Community-Centered Interventions for Improved Vaccine Uptake for COVID-19 (CIVIC): Getting to Yes, Michigan! (G2YMI)
Phase: NA
Conditions: COVID-19 Vaccines, COVID-19 Pandemic
Sponsor: University of Michigan

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Getting to Yes: Increasing COVID-19 vaccination in Michigan 
Community-Centered Interventions for Improved Vaccine Uptake for COVID-19 (CIVIC) 
Funded by: NIH Health and Human Services GRANT13282146  Award # 5R01MD016867-02
National Clinical Trial (NCT) Identified #: NCT05096260 
Principal Investigators: Erica Marsh. M.D. and Ken Resnicow, Ph.D. 
Approved by IRB HUM00204174  
Protocol Version #:  v.12.0 – February 26, 2024 
1. STATEMENT OF COMPLIANCE ....................................................................................................... 4 
1 PROTOCOL SUMMARY ................................................................................................................... 4 
1.1 
Synopsis .................................................................................................................................. 4 
1.2 
Schema ................................................................................................................................... 1 
1.3 
Schedule of Activities (SoA) .................................................................................................. 6 
2 INTRODUCTION ............................................................................................................................... 7 
2.1 
Study Rationale ...................................................................................................................... 7 
2.2 
Background ............................................................................................................................ 8 
2.3 
Risk/Benefit Assessment ...................................................................................................... 8 
3 OBJECTIVES AND ENDPOINTS ........................................................................................................ 9 
4 STUDY DESIGN ............................................................................................................................... 10 
4.1 
Overall Design ...................................................................................................................... 10 
4.2 
Scientific Rationale for Study Design ................................................................................ 13 
4.3 
Justification for Dose .......................................................................................................... 13 
4.4 
End of Study Definition ....................................................................................................... 13 
5 STUDY POPULATION ..................................................................................................................... 13 
5.1 
Inclusion Criteria .................................................................................................................. 13 
5.2 
Exclusion Criteria ................................................................................................................. 13 
5.3 
Lifestyle Considerations ...................................................................................................... 13 
5.4 
Screen Failures ..................................................................................................................... 14 
5.5 
Error! Bookmark not defined. 
6 STUDY INTERVENTION .................................................................................................................. 16 
6.1 
Study Intervention(s) Administration ............................................................................... 16 
6.2 
Preparation/Handling/Storage/Accountability............................................................... 16 
6.2.1 
Acquisition and accountability ........................................................................ 16 
6.2.2 
Formulation, Appearance, Packaging, and Labeling .................................... 17 
6.2.3 
Product Storage and Stability .......................................................................... 18 
6.2.4 
Preparation ........................................................................................................ 18 
6.3 
Measures to Minimize Bias: Randomization and Blinding ............................................ 18 
6.4 
Study Intervention Compliance ......................................................................................... 18 
6.5 
Concomitant Therapy ......................................................................................................... 18 
6.5.1 
Rescue Medicine ................................................................................................ 18 

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7 STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ....................................................................................................... 18 
7.1 
Discontinuation of Study Intervention .............................................................................. 18 
7.2 
Participant Discontinuation/Withdrawal from the Study .............................................. 18 
7.3 
Lost to Follow-Up ................................................................................................................ 19 
8 STUDY ASSESSMENTS AND PROCEDURES ................................................................................. 19 
8.1 
Efficacy Assessments .......................................................................................................... 19 
8.2 
Safety and Other Assessments .......................................................................................... 20 
8.3 
Adverse Events and Serious Adverse Events .................................................................... 22 
8.3.1 
Definition of Adverse Events (AE) .................................................................... 22 
8.3.2 
Definition of Serious Adverse Events (SAE) .................................................... 22 
8.3.3 
Classification of an Adverse Event .................................................................. 22 
1.1.1.1 
Severity of Event .................................................................. 22 
1.1.1.2 
Relationship to Study INTERVENTION .............................. 22 
1.1.1.3 
Expectedness ........................................................................ 23 
1.1.2 
Time Period and Frequency for Event Assessment and Follow-Up ............. 24 
1.1.3 
Adverse Event Reporting .................................................................................. 25 
1.1.4 
Serious Adverse Event Reporting .................................................................... 25 
1.1.5 
Reporting Events to Participants ..................................................................... 25 
1.1.6 
Reporting of Pregnancy .................................................................................... 26 
1.2 
Unanticipated Problems ..................................................................................................... 26 
1.2.1 
Definition of Unanticipated Problems (UP).................................................... 26 
1.2.2 
Unanticipated Problem Reporting .................................................................. 26 
1.2.3 
Reporting Unanticipated Problems to Participants ...................................... 26 
2 STATISTICAL CONSIDERATIONS ................................................................................................... 26 
2.1 
Study Hypotheses ................................................................................................................ 27 
2.2 
Sample Size Determination ................................................................................................ 27 
2.3 
Populations for Analyses .................................................................................................... 27 
2.4 
Statistical Analyses .............................................................................................................. 27 
2.4.1 
General Approach ............................................................................................. 27 
2.4.2 
Analysis of the Primary Efficacy Endpoint(s) ................................................. 27 
2.4.3 
Analysis of the Secondary Endpoint(s) ........................................................... 29 
2.4.4 
Safety and Interim Analyses ............................................................................ 29 
2.4.5 
Baseline Descriptive Statistics ......................................................................... 29 
2.4.6 
Tabulation of Individual Participant Data ...................................................... 29 
2.4.7 
Exploratory Analyses ......................................................................................... 29 
3 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ............................ 29 
3.1 
Regulatory, Ethical, and Study Oversight Considerations ............................................. 29 
3.1.1 
Informed Consent Process ................................................................................ 29 
3.1.1.1 
Consent/assent and Other Informational Documents 
Provided to participants ..................................................... 30 
3.1.1.2 
Consent Procedures and Documentation ......................... 30 
3.1.2 
Study Discontinuation and Closure ................................................................. 30 
3.1.3 
Confidentiality and Privacy .............................................................................. 30 

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3.1.4 
Future Use of Stored Specimens and Data..................................................... 31 
3.1.5 
Key Roles and Study Governance .................................................................... 31 
3.1.6 
Safety Oversight ................................................................................................ 32 
3.1.7 
Clinical Monitoring ............................................................................................ 32 
3.1.8 
Quality Assurance and Quality Control .......................................................... 32 
3.1.9 
Data Handling and Record Keeping ................................................................ 33 
3.1.9.1 
Data Collection and Management Responsibilities ........ 33 
3.1.9.2 
Study Records Retention .................................................... 33 
3.1.10 
Protocol Deviations ........................................................................................... 34 
3.1.11 
Publication and Data Sharing Policy ............................................................... 34 
3.1.12 
Conflict of Interest Policy .................................................................................. 34 
3.2 
Additional Considerations .................................................................................................. 34 
3.3 
Abbreviations ....................................................................................................................... 35 
3.4 
Protocol Amend 
ment History .................................................................................................................................... 35 
3.5 
Appendices ............................................................................................................................. 2 
4 REFERENCES ..................................................................................................................................... 3 
5 PROTOCOL SIGNATURE PAGE 11 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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STATEMENT OF COMPLIANCE 
 
This study will be carried out in accordance with Good Clinical Practice (GCP) as required by the 
following: 
● United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 
and 21 CFR Part 56) 
● NIH Clinical Terms of Award 
All key personnel (all individuals responsible for the design and conduct of this study) have completed 
Human Subjects Protection Training. The protocol and informed consent form(s) will be submitted to the 
Institutional Review Board (IRB) for review and approval.  Approval of both the protocol and the consent 
form will be obtained before any participant is enrolled.  Any amendment to the protocol will first go 
through IRB 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, if this becomes applicable. (i.e. if there is a requested change to the consent form during 
the course of this study) 
1  
PROTOCOL SUMMARY 
1.1 Synopsis  
Title: 
Getting to Yes! Michigan: Increasing COVID-19 vaccinations  
Study 
Description: 
This proposal, entitled Community-Centered Interventions for Improved Vaccine 
Uptake for COVID (CIVIC), is designed to directly address and decrease COVID-19 
vaccine hesitancy and increase vaccine uptake among populations that 
experience COVID-19 related disparities. We will focus on the entirety of the 
state of Michigan, with a keen focus in four counties within Michigan where a 
disproportionate burden of COVID-19 within AA and LX communities, i.e., 
Wayne, Genesee, Kent and Washtenaw Counties. Using a community-based 
participatory research (CBPR) approach, CIVIC will leverage: its long term, 
community-based relationships through an established CBPR Steering 
Committee developed as a Community Engagement Alliance (CEAL) grant 
recipient, the University of Michigan CTSA (MICHR), and the expertise of our 
academic partners to identify and understand factors that contribute to COVID-
19 vaccine hesitancy in AA and LX communities in Michigan. 
 
Objectives: 
 
1: Increase understanding of the barriers and drivers of vaccine uptake and 
hesitancy;  
2: Increase vaccine uptake and decrease vaccine hesitancy through the 
implementation and evaluation of a multilevel, tailored intervention; and 
maintain, enhance, and evaluate the effectiveness of the CIVIC partnerships to 
equitably engage all partners. 
 
Endpoints: 
Primary Endpoint: Vaccination rate between baseline and 6-months 
Secondary Endpoints: Vaccination rate between baseline and 12 months 

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Study Population: 
Adults (>18-years-old) living in the state of Michigan. We have recruited 30 
churches into the intervention, and they will assist in the recruitment of subjects 
from each church alongside study team recruitment in the community. To 
achieve the goal of the study, we must recruit n = 800-1000 (400-500) 
intervention, (400-500) control) subjects. We expect an approximately equal 
distribution of gender. Demographics are expected to reflect local community 
populations from which we recruit.  
 
