Project PEACH2: Promoting Engagement and COVID-19 Testing for Health
Phase: NA
Conditions: COVID-19
Sponsor: Emory University

Study Protocol 
 
 
 Project PEACH2 (Promoting Engagement and COVID-19 Testing for 
Health) 
 
 
Protocol Date: April 26, 2024 
 
 
NCT06141850 

Protocol Title: Promoting Engagement and COVID-19 Testing for Health
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PROTOCOL TITLE:   Project PEACH2 (Promoting Engagement and COVID-19 Testing for Health) 
EXTERNAL (NON-EMORY) COLLABORATORS                                                                   
Rakale Quarells, Morehouse School of Medicine, Department of Community Health and 
Preventative Medicine 
Michael L. Best, Georgia Institute of Technology, School of Interactive Computing 
PRINCIPAL INVESTIGATOR:
Mary Beth Weber, PhD, MPH
Hubert Department of Global Health
Phone:  
Email: 
VERSION: 1.0
FUNDING SOURCE:  NIDDK

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REVISION HISTORY
Revision #
Version 
Date
Summary of Changes
V1.1
8/14/2023
Information about Data Transfer Agreement with DCRI 
included. Data Transfer agreement is pending. 
V1.1
8/14/2023
Page 1: Clarifies that external collaborators’ (MSM & GIT) 
respective IRBs will be also review the study. 
V1.1
8/14/2023
Section 12; Page 10: Vulnerable Populations. A statement 
including pregnant women in the study has been added.
V1.1
8/14/2023
Section 14; Page 11:  Information about recruitment 
materials and eligibility screening has been added to 
Section 14. 
V1.1
8/14/2023
Section 18; Page 12: Compensation to Participants has 
been clarified. 
V1.1
8/14/2023
Section 19; page 14:  Reviewed participantId and left it as-
is as it refers to a unique participant identifier that will be 
created in the nudge database and is defined in the 
description.  “phoneNumber”and “firstName” have been 
updated to “phone number” and “first name” for 
readability. 
V1.1
8/14/2023
Section 23; Page 15: Informed Consent: Section clarified to 
read that potential participants may opt to be contacted 
about participating in an interview and/or to contribute 
their social media data. 
V1.1
8/14/2023
Section 24; Page 15: Non-English-speaking participants: 
Clarified to include why non-English speaking participants 
will not be included. 
V1.1
8/14/2023
Section 24; Page 16: Waiver of documentation of consent 
required. 
V1.1
8/14/2023
Section 26: Multi-site description
V1.2 
10/3/2023
Modification of eligibility screening process to take place 
before informed consent. 

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V1.3
10/11/2023
Removed Institution “institution’s IRB will review” for 
MSM and GT Partners
V1.3
10/11/2023
Updated Section 26 to clarify partner/site activities.
V1.3
10/11/2023
Updated sections 6, 18, 19, 20 to clarify social media study 
participant engagement, data upload, analysis and 
anonymization processes, storage and protections. 
V1.4
1/19/2023
Section 14, Recruitment Methods has been updated to 
describe new screening of potential participants to limit 
fraudulent enrollment. 
V1.5
3/25/2024
Section 26 has been updated to clarify that Grady Health 
System / Grady Diabetes Clinic is a location for study 
promotion via flyers and palm cards.
V1.5
3/25/2024
Section 14, #3 has been updated to include addition of a 
text message check (receive and respond) during the 
eligibility interview to ensure a valid text message.
V1.6
4/26/2024
Section 14, Recruitment, has been updated to include the 
use of lists of participants from other RADxUP studies who 
agreed to be contacted about other studies they might be 
interested in. 

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Table of Contents
1.
Study Summary .......................................................................................................................4
2.
Objectives................................................................................................................................5
3.
Background .............................................................................................................................5
4.
Study Endpoints ......................................................................................................................6
5.
Study Intervention/Design ......................................................................................................7
6.
Procedures Involved................................................................................................................9
7.
Data Specimen Banking.........................................................................................................10
8.
Sharing of Results with Participants......................................................................................10
9.
Study Timelines .....................................................................................................................10
10. Inclusion and Exclusion Criteria.............................................................................................10
11. Population.............................................................................................................................10
12. Vulnerable Populations.........................................................................................................10
13. Local Number of Participants................................................................................................10
14. Recruitment Methods ...........................................................................................................11
15. Risk to Participants................................................................................................................11
16. Potential Benefits to Participants..........................................................................................12
17. Compensation to Participants...............................................................................................12
18. Data Analysis, Management and Confidentiality ..................................................................12
19. Provisions to Monitor the Data to Ensure the Safety of Participants ...................................14
20. Provisions to Protect the Privacy Interest of Participants.....................................................14
21. Economic Burden to Participants..........................................................................................15
22. Informed Consent .................................................................................................................15
23. HIPAA ....................................................................................................................................16
24. Setting ...................................................................................................................................16
25. Resources Available...............................................................................................................17
26. Multi-Site Research When Emory is the Lead Site ................................................................18
27. References.............................................................................................................................19
28. Protocol Checklist..................................................................................................................20

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1. Study Summary
Study Title
PEACH 2: Promoting Engagement and COVID-19 
Testing for Health
Study Design
A mixed methods community-based, adaptive 
intervention trial with quantitative and qualitative 
evaluation components.
Primary Objective
Understand the feasibility, acceptability and 
sustainability of COVID-19 home testing for high-risk 
individuals affected by or at risk for diabetes and their 
household contacts.
Secondary Objective(s)
Test the applicability of a text-based COVID-19 test 
result reporting system and targeted behavioral 
nudges for disease prevention in a pandemic situation
Research 
Intervention(s)/Interactions
Qualitative in-depth interviews; survey 
questionnaires; text-based test result submission; 
testing of behavioral nudges via text messages; 
modeling of news and social media posts
Study Population
Underserved populations in urban and rural Georgia 
affected by or at-risk for diabetes 
Sample Size
 N=600
Study Duration for 
individual participants
12 months
Study Specific 
Abbreviations/ Definitions 
Application Programming Interface (API) 
Database (DB)
Emory Global Diabetes Research Center (EGDRC)
Emory University (EU)
Federally Qualified Health Center (FQHC)
Georgia Center for Diabetes Translation Research 
(GCDTR)
Georgia Institute of Technology (GT)
Morehouse School of Medicine (MSM)
Prevention Research Center (PRC)
Promoting Engagement and COVID-19 Testing for 
Health (PEACH)
Protected Health Information (PHI)

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Rollins School of Public Health (RSPH)
Funding Source (if any)
NIDDK
2. Objectives
The objectives and specific aims are: 
Objective 1: Understand the feasibility, acceptability, and sustainability of at-home testing as 
well as the perceived advantages and disadvantages of home-based testing compared to clinic-
based testing among the high-risk population of individuals affected by or at risk for diabetes.
Objective 2: Test the application of behavioral nudges to change behaviors around disease 
prevention in a pandemic situation. The study team will design and evaluate in a community-
based, adaptive intervention study among individuals affected by diabetes (with diabetes, at 
risk for diabetes, or caring for someone with diabetes), a home-based COVID-19 testing 
program with behavioral nudges delivered via mobile phone texts to increase uptake of COVID-
19 testing and prevention behaviors (vaccination, social distancing, masking, etc.) 
Aim 1: Using mixed methods (continued analysis of the Project PEACH study population, 
qualitative interviews, modeling of news and social media posts, social media data analytics), 
we will describe the current climate around home testing for COVID-19 including current usage, 
views, interest, acceptability, and barriers and facilitators to adoption.
Aim 2a: Evaluate uptake, usage, and views of a home testing nudge platform (encouraging 
home testing, protective health behaviors, and targeted behavioral nudges delivered via text 
messages) in a community-based, adaptive intervention trial (N=600) targeting individuals 
affected by diabetes through collaborations with community partner sites (faith- and 
community-based organizations, Grady Diabetes Clinic, and COVID-19 community testing and 
vaccine distribution sites).
Aim 2b: Evaluate changes in vaccine uptake and hesitancy among study participants and family 
members after implementation of the home-based testing nudge platform. 
3. Background
This study leverages data collected during Project PEACH 1 (Promoting Engagement and COVID-
19 Testing for Health), a RADx-UP funded study to understand barriers to effective and 
equitable COVID-19 testing in high-risk and minority populations in Georgia that are affected by 
diabetes. PEACH 1 applied mixed-methods (quantitative, qualitative, geographic and spatial 
analysis) to gather evidence to describe COVID-19 epidemiology, locate regions and populations 
with low testing and vaccine uptake, and targeting key informant interviewing and monitoring 
social and news media, to identify barriers, motivators, and perceptions around COVID-19 as 
well as related behaviors among different populations and regions.  

