Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing
Conditions: COVID-19
Sponsor: Duke University

National Institute of Health 
Protocol 
SARS-CoV-2 Test  
 RADx-UP HoT 
Confidential 
[version/date] 
1
Rapid Acceleration for Diagnostics in Underserved Populations: 
HOme Testing  
(RADx-UP HoT) 
National Clinical Trial (NCT) Identified Number:  Pending 
Principal Investigators:  Christoph Hornik, MD PhD MPH 
Co-Investigators: Giselle Corbie-Smith, MD, MSc 
 Gaurav Dave, MD, DrPH, MPH 
Sponsor: National Institute of Health 
Funded by: National Institute of Health 
Version Number:  2.0 
19 May 2021 
NCT04949243

National Institute of Health  
 
Protocol  
SARS-CoV-2 Test  
 
RADx-UP HoT 
Summary of Changes from Previous Version: 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
Sections 1.1, 
1.3, 4.1, 4.4, 
and 9.3  
The at-home testing through the public 
health intervention will be 3 times a week 
for 4 weeks, instead of testing twice a 
week for 5 weeks.  
More frequent testing is better suited to 
diagnosing asymptomatic/pre-
symptomatic disease and prevent 
spread. 
Section 1.3 
Questionnaires/surveys will be 
administered only on baseline and weeks 
1, 3, 5, 13, and 21. The Schedule of Events 
table has been updated to reflect these 
timepoints.    
To reduce participant burden, 
questionnaires/surveys will only be 
administered on baseline and weeks, 1, 
3, 5, 13, 21.  
Section 1.3  
The survey on knowledge of prevention 
approaches will be administered on weeks 
5 and 21 instead of weeks 13 and 21. 
Administering this questionnaire at 
week 5 and week 21 allows for a better 
perceptive to see how the participant
knowledge has changed over time.  
Section 1.3 
The survey on feasibility of at-home testing 
has been removed from week 21. It will 
only be administered at week 5. 
To reduce participant burden, this 
survey will only be asked once after the 
testing phase. 
Section 1.3 
Survey questions on Beliefs were added to 
the protocol for weeks 1, 5, and 21.  
No new questions were added. The 
survey questions on Belief were already 
included in the questionnaire. It has now 
been specified as a new category of 
questions within the protocol.  
Section 1.3 
Anthropometrics (weight) was added as a 
measure to be taken at Baseline and week 
5. Anthropometrics (height) was added as 
a measure to be taken at Baseline.  
Socio-Demographic Data was already 
planned at Screening and Enrollment 
(now called Baseline). For additional 
clarity, anthropometrics have now been 
specified at Baseline. Height will be 
taken at Baseline. Since weight 
fluctuates, it will be taken at Baseline 
and week 5.   

National Institute of Health  
 
Protocol  
SARS-CoV-2 Test  
 
RADx-UP HoT 
Section 1.3 
Contact information will be collected 
during the Screening and Enrollment 
phase. It has been added to Schedule of 
Events table under Baseline.  
Contact information was already 
planned to be collected. For additional 
clarity, it has now been added to the 
Schedule of Events table.  
Sections 3 
and 9.4.4 
The method used for the exploratory 
objective to measure participant mobility 
was changed from mobile phone 
geotracking  to surrogates of mobility 
including activity tracker. 
The method of mobility tracking was 
updated since the smartphone 
application for this study is expected to 
be able to access activity tracking 
functions of the phones on which the 
application is installed.  
 
 
 
 

National Institute of Health  
 
Protocol  
SARS-CoV-2 Test  
 
RADx-UP HoT 
STUDY PRINCIPAL INVESTIGATORS 
 
The signature below constitutes the approval of this protocol and the attachments, and 
provides the necessary assurances that this study will be conducted according to all stipulations 
of the protocol, including all statements regarding confidentiality, and according to local legal 
and regulatory requirements and applicable federal regulations and ICH guidelines. 
 
Principal Investigator Signature 
 
 
 
 
Christoph P. Hornik, MD PhD MPH 
 
Date 
 
Co-Investigators Signatures  
 
 
 
 
Giselle Corbie-Smith, MD, MSc 
 
Date 
 
 
 
 
 
Gaurav Dave, MD, DrPH, MPH 
 
Date 
 
 

 
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National Institute of Health  
 
Protocol 
SARS-CoV-2 Test 
 
RADx-UP HoT 
NIH-FDA Clinical Trial Protocol Template  v1.0 7 Apr 2017 
 
1 
STATEMENT OF COMPLIANCE 
The study will be carried out in accordance with International Conference on Harmonization Good 
Clinical Practice (ICH GCP) and the following:  
 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR 
Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812)  
 
National Institutes of Health (NIH)-funded investigators and study staff who are responsible for the 
conduct, management, or oversight of NIH-funded studies have completed Human Subjects Protection 
and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the Institutional Review Board (IRB) for review and approval.  Approval of both the 
protocol and the consent form must be obtained before any participant is enrolled.  Any amendment to 
the protocol will require review and approval by the IRB before the changes are implemented to the 
study.  In addition, all changes to the consent form will be IRB-approved; a determination will be made 
regarding whether a new consent needs to be obtained from participants who provided consent, using a 
previously approved consent form. 
 