Phase: 
N/A 
 
Description of 
Sites/Facilities 
Enrolling 
Participants: 
Will recruit subjects from the community at events such as farmers markets, 
health fairs, social media, etc as well as from the thirty churches from the four 
target counties. We will also recruit with Data Direct, a U-M resource. 
 
 
 
Description of 
Study 
Intervention: 
 
Intervention designed as a randomized control trial implemented over 48 weeks. 
Intervention includes SMS/MMS messages tailored from a Baseline survey for 
people who are either unvaccinated/unboosted. Volunteers who are vaccinated 
may participate as vaccine champions to encourage participants to be 
vaccinated. If the fully vaccinated person has signed up prior to December 2022, 
they can complete 2 trainings to become a vaccine champion plus. They will 
reach out to participants that would like additional information from a vaccine 
champion plus. A fully vaccinated person enrolled after January 2023 will 
become a vaccine champion and will have the opportunity to complete the 
motivational interviewing training but won’t interact with participants. 
 
Study Duration: 
 
48 weeks for intervention and manuscript preparation time 
 
Participant 
Duration: 
 
24 weeks 
 
Related 
separate QI 
initiatives for this 
study 
 
 
N/A 
 
 
1.2 
Schema 
Crossover Individualized Randomized Control Trial 
 
Randomization.   At the time of randomization, eligible participants will be assigned a unique 
randomization number; no participant may begin intervention prior to randomization.  Eligible 
participants will be randomized to Intervention or Control in a 1:1 manner, stratified by vaccination 
status (vaccinated [>1 vaccine received] or unboosted or unvaccinated [0 vaccines received]).  The 
study statistician will prepare the randomization schedule, using computer-generated permuted 

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block randomization with the block size(s) known only by the study statistician.  A secure web-based 
application will be built that will be used by the coordinators to enter participant information (e.g., 
participant ID, stratification factor) and to obtain the randomization number.   
 
Mock Randomization: 
Randomization List 1:  Vaccinated (>1 vaccine received) 
STRAT_NO  STRAT_LABEL 
TRT_GROUP 
TRT_ALLOCATION 
RANDO_NO 
1 
Vaccinated (>1 vaccine received) 
A 
Control 
1327 
1 
Vaccinated (>1 vaccine received) 
A 
Control 
1330 
1 
Vaccinated (>1 vaccine received) 
B 
Intervention 
1333 
1 
Vaccinated (>1 vaccine received) 
B 
Intervention 
1336 
1 
Vaccinated (>1 vaccine received) 
A 
Control 
1339 
1 
Vaccinated (>1 vaccine received) 
B 
Intervention 
1342 
1 
Vaccinated (>1 vaccine received) 
B 
Intervention 
1345 
1 
Vaccinated (>1 vaccine received) 
A 
Control 
1348 
Randomization List 1:  Unboosted or Unvaccinated (0 vaccines received) 
STRAT_NO  STRAT_LABEL 
TRT_GROUP 
TRT_ALLOCATION 
RANDO_NO 
0 
Unboosted or Unvaccinated (0 vaccines received) 
B 
Intervention 
1351 
0 
Unboosted or Unvaccinated (0 vaccines received) 
A 
Control 
1354 
0 
Unboosted or Unvaccinated (0 vaccines received) 
B 
Intervention 
1357 
0 
Unboosted or Unvaccinated (0 vaccines received) 
A 
Control 
1360 
0 
Unboosted or Unvaccinated (0 vaccines received) 
B 
Intervention 
1363 
0 
Unboosted or Unvaccinated (0 vaccines received) 
A 
Control 
1366 
0 
Unboosted or Unvaccinated (0 vaccines received) 
A 
Control 
1369 
0 
Unboosted or Unvaccinated (0 vaccines received) 
B 
Intervention 
1372 
 
Primary Outcome: Primary outcomes will be vaccine completion ((2mRNA or 1 J & J) + bivalent) 
Secondary Outcome: Primary outcome is additional vaccine dose (0 to 1, 1 to 2, or 2 to 3) 
 
We aim to enroll around 500 per arm (moderate effective size e.g., 20% vs. 32% rates in control vs. 
intervention arms). 
 
 
1.3 
Schedule of Activities (SoA) 
 
Note: Times indicated in this table guide our study measures and time points. Our pilot work has 
shown that patient scheduling for activities requires flexibility to accommodate not only the study but 
the needs and schedules of patients. As such, times for data collection may show ‘windows +/- x days). 
Exact time points of data collection will be documented in study logs, and also accounted for during 
analyses.  
 
 
Pre 
Post 

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Event-Time Point 
Baseline 
Follow-up 
 
Church Enrollment 
X 
 
Individual Enrollment  
X 
 
Baseline for unvaccinated 
X 
 
Virtual training for recruited champions 
X 
 
In-person training for recruited champions 
X 
 
Post-intervention Survey 
 
X 
 
2 
 
INTRODUCTION 
 
2.1 
Study Rationale  
Like many states across the country, COVID-19 cases and deaths have impacted communities of 
color in Michigan at disproportionately higher rates than whites. A staggering reality is that while African 
Americans (AA) represent only 13.6% of Michigan’s population, they represent 40% of the deaths from 
COVID-19.  
- Half of the cases and deaths in Michigan occurred in Wayne County.  
- Other Counties in the lower half of Michigan have similar disparities including Genesee, 
Washtenaw, and Kent.  
- - In Genesee County, where AAs represent 20.3% of the population, they represent 35% of COVID-
19 cases and 45% of deaths.  
- - In Washtenaw County, nearly half of the cases to date are located in two majority low-income zip 
codes in the city of Ypsilanti. AA residents, who make up 12% of the Washtenaw population, 
disproportionately constitute more than a quarter of the cases.  
- - And in Kent County, while 10.8% of the population is Latinx (LX), this ethnic group makes up 
32.4% of COVID-19 cases.  
 
Preliminary data from the state reveal that these disparities will likely worsen due to significant 
hesitancy, fear, mistrust and misinformation regarding the COVID-19 vaccine if nothing is done to 
change current trends. This proposal, entitled Community-Centered Interventions for Improved Vaccine 
Uptake for COVID-19 (CIVIC), is designed to directly address and decrease COVID-19 vaccine hesitancy 
and increase vaccine uptake among populations that experience COVID-19 related disparities. 
CIVIC/G2YMI will be offered to anyone in the state of Michigan, we will focus on the four counties within 
Michigan where a disproportionate burden of COVID-19 is within AA and LX communities, i.e., Wayne, 
Genesee, Kent and Washtenaw Counties. Using a community-based participatory research (CBPR) 
approach, CIVIC will leverage: its long term relationships with the communities involved, an established 
CBPR Steering Committee developed and the knowledge gained as a Community Engagement Alliance 
(CEAL) grant recipient, the resources and networks of the University of Michigan CTSA (MICHR), and the 

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expertise of our academic partners to identify and understand factors that contribute to COVID-19 
vaccine hesitancy in AA and LX communities in Michigan.  
 
This aim will develop and test interventions based on community-centered approaches to achieve a 
primary goal of increased vaccine uptake.  
 
We will achieve this goal with the following aims:  
1: Increase understanding of the barriers and drivers of vaccine uptake and hesitancy;  
2: Increase vaccine uptake and decrease vaccine hesitancy through the implementation and 
evaluation of a multilevel intervention; and maintain, enhance, and evaluate the effectiveness of the 
CIVIC partnership to equitably engage all partners. 
 
2.2 
Background  
Like many states across the country, COVID-19 cases and deaths have impacted communities of 
color in Michigan at disproportionate rates. A staggering reality is that while African Americans 
represent only 13.6% of Michigan’s population, they represent 40% of the deaths from COVID-19. Half 
of the cases and deaths in Michigan occurred in Wayne County. Other Counties in the lower half of 
Michigan have similar disparities including Genesee, Washtenaw, and Kent. In Genesee County, where 
African Americans represent 20.3% of the population, 35% of COVID-19 cases and 45% of deaths are in 
these communities. In Washtenaw County, nearly half of the cases to date are located in two majority 
low-income zip codes in the city of Ypsilanti. African American residents, who make up 12% of the 
Washtenaw population, disproportionately constitute more than a quarter of the cases. And in Kent 
County, while 10.8% of the population is Hispanic or Latino, this ethnic group makes up 32.4% of COVID-
19 cases. It is unquestionable that this crisis has exacerbated existing racial/ethnic inequity and health 
disparities in Michigan. Preliminary data from the state reveal that these disparities will likely worsen 
due to significant hesitancy, fear, mistrust, and misinformation regarding the COVID-19 vaccine if 
nothing is done to change current trends. This proposal, entitled Community-Centered Interventions for 
Improved Vaccine Uptake for COVID (CIVIC) is designed to directly address and decrease COVID-19 
vaccine hesitancy and increase vaccine uptake among populations that experience health disparities. 
We will focus on the four counties within Michigan that were hardest hit and/or where a 
disproportionate burden is within AA and LX communities i.e., Wayne, Genesee, Kent and Washtenaw 
Counties. Using a community based participatory research (CBPR) approach, CIVIC will leverage its long 
term relationships with the community, an established Steering Committee, the resources and networks 
of the University of Michigan CTSA (MICHR), our status and knowledge gained as a Community 
Engagement Alliance (CEAL) grant recipient, and the expertise of our academic partners to identify and 
understand factors that contribute to COVID-19 vaccine hesitancy in African-American (AA) and Latinx 
(LX) communities in Michigan and develop and test interventions based on community-centered 
approaches to achieve a primary goal of increased vaccine uptake. 
 