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Analysis of Project PEACH (PEACH 1) data collected from key informants and community 
partners indicated gaps in capacity for and commitment to community testing when vaccines 
became available, and sites were pivoting to prioritize vaccinations even as they continued to 
provide COVID-19 testing. However, COVID-19 testing can be a key tool to address the 
pandemic, particularly in areas with low vaccination rates1 and high diabetes rates2-4 such as 
Georgia. People with diabetes, prediabetes, and obesity have elevated risk for COVID-19 
infection and are 3.5 times, 2.6 times, and 3 times more likely to suffer in-hospital 
complications, respectively.5-7 Further, Diabetes is 2.4 times more common in 
socioeconomically vulnerable and minority populations. Throughout the pandemic, counties 
with predominantly Black communities had a 6-fold COVID-19 death rate compared to those 
that are predominantly White.8  For these reasons, finding sustainable, easy to disseminate, 
and acceptable ways to increase and sustain COVID-19 testing is needed. Further, 
understanding the relationship between attitudes toward testing in situations of continued 
vaccine hesitancy and resistance and developing insights in how to address them in a dynamic 
pandemic situation will be fundamental to future pandemic response. 
Home-based testing may help people overcome barriers to testing (identifying where to get 
tested, scheduling and attending appointments, stigma).9 However, in order for it to be 
successful we need to understand the feasibility, acceptability, and sustainability of at-home 
testing as well as the perceived advantages and disadvantages of home-based testing 
compared to clinic-based testing among the high-risk population of individuals affected by or at 
risk for diabetes. This information can be used to create targeted behavioral “nudges”.10 
Nudges are indirect suggestions and positive reinforcements designed to encourage certain 
choices. They may be a useful means of promoting acceptability and usage of home-based 
testing as well as increasing an understanding of and acceptability of other key preventive 
behaviors like COVID-19 vaccination. These targeted messages, sent via text messages, would 
be designed based on findings from PEACH 1 and the Georgia CEAL Study (1OT2HL156812-
01/16-312-0217571-66105L). Behavioral nudges have been shown to have a noticeable effect 
on health behaviors and study recruitment,11,12 however, research testing the application of 
behavioral nudges relating to behavior change around disease prevention in a pandemic 
situation is needed.  
4. Study Endpoints
Aim 1 Endpoint: Development of a suite of behavioral nudges text message designed to inform 
(Knowledge) and encourage (Persuade) study participants to perform COVID-19 testing at home 
or at other locations (primary behavior change focus) and other COVID-19 prevention activities 
(masking when needed, vaccination/boosters, etc.). Persuasive messaging will address 
perceived characteristics of COVID-19 testing and home-based testing (relative advantage, 
compatibility, complexity, trialability, observability) and be adapted to subgroups such as 
vaccination status and demographic data provided in the baseline survey.

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Aim 2a Endpoint: Evaluation of uptake, usage, and perception of a community-based, adaptive 
intervention trial targeting individuals affected by diabetes through collaborations with 
community partner sites. The intervention entails reporting of COVID-19 testing via a text-
based reporting system and targeted behavioral nudges delivered via text messages.
Aim 2b: Evaluation of changes in vaccine uptake and hesitancy among study participants and 
family members post-implementation of the home-based testing platform as well as 
acceptability of nudges to affect behavior change.  
5. Study Intervention/Design 
PEACH 2 is a community-based, mixed methods, randomized, adaptive intervention trial, 
targeting individuals affected by diabetes.  Study participants will be randomized into the 
PEACH2 Intervention Arm or the Control Arm (See Figure 1 below). Participants may also opt to 
participate in an in-depth interview at the end of the intervention and/or to contribute social 
media data (see descriptions below).
All participants will be asked to complete surveys at baseline and again post intervention at 
Months 4 and end of follow-up at month 12. T The intervention period will last 16 weeks.  
Baseline surveys will capture demographic data, history of COVID-19, diabetes and diabetes risk 
factors, views about COVID-19 risk factors and preventive behaviors, and experiences with 
COVID-19 testing; follow-up surveys at 4 and 12 months will collect information on intervention 
acceptability, COVID-19 testing, prevention, and vaccine behaviors and views from all 
participants.  
PEACH 2 Intervention Participants:  Intervention arm and control arm participants will be sent 
weekly text messages throughout the intervention period. Control arm participants will receive 
messages with general diabetes prevention/management information including messages on 
COVID-19 prevention, but these messages will not be tailored to the participant.
Intervention arm participants will receive weekly text messages with behavioral nudges 
targeted to their demographic and vaccination group targeting COVID-19 prevention behaviors. 
Results of qualitative interviews, social media reporting, and feedback from community 
partners from Project PEACH will be analyzed and used to draft group specific nudges for 
testing and other prevention behaviors. In weeks 4, 8, and 12, participants will be sent a series 
of text messages to determine if:
1. They had any COVID-19 symptoms in the past 4 weeks; and, if so:
2. They did a COVID test.
Following the adaptive intervention design (Figure 1), at weeks 4, 8 and 12 participants who 
report COVID-19 symptoms but no COVID-19 testing will receive targeted behavioral nudges via 
mobile phone text message that will encourage adherence to COVID-19 testing 
recommendations.  Behavioral nudges targeting other COVID-19 preventive behaviors such as 

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staying home when sick, wearing a mask, etc. will be sent to all PEACH2 Intervention 
participants in weeks 1-3, 5-7 and 9-11. 
In-depth Interviews
From among all study participants, a sub-sample of 30 information-rich participants (10 control, 
20 intervention) will be invited to participate in in-depth interviews to understand participant 
perceptions of the intervention and text messages as well as topics important for future testing 
or dissemination efforts (e.g., suggestions for other ways to deliver these health messages). 
Social Media Analytics
As a stream of data analysis to inform the nudge intervention, the Georgia Tech team plans to 
conduct social media analytics. We will use two forms of social media data: data collected from 
publicly accessible posts and data collected from participants. This data will be stored on the 
Georgia Tech server (described below in Section 18).
Publicly Accessible Social Media Data
We will be downloading publicly accessible posts from X (formerly Twitter), Facebook, and 
Instagram using the respective platforms’ APIs. Publicly accessible posts containing COVID 
testing-related keywords, along with the posts’ publicly accessible metadata including 
timestamp and engagement metrics, will be downloaded for a curated set of accounts on each 
platform. These accounts, in addition to having technically publicly accessible content, are also 
generally “public” facing accounts, such as those of government agencies, community-based 
organizations, media and other companies, prominent influencers, and public online groups. 
Data will be downloaded prior to the intervention, dating back to May 2021 to match the 

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beginning of survey data being used to inform this study; data collection will be continued 
throughout the period of the intervention. Analyses will include natural language processing 
techniques such as topic modeling and sentiment analysis and analyzing trends in engagement 
data. Reporting will involve sharing aggregate statistics, as well as example individual posts.
Participant Social Media Data Contribution
Participants will have the option to contribute additionally to the study by sharing their own 
social media data with the study. We will focus on the following data from participants’ 
Facebook, Instagram, and X (Twitter) accounts: the accounts, pages, and groups they follow; 
other accounts’ content that they have engaged with; and their own posted content related to 
COVID-19 and health. Social media data collected from participants will be used to inform our 
collection and analysis of publicly available social media data (described above) as well as 
additional analysis of participants’ social media engagement and posted content. This will allow 
us to better curate our data collection to include accounts followed and engaged with by our 
participants as well as analyze what kinds of social media accounts and content different 
demographics of participants follow and engage with. For participant social media content (i.e., 
their own posts on social media), we will use state-of-the-art natural language processing 
techniques, such as sentiment analysis and word embeddings, and other metadata like post 
length to reduce such data to key pieces of metadata for analysis.
6. Procedures Involved
Study participants in PEACH 2 will be asked to complete baseline surveys as well as follow-up 
surveys at completion of the intervention period (Month 4) and again at Month 12, about their 
experiences and perceptions of COVID-19 testing and vaccination. Survey data will be captured 
using REDCap.  Selected participants that agree to be contacted on their informed consent form 
may also be invited to participate in semi-structured interviews. These will be conducted over a 
secure Zoom account. Semi-structured in-depth interviews will explore acceptability and 
experiences with the text messaging program. 
Participants will also be asked if they are willing to contribute data from their social media posts 
(detailed methods below). Those that are willing will receive an automated link from REDCap 
with additional information about participation in the social media part of the study as well as 
an informed consent form specific to that part of the study. Participants will be given the option 
to share or not share data from the different platforms they use; their consent for this social 
media data collection will have no implications for their participation in the rest of the study.
Participant social media data contribution
Data we collect about study participants’ social media accounts and activity will be 
retrospective and limited. Data would be collected at two time points: once towards the start of 
the intervention period and once after the end. 
Social media data to be collected includes:
1. Other accounts that they follow:

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o
Facebook: “Pages” and “Groups” which the participant follows. (This does NOT 
include the participant’s Facebook “Friends.”)
o
Instagram: Accounts which the participant follows.
o
X (Twitter): Accounts which the participant follows.
2. Their engagement with content from other accounts:
o
Facebook: “Reactions” to others’ posts (including “likes”), comments by the 
participant’s account on others’ posts
o
Instagram: “Likes” of others’ posts and stories, comments by the participant’s 
account on others’ posts
o
X (Twitter): “Likes” of others’ tweets
3. Content that they themselves posted related to COVID-19 and health:
o
Facebook: Posts
o
Instagram: Posts and stories (text captions only)
o
X (Twitter): Tweets and retweets
o
These will be filtered to content that contains any COVID-19 and health related 
keywords:
o
COVID-related keywords: covid, coronavirus, corona, rona, omicron, vaccine, 
vacunas, vax, vaccinated, vxxed, unvxxed, pandemic, pandemia, masks, n95, 
quarantine, booster, pcr, antigen, binax, binaxnow.
o
Health-related keywords: We will use the “body” and “health” category 
keywords in LIWC (Linguistic Inquiry and Word Count) 2015, a labeled set of 
words which is popularly used for textual analysis. These two categories 
contain a total of 509 words.
To remove possible personally identifying information in any of the above social media data 
that includes text content, such as posts and comments, we will use a named entity recognition 
algorithm to remove and auto-delete mentions of any usernames (which appears as 
“@username”), and mentions of people’s names.
The following data will be removed, auto-deleted and will NOT be stored or analyzed for this 
study: social media account username, multimedia (photos, videos) from participants’ own 
social media content, device identifiers, geotag of posts, login and logout or any other platform 
access and time use metadata, and private messages (i.e., Facebook/Instagram Messenger or X 
(formerly Twitter) direct messages).
7. Data Specimen Banking
No specimens will be banked. 
8. Sharing of Results with Participants

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Results of the nudging trial will be shared with collaborating partners through in-person 
meetings, feedback sessions and presentations, and with participants through an end-of-study 
newsletter.
9. Study Timelines
The duration of time an individual will be asked to participate in the study will be approximately 
12 months, from completion of baseline survey through enrollment and randomization, 
participation in the nudge intervention trial and follow-up surveys and interviews. 
10. Inclusion and Exclusion Criteria
Inclusion criteria: English speaking adults, at or over the age of 18, living in Georgia, with access 
to a cellphone, not currently pregnant, and at-risk for diabetes, have diabetes, or are a family 
caregiver of someone living with diabetes. Participants must agree to receive text messages and 
be randomized to the intervention or control arm of the study.
Exclusion Criteria: Individuals that do not meet the inclusion criteria or are unwilling to receive 
text messages or be randomized will not be eligible. 
11. Population
The study population for Project PEACH2 will be recruited in both urban and rural areas of 
Georgia to capture inherent diversity in geographic and population characteristic backgrounds 
which may affect differences in response to COVID-19 risk, attitude, barriers, and testing 
strategies in the area. 
12. Vulnerable Populations
Participants must be able to use a cellphone to receive nudge messages. Therefore, prisoners, 
adults unable to consent, and children under the age of 18 will not be included in the study. 
Pregnant women with or at risk for diabetes need different and specific advice and therefore 
would require specific health messaging that is targeted to pregnant women, and is out of the 
scope of this study.  Pregnant women will not be included. 
13. Local Number of Participants
Six hundred (n=600) participants will be recruited to participate in the study, and randomly 
assigned to participate in the intervention and control groups. Randomization will be done 
using a random allocation table created in SAS. Study participants that indicate they would be 
willing to participate in an interview will comprise the qualitative interview sampling frame. 
From total study sample, up to thirty in-depth interviews will be conducted with information 
rich individuals from the Control (N=10) and PEACH2 Intervention (N=30) arms. Interview 
participants will be purposively selected based on data collected in the baseline survey. 
Demographics, vaccination status, prior experience with COVID-19 and testing, and testing 
reporting will be considered when compiling the contact list for interview. 

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The sample size of 600 was estimated using the following assumptions: (a) 80% power; (b) 
Alpha of 0.05; and (c) the percentage of participants receiving a COVID-19 test in the past 
month in the control arm would be equal to the percentage of the Georgia population getting a 
PCR test for COVID-19 in the month of June: 3.44 (standard deviation [SD] 0.49). Using these 
assumptions, a sample size of 520 (260 per study arm) will be powered to see a 4.5% increase in 
the percentage of individuals receiving COVID-19 test in the intervention arm compared to 
controls. We plan to randomize 600 individuals to allow for attrition.
Social media analysis enrollment
Given the complexity of the data download and upload process for participants to complete, we 
anticipate a significant amount of attrition. Thus, we will conduct individual phone call follow-
ups with a selected subset of participants who had consented to being contacted about sharing 
their social media data for the study, but have not at that time completed the social media data 
contribution process. As we are conducting this data collection as a proof-of-concept, 
participants chosen for individual follow-up would be sampled (out of those who indicated use 
of a social media platform of interest) to cover different demographic groups and other 
characteristics that are represented by the broader participant pool, and from both the control 
and intervention arms. We aim to conduct individual follow-up with up to 50 participants.
14. Recruitment Methods
Emory, MSM and GT will leverage their existing relationships with community organizations and 
partners. Specific partner organizations include faith-based organizations (Big Miller Grove 
Baptist Church, Elizabeth Baptist Church), a community-based organization (Rx MTM), and a 
diabetes clinic (Grady Diabetes Center), and other Emory RADxUP studies. These partners have 
experience conducting COVID-19 testing activities and/or will be of assistance in recruitment.  
Informational materials such as palm cards, flyers and posters with eligibility information and a 
QR code that links to the study website will be disseminated through study partners.  
Participants will be recruited at in-person events, and via the Project PEACH studies website 
(www.projectpeach.org).  
Due to several attempts of fraud when data collection began, the study team has added layers 
of authentication screening that intend to help to identify fraudulent attempts by incentive 
miners utilizing bots and AI. These include hidden questions in REDCap that capture timestamps 
and location, and qualitative questions that are visible to bots but hidden from a person. These 
include:
1. Completion of a short consent to be contacted form that asks for first and last name, 
cellphone number and email address in REDCap.  
a. This form will capture the timestamps of the machine that opens the survey and 
the Emory server for comparison, as well as the latitude and longitude, if 
allowed. 

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b. The potential participant’s information will be searched in the Project PEACH 
database to identify any overlap in participants or reuse of information.
c.
The participants information will be searched for online. Any information 
pertaining to someone with the same name or phone number, will be noted and 
used to compare to what the individual says to the interviewer.
2. Those determined most likely to be genuine potential participants and eligible to 
participate will be emailed a link to complete the eligibility screener. 
3. An eligibility interview over Zoom will be scheduled with participants that complete the 
form.  The team member will review key points of the study (timeframe; what is 
involved), informed consent, discuss what is involved, and ask questions relating to the 
information found on their identity. This will be used to help determine if the individual 
is eligible to participate prior to officially initiating the study.  The individual will also be 
asked to verbally provide a cell-phone number, we will text them and ask them to 
respond.  This will be done to ensure that a) we have a valid cellphone number for 
them, and 2) the number we have is correct. 
4. If determined to be eligible, the individual will be emailed a link to complete the 
informed consent in REDCap; if they agree to participate, they will receive the link to 
take the baseline survey and officially enroll in the study.
Data on those deemed not eligible will be captured and used in the authenticity screening (Step 
1.b above) of future participants. 
Participants may request to be contacted by a study team member who can conduct the 
informed consent, answer any additional questions and ensure that the potential participant is 
both eligible and understands what the study entails. 
For each part of the study (text message nudge study/surveys; social media, in-depth 
interview), all potential participants that would like to join the study and participate will be 
asked to indicate their agreement to participate in the study by entering their name and 
contact information at the bottom of the informed consent survey form. They will be advised 
that checking “yes” to statements about being contacted by a study team member for 
information about the survey, and that they agree to participate indicates that they choose to 
participate.  
We will also contact individuals that self-report being at risk for diabetes and have participated 
in other RADxUP studies, and agreed in their informed consent form to be contacted about 
other studies they might be interested in. Study team members will contact them via email or 
text message according to their indicated preference advising them about the study and 
directing them to the website for more information and to complete the contact form if they 
are interested. 