 

National Institute of Health  
 
Protocol 
SARS-CoV-2 Test 
 
RADx-UP HoT 
NIH-FDA Clinical Trial Protocol Template  v1.0 7 Apr 2017 
 
2 
1 
 
PROTOCOL SUMMARY 
1.1
SYNOPSIS  
Title: 
Rapid Acceleration for Diagnostics in Underserved Populations: Home 
Testing (RADx-UP HoT) 
Study Description: 
This observational, cohort sub-study is embedded within a larger public 
health intervention that distributes at-home, self-administered,  SARS-
CoV-2 antigen testing kits to households within pre-selected communities 
through the CDC. Within this sub-study, we will evaluate the socio-
behavioral mechanisms of SARS-CoV-2 community transmission, including 
social interactions, health behaviors, healthcare utilization, knowledge, 
disease burden, and feasibility of at-home testing.  The study hypothesis is 
that positive at-home test results will be associated with altered self-
reported social interactions and altered health behaviors compared to 
negative test results. Surveys and questionnaires will be completed by 
participants through the smartphone app or via call center phone calls 
according to the schedule of events. Questionnaires will collect data on 
demographic characteristics, medical history and health status, COVID 
testing and symptoms, social interactions, knowledge of prevention 
strategies, infection risk, and attitudes towards vaccines.  
Objectives: 
 
Primary Objective: 
To assess self-reported social interactions following SARS CoV-2 at-
home test result over the study period 
Secondary Objectives:  
To assess change in self-reported behaviors before and following 
SARS CoV-2 at-home test result over the study period 
To assess the impact of at-home testing regimen on self-reported 
healthcare utilization for SARS CoV-2 treatment  
To assess knowledge of SARS CoV-2 prevention approaches over 
the study period 
Endpoints:
Primary Endpoint:
Proportion of respondents that report adhering to social 
distancing guidelines after a test result; comparison of proportion 
adherent after positive vs. negative test result 
Secondary Endpoints:
Proportion of respondents that decide to act on precautionary 
behaviors after a test result  
Point estimate and 95% confidence interval for each healthcare 
utilization measure and composite measure  
Proportion of respondents that are knowledgeable of 
precautionary measures to prevent infection  
Prevalence of positive test results with 95% confidence intervals  
Study Population:
Adults and children > 8 years of age living within pre-identified 
communities participating in the public health intervention  
Phase:
Not applicable

National Institute of Health  
 
Protocol 
SARS-CoV-2 Test 
 
RADx-UP HoT 
NIH-FDA Clinical Trial Protocol Template  v1.0 7 Apr 2017 
 
3 
Description of 
Sites/Facilities Enrolling 
Participants: 
This is a site-less, direct to participant study. Participants, up to 300,000,
will be recruited for the sub-study within the communities participating in 
the larger public health intervention. 
Description of Study 
Intervention: 
Collection of survey data
Study Duration: 
Total of up to 29 weeks, including up to 4 weeks of screening period and 
25 weeks from the start of the study.  
Participant Duration:
Up to 25 weeks: 4 weeks of active testing period and 17 weeks of follow-
up. Last follow-up will be at week 21 with a 4 week window (up to week 
25) to complete the surveys. 
1.2
SCHEMA 
 
 
 

National Institute of Health  
 
Protocol 
SARS-CoV-2 Test 
 
RADx-UP HoT 
NIH-FDA Clinical Trial Protocol Template  v1.0 7 Apr 2017 
 
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1.3
SCHEDULE OF ACTIVITIES (SOA) 
 
Study Period/Phase:
Screening 
& 
Enrollment 
Phase  
 
Sub-study Questionnaires/Surveys 
Comments & Notes 
 
Testing Phase  
(Public Health 
Intervention)* 
Follow-Up Phase 
Week:
Weeks  4 to 0 
Baseline 
Week 1  
Week 2 
Week 3 
Week 4 
Week 5 
Week 13 
Week 21 
 
Informed Consent and Assent 
when applicable 
 
X 
 
 
 
 
 
 
 
e-Consent via app or verbal consent 
via call center 
Create mobile app account 
 
X 
 
 
 
 
 
 
 
For participants using the mobile app
Contact Information  
 
X 
 
 
 
 
 
 
 
 
Socio-Demographic Data 
 
X 
 
 
 
 
 
 
Medical History 
 
X 
 
 
 
 
 
 
 
 
Anthropometrics  Weight  
 
X 
 
 
 
 
X 
 
 
 
Anthropometrics  Height  
 
X 
 
 
 
 
 
 
 
 
Questionnaires 
 
 
 
 
 
 
 
 
 
Questionnaires can be completed
during the week after each test 
(regardless of the result). 
Social interactions 
Behaviors 
Symptoms  
Healthcare utilization 
 
X 
X 
 
X 
 
X 
X 
X 
 
Beliefs  
 
X 
X 
 
 
 
X  
 
X 
 
Knowledge of prevention 
approaches 
 
 
 
 
 
 
X 
 
X 
 
Feasibility of at-home 
testing 
 
 
 
 
 
 
X 
 
 
 
Testing Adherence/Compliance 
reminders 
 
 
X 
X 
X 
 
X 
 
X 
X 
X 
 
*The public health intervention (3 times a week at-home testing) does not require consent. Consent is 
only required for this sub-study which involves the questionnaires/surveys that are administered during 
the testing phase and follow-up phase.  
 