2.3 
Risk/Benefit Assessment   
Risk Likelihood: There is the rare potential risk that participants may be embarrassed or upset by 
questions in the questionnaires or interviews. Risks or discomforts from this research are minimal and 
may include discomfort with speaking to unvaccinated individuals about their barriers and beliefs about 
the COVID-19 vaccine. 
Risk Seriousness: You have the option to not answer any questions that you feel is too sensitive. 
Questions were previewed by community members, religious and spiritual leaders, and those questions 
deemed too sensitive were removed.  

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Measures to minimize risk: Privacy is very important, and the study investigators use many safety 
measures to protect subject privacy.  
Participation in this research is voluntary, and you may choose to withdraw at any time by 
contacting the study team at gettingtoyesMI@med.umich.edu 
Participation in this research is confidential. All research data will be de-identified, and you 
will be identified by number and not by name. No information by which you can be identified 
will be released or published in connection with this study. 
No information by which you can be identified will be released or published in connection 
with this study. In spite of all of the safety measures that we will use, however, we cannot 
guarantee that your identity will never become known.  
Study paper data (i.e. consent forms and history forms will be stored in locked cabinets) and 
electronic data is stored on servers accessible via password-protected computers. 
Study data will be stored in a relational database on a separate highly restricted secure 
server. Databases will be backed up daily to an offsite NAS storage device using automatic 
backup software that is available 24/7 except for scheduled maintenance. Only the primary 
investigators and other authorized research team members named in the approved IRB 
application will have access to the de-identified data. These standards will help ensure that 
violations of confidentiality will be minimal. 
There is the potential risk that participants may be embarrassed or upset by questions in the 
questionnaires or interviews. Subjects will have the option to not answer any questions that 
they determine to be too sensitive. 
 
The direct benefits of your participation may include: 
- increased knowledge about the COVID-19 vaccine. 
There are no immediate health benefits to the study subjects. This study, however, will provide 
important information about the beliefs, behaviors, sources of truth, and misinformation that drive 
COVID-19 vaccine uptake so that in the future others might benefit from this study.  
Participants who wish to receive communication training will receive a link to the Articulate 360 training. 
Newly Enrolled (Post December 2022) Vaccine Champions will complete the virtual, MI-based, 
(Articulate) communications training only. No incentive will be paid to newly enrolled Vaccine 
Champions. Note: Currently enrolled (prior to December 2022) Vaccine Champions Plus will be trained 
on program specifics to aide in discussions with participants to answer questions regarding vaccination. 
They will receive abbreviated PEERRS training as well as Motivational Interviewing techniques. We will 
distribute vaccine champions plus initial $50 payment after a self-paced virtual and $50 for a live-virtual 
MI-based communication trainings. 
 
Vaccine Champions Plus (those recruited prior to Dec 22) will be matched manually to 
unvaccinated/unboosted participants manually by the study team. 
Link to Articulate Training: https://rise.articulate.com/share/U3TRBPxQQKA5Vd8yOs4w6aVOtuq-
FKyJ 
 
3 
OBJECTIVES AND ENDPOINTS  
1: Increase understanding of the barriers and drivers of vaccine uptake and hesitancy;  
2: Increase vaccine uptake and decrease vaccine hesitancy through the implementation and 
evaluation of a multilevel intervention; and  
3: Maintain, enhance, and evaluate the effectiveness of the CIVIC partnership to equitably engage all 
partners. 

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4 
STUDY DESIGN  
 
4.1 
Overall Design 
Overview and Study Design.  
We will develop and test, with the active engagement of the CIVIC SC, the impact of a tailored 
mobile-optimized web intervention on vaccine uptake. Individually tailored interventions have 
consistently been shown to be more efficacious than group-level or static messages. 
 
Building on several prior individually-tailored interventions we have developed for AAs, we designed 
a user-friendly, culturally-sensitive, interactive intervention that addresses key determinants of vaccine 
behavior—e.g., knowledge gaps, barriers, beliefs, values, ethnic identity, medical mistrust, 
discrimination, and communal responsibility. The comparison group will receive a mobile-optimized web 
program absent individual tailoring (i.e., standard, static content). Participants, (unboosted or 
unvaccinated) will be randomly assigned to each condition, for both Aims 2 and 3. The primary outcome 
will be self-reported COVID-19 vaccine uptake (at least one dose) after six months from the start of the 
Aim 2 study. To detect a 15% absolute difference in vaccine rates (.40 versus .55), we will require 
approximately 700 individuals at posttest (350 from intervention, 350 from control) 
All intervention materials are available in English and Spanish including: the web-based program 
messages through testimonials, infographics, and links to other content, promotional materials.  
 
App Structure.  
The “App,” which will be web-based rather than a native program running in iOS or Android, will be 
optimized for use with various screen sizes, devices, and operating systems. This allows us to avoid the 
time and cost of developing and posting native versions in iOS/Swift and Android. To allow use across 
multiple device types (e.g., phone, PC, or tablet) without requiring participants to download an actual 
“App.” The mobile website is a hybrid, meaning that it is neither a truly native mobile application 
(because much of the computation is done via the web) nor purely web-based. Our team has built 
numerous similar sites and has extensive experience with Qualtrics, Cordova, CSS, HTML, Python, and 
Java, including projects by Drs. Resnicow and An. Users will “download” and bookmark the “App” which 
will “launch” upon clicking, mimicking a true App experience. 
 
App Development.  
The Center for Health Communications Research (CHCR), which will design the tailored web 
program for this study, has been at the forefront of theory-driven, culturally-tailored interventions for 
over 20 years. CHCR iteratively evaluates and improves the user experience throughout the 
development process, relying on a range of feedback methods including contextual interviews, focus 
groups, heuristic evaluation, and formal usability testing conducted in accordance with best practices 
outlined at usability.gov. As part of the project lifecycle, CHCR performs qualitative and quantitative 
evaluation of user experience with mature programs (e.g. system usability and paradata assessment) 
and the impact of user experience on intervention impact. A robust and refined project lifecycle, based 
on quality principles and modern agile development methodologies, guides all planning, development, 
and implementation activities. This standard process helps ensure well-conceived, high-quality products 
by defining goals, methods, and quality assurance procedures for each of the project’s stages. CHCR uses 
a standards-based, cross-platform, open-source application that enables the efficient creation, testing, 
and delivery of richly tailored communications. These communications may include individually-tailored 

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text and media (photos, graphics, animations, audio, video) delivered via a range of channels. Because 
of the common technical platform, resulting in tailored programs are easier to disseminate. 
 
Theoretical Framework.  
Our primary framework that will guide the web content is Self-Determination Theory (SDT). SDT 
differentiates between autonomous and controlled behavioral regulation. Behaviors are autonomous 
when they result from conscious choice and are personally relevant. Conversely, behaviors are 
considered controlled when performed due to pressure or coercion, either by external or internal 
forces. A key principle of SDT is that messages that enhance autonomy and perceived competence and 
are consistent with a person’s values and goals will be more effective in changing behavior than 
messages focusing on external rewards such as pleasing others, fear of disease, or avoiding guilt, 
anxiety, or shame. To link vaccination to broader values and goals, in the baseline assessment, 
participants will be presented with approximately 20 values/life goals, from which they will select 3-4 
goals that are important to them; individually tailored messages will link each of these values to 
vaccination. For example, if an individual chooses family or strength as key values, we will provide 
messages that link vaccination to being there for their family or to remain independent. We will also 
tailor testimonials based on member values and communication style preference (see below). Another 
component of autonomy that is relevant here is providing choice as to how much and what information 
participants receive. 
 
Individual-Level Tailoring Message Content.  
CHCR will tailor the content based on key determinants of vaccine behavior including knowledge, 
barriers, benefits/drivers, cultural values, mistrust, ethnic identity, communication preferences, and the 
personal meaning of vaccination. The final list for tailoring content will be determined by our Aim 1 
formative research, preliminary data collected as part of our C3 study, and analysis of other sources. The 
CIVIC SC will play a critical role in reviewing these materials and deciding on the final list of content for 
tailoring. The mobile-optimized website will include a brief assessment of these constructs, generally 
using measures we have already developed. Using other methods such as testimonials, we will deliver 
individualized content addressing each of these constructs. For example, for someone who reports they 
are worried about contracting the virus from the vaccine, we will offer them what we call “essential 
facts” about the topic and then provide “drill down” options if they want to learn more. We will also 
tailor messages to drivers that we know are primary for the COVID-19 vaccine: communal responsibility 
and individual choice/personal health protection. For example, for someone high on communal 
responsibility, we will reflect this back to them in their message as “… if you got vaccinated, you would 
feel you are protecting others in your community…” or “… how will you feel about being a leader in your 
community by getting vaccinated?” Similarly, someone high on individual choice/personal health 
protection will be provided with feedback such as “getting the vaccine is a personal choice for you, not 
something you want to be shamed or pressured into doing.” Similar tailored messages will be developed 
for each of the target mediators.  

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AAs are heterogeneous with regard to racial identity and this variability should be considered when 
designing health messages and programs for AAs. We have demonstrated that for AAs whose racial 
identity is central to their overall identity, messages that refer to or link race to the target behavior can 
be highly salient. However, for AAs with low racial centrality, framing messages around race can be 
poorly received or even harmful. Thus, we will use our brief message of racial centrality, based on the 
work of Sellers, to classify individuals by their ethnic identity and deliver messages differentially framed 
on respondents’ identity. For example, for those with high racial centrality, we would frame their 
message as “… getting the vaccine can help protect other AAs from getting COVID” or “AAs have a 
higher rate of COVID than other Americans.” For those with low racial salience, we would frame the 
message as “… getting the vaccine can help protect other Americans from getting COVID” or “Americans 
have a higher rate of COVID than other countries.”  
 