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Withdrawal of Participants
A participant may withdraw at any time by contacting the study team at the phone number or 
email address provided on the consent form. Any data collected up to the point of withdrawal 
will be retained and the individual will not be contacted again unless they agreed on the 
original consent form to be contacted about future research opportunities. 
15. Risk to Participants
Risks to participants include the possibility someone could gain access to study participant 
survey, social media and/or interview data.  Survey and interview data will be carefully 
controlled and maintained on a secure HIPAA compliant, EU OneDrive account or RSPH IT 
server folder.  Limited participant data to be used for the text message nudges and participant 
social media data will be housed on the Georgia Tech server. Only team members designated 
by the study or site PI, that have completed the necessary ethics trainings (CITI certification), 
and are included on the EU and/or partner IRB will be given access to the survey data. Survey 
data and informed consent will be collected from participants and stored using REDCap.  
Qualitative data: Similar to survey data, qualitative interview data will be carefully controlled 
and maintained on a secure, HIPAA compliant, One Drive account and as above, only study 
team members designated by the PI and involved in data collection, management or analysis 
will have access to the folders. Interviews will be conducted and recorded using a secure EU 
Zoom account.  
Text messages: Participants will be advised that there is a risk that someone that has access to 
their phone might learn of their participation via SMS messages to their device. Participants will 
be asked to help protect their data and ensure the integrity of the data by not sharing the text 
messages we send them with others and not allowing others to view the messages. 
Social media data sharing: Risks to participants include the possibility someone could gain 
access to participant social media data, which may include identifying information or private 
content. To mitigate these risks, as described (in Section 18), we are collecting and keeping 
participant social media data in a secure environment, and conducting further social media data 
sub-selection and anonymization to minimize the potential sensitivity of the data we go on to 
analyze. Furthermore, by having the participants download their social media account data 
themselves from the social media platforms before sharing it with us, we hope the data sharing 
process and content of the data shared will be more transparent to participants.
16. Potential Benefits to Participants
While there is no direct benefit to subjects who participate in the study, information gained 
from their participation in the study may be used to develop resources that could support them 
in the event of a future pandemic. Further, data shared with the community partners might be 
used to improve COVID-19 education and testing at their respective sites. 
17. Compensation to Participants

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Study participants will receive e-gift cards via email for their time and participation. Survey 
participants will receive $25 after they complete the baseline survey, $35 after they complete  
the 4-month survey, and $40 after they complete  the 12-month survey. Those that participate 
in an interview will receive a $25 gift card for their participation after the interview. Participants 
contributing their data to the social media component will receive a $40 gift card after the 
upload has been completed. 
18. Data Analysis, Management and Confidentiality
Informed consent and survey data will be collected using and stored in REDCap.  REDCap will 
assign a unique project ID number to participants when they complete informed consent. In-
depth interview and survey questionnaire data will be collected from participants. In-depth 
interview data collection will be conducted in-person, over Zoom or phone (according to the 
participant’s preferences) and stored on EU’s OneDrive. Any personally identifiable information 
will be removed from data sets and interview transcripts prior to sharing with the study team 
for analysis. To enable follow-up, a file linking the name and project ID of participants will be 
available only to the project PI, study team members involved in data collection and 
management, and key co-investigators. To ensure data quality and participant eligibility, a 
respondent authentication protocol will be implemented for individuals not taking the survey 
with a study team member present. Only team members designated by the study PI, that have 
completed the necessary ethics trainings (CITI certification), and are included on the EU and/or 
partner IRB will be given access to the survey data.
Nudge Dashboard and Nudge Platform development
Figure 2. Security and data design for technical applications supporting the project

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Participant survey data storage and handling
Georgia Tech is developing several technical applications for sending nudge messages, and will 
house limited participant data (described below) and de-identified, participant social media 
data in a Limited Study Database. This database will be maintained separately from the Nudge 
Database and the social media collection and analytics platform. The Georgia Tech Team is 
developing the Nudge Dashboard. The dashboard will be available for users among the study 
team to select nudges to send to study participants and also view (aggregated) analysis results. 
This Nudge Dashboard will then send these participant-nudge message assignments to the 
Nudge Platform via the Nudge Control API, which will handle sending these as SMS messages to 
the participants (See Figure 2 above).
Participant survey data will be exported by a member of the study team with access to REDCap 
and uploaded via HTTPS via 2-Factor VPN to one of two databases which support the 
Dashboard and the Nudge Platform. This export will include a “participantId”, which is a pseudo 
ID unique to this study and has no relationship to other participant identifiers. 
The Limited Study Database (DB) will be maintained separately from both the social media data 
collection and analytics platform, and from the Nudge Database (DB) to minimize risks and 
control access. The Limited Study DB used by the Dashboard will contain the participantId, age 
in years, race, ethnicity, gender, testing history, vaccine status, diabetes status, study 
enrollment status and history; if provided, participant social media account and activity data 
will be maintained in the Limited Study Database following collection and anonymization. The 
Nudge DB will contain the participantId, cell phone number, first name, nudge response, nudge 
status, and an optional REDCap survey link. 
The Nudge Platform will only be accessible via the Dashboard. The Dashboard will implement 
role-based access controls to limit who is able to send nudge messages to approved study staff. 
Operators of the Dashboard will have access to nudge responses and the status of a nudge 
message, but no operator will have direct access to the participant phone numbers, first name, 
or personalized survey link (if used). Nudges will be delivered to users via the Twilio SMS text 
messaging platform using secure communications. Nudge responses will be delivered via secure 
callbacks to the Nudge Platform via Twilio. 
Should the study include social media data collection from participants, this will be collected via 
a secure website using a non-reversible encrypted user key which can only be mapped to the 
participantId (or other information) in the Limited Study DB. Both the Nudge Dashboard and 
Platform will be developed and maintained by the Georgia Tech study team. Access will be 
restricted to select members of the study team. All access to the Dashboard by EU, MSM or GT 
will require a Georgia Tech account or guest account, sponsored by the GT sub-award Co-PI. 
Access will require the use of 2-Factor authentication to a VPN and 2-Factor authentication to 
the web Dashboard. No public access will be possible. The Nudge Platform will only support 
access via the Dashboard. Certificate-based authentication for all transactions with the Nudge 

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Platform by the study team and participants will be required and logged.  This includes 
authorized Dashboard users. All data will be encrypted “at rest” and “in flight” (over the 
network). Georgia Tech endpoint security protections will be used for hosts used for the Nudge 
Dashboard and Nudge Platform. Endpoint protections include a secure Linux-based host 
(patched monthly), a network firewall restricting access to the GT 2-FA VPN, Antivirus and 
intrusion detection tools installed locally, Georgia Tech authentication restricted to appropriate 
personnel, regular backups, and host firewalls with “deny by default” polices enabled.
Participant social media data storage and handling
The participant social media data portal website will be hosted on a Georgia Tech server, the 
uploaded file will be encrypted by the upload process. The encrypted file will be moved inside 
Georgia Tech’s dedicated protected health data infrastructure (PHDI) environment, where the 
decryption and any processing of the files participants upload through the portal website will 
be handled prior to sending processed, limited participant social media data to the limited 
study database. All communication between the external facing portion of the portal (i.e., what 
the participants will directly access via the internet) and the server will be over secure 
protocols.
The social media account data that participants will receive from their social media platforms 
are in the format of a .zip file, with multiple sub-files containing different types of social media 
account data. Upon the participant uploading a file on the social media portal website, the 
portal will first automatically check that participants have uploaded a correct file format (i.e., a 
.zip file that has a structure that matches what we would expect for a Facebook, Instagram, or 
X/Twitter account data file). If the file uploaded by the participant is not of the correct format, 
we will immediately automatically delete the file, and notify the participant through the social 
media data portal website that their file was not the correct format and has been deleted. If the 
file is the correct format, we will then automatically delete any sub-files that do not contain 
data of interest to us (including data like private direct messages, account profile information, 
photo and video media associated with posts, device information, login timestamps, etc.). 
Then, we will automatically do further processing and deletion of irrelevant data, namely to 
delete participants’ posts that are not related to COVID-19 or health, and remove username 
and persons’ names mentions.
The resulting participant social media data will be stored in the Limited Study Database, which 
will be carefully controlled and maintained on a secure HIPAA compliant environment, on the 
Georgia Tech server. Team members designated by the study PI, that have completed the 
necessary ethics trainings (CITI certification), and are included on the EU and/or partner IRB will 
be given access to the survey data only. Social media data contribution survey data and 
informed consent will be collected from participants and stored using REDCap. 
Social Media Data analysis and usage