2 
 
INTRODUCTION 
 
2.1
STUDY RATIONALE  
 
The public health crisis of the COVID-19 pandemic continues to rage on across the US. Novel mitigation 
strategies and community level public health interventions are critical to stop the spread of this virus. 
One of these interventions is frequent, low-cost, rapid-result, at-home viral screening of asymptomatic 
and symptomatic individuals. The goal of frequent home testing is to identify SARS-CoV-2 index cases 
early, trigger isolation and quarantining precautions, and ultimately decrease community transmission. 
 

National Institute of Health  
 
Protocol 
SARS-CoV-2 Test 
 
RADx-UP HoT 
NIH-FDA Clinical Trial Protocol Template  v1.0 7 Apr 2017 
 
5 
The Centers for Disease Control, through coordination with public health departments, is conducting a 
public health intervention of frequent home testing, completed in a timeline needed to address the 
pressing need in high-risk communities. This intervention of home testing requires intentional 
engagement and a clear recognition of risk. Within pre-selected communities, CDC will distribute at-
home, self-collect/self-test SARS-CoV-2 tests with instructions to complete regular testing irrespective of 
symptoms or exposure history.  Previous at-home testing studies have generated inconclusive results, in 
part due to multiple factors including inadequate community engagement strategies to promote uptake 
and consistent testing in the target population as well as limited testing and prevention knowledge, 
attitudes and behavior. 
 
This cohort sub-study in a subset of the population will explore the community and human behavior 
factors in response to at-home testing. Participants in the public health intervention who meet eligibility 
criteria will be invited to participate in the sub-study, consented, and asked to complete questionnaires 
aimed at evaluating self-reported social interactions, behaviors, and health system utilization in 
response to results from the at-home SARS CoV-2 antigen test. This sub-study will provide participant 
level behavioral information essential to understanding the relationship between large scale at-home 
testing and community transmission during the SARS-CoV-2 pandemic and relevant for implementation 
of public health interventions in future pandemics.      
 
2.2
BACKGROUND  
 
In the US, > 4 million people have been infected with the SARS-CoV-2 virus and >400,000 died. Infections 
and deaths, however, have disproportionally affected historically marginalized populations. Early in the 
pandemic the focus has been on testing to identify symptomatic individuals to reduce morbidity and 
mortality from infection.  As public health measures have scaled up mitigation strategies are increasingly 
being considered to reduce community spread of infection. The availability of rapid tests for detecting 
SARS-CoV-2 presents opportunities for rapid, frequent and low-cost at-home testing in asymptomatic 
populations as part of a broader mitigation strategy that includes protective measures (masking, social 
distancing, increased hygiene) and contact-tracing and isolation. With 50% or more of infections 
resulting from pre-symptomatic or asymptomatic transmission, at-home testing may offer an effective 
option for screening and for breaking chains of transmission. Rapid antigen tests are relatively 
inexpensive and therefore can be used frequently for detecting infected individuals who are 
asymptomatic, pre-symptomatic and without known or suspected exposure to SARS-CoV-21. However, 
even with antigen tests, the implementation of community level testing will be challenging, with an 
impact that is still to be determined2. 
 
2.3
RISK/BENEFIT ASSESSMENT   
 
2.3.1
KNOWN POTENTIAL RISKS  
 
Study-related risks include potential loss of confidentiality but steps will be undertaken to minimize this 
risk. There are no interventions involved in this study.   
 
2.3.2
KNOWN POTENTIAL BENEFITS  
 

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NIH-FDA Clinical Trial Protocol Template  v1.0 7 Apr 2017 
 
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The benefit of this study is to learn testing impact on reducing the community spread of the infection, 
however there is no direct benefit to participants. 
 
 

National Institute of Health  
 
Protocol 
SARS-CoV-2 Test 
 
RADx-UP HoT 
NIH-FDA Clinical Trial Protocol Template  v1.0 7 Apr 2017 
 
7 
3 
OBJECTIVES AND ENDPOINTS 
 
Objectives 
Outcome Measures  
Endpoint 
Primary 
1.
To assess self-reported social 
interactions following SARS CoV-
2 at-home test result over the 
study period 
Assessments: self-reported data on 
social distancing, quarantine, social 
connectedness, healthcare 
utilization, well-being  
Proportion of respondents that
report adhering to social 
distancing guidelines after a test 
result for the entire study cohort 
and stratified by participant 
demographics (e.g., sex) of 
interest; comparison of 
proportion adherent after 
positive vs. negative test result 
Secondary 
 
 
2.
To assess change in self-reported 
behaviors before and following 
SARS CoV-2 at-home test 
result over the study period 
Assessments: self-reported data on 
awareness of the issue, engagement, 
decisions to act, action, and 
maintenance 
Proportion of respondents that 
decide to act on precautionary 
behaviors after a test result for 
the entire study cohort and 
stratified by participant 
demographics (e.g., gender) of 
interest 
3.
To assess the impact of at-home 
testing regimen on self-reported 
healthcare utilization for SARS 
CoV-2 treatment  
Assessments: self-reported ED visits, 
hospitalizations, and ICU admission, 
for SARS CoV-2 evaluation or 
treatment 
Point estimate and 95% 
confidence interval for each 
healthcare utilization measure 
and composite measure for the 
entire study cohort and stratified 
by participant demographics 
(e.g., gender) of interest  
4.
To assess knowledge of SARS 
CoV-2 prevention approaches 
over the study period 
Assessments: self-reported data on 
perceptions and prevention of risks 
of contracting SARS CoV-2 infection 
Proportion of respondents that 
are knowledgeable of 
precautionary measures to 
prevent infection for the entire 
study cohort and stratified by 
participant demographics (e.g., 
gender) of interest 
5.
Prevalence of positive test result 
for SARS CoV-2 
Assessments: reported results of self-
administered SARS CoV-2 antigen 
test 
Prevalence of positive test results 
with 95% confidence intervals for 
the entire study cohort and 
stratified by participant 
demographic variables of interest
 