Individual-Level Tailoring Message Tone.  
In several prior studies, we found that message tone impacts uptake. We have developed a tailoring 
algorithm that optimizes message tone based on communication preference. We assess preference with 
two items, one assessing the global trait preference and the other assessing preferences related to 
vaccine uptake. The trait item will be: "In general, when it comes to my health I would rather an expert 
just tell me what I should do." The state item will be: “When it comes to getting a COVID-19 vaccine I 
would rather an expert just tell me what I should do". 
 
The two preference styles, which we call PUSH (directive) and PULL (autonomy-supportive), receive 
different tone, language, and content. The PULL tone uses more tentative and autonomy-supported 
language, whereas the PUSH tone is more definite and directive. Specifically, individuals preferring the 
PUSH style will be provided with directive advice describing what they "should do" regarding COVID-19 
vaccination. Individuals preferring the more autonomy-supportive PULL tone will receive more tentative 
language such as “might” or “can,” using questions (e.g., “How might you feel about getting the 
vaccine?” versus “You will feel good about yourself if you get the vaccine”) and suggestions more than 
commands, helping them find personal meaning to make a vaccination decision. 
 
App Usage 

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Champions are vaccinated persons from participating counties, who agree to consent to the study, and 
receive Motivational Interviewing Training to communicate with community members about their 
motivators and barriers to receiving the COVID-19 vaccine. Champions may join the study as vaccinated 
persons, or if previously enrolled as an unvaccinated participant, can become a Champion once 
vaccinated. 
 
4.2 
Scientific Rationale for Study Design 
Aims 2 and 3 uses an individually randomized design spanning 6-months. This greatly improves the 
feasibility of the study as our community partners strongly encouraged us to allow all participants to 
receive the social marketing and Champions interventions without much delay.  
 
Secondary outcomes include Vaccine Intentions, a continuous variable. 
Participants who were unvaccinated or unboosted at will receive the intervention after completing 
follow-up at six months. This cohort will be followed until they are vaccinated or until the end of the 
study, six-months after follow-up of the primary intervention. 
 
4.3 
Justification for Dose 
 
1 vaccine from baseline survey 
 
4.4 
End of Study Definition 
At the end of the intervention period following the completion of follow-up survey. PHI will be 
stripped, data will be deidentified. 
 
5 
STUDY POPULATION 
  
5.1 
Inclusion Criteria 
Eligibility inclusion criteria:  
- unvaccinated and unboosted adults 18 years and older who are interested in participating in the 
study 
- Must be able to read and write in English or Spanish 
- Must be able to receive SMS/MMS/text messages 
 
5.2 
Exclusion Criteria 
 Exclusion criteria: 
- Persons under the age of 18  
- unable to read or write English or Spanish 
- unable or unwilling to receive SMS/MMS 
- unwilling to consent  
- for vaccine champions-unwillingness to complete communication trainings in English 
 
No specific racial, ethnic, nor gender group is excluded.  
 
5.3 
Lifestyle Considerations 

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Not applicable. 
 
5.4 
Screen Failures 
- Persons under the age of 18  
- unable to read or write English or Spanish 
- unable or unwilling to receive SMS/MMS 
- unwilling to consent 
-for vaccine champions-unwillingness/unable to complete communication trainings in English 
 
5.5 
Strategies for Recruitment and Retention of Participants 
1) Change in recruitment procedures or documentation. 
a. Recruitment will be expanded to allow all Michiganders to enroll. 
b. In addition to recruiting from churches, we will expand enrollment to public events and 
forums such as attending health fairs, community baby showers, farmers markets, bus stops, 
social media, online blogs, etc. 
c. After Ame00138260, Recruitment expanded to include Data Direct 
i. Individuals meeting eligibility criteria from DataDirect will be contacted by phone, up 
to 8 times over a 6-week period. Recruiters will use the script in "8.1-
6_AME00138260_HUM00204174_Data-Direct-Recruitment-Script_English.pdf(0.01)" or 
"8.1-6_AME00138260_HUM00204174_Data-Direct-Recruitment-
Script_Spanish.pdf(0.01)" as appropriate. Individuals will be contacted by IRB-approved 
study team members from the study's phone # (734) 615-2860. Individuals identified as 
meeting eligibility criteria from DataDirect will be included in a file sent securely to the 
G2YMI study team. File data elements include name, phone, email. While vaccination 
status is not included in the file, only individuals who are not currently up-to-date, 
according to their MiChart EMR, will be provided to the study team, and contacted to 
invite to participate. 
2) If someone is interested in participating they may enroll at www.g2ymi.org ("the website"). The 
electronic survey and responses are stored on secure servers. They may access this URL by: 
a. type "the website" into an internet browser or 
b. request a link to "the website" be sent to them via SMS (data and service charges may 
apply depending on a person's phone carrier and plan) 
c. receive the link in their secured inbox in their U-M Health Research account 
d. Receive the link by phone. 
 
Newly Enrolled (post December 2022) Vaccine Champions will complete the virtual, MI-based, 
(Articulate) communications training only. No incentive will be paid to newly enrolled Vaccine 
Champions. Note: Currently enrolled (prior to December 2022) Vaccine Champion Plus will be trained on 
motivational interviewing and COVID-19 vaccine facts. They will receive abbreviated PEERRS training as 
well as Motivational Interviewing techniques. We will distribute vaccine champions initial $50 payment 
after a self-paced virtual and $50 for a live-virtual MI-based communication training. 
 
 
 

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Privacy is critical to the study team and steps to maintain confidentiality of research subjects is 
described in Section 6 of this application.  
 
Neither participant information, nor consent/enrollment status, will not be shared with any 
participants’ healthcare providers. 
 
P.I. Dr. Ken Resnicow and Co-I Pastor Williams meets with RSL from the four intervention counties, who 
meet on a monthly basis, and will decrease as the study continues. All RSL from the counties are invited 
and encouraged to attend the meetings, along with study team members. These meetings are currently 
virtual. 
 
 
6 
STUDY INTERVENTION 
 
6.1 
Study Intervention(s) Administration 
MI Training for Champions the digital version can be found here.  
https://360.articulate.com/review/content/1b8f6140-026e-4ee8-91b7-419bdc3cf7c3/review 
SMS/MMS Intervention 
 
Human Subjects Training for Vaccine Champions the digital version can be found here. 
https://docs.google.com/presentation/d/1t2SD4gAPkggBPTwRbByaXxPVKoPDt2NsbAWnPEiT8gA/edit?u
sp=sharing 
 
6.2 
Preparation/Handling/Storage/Accountability   
 
6.2.1 Acquisition and accountability 

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6.2.2 Formulation, Appearance, Packaging, and Labeling 
 
 
 

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6.2.3 Product Storage and Stability 
Not applicable 
 
 
6.2.4 Preparation 
Not applicable 
 
6.3 
Measures to Minimize Bias: Randomization and Blinding 
Using an individual-randomized design and working through the same churches (AA only) that 
participated in the Aim 2 multilevel intervention, we will develop and test, with the active engagement 
of the CIVIC SC, the impact of a tailored mobile-optimized web intervention on vaccine uptake. 
Individually tailored interventions have consistently been shown to be more efficacious than group-level 
or static messages. Participants, none of whom will have been vaccinated, will be randomly assigned to 
each condition. 
6.4 
Study Intervention Compliance 
We are not anticipating any AE’s. We are collecting limited data from subjects. Routine study 
monitoring by the PMs and technology staff at CHCR, could identify a reportable event, such as concerns 
following the approved protocol, IRB application, or agreements with the NIH and this award. 
Unexpected adverse events (i.e., has NOT been addressed or described in one or more of the following: 
Informed consent document(s) for this study, IRB application for this study, grant application or study 
agreement, protocol or procedures for this study, investigators’ brochure or equivalent (for FDA 
regulated drugs or devices), DSC Reports, published literature, other documentation) 
 
 
6.5 
Concomitant Therapy 
Not applicable. 
 
6.5.1 Rescue Medicine 
Not applicable. 
 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
 
7.1 
Discontinuation of Study Intervention 
Previously collected data will remain intact, until the end of the intervention collection period when 
it’s deidentified. No further contact or data collection will occur. 
 
7.2 
Participant Discontinuation/Withdrawal from the Study 
While the study team does not anticipate the need to end a subject’s participation, nor a Champion’s 
participation, they will routinely monitor and review the study for adverse events (AE) or other 
reportable events such as protocol deviations (ORIO). Unexpected, clinically significant, findings will 
be reported as an AE/ORIO with this application.  

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Should a participate request withdraw, the study team member will follow-up with the participant, 
unless requested not to be contacted, to assess a possible reportable event.  
 
If a Champion is found to disseminate information in contradiction to the information provided with 
their MI training or the CDC recommendations, they may be corrected and offered an opportunity 
for improvement or be asked to stop their participation.  
 
7.3 
Lost to Follow-Up 
Participants who have not been reached for at least 8-weeks after enrollment, or about 10 times 
for recruitment, will be considered lost to follow-up. Participants may resume the intervention at the 
point they left off., 
 
 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1 
Efficacy Assessments  
Eligibility:  
- unvaccinated/unboosted adults 18 years and older who are interested in participating in the study 
- Must be able to read English or Spanish 
- Must be able to receive SMS/MMS/text messages 
 
Screening: Community members who text to enroll will receive an SMS/MMS with a link to 
complete eligibility screening and consent. 
- Unvaccinated/unboosted enrollees may enroll in the SMS/MMS intervention. 
- Fully Vaccinated individuals may become Vaccine Champions for their community. Prior to 
December 2022, those that are enrolled will become Vaccine Champion Plus and were primarily 
recruited through the collaborating churches. VC+ will complete the Motivational Interviewing (MI) 
Training, which provides evidence-based methods to communicate about motivators and barriers to 
health interventions, over Zoom, if in-person activities are not permitted at the time of the training. At 
the MI Training, Champions will be informed of how to assess when the person might need follow-up to 
discuss their barriers and motivators for the vaccine. VC+’s will be manually matched to participants by 
the study team. They will have access to identifiable information through the G2YMI dashboard under 
the vaccine champion permissions on G2YMI. 
-After January 2022, fully vaccinated individuals can become vaccine champions. They will not 
interact with participants. The champions can complete the Motivational Interviewing training on the 
Articulate 360 platform.  
 