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Participants’ social media data will be used to inform our collection and analysis of publicly 
available social media data (described elsewhere in the protocol), as well as additional analysis 
of participants’ social media engagement and posted content. For our analysis of publicly 
available social media data, we will be able to better curate our data collection to include 
accounts followed and engaged with by our participants, as well as analyze what kinds of social 
media accounts and content different demographics of participants follow and engage with. For 
participant social media content (i.e., their own posts on social media), we will use state-of-the-
art natural language processing techniques, such as sentiment analysis and word embeddings, 
and other metadata like post length to reduce such data to key pieces of metadata for analysis. 
This will inform us about how our participants post and share online about health-related 
topics, for example what kind of health-related topics they engage with the most and the 
language they use online when doing so, which can in turn inform how we choose to write 
nudge messages for the study.
There are no international sites. 
19. Provisions to Monitor the Data to Ensure the Safety of Participants
This study poses minimal risk to participants. 
20. Provisions to Protect the Privacy Interest of Participants
Participants will have the option to participate in the study or not as they choose.  They will 
have the option of opting to be contacted to participate in other studies if they are interested. 
During the informed consent process, potential participants will be made aware of possible 
discomforts, who is able to access their information, and what kind of information they can 
access, how we plan to maintain their confidentiality, and the measures in place to protect their 
data. Potential study participants will have the opportunity to ask questions before they agree 
to participate in the study as well as other interactions (interviews, sharing social media data). 
Personal identifiable data will be maintained on EU’s REDCap account, in a dedicated, password 
protected OneDrive account, or as detailed above, limited personal identifiable information will 
be stored on the Georgia Tech server. 
Social media data contribution
Those agreeing to contribute their social media data will be asked to provide their downloaded 
social media data to the study team as described above in Sections 14 and 18. For those that 
consent to participate provide their social media data, a unique identifier will be created when 
data is shared with the study team (See #19, Figure 2: Security and data design for technical 
applications supporting the project). 
Data will be preserved through the end of the project, or until the period of time stipulated by 
the funding agency. No data will be maintained in medical records. 
21. Economic Burden to Participants
There are not costs to participants related to their participation in the study. 

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22. Informed Consent 
Individuals expressing interest in the study will be directed to the study site to complete an e-
consent form.  When conducting onsite recruitment, a study team member that is trained in 
conducting informed consent and is registered on the study IRB may be available to read 
through the informed consent form with the potential participant. In this case, the consent 
process will be performed in a private location, and any questions the participant has will 
addressed. 
Optional additional participation: Participants will be asked in the informed consent in-take 
questionnaire, if they would be willing to participate in an interview as a part of the study as 
well as to contribute their social media data.  Participants are not required to be interviewed or 
contribute their social media data to participate in the study. During the informed consent, they 
will have the option to agree to be contacted about participating in an interview and/or to be 
contacted about contributing their social media data. 
Before each interview, a trained interviewer will review the consent document with the 
participant and obtain verbal consent for both the interview and recording of the discussion.  
Participant social media consent and contact
During the baseline survey, participants will be asked whether they consent to being contacted 
about sharing their social media data for the study. Those who indicated that they are willing, 
and also indicated on the baseline survey that they use at least one of Facebook, Instagram, or 
X (Twitter), will receive an automated email and link from REDCap with additional information 
about participation in the social media part of the study as well as an informed consent form 
specific to that part of the study if they decide to contribute their social media data. 
Participants’ consent for this social media data contribution would have no implications for 
their participation in the rest of the study.
Non-English-Speaking Participants  
Non-English-speaking participants will not be included in the study due to funding limitations.  
Cognitively Impaired Adults  
No cognitively impaired adults will be eligible for inclusion in the study.
Adults Unable to Consent  
Participants that cannot provide consent will not be eligible for inclusion in the study. 
Waiver or Alteration of Consent Process 
A waiver of alteration of the consent process will be required. In lieu of a signed informed 
consent form, at the end of the Informed Consent form, the following information will be 
included: 

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Informed consent will be obtained, required information will not be disclosed and research 
does not involve deception. An encrypted copy of the form will be emailed to participants.  
23. HIPAA
This study will not record identifiers from medical records of living or non-living subjects. A 
unique study identifier will be created when the participant completes the informed consent 
and enrolls in the study. PHI collected is self-reported data and will be used to assign the 
participant to a nudge group based on how they are affected by or at risk for diabetes.  
Identifiable study data will be maintained in the study’s secure REDCap project database, which 
is password protected and HIPAA compliant and in Georgia Tech’s Nudge Platform.  Only 
authenticated study team members that have assigned user privileges will have access to PHI.  
24. Setting
Potential participants will be recruited through existing EU, MSM and GT partnerships with 
community based (RX MTM) and faith-based organizations (Big Miller Grove Baptist Church, 
Elizabeth Baptist Church), Diabetes clinics (Grady Diabetes Center) and FQHCs that serve 
communities at risk across Georgia. Partners will promote the study at their sites via in-person 
presentations, flyers and distribution of palm cards, or to their patients (clients), and direct 
them to the study website to complete the e-informed consent and online eligibility and study 
enrollment forms. Those that enroll will agree and consent to utilize their own cellular devices 

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to receive behavioral nudge text messages and submit responses about whether they had 
COVID symptoms in the past 30 days (Y/N) and if they took a COVID-19 test (Y/N). 
The study will continue the community advisory board (CAB) started during Project PEACH, 
which is comprised of members of the partner organizations, community investigators, and 
local stakeholders. Parter organizations involved in Project PEACH, but not PEACH2, will be 
informed that they can choose to continue in an advisory role or leave the group as they wish. 
Any new community organizations that join the study team will have a member seated on the 
CAB.  Members of partner organizations will not be involved in recruitment beyond the 
distribution of promotional information. Their participant-related contact will be limited to 
assisting participants to access the e-informed consent form.
25. Resources Available
Facilities: Emory University (EU), Georgia Institute of Technology (GT) and Morehouse School of 
Medicine (MSM) all house institutes and centers that engage with or include the other partner 
institutions. The PEACH 2 study PIs and team members are members of the Georgia Center for 
Diabetes Translation Research (GCDTR) with PIs (EU: Weber, Narayan MSM: Quarrels; GT:  
Best) also serving on or leading the GCDTR Cores (Design and Evaluation; Engagement and 
Behavior Change; Disparities; Enrichment Program).  GCDTR Cores afford access to subject area 
expertise relevant to the study, including diabetes and related risk factor epidemiology, 
biostatistics, engineering, and demography.  Other EU, GT, MSM collaborations and centers 
provide a rich pool of subject matter expertise and community partners that can be leveraged 
for this project.  The Georgia Institute of Technology team members are also members of the 
GT Institute for People and Technology and GT Center for Health and Humanitarian Systems.  
The MSM team members are PIs and key investigators of the Georgia CEAL, the GCTSA 
Community Engagement (CE) Program and the MSM Prevention Research Center (PRC). 
Further, each institution is involved in other RADx projects, such as The Atlanta Center for 
Microsystems Engineered Point-of-Care Technologies (ACME POCT)’s Rapid Acceleration of 
Diagnostics (RADx) Validation Core (U54 EB027690-02S1) at EU, Children’s Healthcare of 
Atlanta.  GT assesses user needs for novel COVID-19 devices and evaluates point of care devices 
for performance (EU/GT).
Study Team: PEACH2 PIs and study team members began collaborating during Project PEACH 
and will utilize lessons learned and gaps identified through Project PEACH as well as leverage 
community partnerships and infrastructure for this study. 
Sample Size: The sample size of 600 was estimated using the following assumptions: (a) 80% 
power; (b) Alpha of 0.05; and (c) the percentage of participants receiving a COVID-19 test in the 
past month in the control arm would be equal to the percentage of the Georgia population 
getting a PCR test for COVID-19 in the month of June: 3.44 (standard deviation [SD] 0.49). Using 
these assumptions, a sample size of 520 (260 per study arm) will be powered to see an 4.5% 