 

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Exploratory 
6.
To assess the feasibility of at-
home self-administered  SARS 
CoV-2 antigen tests 
Assessments: self-reported data on 
acceptability, practicality, integration, 
penetration, and demand of at-home 
self-administered antigen test 
Proportion of respondents that 
find at-home self-administered 
antigen test acceptable for the 
entire study cohort and stratified 
by participant demographics 
(e.g., gender) of interest 
7.
To assess participant mobility  
following SARS CoV-2 at-home 
test results over the study period 
Assessment:  mobility patterns as 
captured by surrogates including 
activity trackers 
Distribution of individual mobility 
data in response to positive vs. 
Negative SARS CoV-2 test results.  
8.
To assess attitudes towards SARS 
CoV-2 vaccination over the study 
period 
Assessments: self-reported data on 
perceived susceptibility, severity, 
benefits, barriers, and cues to action 
related to SARS CoV-2 vaccination 
perception about SARS CoV-2 
vaccination for the entire study 
cohort and stratified by 
participant demographics (e.g., 
gender) of interest 
 
 
4 
STUDY DESIGN  
 
4.1
OVERALL DESIGN 
 
This is an observational, direct-to-participant, nested cohort, sub-study embedded within a public health 
intervention that distributes at-home, self-administered, SARS-CoV-2 antigen testing kits. Adults and 
children over 8 years of age living within the pre-identified communities will be included. This sub-study 
focuses on gathering participant-level data to evaluate behavioral determinants of home testing and 
socio-behavioral mechanisms of SARS-CoV-2 community transmission.   
 
The smartphone application developed by CareEvolution, called MyDataHelps, will be used for this 
study, and it is free of charge on Apple or Android devices3. As part of the public health intervention, 
households will receive test kits and included in them will be information about the app and a QR code 
to facilitate access. Only after the participants have received information about the public health 
intervention and received the testing kits, will they be offered the option to participate in this sub-study. 
Once registered, if the participant wants to be a part of the sub-study, eligibility criteria will be verified 
and e-consent will be obtained through the app. The smartphone app includes instructions to administer 
at-home tests, for all participants in the public health intervention. Push notifications will be 
programmed with messaging to promote adherence including personalization, context, and timing for 
all pariticipants in the public health intervention. Additionally, participants will have an option to opt-in 
to reminders for testing 3 times a week at a time of their preference. For participants who provide 
consent to the sub-study, the app will also feature the ability to report the results of their test results 
(upload images of test trips), track testing history, respond to surveys and questionnaires, and access 
As an alternative to the app, participants can participate in the study 
via phone interviews conducted by a centralized study call center. Home test kits will include a QR code 
for the public health intervention app which will link to DCRI call center/eConsent for those interested in 
participating. Using scripted interview guides, call center staff will be ready to explain study 
participation, obtain verbal consent, administer study questionnaires including soliciting test results, and 
issue phone reminders for participants who chose not to use the study app. 

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NIH-FDA Clinical Trial Protocol Template  v1.0 7 Apr 2017 
 
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Using PhenX and Common Data Element (CDE) measures, the surveys and questionnaires will collect 
data on demographic characteristics, medical history and health status, SARS-CoV-2 testing and 
symptoms, social interactions, knowledge of prevention strategies, and infection risk, and attitudes 
towards vaccines.  
 
4.2
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
This study involves a direct-to-participant approach that minimizes participant burden and accelerates 
translation of study findings into daily life settings. This study designs bypasses the traditional settings 
within healthcare environments, and instead brings 
A 
direct-to-participant approach minimizes risks by leveraging the public health intervention community 
engagement, recruitment, and intervention dissemination efforts, and maximizes rewards by selectively 
complementing study data with participant specific information on behaviors and clinical outcomes 
associated with frequent at-home testing.  
 
The objective of the study is to gather participant level information about social behaviors in response 
to at-home test results during the SARS-CoV-2 pandemic. Therefore, a direct-to-participant design, 
which maximally integrates assessments into particip
accurate representation of behaviors.  
There are certain limitations to this study design. A slow enrollment is the greatest challenge to any 
prospective cohort study. By nesting the sub-study within the public health intervention, the sub-study 
leverages the multimodal community engagement and kit dissemination strategies of the public health 
intervention. Non-compliance with study procedures is a risk for community based and direct-to-
participant studies, where traditional health care visits are not available to perform procedures or 
reinforce compliance. Participation will be facilitated by creating two participation pathways, app and 
call center enabled.  
As a result of these efforts, the goal is to establish a systematic approach combining community 
engagement and at-home testing to decrease transmission of SARS-CoV-2 as well as inform public 
health interventions for future pandemics. 
 
4.3
JUSTIFICATION FOR DOSE 
 
There is no study specified administration of a test product. The SARS-CoV-2 test is being self-
administered as part of the public health intervention, and is not part of this sub-study protocol.
4.4
END OF STUDY DEFINITION 
 
A participant is considered to have completed the study if he or she has completed the active testing 
period (at-home testing 3 times a week for 4 weeks) along with the questionnaires/surveys during those 
4 weeks. Questionnaires/surveys will continue to be offered during the follow-up period (up to 17 
weeks). Any amount of testing data and survey responses completed will be acceptable and analyzed.  
 