Recruitment and study procedures:  
RSL will agree to recruit their church attendees by completing the via one church-wide 
announcement using the communication method preferred by their congregation (i.e face-to-face, 
phone, email) using the Key Facts Script that includes the URL and QR code to the Eligibility Screener and 
Consent.  
 

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We will also work with the CIVIC Steering Committee (SC) for recruitment of individuals  in the four 
focal communities. The SC is made up of community leaders from across Wayne, Washtenaw, Genesee 
and Kent counties.  
 
Previous to the RCT change, we enrolled church RSL who expressed interest in participating by 
completing the survey located in 10-1.6 Church-Eligibility-Survey_HUM00206580. Recipients of the 
survey will be encouraged to distribute the survey to their own networks to reach the eligible churches. 
We will continue to work with the RSL and staff from our 32 collaborating churches. 
- Survey data collection is done using Qualtrics (baseline, check-in, 6mo follow-up). We use the 
instance of Qualtrics under the UM license which is approved for collection of sensitive data. 
- Electronic signatures are obtained for CIA and PPA forms using SignNow. 
Potential Enrollees who text to enroll will receive an SMS/MMS with a link to complete eligibility 
screening and consent. 
- SMS/MMS are sent via Twilio. 
- Unvaccinated/unboosted enrollees may enroll in the SMS/MMS intervention 
- Vaccinated enrollees  
- Enrolled prior to Dec 2022, may become vaccine Champions for their community. Champions 
will complete the Motivational Interviewing (MI) Training, which provides evidence-based methods to 
communicate about motivators and barriers to health interventions, over Zoom, if in-person activities 
are not permitted at the time of the training. At the MI Training, Champions will be informed of how to 
assess when the person might need follow-up to discuss their barriers and motivators for the vaccine. 
Human subjects in research training will also be provided.  
- Enrolled after Dec 2022, may complete the MI (Articulate) online training to aid conversations 
around vaccine hesitancy but will not interact with participants. 
We will be recruiting people at community events and locations such as health fairs and bus stops. 
We will also utilize social media in our recruitment efforts. We will be using face-to-face 
communications, scripts (attached) and other recruitment materials such as flyers, posters, business 
cards.  
Recruitment of those from Data Direct will contact individuals using IRB-approved phone scripts 
(attached in eResearch 08-1). 
 
8.2 
Safety and Other Assessments 
A Data Safety Committee (DSC) will be put into place as an integral part of the study’s manual of 
procedures—to monitor participant safety and evaluate the ability of the investigators to conduct the 
proposed study with utmost regard for participant, Champion, and church protection and 
confidentiality. The study will not begin without approvals of the University of Michigan IRB. The PI and 
study team will conduct periodic reviews of regulatory requirements.  
 
In addition, in accordance with federal regulations, the Data Safety Committee will convene to act in 
an advisory capacity to the study and NIH NIDDK to monitor patient safety and evaluate the ability of 
the investigators to conduct the proposed research with utmost regard for patient protection and 
confidentiality. The DSC will undertake the following tasks:  
 
1. Approve initiation of the proposed study prior to study enrollment. 
2. Review the research protocol, informed consent documents, and plans for data safety and 
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3. Evaluate the progress of the study including periodic assessments of data quality and timeliness, 
participant recruitment, accrual and retention, participant risk versus benefit, performance of the 
clinical centers, and other factors that may affect study outcomes. This will occur on an ongoing basis.  
4. Consider factors external to the study when relevant information becomes available, such as 
scientific or therapeutic developments that may have an impact on the safety of the participants or the 
ethics of the study.  
5. Protect the safety of the study participants. 
6. Report on the safety and progress of the study. 
7. Make recommendations to the study team and NIH HHS, and if required, to the IRBs concerning 
continuation, termination or other modifications of the study based on the observed beneficial or 
adverse effects of the study procedures. 
8. Review interim analysis in accordance with stopping rules that will be developed for the study 
protocol and that will be defined in advance of data analysis and have approval of the DSC. 
9. Ensure the confidentiality of the study data and the results of monitoring. 
10. Assist the funding agency by commenting on any problems of study conduct, enrollment, sample 
size, and/or data collection. 
 
All aspects of the proposed research will be conducted with utmost regard for the welfare and 
privacy of the volunteer participants. The DSC meetings shall be closed to the public because discussions 
may address confidential patient data. Urgent or emergent meetings of the DSC may be called at any 
time or in the event of issues regarding patient safety. The format for the DSC meetings may be open or 
closed as dictated by the agenda of the meeting.  
 
Termination of the Study: A majority vote of the DSC will be required to issue a study termination 
recommendation. Potential reasons could be but are not limited to: 
1. An exceedingly large number of serious and unexpected adverse events. 
2. Severe and not rectifiable logistical or data quality problems. 
 
The DSC will consist of study team members who include a clinical leader and well-established 
researcher, PMs, Research Assistants, and the PI. The study biostatistician will be available to provide 
input and/or attend the DSC meetings, as needed. 
 
In addition, any data integrity and patient safety-related issues will be prioritized. At study start, all 
research personnel, coaches and staff will undergo training and in-service meetings about study 
procedures. The importance of data security and compliance with procedures will be emphasized. All 
study personnel are required to complete and be certified by the Program for Education and Evaluation 
in Responsible Research and Scholarship (PEERRS) at the University of Michigan every 3 years (or 
equivalent, i.e. CITI training as applicable depending on University/site affiliation). A standard reporting 
form for adverse events will be created and completed by study personnel on an as-needed basis. 
Adverse events will be discussed at biweekly team meetings or sooner if needed and reported to the 
IRB. Documentation of completion of tasks and DSC activities will available in the team meeting minutes 
and ORIO/AEs submitted to the IRB.  
A Regulatory and Compliance Dropbox folder will also contain all communications to the IRB, 
including the initial application, study protocol, any amendments, annual IRB renewal, IRB approvals, 
and a summary of adverse events. It will be the responsibility of the project team to maintain and 
update the folder. In addition, the Project Manager/Coordinator will review consent forms, and source 
data at regular intervals along the study, with reviews documented in a Monitoring Log, accompanied by 
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Lastly, this project includes an applicable clinical trial registered with ClinicalTrials.gov, 
NCT#05096260. 
   
8.3 
Adverse Events and Serious Adverse Events 
 
8.3.1 Definition of Adverse Events (AE) 
According to the UM Medical School Office of Research definition, an adverse event (AE) is any 
experience or abnormal finding that has taken place during the course of a research project and was 
harmful to the subject participating in the research, or increased the risks of harm from the research, or 
had an unfavorable impact on the risk/benefit ratio. 
 
8.3.2 Definition of Serious Adverse Events (SAE)  
An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the view of either 
the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse 
event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant 
incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital 
anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or 
require hospitalization may be considered serious when, based upon appropriate medical judgment, 
they may jeopardize the participant and may require medical or surgical intervention to prevent one of 
the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm 
requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do 
not result in inpatient hospitalization, or the development of drug dependency or drug abuse. 
 
8.3.3 Classification of an Adverse Event 
1.1.1.1 Severity of Event 
According to the UM eResearch definition, adverse events are categorized according to the 
following grading system: 
 
0 - No adverse event 
1 - Mild AE – No treatment needed 
2 - Moderate AE – Resolved with treatment 
3 - Severe AE – Inability to carry on normal activities, required professional medical attention 
4 - Life-threatening or disabling AE 
5 - Fatal AE 
 
1.1.1.2 Relationship to Study INTERVENTION 
We will use the following levels of relationship to study intervention, which is in accordance to 
eResearch: 
 
• 
Definitely Related – There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. The clinical event, occurs in a plausible time relationship 
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drugs or chemicals. The response to withdrawal of the study intervention (dechallenge) should 
be clinically plausible.  
• 
Probably Related – There is evidence to suggest a causal relationship, and the influence of other 
factors is unlikely. The clinical event occurs within a reasonable time after administration of the 
study intervention, is unlikely to be attributed to concurrent disease or other drugs or 
chemicals. 
• 
Possibly Related – There is some evidence to suggest a causal relationship (e.g., the event 
occurred within a reasonable time after administration of the trial medication). However, other 
factors may have contributed to the event (e.g., the participant’s clinical condition, other 
concomitant events). Although an AE may rate only as “possibly related” soon after discovery, it 
can be flagged as requiring more information and later be upgraded to “probably related” or 
“definitely related”, as appropriate. 
• 
Unlikely to be related – A clinical event, including an abnormal laboratory test result, whose 
temporal relationship to study intervention administration makes a causal relationship 
improbable (e.g., the event did not occur within a reasonable time after administration of the 
study intervention) and in which other drugs or chemicals or underlying disease provides 
plausible explanations (e.g., the participant’s clinical condition, other concomitant treatments). 
• 
Not Related – The AE is completely independent of study intervention administration, and/or 
evidence exists that the event is definitely related to another etiology.  
 