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increase in the percentage of individuals receiving COVID-19 in the intervention arm compared 
to controls. We plan to randomize 600 individuals to allow for attrition. In addition, given the 
rapidly changing status of COVID testing, we will employ a two-stage adaptive approach to 
recalculate sample size using first stage study data, as recommended by Brown and others for 
adaptive intervention studies.13
Medical or psychological resources: It is unlikely that study participants will require mental 
health support following participation in the study. Regardless, the study team will have a list of 
resources gathered from community partners to provide participants requesting help finding 
resources. There are no funds available to cover these services.  
Research Team Preparation: The protocol and research procedures will be presented to study 
team members at partner institutions and organizations as they join the study team. SOPs that 
detail each activity (participant enrollment; survey data collection; qualitative data collection) 
will be reviewed with and available for the study team to follow.  The study team will be 
organized into functional teams with scopes of work detailing functions for each role.  Project 
coordinators will be responsible for ensuring team members on their teams are trained and 
understand the process, and for monitoring their work. 
26. Multi-Site Research When Emory is the Lead Site
The total number of participants that will be recruited across the study is 600. 
Study-wide Recruitment Methods/Participant Recruitment
Study partners (EU, GT, MSM) will utilize the same study recruitment methods as described in 
Section 14. All study partners will have access to copies of the most recent version of the 
protocol and study documents in SharePoint. Informed consent documents are available both 
in SharePoint and in REDCap at Emory. Relevant study team members (i.e., internal study team 
members; External Study Team List members whose roles include data collection) that will 
assist participants or conduct informed consent will have access to the most current documents 
in REDCap.  All study team members involved in participant recruitment, performing informed 
consent, survey data collection and management, will undergo training. 
Emory, MSM and GT will leverage their existing relationships with community organizations and 
partners for participant recruitment. Partner organizations include faith-based organizations 
(Big Miller Grove Baptist Church, Elizabeth Baptist Church), a community-based organization (Rx 
MTM), a diabetes clinic (Grady Diabetes Center) and Emory School of Medicine. These partners 
have experience conducting COVID-19 testing activities and/or diabetes care, treatment and/or 
prevention, and will help to disseminate the study among their communities to promote the 
study. 

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Grady Diabetes Clinic and Emory School of Medicine’s involvement is limited to study 
promotion and will be limited to display of promotional materials (palm cards and flyers) in 
allowable patient areas and mention of the study to clients (patients) by providers.  Individuals 
interested in participating will complete the online request for information form via the study 
website. No in-person study recruitment will take place.  
Informational materials (palm cards, flyers, posters and promotional letters to community 
organizations with an interest in diabetes prevention and care) that contain study participation 
and eligibility information and a QR code that links to the study website will be disseminated 
through study partners. These have been co-developed by EU, MSM and GT study team 
members, with input from Community Investigators and Partners. These provide information 
about the study, what the study entails (complete 3 surveys at start, after 4 months, after 12 
months; receive and respond to weekly text messages (16), participation in an optional 
interview, participation in an optional 
Additionally, the Project PEACH study website (www.projectpeach.org) will be updated and 
refreshed to include detailed study information and eligibility criteria for PEACH2, with links to 
an eligibility screener. Participants will complete the online screener in REDCap; those eligible 
will continue to go on to complete the informed consent for the study online.  Data on those 
not eligible will not be captured. Participants may also opt to be contacted by a study team 
member who can conduct the informed consent, answer any questions and ensure that the 
potential participant is both eligible and understands what the study entails.
No recruitment methods are not under control of the Lead site (EU). 
Emory University’s Activities: 
Emory University is responsible for the overall coordination of the study, including weekly study 
team meetings, overseeing training of EU/MSM and GT study team members involved in study 
promotion and recruitment, and survey data and interview data collection. This includes 
consenting participants at in-person events and in-depth interviewing. Study survey data will be 
housed in an Emory REDCap Project; interview study data (audio-recordings, transcripts) will be 
collected by EU and MSM study team members and housed on Emory’s server in a secure 
SharePoint Folder with restricted access to team members as described above in Section 18. 
Access to interview data will be controlled by the Emory study PI and Project Coordinators. 
Emory research staff will schedule and send weekly behavioral text message “nudges” via the 
Nudge Dashboard developed by and housed at GT. Together with PIs and study staff from GT 
and MSM, the EU team will develop, test and refine the survey questionnaires and interview 
guides. EU, MSM and GT team members will collaborate on data analysis, write up and 
dissemination of results. Emory staff and research assistants will provide support to study 
participants and cover the Google phone account and check the study’s email box. 
Georgia Institute of Technology’s Activities
Georgia Tech is responsible for developing and maintaining the text message nudge platform 
and dashboard. GT will receive and upload limited participant and demographic data to the 

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platform. They will upload, process and store participate social media data.  The GT team will 
conduct data analysis of publicly accessible data on social media platforms that provide health 
information, and participant social media data relating to diabetes, health, and COVID-19 and 
testing, which will contribute to an understanding of the kinds of information that people have 
access to and that they consume, and to inform the development of text message nudges. GT 
staff and research assistants will provide support to study participants interested in 
contributing their social media data to the study, and may provide additional support to the 
study team, including in-person recruitment at events, conducting qualitative interviews, 
covering the Google phone account and check the study’s email box. EU, MSM and GT team 
members will collaborate on data analysis, write up and dissemination of results.
Morehouse School of Medicine’s Activities
Morehouse School of Medicine’s study team will be responsible for community partner 
engagement.  This includes involving community investigators in the process of refining the 
survey questionnaire to ensure questions are relevant to the community as well as to ensure 
that questions are readable and easy to understand, the promotional materials are meaningful 
and relevant, and to promote the study.  The MSM team will be engaged in study promotion, 
and recruitment, and survey data and interview data collection. This may include consenting 
participants at in-person events, assisting them to complete the baseline survey, and in-depth 
interviewing.  EU, MSM and GT team members will collaborate on data analysis, write up and 
dissemination of results. MSM staff and research assistants will provide support to study 
participants and cover the Google phone account and check the study’s email box.

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Resolution of Disputes
The study team (Emory, Morehouse, Georgia Tech) meets bi-weekly to discuss progress and 
issues.  All questions and/or issues are discussed and resolved as a group. If a reportable event 
were to occur, the event would be documented and reported as soon as identified. Study team 
members are expected to maintain participant confidentiality and adhere to the responsible 
conduct of research.  The study team has cross-institutional functional teams. These teams 
have members from each institution, and are responsible for conducting the work of the study. 
These teams include study promotion and data collection, qualitative interviews, social media, 
and nudge development. 

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27. References
1. Patel SA, Narayan KMV, Del Rio C, et al. COVID-19 Health Equity Interactive 
Dashboard/Vaccination Tracker. https://covid19.emory.edu/Vaccine-Tracker. Published 
2021. Accessed July 2, 2021.
2. Dwyer-Lindgren L, Mackenbach JP, Lenthe FJv, Flaxman AD, Mokdad AH. Diagnosed and 
Undiagnosed Diabetes Prevalence by County in the U.S., 1999–2012. Diabetes Care. 
2016;39(9):1556-1562.
3. Patel SA, Narayan KMV, Ali MK, Mehta NK. Interstate Variation in Modifiable Risk Factors 
and Cardiovascular Mortality in the United States. PLoS ONE. 2014;9(7):e101531.
4. Barker LE, Kirtland KA, Gregg EW, Geiss LS, Thompson TJ. Geographic distribution of 
diagnosed diabetes in the U.S.: a diabetes belt. American Journal of Preventive Medicine. 
2011;40(4):434-439.
5. Gao F, Zheng KI, Wang XB, et al. Obesity Is a Risk Factor for Greater COVID-19 Severity. 
Diabetes Care. 2020;43(7):e72-e74.
6. Cai Q, Chen F, Wang T, et al. Obesity and COVID-19 Severity in a Designated Hospital in 
Shenzhen, China. Diabetes Care. 2020;43(7):1392-1398.
7. Wang S, Ma P, Zhang S, et al. Fasting blood glucose at admission is an independent 
predictor for 28-day mortality in patients with COVID-19 without previous diagnosis of 
diabetes: a multi-centre retrospective study. Diabetologia. 2020;Online ahead of print.
8. Yancy CW. COVID-19 and African Americans. JAMA. 2020.
9. Hall EW, Luisi N, Zlotorzynska M, et al. Willingness to Use Home Collection Methods to 
Provide Specimens for SARS-CoV-2/COVID-19 Research: Survey Study. J Med Internet Res. 
2020;22:e19471.
10. Thaler RH, Sunstein CR. Nudge: Improving Decisions About Health, Wealth, and Happiness. 
New Haven: Yale University Press; 2008.
11. Arno A, Thomas S. The efficacy of nudge theory strategies in influencing adult dietary 
behaviour: a systematic review and meta-analysis. BMC Public Health. 2016;16:676.
12. VanEpps EM, Volpp KG, Halpern SD. A nudge toward participation: Improving clinical trial 
enrollment with behavioral economics. Sci Transl Med. 2016;8(348):348fs313.
13. Brown CH, Ten Have TR, Jo B, et al. Adaptive designs for randomized trials in public health. 
Annu Rev Public Health. 2009;30:1-25.