5 
STUDY POPULATION 
 

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5.1
INCLUSION CRITERIA 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
1.
Self-reported primary residence within the pre-identified communities 
2.
Age > 8 years at enrollment  
3.
Provision of signed and dated informed consent form 
 
5.2
EXCLUSION CRITERIA 
There are no exclusion criteria for this study, if all above inclusion criteria are met. 
5.3
LIFESTYLE CONSIDERATIONS 
 
Not applicable  
 
5.4
SCREEN FAILURES 
 
Screen failures are defined as participants who consent to participate in the sub-study but are not 
subsequently entered in the study because they do not meet the inclusion criteria for participation or 
decide not to participate at anytime  
 
5.5
STRATEGIES FOR RECRUITMENT AND RETENTION 
 
Participants for this sub-study will be recruited within the communities participating in the larger public 
health intervention. Recruitment strategies include marketing with public health messaging in 
collaboration with local health departments, media and targeted social media outreach for awareness 
and education, as well as other strategies that would be tailored to the different distribution scenarios. 
Participants may be compensated up to $50 for completion of all surveys. The sample size is up to 
300,000 for the sub-study. The test kits distributed as part of the larger study will contain information 
about the sub-study and how-to consent using either a mobile device based application (e-consent) 
accessible free of charge to participants or via phone consenting (verbal consent). All participants who 
consent to the sub-study could be re-contacted for future research opportunities. An option to opt-out 
of re-contacting will be provided in the consent. 
 
 
6 
STUDY INTERVENTION 
 
6.1
STUDY INTERVENTION(S) ADMINISTRATION 
 
 
6.1.1
STUDY INTERVENTION DESCRIPTION 
The smartphone app used in this study, MyDataHelps, is an NIH funded app that uses secure file transfer 
protocols and can administer consent forms, surveys, and capture multimedia information. 
6.1.2
DOSING AND ADMINISTRATION 

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Not Applicable 
 
6.2
PREPARATION/HANDLING/STORAGE/ACCOUNTABILITY 
Not Applicable 
6.2.1
ACQUISITION AND ACCOUNTABILITY 
 
Not Applicable 
 
6.2.2
FORMULATION, APPEARANCE, PACKAGING, AND LABELING NOT APPLICABLE 
 
Not Applicable 
 
6.2.3
PRODUCT STORAGE AND STABILITY 
 
Not Applicable 
 
6.3
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
 
This study will be conducted as a non-randomized cohort sub-study design to assess the individual social 
behavior during a community level at-home testing program. Eligible communities receiving will be 
selected per criteria in the public health intervention.  
 
6.4
STUDY INTERVENTION COMPLIANCE 
 
Push notifications will be programmed in the app along with text messaging to promote adherence to 
the at-home testing schedule as well as the survey and questionnaire schedule as part of the public 
health intervention The app also includes a personal tracker of participant test history. Phone call 
reminders will be provided for participants who choose not to use the app. Deviations to the public 
health intervention will not be tracked. 
 
6.5
CONCOMITANT THERAPY 
 
Not applicable 
 
 
6.5.1
RESCUE MEDICINE 
 
Not applicable 
 
 

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7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
 
7.1
DISCONTINUATION OF STUDY INTERVENTION 
 
No study intervention-not applicable 
 
7.2
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Participants are free to withdraw from participation in the study at any time. The reason for participant 
discontinuation or withdrawal from the study will be collected on the app or through phone call via call 
center. Participants who provide consent, and subsequently withdraw, will not be replaced. 
 
7.3
LOST TO FOLLOW-UP 
 
A participant will be considered lost to follow-up if he or she fails to complete the at-home testing and 
scheduled questionnaires/surveys and is unable to be contacted by the call center.  
 
The DCRI call center will attempt to contact the participant and counsel the participant on the 
importance of maintaining the assigned study schedule and ascertain if the participant wishes to and/or 
should continue in the study. Should the participant continue to be unreachable, he or she will be 
considered to have withdrawn from the study with a primary reason of lost to follow-up. 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1
EFFICACY ASSESSMENTS  
 
The questionnaires/surveys will assess patient-report outcomes related to social behaviors, healthcare 
utilization, knowledge of SARS CoV-2 prevention approaches, and the feasibility of at-home self-
administered testing. Adherence to the at-home testing and questionnaire/survey schedule will also be 
assessed.  
 
8.2
SAFETY AND OTHER ASSESSMENTS 
 
The healthcare utilization questionnaire will be routinely administered during the treatment and follow-
up phase, and it will ask about any emergency department visits, hospitalizations, and ICU admission 
related to SARS COV-2 evaluation or treatment.   
 
8.3
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
8.3.1
DEFINITION OF ADVERSE EVENTS (AE) 

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Not applicable 
 
8.3.2
DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
 
Not applicable 
 
8.3.3
CLASSIFICATION OF AN ADVERSE EVENT 
8.3.3.1
SEVERITY OF EVENT 
 
Not applicable 
8.3.4
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
 
Not applicable 
 
8.3.5
ADVERSE EVENT AND SERIOUS ADVERSE EVENT REPORTING  
 
Not applicable 
 
9 
STATISTICAL CONSIDERATIONS  
Additional details of the planned statistical analyses will be provided in a separate statistical analysis 
plan.  
 
