issued a communication to recommend that patients, caregivers, and health care 
providers do not use Cue Health’s COVID-19 Tests due to an increased risk of false 
results.  
 
We are determining next steps for the ImmunoCARE Study. In the meantime, please 
discontinue use of your Cue Health tests. We thank you for your participation and apologize 
for any inconvenience this may cause.  
 
Take Care, 
The ImmunoCARE Study Team 
Questions? Reach out to us at Immunocare@scripps.edu 
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Appendix 27: FDA Alert Push Notification/SMS 
Theme: FDA Alert Push/SMS 
Trigger: Push once IRB approved 
Title: Don’t Use Cue Health Device 
Push or SMS copy: Cue Health’s COVID-19 Tests Have a Risk of False Results, please 
discontinue use 
 
Appendix 28: ImmunoCARE Study Closure  
SUBJECT LINE: 
The ImmunoCARE Study is Ending 
PREHEADER: 
Please take your End of Study Survey 
BODY COPY: 
Dear [FIRST NAME], 
We are writing you as a valued participant in the ImmunoCARE study to share important 
news. We are stopping the ImmunoCARE study early in response to the FDA warning 
calling for discontinuing use of Cue COVID-19 tests. 
 
The ImmunoCARE study team appreciates your participation and understanding. If you 
have not done so already, please take your end of study survey and share your claims 
data. Participants who agree to connect their health claims data will receive a $30 Amazon gift 
card as a thank you, while supplies last.  
Take Care, 
The ImmunoCARE Study Team 
Questions? Reach out to us at Immunocare@scripps.edu 
 
 
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