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28.
Protocol Checklist
Please note that protocol sections with an asterisk (*) should always be included in the protocol; if 
the section does not have an asterisk, and you have not included the section in the protocol, the 
IRB will consider it your attestation that the section does not apply to your study.
Protocol Section
Added 
to the 
protocol
?
External Collaborators- if applicable, add each external collaborator information and 
indicate whether that institution’s IRB will review (or has already reviewed) that individual’s 
engagement in human participants research activities)  
☒ Yes
Funding Source*: Include the information for the funding entity for this study.  Please 
explain if this study is covered by a sub-award or other pertinent information. Say 
“department” if you do not have any other funding.
☒ Yes
Objectives*: Describe the purpose, specific aims, or objectives and state the hypotheses to 
be tested
☒ Yes
Background*: Describe the relevant prior experience and gaps in current knowledge. 
Describe any relevant preliminary data. Provide the scientific or scholarly background for, 
the rationale for, and significance of the research based on the existing literature and how 
will it add to existing knowledge.  Describe any relevant preliminary data or knowledge to 
be built upon in this study. Examples of issues to address are cultural expectations, political 
conditions, economic conditions, disease prevalence/incidence, environmental factors.
Provide the scientific or scholarly background for, the rationale for, and significance of the 
research based on the existing literature and how will it add to existing knowledge.
Include any other non-research rationale for the work, if this study is a mix of non-research 
and research
☒ Yes
Study Endpoints: Sample: provide some information about the data set that the research 
team will be analyzing.
☒ Yes
Study Intervention/Design*: Describe the study intervention that is being evaluated, and/or 
the nature of interactions proposed.
☒ Yes
Procedures involved*: Describe and explain the study design in more detail.
Describe all research procedures being performed and when they are performed, including 
procedures being performed to monitor participants for safety or minimize risks. 
Procedures performed to lessen the probability or magnitude of risks.
☒ Yes
Procedures-Source Records*: The source records that will be used to collect data about 
participants. (Attach all surveys, scripts, and data collection forms in the smartform on the 
☒ Yes

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“Study-Related Documents” page under “Other Attachments.” If unable to attach data 
collection instruments due to copyright requirements, include a description of the 
instrument in the protocol document
Procedures-Data collection*: What data, specifically, will be collected during the study, and 
how that data will be obtained. If audio/video-recordings will be generated, describe 
processes for transcribing audio/video recordings.  Will audio-recordings be destroyed after 
transcription?  If so, how long after transcription?  If not, how will they be kept secure?  If 
video-recordings will be used beyond the current research procedures for 
educational/presentation purposes.
☒ Yes
Procedures- Long Term Follow Up*: If there are plans for long-term follow-up (once all 
research-related procedures are complete), what data will be collected during this period. 
☒ Yes
Procedures-Deception: Does the research design require subjects to be deceived? Describe 
and justify the need for deception. Describe the plan to debrief participants after study 
participation is completed.  Will the subjects be exposed to any stress?  Describe and justify 
the need for stress.
☒ Yes
Data and Specimen Banking: If data or specimens will be banked for future use, describe 
where the data or specimens will be stored, how long they will be stored, how the data or 
specimens will be accessed, and who will have access to the data or specimens.  List the 
data to be stored or associated with each specimen. Describe the procedures to release 
data or specimens, including the process to request a release, approvals required for 
release, who can obtain data or specimens, and the data to be provided with specimens.
☐ Yes
Sharing of Results with Participants*: Describe whether results (study results or individual 
subject results, such as results of investigational diagnostic tests, genetic tests, or incidental 
findings) will be shared with participants or others (e.g., the subject’s primary care 
physicians) and if so, describe how the results will be shared.
☒ Yes
Study timelines*: Describe the duration of an individual subject’s participation in the study, 
the duration anticipated to enroll all study participants, and the approximate total duration 
of the overall study
☒ Yes
Population and Inclusion/Exclusion Criteria*: Describe how individuals will be screened for 
eligibility; the criteria that define who will be included or excluded in your final study 
sample; and indicate specifically whether you will include or exclude each of the following 
special populations: 

Adults unable to consent
☒ Yes

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
Individuals who are not yet adults (infants, children, teenagers)

Pregnant women

Prisoners
Note: you cannot exclude people with limited English proficiency unless you can 
demonstrate the scientific need for such exclusion.
Community Participation: For studies aimed at addressing issues that affect a certain 
community or group: How, if at all, will this study involve people from the target community 
in the design of the study? Conduct of the study? How will the results of the research be 
shared with the participants and/or the target community/ies?  
Research with pregnant women, fetuses, or neonates: review this checklist to verify you 
have provided enough information to ensure the safety and well-being of this population.
☐ Yes 
Research with neonates of uncertain viability: review this checklist to verify you have 
provided enough information to ensure the safety and well-being of this population.
☐ Yes
Research involving prisoners: review this checklist to verify you have provided enough 
information to ensure the safety and well-being of this population.
☐ Yes 
Research involving children: review this checklist to verify you have provided enough 
information to ensure the safety and well-being of this population.
☐ Yes 
Research involving cognitively impaired adults: review this checklist to verify you have 
provided enough information to ensure the safety and well-being of this population.
☐ Yes 
Research involving economically or educationally disadvantaged persons: describe the 
additional safeguards that have been included in the study to protect the rights and welfare 
of these subjects
☐ Yes 
Local Number of Participants*: Indicate the total number of participants to be accrued 
locally. If applicable, distinguish between the number of participants who are expected to 
be enrolled and screened, and the number of participants needed to complete the research 
procedures (i.e., numbers of participants excluding screen failures.) 
Provide your projected enrolling goals, including the percentage of participants according to 
sex and race.   
☒ Yes
Recruitment Methods*: Describe when, where, and how potential participants will be 
recruited, who will make initial contact and how, and if physicians or staff refer participants. 
Describe the source of participants. Describe the methods that will be used to identify 
☒ Yes

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potential participants. Describe materials that will be used to recruit participants. (Attach 
copies of these documents in Smartform on the “Study-Related Documents” page under 
“Recruitment material templates.”  with the application. For advertisements, attach the 
final copy of printed advertisements. When advertisements are taped for broadcast, attach 
the final audio/videotape. You may submit the wording of the advertisement before taping 
to preclude re-taping because of inappropriate wording, provided the IRB reviews the final 
audio/videotape.) How will eligibility be determined? Provide a detailed description of any 
eligibility screening done before enrolling the subject (including whether any identifiers will 
be recorded – note that IP address is an identifier). If recruiting online, describe how 
potential participants would be directed to your recruitment information and study 
description.  
If using contests or raffles as an incentive, you must offer entry to all potential participants, 
not just those who enroll in the study/complete study-related procedures, per Georgia State 
Law.
If recruiting online, describe how potential participants would be directed to your 
recruitment information and study description. 
All research recruitment through social media needs to follow this guidance, which does not 
allow the use of personal social media accounts for some recruitment activities
Withdrawal of Participants*: Describe anticipated circumstances under which participants 
will be withdrawn from the research without their consent. Describe procedures that will be 
followed when participants withdraw from the research, including partial withdrawal from 
procedures with continued data collection.
☒ Yes
Risk to Participants*: List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the participants related to the participant's participation in the research. 
Include as may be useful for the IRB’s consideration, a description of the probability, 
magnitude, duration, and reversibility of the risks. Consider physical, psychological, social, 
legal, and economic risks. Include risks of loss of privacy or breach of confidentiality.
If applicable, indicate which procedures may have risks to the participants that are currently 
unforeseeable.
If applicable, indicate which procedures may have risks to an embryo or fetus should the 
subject be or become pregnant.
If applicable, describe risks to others who are not participants.
Do not state that there are no risks.
☒ Yes
Potential Benefits to Participants*: Describe the potential benefits that individual 
participants may experience 
Indicate if there is no direct benefit. Do not include benefits to society or others.
Describe areas of knowledge that would be strengthened.
Compensation should NOT be stated as a benefit.
☒ Yes