9.1
STATISTICAL HYPOTHESES 
 
The proposed analysis is primarily descriptive rather than inferential, as it designed to provide a general 
assessment of participant level behaviors in the context of a community testing intervention. An 
exploratory hypothesize is that positive at-home SARS-CoV-2 antigen test results will lead to altered self-
reported social interactions and altered health behaviors compared to negative test results. 
 
9.2
SAMPLE SIZE DETERMINATION 
 
A formal power calculation is not performed for this observational cohort study. However, a sample size 
in the ranges of 1000 to 10,000 participants would be sufficient to estimate positive test incidence and 
prevalence, describe behavioral changes associated with test results, and conduct multivariable 
modeling to inform understanding of the causal chain between frequent testing and community burden 
of disease. To illustrate this, suppose the proportion of participants who adhere to social distancing is 
50%. In that case, a sample size of 5,000 participants will be sufficient at a confidence level of 95% to 
estimate the prevalence with a margin of error of 1.5%. Additional examples of estimate precision at 
varying sample sizes are provided below. Overall, even with a sample size of 1000 participants and for 
an endpoint with a 50% proportion, there will be a 95% chance that the real value of this proportion is 
within 3.1% of the observed value.  
 

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Sample Size N= 
Point estimate of proportion
Margin of error
10,000 
1% 
0.19%
10,000 
10% 
0.58%
10,000 
50% 
0.96%
10,000 
80% 
0.77%
5000
1% 
0.27%
5000
10% 
0.82%
5000
50% 
1.37%
5000
80% 
1.10%
1000
1% 
0.62%
1000
10% 
1.86%
1000
50% 
3.09%
1000
80% 
2.48%
 
9.3
POPULATIONS FOR ANALYSES 
 
The following populations are also defined: 
 
Population
Description
Evaluable Population- Per 
protocol (PP) 
Per protocol population will be those that report adhering to the 
following: 
1.
Self-administer the at-home test three times a week for 4 
weeks 
2.
Complete questionnaires/surveys during the 4 week testing 
period  
Modified per-protocol 
Will include any participant who performed at least one at-home test 
Second modified per-
protocol  
Will include any participant who completed at least one survey
All analyses will be conducted in the PP. A subset of analyses will be repeated in the modified PP 
populations as applicable.  
 
9.4
STATISTICAL ANALYSES 
 
9.4.1
GENERAL APPROACH 
 
The approach to analysis will be primarily descriptive. Demographics, questionnaire data, and testing 
results will be reviewed and summarized using graphical techniques and summary statistics. Where 
applicable, exact method confidence intervals will be computed around point estimates. Trends over 
time will be evaluated graphically. The proportion of participants adhering to social distancing guidelines 
after a positive vs. negative test result will be compared using tests of proportion clustered by 
participants with various levels of intra-participant correlation. Stratified analyses by test or week 
number will also be performed. We will explore the associations between positive test results and 
critical behavioral measures using mixed modeling techniques to account for the participant and 

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household correlations. Analyses will be conducted using SAS (SAS Institute, Cary NC) and R with R 
Studio (R-project). 
 
9.4.2
ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S) 
 
Point estimates with 95% confidence intervals will be reported.  The analysis will be done for applicable 
study populations as described above, and stratified by participant demographics of interest (e.g., age, 
gender). There will be a comparison of the proportion of participants that report adhering to social 
distancing guidelines after positive vs. negative test result.  
 
9.4.3
ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 
The first secondary objective is to assess change in self-reported behaviors before and 
following SARS CoV-2 at-home test result over the study period. This will be measured via 
Precaution Adoption Process Model Assessments of self-reported data on awareness of the 
issue, engagement, decisions to act, action, and maintenance. The proportion of 
respondents that decide to act on precautionary behaviors after a test result will be 
analyzed for the entire study cohort and stratified by participant demographics of interest 
(e.g., age, gender).  
 
The second secondary objective is to assess the impact of at-home testing regimen on self-
reported healthcare utilization for SARS CoV-2 treatment. This will be measured via self-
reported Emergency Department visits, hospitalizations, and ICU admission for SARS CoV-2 
evaluation or treatment. The proportion of respondents that decide to act on precautionary 
behaviors after a test result will be analyzed for the entire study cohort and stratified by 
participant demographics of interest (e.g., age, gender).  
The third secondary objective is to assess knowledge of SARS CoV-2 prevention approaches 
over the study period. This will be measured via self-reported data on perceptions and 
prevention of risks of contracting SARS CoV-2 infection. The proportion of respondents that 
are knowledgeable of precautionary measures to prevent infection will be analyzed for the 
entire study cohort and stratified by participant demographics of interest (e.g., age, gender). 
 
The fourth secondary objective is to assess prevalence of positive test result for SARS CoV-2. 
This will be measured via self-reported results of self-administered SARS CoV-2 antigen test. 
The prevalence of positive test results will be analyzed with 95% confidence for the entire 
study cohort and stratified by participant demographics of interest (e.g., age, gender). 
 
9.4.4
ANALYSIS OF THE EXPLORATORY ENDPOINTS 
 
The first exploratory objective is to assess the feasibility of at-home self-administered SARS 
CoV-2 antigen tests. This will be measured via self-reported data on acceptability, 
practicality, integration, penetration, and demand of at-home self-administered antigen 
test. The proportion of respondents that find at-home self-administered antigen test 
acceptable will be analyzed for the entire study cohort and stratified by participant 
demographics (e.g., age, gender).  
 