1.1.1.3  Expectedness  
The principal investigator will be responsible for determining whether an adverse event (AE) is 
expected or unexpected.  An AE will be considered unexpected if the nature, severity, or frequency of 
the event is not consistent with the risk information previously described for the study intervention.  
● Psychosocial difficulties 
o Potential expected and unexpected risks will be outlined for patients in the informed 
consent document(s). 
● Potential Benefits 
o There are no immediate health benefits to the study subjects. This study, however, will 
provide important information about the beliefs, behaviors, sources of truth, and 
misinformation that drive COVID-19 vaccine uptake so that in the future others might 
benefit from this study. The risks of the study are considered minimal. 
● Potential Risks 
o Likelihood: There is the "rare" potential risk that participants may be embarrassed or 
upset by questions in the questionnaires or interviews.  
o Seriousness: We anticipant <1% risk as subjects will have the option to not answer any 
questions that they determine to be too sensitive. Questions have been previewed by 
community members, religious and spiritual leaders, and items deemed too sensitive 
were removed from the intervention, and not listed in this application.  
o Measures to minimize risk: Privacy is very important, and the study investigators will use 
many safety measures to protect subject privacy.  
o Participation in this research is voluntary, and they may choose to withdraw at any time 
by contacting the study team at gettingtoyesmi@med.umich.edu 
o Participation in this research is confidential. All research data will be de-identified, and 
subjects will be identified by number and not by name. No information by which the 
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o No information by which the subject can be identified will be released or published in 
connection with this study. In spite of all of the safety measures that we will use, 
however, we cannot guarantee that subject identity will never become known.  
o Study paper data i.e. consent forms and history forms will be stored in locked cabinets, 
and electronic data will be stored servers accessible via password-protected computers. 
o Study data will be stored in a relational database on a separate highly restricted secure 
server. Databases will be backed up daily to an offsite NAS storage device using 
automatic backup software that is available 24/7 except for scheduled maintenance. 
Only the primary investigators and other authorized research team members named in 
this application will have access to the de-identified data. These standards will help 
ensure that violations of confidentiality will be minimal. 
o The procedures outlined in this proposal are considered minimal risk. There are no 
anticipated medical risks.  
o There is the potential risk that participants may be embarrassed or upset by questions in 
the questionnaires or interviews. Subjects will have the option to not answer any 
questions that they determine to be too sensitive. 
 
The definitions from eResearch on expectedness is as follows: 
● Unexpected adverse events (i.e., has NOT been addressed or described in one or more of the 
following: Informed consent document(s) for this study, IRB application for this study, grant 
application or study agreement, protocol or procedures for this study, investigators' brochure or 
equivalent (for FDA regulated drugs or devices), DSC Reports, published literature, other 
documentation) 
● Expected adverse events (i.e., has been addressed or described in one or more of the following: 
Informed consent document(s) for this study, IRB application for this study, grant application or 
study agreement, protocol or procedures for this study, investigators' brochure or equivalent 
(for FDA regulated drugs or devices), DSC Reports, published literature, other documentation, or 
characteristics of the study population)  
● This study is minimal risk and we anticipate an increased uptake in the COVID-19 vaccine in the 
four target counties. This will help reduce the spread of COVID-19 virus and associated 
misinformation. 
1.1.2 Time Period and Frequency for Event Assessment 
and Follow-Up 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention 
of study personnel during interviews of a study participant presenting for medical care, or upon review 
by a study monitor. 
 
All AEs including local and systemic reactions not meeting the criteria for SAEs will be captured on 
the appropriate case report form (CRF). Information to be collected includes event description, time of 
onset, clinician’s assessment of severity, relationship to study product (assessed only by those with the 
training and authority to make a diagnosis), and time of resolution/stabilization of the event. All AEs 
occurring while on study must be documented appropriately regardless of relationship. All AEs will be 
followed to adequate resolution. 
 

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The study team will record all reportable events with start dates occurring any time after informed 
consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study 
participation.  Events will be followed for outcome information until resolution or stabilization.  
 
1.1.3 Adverse Event Reporting  
We will report all adverse event according to the UM Medical School Office of Research reporting 
timetable: 
 
 
 
 
1.1.4 Serious Adverse Event Reporting  
We will report serious adverse events according to the Office of Research timetable above. DSC 
described in section 8.2. We do not anticipate any study-related serious adverse events to occur as this 
is a study with no more than minimal risk. 
  
1.1.5 Reporting Events to Participants  
Not applicable – Any adverse events that may happen will likely be due to individual differences, e.g. 
baseline mental and physical health status, instead of systemic issues. 

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1.1.6 Reporting of Pregnancy  
N/A 
 
1.2 
Unanticipated Problems 
 
1.2.1 Definition of Unanticipated Problems (UP) 
The Office for Human Research Protections (OHRP) considers unanticipated problems involving risks 
to participants or others to include, in general, any incident, experience, or outcome that meets all of 
the following criteria: 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
participant population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized. 
 
1.2.2  Unanticipated Problem Reporting  
According to UM Medical School Office of Research guidelines: 
Serious unanticipated problems and Unanticipated Adverse Device Effects (UADEs) must be 
reported within 7 calendar days of the problem (or within 7 calendar days of the study team becoming 
aware of the problem). Non-serious unanticipated problems must be reported within 14 calendar days 
of the problem (or within 14 calendar days of the study team becoming aware of the problem). 
 
If the unanticipated problem involved one or more persons experiencing actual harm, report the 
unanticipated problem as an adverse event. Refer to the AE Reporting page 
(https://az.research.umich.edu/medschool/guidance/adverse-event-reporting) and follow the 
instructions provided, using the external or internal form as appropriate. 
 
If a person did not experience actual harm but an unanticipated problem entailed potential harm, 
and/or risk of harm to subjects or others, refer to the ORIO Reporting page 
(https://az.research.umich.edu/medschool/guidance/other-reportable-information-or-occurrence-orio) 
and follow the instructions provided. 
 
If the IRB concurs that an event is an unanticipated problem the study team will follow the policies 
and procedures outlined in the University of Michigan Human Research Protection Plan Operations 
Manual, part 12. 
 
1.2.3 Reporting Unanticipated Problems to Participants  
N/A 
 
2 
STATISTICAL CONSIDERATIONS  

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2.1 
Study Hypotheses 
To increase the uptake of COVID-19 vaccinations amongst African American/Black and Latinx 
persons living in the counties of Washtenaw, Kent, Wayne, and Genesee. 
 
1: Increase understanding of the barriers and drivers of vaccine uptake and hesitancy;  
2: Increase vaccine uptake and decrease vaccine hesitancy through the implementation and evaluation 
of a multilevel intervention; and maintain, enhance, and evaluate the effectiveness of the CIVIC 
partnership to equitably engage all partners. 
 
2.2 
Sample Size Determination 
PIs Resnicow and Spino have calculated sample size to account for power and individually 
randomized control trial.  
 
2.3 
Populations for Analyses 
Individuals enrolled in the study will be from predominately African American/Black and Latinx 
populations. 
 
2.4 
Statistical Analyses 
 
2.4.1 General Approach 
We will follow international guidelines for analysis and reporting of individually randomized clinical 
trials. We will first examine the distributions of all study variables to assess missing data, possible coding 
errors, and distributional form, including skewness, variance, and extreme values.  
 
Participants will see a public “control” website until their group changes into Intervention.  
 **While the enrollment period is open throughout the intervention, only those who 
complete the baseline prior to the first bi-monthly check-in will have a tailored text message 
experience.  
 
2.4.2 Analysis of the Primary Efficacy Endpoint(s) 
For the primary outcome (vaccine uptake), All data will be de-identified to ensure confidentiality of 
participants, with results presented in summary to protect confidentiality. Analysis of quantitative 
questionnaire data will involve descriptive statistics, comparison of years 1-5, and examination by 
partner role (community or academic). Given the small number of SC members (n=19), statistical tests of 
significance will not be used; rather, we will identify trends for further discussion. We will use a 
systematic process of coding and constant comparison of all qualitative data to conceptualize group 
content127 and to consider similarities and differences in responses for different groups (e.g., academic, 
community). Key quotes from the qualitative data will be selected to illustrate themes. 
 
Descriptive statistics will be tabulated and graphical methods will be used to characterize individuals 
and churches. In Aim 2, summaries over time also provides information on intervention status to allow 
consideration of selection biases and balance. An intention-to-treat approach will be used to define the 

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analysis population: all participants enrolled in each randomized church for Aim 2 will be analyzed. We 
will summarize the extent of missing data over time for the primary endpoints. Differences in participant 
demographics and baseline characteristics between those with and without missing follow-up data will 
be given overall and by intervention group. Two-sided p-value will be reported and no adjustments for 
multiplicity will be made. Thus, p-values for secondary and exploratory outcomes will be interpreted 
with caution. Confidence intervals will be provided to summarize differences between interventions. A 
statistical analysis plan will be finalized prior to locking the databases. The primary outcome is the binary 
variable of patient reported vaccine uptake over the 6 month assessment period of the stepped wedge. 
Analyses will use a generalized linear mixed model with a logit link to account for the binary primary 
outcome; vaccinated (YES/NO). The model addresses the stepped-wedge design features including 
adjusting for calendar time as a fixed effect (time period) and an indicator variable that describes the 
treatment in each cluster (church) at each time. Given the cluster randomized nature and cohort follow-
up in our stepped-wedge design, we will include a random intercept to account for church clustering 
(ICC) and a random effect for individuals in the model. An exchangeable correlation matrix that assumes 
similar correlation between outcomes for participants within the same church will be used. The primary 
statistic of interest is in the odds of vaccination between the intervention and waiting conditions, 
controlling for church level clustering (ICC) as well as individual level covariates, e.g., age, gender, 
income, education, all of which have been shown to influence vaccine uptake. Relationships between 
the demographics and outcome variables will be examined in bivariate analyses (Pearson and Spearman 
correlations, t-tests, and χ2-tests). The selection of appropriate covariates for multivariable analyses will 
follow the variable selection approach of Heinze et al15,16 that incorporates background knowledge as 
well as statistical criteria (such as significance of covariates with p < 0.05 or Akaike information 
criterion). Continuous variables such as our secondary outcome, i.e., intentions to vaccinate, will be 
analyzed similarly, using the identity link and the normal distribution. A priori interaction terms 
(intervention effect modifiers) that will be test include gender, income, education, church 
denomination, and ethnic identity. We will also test time interactions with treatment condition. This will 
allow us to determine if different lengths of exposure to the intervention yield greater outcomes, i.e., 
dose response effects. We expect missingness of vaccine data to be modest (< 20%), and our models 
account for any missingness at random. If there is substantial missingness or missingness not at random, 
we will use the most advanced missing data handling methods (e.g., multiple group multiple imputation) 
to maintain sample size and methods such as selection and pattern mixture modeling17. Sensitivity 
analyses for each Aim’s primary endpoint will be performed to assess the impact of missingness 
assumptions and approach on study conclusions.  
 