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Compensation to Participants*: Describe if/how subjects will be compensated for 
participation in this study. Indicate what method compensation will be delivered (e.g. cash, 
gift card, school credit). 
Describe the amount and timing of any payments to participants.  How much?  What kind?  
Is tax information required? (if so, must be reflected in the informed consent form). Will 
payments be pro-rated if a participant withdraws early?
☒ Yes
Data Analysis, Management and Confidentiality*: Describe the data analysis plan, including 
any statistical procedures or power analysis. Describe the steps that will be taken to secure 
the data (e.g., training, authorization of access, password protection, encryption, physical 
controls, certificates of confidentiality, and separation of identifiers and data) during 
storage, use, and transmission. Describe any procedures that will be used for the quality 
control of collected data. 
☒ Yes
Describe how data or specimens will be handled study-wide*: What information will be 
included in that data or associated with the specimens?
•
Where and how data or specimens will be stored?
•
How long the data or specimens will be stored?
•
Who will have access to the data or specimens?
•
Who is responsible for receipt or transmission of the data or specimens?
•
How data or specimens will be transported?
☒ Yes
Data Monitoring and Participants Safety 
(if this study is no more than minimal risk, this section is not required)
•
Ensure that you review our Data and Safety Monitoring plan guidance for specific 
details about this section, and examples of what the IRB will be requiring according to 
the level of risk.
•
If a DSMB is needed, please describe the composition of the board (if not already 
detailed in the protocol).  Review this guidance for more information.  If the sponsor 
protocol does not contain all required information, please in this section. 
•
Describe the plan to periodically monitor the data at the site level, and if you have 
international sites. 
•
Description of the plan for notifying the IRB of reportable events; whether the sponsor 
requires reporting above and beyond the Emory IRB reporting requirements, and if so, 
a description of the requirements and plan for meeting them. 
•
Please address the specific details below. If deemed not applicable, please provide 
rationale:
•
Subject safety:
☒ Yes

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o
Specific subject safety parameters 
o
Frequency of subject safety observations
o
Individual responsible for safety monitoring
o
Subject stopping rules – under what conditions will a subject be removed 
from study participation and who will make the decision?
o
o
Study stopping rules - under what conditions will the study be modified or 
stopped and who will make the decision?
o
Reporting mechanisms (i.e. Deviations, adverse events, UPs)
•
Data Integrity:
o
Specific data elements to be reviewed
o
Frequency of monitoring data, points in time, or after a specific number of 
participants
o
Individual responsible for data monitoring
Provisions to Protect the Privacy Interests of Participants*: 

Describe the steps that will be taken to protect participants’ privacy interests. “Privacy 
interest” refers to a person’s desire to place limits on whom they interact with or whom 
they provide personal information.

Describe what steps you will take to make the participants feel at ease with the 
research situation in terms of the questions being asked and the procedures being 
performed. “At ease” does not refer to physical discomfort, but the sense of 
intrusiveness a participant might experience in response to questions, examinations, 
and procedures.

Indicate how the research team is permitted to access any sources of information about 
the participants.
☒ Yes
Economic Burden to Participants*: Describe any costs that participants may be responsible 
for because of participation in the research.
☒ Yes
Informed Consent*: Describe where the consent process will take place, any waiting period 
available between informing the prospective subject and obtaining the consent; and the 
process to ensure ongoing consent.
Describe the role of the individuals listed in the application as being involved in the consent 
process; the time that will be devoted to the consent discussion; steps that will be taken to 
minimize the possibility of coercion or undue influence; and steps that will be taken to 
ensure the participants’ understanding.
☒ Yes

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Note: If you are planning to obtain consent via electronic signature, please review this 
document. Additional guidance on consent documentation and process can be found on our 
website, under the consent toolkit. 
Consent Process-Non-English-Speaking Participants*: 
Indicate what language(s) other than English are understood by prospective participants or 
representatives.
If participants who do not speak English will be enrolled, describe the process to ensure that 
the oral and written information provided to those participants will be in that language. 
Indicate the language that will be used by those obtaining consent.
If you checked N/A, please provide reasoning of why subjects with limited English 
proficiency are excluded. 
Note: if you stated that subjects with LEP will be enrolled, you are approved for the use of 
the Emory IRB short forms.  Please read the guidance about the use of short forms here.
☐ Yes
Consent Process-Children: After determining if the subject is a child per GA law (or if 
enrolled outside GA, per state/country law), please describe whether parental permission 
will be obtained from:

Both parents unless one parent is deceased, unknown, incompetent, or not reasonably 
available, or when only one parent has legal responsibility for the care and custody of 
the child.

One parent even if the other parent is alive, known, competent, reasonably available, 
and shares legal responsibility for the care and custody of the child.
Describe whether permission will be obtained from individuals other than parents, and if so, 
who will be allowed to provide permission.  Describe the process used to determine these 
individuals’ authority to consent to each child’s general medical care.
When assent of children is obtained describe whether and how it will be documented per 
Emory Policies and Procedures
☐ Yes 
Consent Process-Cognitively Impaired Adults:  describe the process to determine whether 
an individual is capable of consent. The IRB allows the person obtaining assent to document 
assent on the consent document and does not routinely require assent documents and does 
not routinely require children to sign assent documents.
☐ Yes
Consent Process-Adults Unable to Consent:  List the individuals from whom permission will 
be obtained in the order of priority. (E.g., durable power of attorney for health care, a court-
appointed guardian for health care decisions, spouse, and adult child.)
☐ Yes

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For research conducted in the state, review “46 LEGALLY AUTHORIZED REPRESENTATIVES 
AND SURROGATE CONSENT” to be aware of which individuals in the state meet the 
definition of “legally authorized representative.”
For research conducted outside of the state, provide information that describes which 
individuals are authorized under applicable law to consent on behalf of a prospective 
subject to their participation in the procedure(s) involved in this research. 
Describe the process for the assent of the participants. Indicate whether:

Assent will be required of all, some, or none of the participants. If some, indicated, 
which participants will be required to assent and which will not.

If assent will not be obtained from some or all participants, an explanation of why not.
Describe whether the assent of the participants will be documented and the process to 
document assent. The IRB allows the person obtaining assent to document assent on the 
consent document and does not routinely require assent documents and does not routinely 
require participants to sign assent documents
Waiver or Alteration of Consent and HIPAA authorization (consent will not be obtained, 
required information will not be disclosed, or the research involves deception) 
Review the Emory IRB waiver document to ensure you have provided sufficient information 
for the IRB to make these determinations.
If the research involves a waiver of the consent process for planned emergency research, 
please review the Emory P&Ps, Chapter 48, WAIVERS OF, AND EXCEPTIONS FROM, 
INFORMED CONSENT FOR PLANNED EMERGENCY RESEARCH to ensure you have provided 
sufficient information for the IRB to make these determinations.
☒ Yes
Setting*: Describe the sites or locations where your research team will conduct the research 
including where the subject will be identified and recruited, where the research procedures 
will be performed, and if you will involve a community advisory board.  For research 
conducted outside the organization and its affiliates describe the site-specific regulations or 
customs affecting the research outside the organization and the local scientific and ethical 
review structure outside the organization.
☒ Yes
Resources Available*: Describe the resources available to conduct the research such us the 
feasibility of recruiting the required number of suitable participants within the agreed 
recruitment period; describe the time that you will devote to conducting and completing 
the research; describe the availability of medical or psychological resources that participants 
might need as a result of an anticipated consequences of the human research; describe your 
process to ensure that all persons assisting with the research are adequately informed 
about the protocol, the research procedures, and their duties and functions.
☒ Yes

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Multi-Site Research when Emory is the Lead Site
Study -Wide Number of Participants: indicate the total number of participants to be accrued 
across all sites.
Study-Wide Recruitment Methods: If this is a multicenter study and participants will be 
recruited by methods not under the control of the local site (e.g., call centers, national 
advertisements) describe those methods.  
Describe when, where, and how potential participants will be recruited.
Describe the methods that will be used to identify potential participants.
Describe materials that will be used to recruit participants. 
Describe the processes to ensure communication among sites. See “WORKSHEET: 
Communication and Responsibilities (HRP-830).” All sites have the most current version of 
the protocol, consent document, and HIPAA authorization.
All required approvals (initial, continuing review and modifications) have been obtained at 
each site (including approval by the site’s IRB of record).
All modifications have been communicated to sites and approved (including approval by the 
site’s IRB of record) before the modification is implemented.
All engaged participating sites will safeguard data, including secure transmission of data, as 
required by local information security policies.
All local site investigators conduct the study in accordance with applicable federal 
regulations and local laws. 
All non-compliance with the study protocol or applicable requirements will be reported in 
accordance with local policy
Describe the method for communicating to engaged participating sites (see “WORKSHEET: 
Communication and Responsibilities (HRP-830)”):

Problems (inclusive of reportable events).

Interim results.

The closure of a study
If this is a multicenter study where you are a participating site/investigator, describe the 
local procedures for maintenance of confidentiality. (See “WORKSHEET: Communication and 
Responsibilities (HRP-830).”)

Where and how data or specimens will be stored locally?

How long the data or specimens will be stored locally?

Who will have access to the data or specimens locally?

Who is responsible for receipt or transmission of the data or specimens locally?

How data and specimens will be transported locally?
☒ Yes