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The second exploratory objective is to assess participant mobility following SARS CoV-2 at-
home test results over the study period. This will be evaluated using surrogate of mobility, 
including activity trackers.  
 
The third exploratory objective is to assess attitudes towards SARS CoV-2 vaccination over 
the study period. This will be measured via Health Belief Model Assessments using self-
reported data on perceived susceptibility, severity, benefits, barriers, and cues to action 
related to SARS CoV-2 vaccination. The d
CoV-2 vaccination will be analyzed for the entire study cohort and stratified by participant 
demographics (e.g., age, gender).  
 
9.4.5
SAFETY ANALYSES 
 
Not Applicable 
 
9.4.6
BASELINE DESCRIPTIVE STATISTICS 
 
Will be reported for demographic and medical history information.  
 
9.4.7
PLANNED INTERIM ANALYSES  
 
Not Applicable 
 
9.4.8
SUB-GROUP ANALYSES 
 
The majority of the primary, secondary, and exploratory endpoints analyses will also be stratified based 
on age, sex, race/ethnicity or other demographic characteristics.  
 
9.4.9
TABULATION OF INDIVIDUAL PARTICIPANT DATA 
 
Individual participant data and listings may be analyzed as needed during the study.  
 
 

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10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
10.1.1 INFORMED CONSENT PROCESS 
 
10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
 
 
Consent forms describing in detail study procedures, and risks are given to the participants via the app 
(eConsent) or read to the participants through the phone (verbal consent). Informed consent is required 
prior to enrollment in this study.  The following consent materials are submitted with this protocol: 
Adult ICF (above age 18), Age of Majority ICF (for those who turn 18 during the course of the study), and 
the Assent (below age 18).  
 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
Consent forms will be Institutional 
Review Board (IRB)-approved. Individuals participating via the app will be asked to read, review and 
electronically give their consent directly on the app. For individuals participating via the phone, the call 
center staff will explain the research study to the participant and answer any questions that may arise. A 
verbal explanation will be provided in terms suited to the 
comprehension of the purposes, 
procedures, and potential risks of the study and of their rights as research participants.  Participants will 
have the opportunity to ask questions prior to giving their verbal consent. Participants must be informed 
that participation is voluntary and that they may withdraw from the study at any time, without 
prejudice. The informed consent process will be conducted and documented, including the date 
consented, before the participant undergoes any study-specific procedures.  
 
 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause.  Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party to study participants, investigator, funding agency, the 
sponsor and regulatory authorities.  If the study is prematurely terminated or suspended, PI will 
promptly inform study participants, the IRB, and sponsor and will provide the reason(s) for the 
termination or suspension.  Study participants will be contacted, as applicable, and be informed of 
changes to study schedule. 
  
Circumstances that may warrant termination or suspension include, but are not limited to: 
Determination of unexpected, significant, or unacceptable risk to participants 
Demonstration of efficacy that would warrant stopping    
Insufficient compliance to protocol requirements 

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Data that are not sufficiently complete and/or evaluable 
Determination that the primary endpoint has been met 
Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the sponsor and IRB.  
 
10.1.3 CONFIDENTIALITY AND PRIVACY  
 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their 
staff, and the sponsor and their interventions. No information concerning the study or the individual 
participant data will be released to any unauthorized third party without prior written approval of the 
sponsor.  
 
securely saved for internal use during the study. At 
the end of the study, all records will continue to be saved securely for as long a period as dictated by the 
reviewing IRB, Institutional policies, or sponsor requirements. 
 
Study participant research data collected via the app or the call center, which is for purposes of 
statistical analysis and scientific reporting, will be securely stored. 
contact or identifying information. Data transmitted to CareEvolution will be de-identified when 
extracted by the study team. Information collected by the CareEvolution app will be securely stored on 
CareEvolution servers in the United States, or on servers owned by third party service providers that 
CareEvolution contracts with to securely store information in the United States. The study data entry 
and study management systems will be secured and password protected. At the end of the study, all 
study data from the app will be de-identified and archived.  
 
 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
 
Data generated from this study will be analyzed in this study.  In addition, the NIH Data Sharing Policy 
applies to this study, and de-identified data from this study will be made available to other researchers. 
 
No data will be shared with the test manufacturer and the data generated in this study will not be used 
to support any regulatory claims. 
 
All participants in the sub-study will have the option to consent to re-contacting for future research. An 
option to opt-out of re-contacting will also be provided in the consent.  
 
 
 

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10.1.5 KEY ROLES AND STUDY GOVERNANCE 
 
Principal Investigator 
Co-Investigator
Co-Investigator 
Christoph Hornik, MD, PhD, MPH 
Giselle Corbie-Smith, MD, MSc
Gaurav Dave, MD, DrPH, MPH 
Duke Clinical Research Institute  
University of North Carolina 
University of North Carolina 
300 W. Morgan Street 
Durham, NC  27701 
333 South Columbia Street 
Chapel Hill NC 27599-7240 
160 N Medical Rd, Chapel Hill, 
NC 27599. 
919-668-8935 
919-962-1136 
919-843-9632
christoph.hornik@duke.edu 
gcorbie@med.unc.edu
gjdave@unc.edu
 
10.1.6 SAFETY OVERSIGHT 
 
Since there are no medications or interventions being prescribed as part of the study, and due to the 
minimal risk of the survey data only the study will not have a Data and Safety Monitoring Board (DSMB). 
Instead, the DCRI PI will serve as the medical monitor. 
 