Mediation Analyses.  
We will use mediation analyses 18 19,20-22 under the direction of Drs. Resnicow and  Spino to 
examine whether intervention effects on vaccine uptake and vaccine intentions, if observed, can be 
explained by changes in key psychosocial variables. Similar analyses will be conducted for the Aim 2 
study. Specifically, we will examine whether changes in intervention targets such as vaccine attitudes, 
vaccine barriers, vaccine confidence, autonomous motivation, social norms, etc. account for 
intervention effects. Full mediation, a rare phenomenon, occurs when the association between 
treatment and outcome is fully eliminated in regression analyses. Mediation will be tested in a three-
step process.21 First, the mediator must be affected by the independent variable (IV) of intervention. 
Second, the intervention must be shown to affect outcomes. Finally, it must be shown that when the 
dependent variable is regressed on both the independent and mediator(s), the association between IV 
and outcomes is attenuated. We will estimate the direct and indirect effects of the mediating variables 
on primary outcomes and the structural relationships (or paths) linking them using the causal inference 
approaches to measure the direct and effects22-24. In addition to the regression approach, we will also 

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use structural equation modeling (SEM) to test and visualize mediation effects. We will examine the 
mediators using the R package lavaan to determine indirect effects using bootstrapping. Bootstrapping 
does not assume normality of the product term used to examine indirect effects. Moreover, lavaan can 
use full information maximum likelihood estimation to efficiently address any missing data that is either 
missing completely at random or missing at random in any of these constructs. Finally, we will explore 
whether improvements in primary outcomes are associated with different exposures such as time in the 
social marketing intervention or number of Champion contacts. 
 
2.4.3 Analysis of the Secondary Endpoint(s) 
Vaccine intentions will be assessed by asking, on a scale of 0-10, “how likely is it that you will get the 
COVID-19 vaccine?”, with 0 being very unlikely and 10 being very likely. This will be analyzed using linear 
regression as described in the data analysis section. " 
 
2.4.4 Safety and Interim Analyses 
Safety monitoring, classification of events and reporting are described in section 8. While there are 
no planned interim analyses other than what is done for study data safety along enrollment for the 
study, we may begin analysis sooner.  
 
● The DSC members will review the following on an ongoing basis. Number screened, number 
enrolled, number withdrawn. 
● Demographics for patients enrolled in control and intervention clinics. 
● Adverse events analysis which will include descriptive analyses of the adverse event, severity, 
whether unexpected or expected, whether or not there were associated hospitalizations.  
 
2.4.5 Baseline Descriptive Statistics 
 
2.4.6 Tabulation of Individual Participant Data 
Individual participant data will not be listed by measure and time point except for safety monitoring 
and reporting to IRB— and then only as aggregate and not identifiable, as outlined in section 8.  
 
2.4.7 Exploratory Analyses 
 
3 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
3.1 
Regulatory, Ethical, and Study Oversight Considerations 
 
3.1.1 Informed Consent Process 
This study protocol will not be implemented until reviewed and approved by the University of 
Michigan IRB. Potential subjects who approach study staff in person, via phone, in writing or via email, 
will be contacted by study staff, informed about the study and presented with the option to participate. 
Informed consent will be obtained prior to participation by study staff. Subjects will be informed in all 
cases about their rights as research subjects. Their participation is voluntary. They may decline 
participation without penalty or loss of any healthcare benefit or service to which they are entitled. All 
recruiting site personnel convey this information through the written and verbal consent process. 

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3.1.1.1 Consent/assent and Other Informational Documents Provided to participants 
Consent will be obtained through the study website.  Instead of a signature, they will be asked if 
they agree to be in the study. Answering “yes” to that question indicates consent to enroll in the study. 
The consent form describes in detail the study intervention, study procedures, risks and benefits, and 
contact information for the study team. Copy of the consent forms (one for patients enrolled to serve as 
controls and other for patients enrolled to receive intervention) are uploaded in eResearch. 
 
3.1.1.2 Consent Procedures and Documentation 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the 
study and continues throughout the individual’s study participation.  The consent process will be 
completed electronically through the study website. 
 
 
The participant will sign/say yes to and complete the informed consent process prior to any 
procedures being done specifically for this study and activities that are not unregulated. Participants will 
be informed that participation is voluntary and that they may withdraw from the study at any time, 
without negative impact to them (without prejudice). An electronic copy of the informed consent 
document will be given or sent to the participants for their records. The informed consent process will 
be conducted and documented in the source document (including the date), and the form signed, 
before the participant undergoes any study-specific procedures. The rights and welfare of the 
participants will be emphasized and consent will include a specific statement that the quality of their 
medical care will not be adversely affected if they decline to participate in this study.  
 
3.1.2 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, and 
regulatory authorities as appropriate.  If the study is prematurely terminated or suspended, the Principal 
Investigator (PI) will promptly inform study participants, the Institutional Review Board (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 visit schedule. 
  
Circumstances that may warrant termination or suspension include, but are not limited to: 
● Determination of unexpected, significant, or unacceptable risk to participants 
● Demonstration of efficacy that would warrant stopping    
● Insufficient compliance to protocol requirements 
● 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, DSC and IRB.  
 
3.1.3 Confidentiality and Privacy  

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Participant confidentiality and privacy is strictly held in trust by the participating investigators, their 
staff, and the sponsor(s) and their interventions. This confidentiality is extended to cover testing of 
biological samples, patient-reported measures (either during coaches or study surveys) and clinical 
information relating to participants. Therefore, the study protocol, documentation, data, and all other 
information generated will be held in strict confidence. No information concerning the study or the data 
will be released to any unauthorized third party without prior written approval of the sponsor.  
 
The study monitor, other authorized representatives of the sponsor, representatives of the 
Institutional Review Board (IRB), or regulatory agencies may inspect all documents and records required 
to be maintained by the investigator, including but not limited to medical records (office, clinic, or 
hospital) and pharmacy records for the participants in this study. In this case the clinical study site will 
permit access to such records. 
 
The study participant’s contact information will be securely stored on a secure server at U-M for as 
long a period as dictated by the reviewing IRB, institutional policies, or sponsor requirements. 
 
The database that contains survey results and clinical data will only be identified by study ID’s. A 
separate file will be created to link the participant’s name and other identifiable data to the study ID. 
Only the core study team (e.g. PI and research assistants) will have access to the password protected 
linking file. We do not anticipate any information to be identifiable without the linking file. Only key 
personnel will be able to have access to identifiable information on participants. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, 
will be transmitted to and stored at the University of Michigan. All transferred data will abide by local 
and UM policies regarding sharing data and encryption. The study data entry and study management 
systems used by clinical sites and by University of Michigan research staff will be secured and password 
protected. At the end of the study, all study databases will be de-identified and archived at the 
University of Michigan. 
 
Certificate of Confidentiality  
To further protect the privacy of study participants, a Certificate of Confidentiality will be issued by 
the National Institutes of Health (NIH).  This certificate protects identifiable research information from 
forced disclosure. It allows the investigator and others who have access to research records to refuse to 
disclose identifying information on research participation in any civil, criminal, administrative, legislative, 
or other proceeding, whether at the federal, state, or local level. By protecting researchers and 
institutions from being compelled to disclose information that would identify research participants, 
Certificates of Confidentiality help achieve the research objectives and promote participation in studies 
by helping assure confidentiality and privacy to participants. 
  
3.1.4 Future Use of Stored Specimens and Data  
- Deidentified data will be retained for study record keeping purposes and future research, it will be 
stored, indefinitely, on secure servers at U-M.  
- Data will be stripped of all identifiers before storage. 
 
3.1.5 Key Roles and Study Governance 
 
Principle Investigator:  

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Kenneth Resnicow, PhD, 
Irwin M. Rosenstock Collegiate Professor  
Associate Director, Community Outreach and Health Disparities Research Rogel Cancer Center 
Department of Health Behavior Health Education 
University of Michigan  
Building 16, North Campus Research Complex Office 16-G036E 2800 Plymouth Rd. 
Ann Arbor MI 48109 
United States 
kresnic@umich.edu 
 
Co-investigators/Study Team: Larry An, M.D., Chris Coombe, Barbara Israel, Ph.D., Erica Marsh, 
M.D., M.P.H., Catherine Spino, Ph.D., Charles Williams, Charley Jiang, Emerson Delacroix, LLP, MACP, 
Patricia Piechowski, Arthi Ramakrishnan, Liz Bacon, MPH, Mary Beth Damm, MPP, Kirsten Trzeciak. 
 