10.1.7 CLINICAL MONITORING 
 
As a direct-to-
 
formal monitoring of the study. Study personnel will still ensure that the rights and well-being of study 
participants are protected, that the reported study data are accurate, complete, and verifiable, and that 
the conduct of the study is in compliance with the currently approved protocol, International 
Conference on Harmonisation Good Clinical Practice (ICH GCP), and with applicable regulatory 
requirement(s).  
 
 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
 
The DCRI will perform internal quality management of study conduct, data collection, documentation 
and completion.   
 
Quality control (QC) procedures will be implemented beginning with the data entry system and data QC 
checks that will be run on the database. The study team will be responsible for monitoring data 
collected via the mobile application to ensure that the reported study data are accurate, and complete, 
reported in compliance with the protocol, International Conference on Harmonisation Good Clinical 
Practice (ICH GCP), and applicable regulatory requirements (e.g., Good Laboratory Practices (GLP), Good 
Manufacturing Practices (GMP)).  
 
The study team will provide access to all study related source data/documents, and reports for the 
purpose of monitoring and auditing by the sponsor, and inspection by local and regulatory authorities. 
 
 

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10.1.9 DATA HANDLING AND RECORD KEEPING  
 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
 
Using PhenX and RADx-Up CDE measures, the questionnaires/surveys will collect data on demographic 
characteristics, medical history and health status, SARS-CoV-2 testing and symptoms, social interactions, 
knowledge of prevention strategies, and infection risk, and attitudes towards vaccines. All data capture 
will be electronic for participants who choose to participate using the MyDataHelps app. The app 
platform will be the technology that underpins data collection and management. The mobile application 
functions as a communication platform between the participants, investigators, and the study team. It 
supports daily reminders, seamless data collection, surveys/questionnaires, and data exchange between 
participants and the study team. In addition to its function as a communication platform, it is also a 
source documentation platform that is used to record, document, and store all information collected by 
the study team. All source data entered into the application has an audit trail, which documents who 
completes data entry and when, with all data legibly recorded. Study team members entering source 
data into the application do so in real time as they are collecting the data. For those participating via the 
phone calls, the data provided by the participant will be documented into the app by the call center 
member.  
 
10.1.9.2 STUDY RECORDS RETENTION  
 
Study documents should be retained for a minimum of 2 years after the last approval of a marketing 
application in an International Conference on Harmonization (ICH) region and until there are no pending 
or contemplated marketing applications in an ICH region or until at least 2 years have elapsed since the 
formal discontinuation of clinical development of the study intervention. These documents should be 
retained for a longer period, however, if required by local regulations. No records will be destroyed 
without the written consent of the sponsor, if applicable. It is the responsibility of the sponsor to inform 
the investigator when these documents no longer need to be retained. 
 
 
10.1.10
PROTOCOL DEVIATIONS  
 
Protocol deviations will not be collected or tracked for this observational study. 
 
10.1.11
PUBLICATION AND DATA SHARING POLICY 
 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
 

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This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 
such, this study will be registered at ClinicalTrials.gov, and results information from this study will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-
reviewed journals.  Data from this study may be requested from other researchers 10 years after the 
completion of the primary endpoint by contacting Dr. Christoph Hornik or Dr. Gaurav Dave.   
 
 
10.1.12
CONFLICT OF INTEREST POLICY 
 
The independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical.  Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this study will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a 
way that is appropriate to their participation in the design and conduct of this study.  The study 
leadership in conjunction with the NIH Institute has established policies and procedures for all study 
group members to disclose all conflicts of interest and will establish a mechanism for the management 
of all reported dualities of interest. 
 
10.2 ABBREVIATIONS 
 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
DCC 
Data Coordinating Center 
eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
HIPAA 
Health Insurance Portability and Accountability Act  
ICH 
International Conference on Harmonisation  
ICMJE 
International Committee of Medical Journal Editors 
IRB 
Institutional Review Board 
MedDRA 
Medical Dictionary for Regulatory Activities 
SOE 
Nares swab  
NIH  
National Institutes of Health 
NIH IC 
NIH Institute or Center 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
RADX-UP
Rapid Acceleration for Diagnostics in Underserved Populations
SAE 
Serious Adverse Event 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
US 
United States 
 
 
 

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10.3 PROTOCOL AMENDMENT HISTORY 
The table below is intended to capture changes of IRB-approved versions of the protocol, including a 
description of the change and rationale. A Summary of Changes table for the current amendment is 
located in the Protocol Title Page.  
 
Version
Date 
Description of Change
Brief Rationale 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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11 REFERENCES  
 
 
1. 
Toptan T, Eckermann L, Pfeiffer AE, et al. Evaluation of a SARS-CoV-2 rapid antigen test: 
Potential to help reduce community spread? J Clin Virol. 2020;135:104713. 
2. 
Bosetti P, Kiem CT, Yazdanpanah Y, et al. Impact of mass testing during an epidemic rebound of 
SARS-CoV-2: a modelling study using the example of France. Euro Surveill. 2021;26(1). 
3. 
CareEvolution L CareEvolution, LLC. https://careevolution.com/. Accessed January 17, 2021.