3.1.6 Safety Oversight 
Safety oversight will be under the direction of a Data and Safety Committee (DSC) composed of 
individuals with the appropriate expertise.  The DSC will consist of selected members who have no 
conflicts of interest with the study. The DSC will be led by the PI. He has served on other DSCs and is 
both a clinical leader and well-established researcher. As needed, the PI and study biostatistician will be 
available to provide input and attend the DSC meetings.  The DSC has approved initiation of the 
proposed study for enrollment of human subjects, evaluate the progress of the study at initiation, when 
enrollment is 25% complete, 50% complete, and 100% complete.  Additionally, if the study is slow to 
recruit, the DSC will meet at least yearly.  In addition, urgent or emergent meetings of the DSC may be 
called at any time by the chair of the DSC or NIH project officer in event of any issues regarding patient 
safety.  At this time, each data element that the DSC needs to assess will be clearly defined. DSC reports 
will be included in status reports (RPPR reporting) to the NIH yearly.  
 
3.1.7 Clinical Monitoring 
N/a 
 
3.1.8 Quality Assurance and Quality Control 
To ensure consistent delivery of the intervention and uniform application of enrollment and data 
collection protocols, we hosted a kick-off meeting in Year 1 attended by prospective Religious and 
Spiritual Leaders, research staff, project support and Steering Committee members. Goals of the study 
were discussed along with design and procedures. Study team members have been split into teams and 
assigned aspects of the study to develop and give input on study materials development. In addition, we 
brought in experts in quality improvement (through UM Quality and Innovation Program) and leaders on 
the study team in continuous quality improvement (CQI). With study team member input, we have 
developed a study team communication plan for study personnel, staff, co-investigators, as well as 
providers and staff in involved clinics. We are working with staff at UM to develop an online project 
website, and there will be an additional secure/password protected feature for providers from involved 
clinics to sign in and learn more about the study. Descriptions of the study will be produced in a variety 
of formats for distribution via group emails and as handouts in the community that include study key 
facts for consistency.  
 

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In addition, for specific study procedures, we will produce data collection manuals with detailed 
instructions for issues such as how to note missing data, how to make changes on data collection forms, 
and how to adjudicate decisions when survey response options are unclear and have this reviewed by 
our colleague experts in CQI. In addition, once enrollment begins, data quality issues will be discussed at 
weekly meetings between project staff and the PI. Data integrity and completeness will be checked 
periodically by research personnel and reported at biweekly team meetings as described previously in 
section 8.2. 
 
Quality control (QC) procedures will be implemented beginning with the data entry systems and 
data QC checks that will be run on the database will be generated. Any missing data or data anomalies 
will be communicated to staff for clarification/resolution. 
 
The investigational site will provide direct access to all trial related sites, source data/documents, 
and reports for the purpose of monitoring and auditing by the sponsor, and inspection by local and 
regulatory authorities. 
 
Rigor and reproducibility will be maximized by quality control of all study protocols and procedures 
and by using a robust experimental design for the intervention. This study applies high standards in its 
methodology and its analysis plan which will be continued through interpretation and results reporting. 
We will be transparent in reporting experimental details so that others may reproduce and extend the 
findings in the future. 
 
3.1.9 Data Handling and Record Keeping  
Data will be deidentified for indefinite storage on secured servers at U-M, to assist with future 
research. Study data will be stored in a relational database on a separate highly restricted secure server. 
Databases will be backed up daily to an offsite NAS storage device using automatic backup software that 
is available 24/7 except for scheduled maintenance. Only the primary investigators and other authorized 
research team members named in this application will have access to the de-identified data. These 
standards will help ensure that violations of confidentiality will be minimal. 
 
3.1.9.1 Data Collection and Management Responsibilities  
 
All source documents should be completed in a neat, legible manner to ensure accurate 
interpretation of data.   
 
Study data will be stored on research compliant servers provided by the University of Michigan. The 
data system includes password protection and internal quality checks, such as automatic range checks, 
to identify data that appear inconsistent, incomplete, or inaccurate.  
 
3.1.9.2 Study Records Retention  
 
Study documents will be retained until the formal discontinuation 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. 
 

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3.1.10 Protocol Deviations  
 
It is the responsibility of the PI to use continuous vigilance to identify and report deviations.  All 
deviations will be addressed in study source documents, reported to the NIH Program Official and 
University of Michigan Institutional Review Board (IRB). The site investigator is responsible for knowing 
and adhering to the reviewing IRB requirements.  
 
3.1.11 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. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-
Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission 
rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will 
be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-
reviewed journals.  Data from this study may be requested from other researchers years after the 
completion of the primary endpoint by contacting Ken Resnicow, Ph.D. 
 
3.1.12 Conflict of Interest Policy 
 
The independence of this study from any actual or perceived influence is critical.  Therefore, any 
actual conflict of interest of persons who have a role in the design, conduct, analysis, publication, or any 
aspect of this trial will be disclosed and managed. Furthermore, persons who have a perceived conflict 
of interest will be required to have such conflicts managed in a way that is appropriate to their 
participation in the design and conduct of this trial.  The study leadership in conjunction with the NIH 
and U-M that have 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. 
 
3.2 
Additional Considerations 
Not applicable. 
 

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3.3 
Abbreviations 
 
AA 
African Americans 
AE 
Adverse Event 
CIVIC 
Community-centered Interventions for Vaccine Uptake for COVID-1( 
DSC 
Data Safety Committee 
GCP 
Good Clinical Practice 
       G2YMI 
Getting to Yes, Michigan! 
HIPAA 
Health Insurance Portability and Accountability Act  
IRB 
Institutional Review Board 
LX 
Latinx 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
PI 
Principal Investigator 
RA 
Research assistant / research associate 
U-M 
University of Michigan 
UP 
Unanticipated Problem 
US 
United States 
 
3.4 
Protocol Amendment History 
 
Amendment #1: Ame00123018 Recruitment 
1. Recruitment materials have been updated to exclude outdated language not approved in original 
app. These added recruitment materials for use at churches (e.g. posters, business cards, prompts 
for written communications from RSL to church attendees). 
2. Additional churches have opted to participate and added to Participating sites. 
3. Spanish consent has additional sentence added. 
4. Updated study email from gettingtoyesmichigan@umich.edu to gettingtoyesmi@med.umich.edu. 
 
Amendment #2: Ame00123968 Staff, Church Recruitment Pkt/Flyers 
1. Study Team Members have been updated to include new RAs and remove staff off the project. 
2. Updated church fliers and welcome packet to include HUM# and reformatted for improved 
aesthetic.  
3.  Fully executed Collaborating Institution and Project Participation Agreements added to each 
church in 3-1.1* Performance Sites. 
4. Removed churches from section 3-1.1 Performance Sites that are no longer participating in the 
study.  
 
Amendment #3: Ame00128520 RCT 
1. Changed statistical design from Stepped Wedge to RCT 
2. Changed eligibility criteria to include updated booster guidelines per CDC 
3. Expanded recruitment to include non-church community members to allow for public recruitment 
events, rather than faith-based recruitment events 
4. Recruiting Vaccine Champions who will go through virtual training only. Newly recruited Vaccine 
Champions will not receive incentives and will not interact directly with participants. 
5. Updated consent to include eligibility and recruitment changes noted above. 

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6. Updated enrollment numbers 
7. Included of MMS messages 
8. Update study team members. 
 
Amendment #4: Ame00133699 Audit Edits 
1. Add completed GCP trainings for all study team members. 
2. Update Protocol  
3. Update funding 
4. Update consent 
5. Update DSMB to DSC 
 
Amendment # 5: Ame00136269 SPAN-flyer 
1. Add Spanish translation of approved English recruitment flyer. 
2. Edit team members. 
Amendment #6: Ame00137511 New Ads, Staff 
1. Add new social media ads 
2. Edit team members 
 
Amendment-7: Ame00138260 Data Direct, Staff 
1. Recruitment Expansion to add Data Direct added to Protocol and application. Added 
recruitment Scripts in English and Spanish to 08-1. 
2. Edit team members 
 
Amendment-8: Ame00141536 Omicron Booster 
1. Survey and content will be updated to reflectthe FDA updated guidelines for defining "up-to-date" 
as receiving the bivalent (“Omicron”) booster. 
2. Staff members added/removed. 
3. Enrollment target is increased to 800 to have power for analysis after guide changes. 
 
Amendment-9: Ame00144824 Update Articulate, Enrollment 
1. Increase Enrollment to 1000 to increase population eligible for analysis.  
2.   Update Vaccine Champion Articulate Training with up-to-date content related to Sept 
2023 vaccine.  
3.   Update Public Articulate Training with up-to-date content related to Sept 2023 vaccine. 
 
Amendment-10: Ame00146052 Protocol 
1. Update protocol.

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3.5 
Appendices 
APPENDIX 1: OUTCOME MEASURES 
Variable 
Time point(s) 
Variable 
type 
Outcome type 
Demographics/patient characteristics (age, sex, gender, race, ethnicity, 
education, income) 
t(0) 
continuous, 
categorical 
N/A 
Participant SMS/MMS responses response for vaccine uptake 
 
continuous, 
categorical 
primary 
Participant perceptions 
t(1), t(2), t(3) 
continuous 
exploratory 
Vaccine intention 
t(1), t(2), t(3) 
continuous 
exploratory 
 
 
 
 
 
 

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PROTOCOL SIGNATURE PAGE 
 
Protocol Title: Community-Centered Interventions for Improving Vaccine Uptake for COVID-19: 
Getting to Yes, Michigan! 
 
 
Protocol Number: Version 12.0 
 
 
Protocol Version/ Date: February 26, 2024 
_________________________________________________________________ 
 
 
Sponsor Name: National Institutes of Health 
 
 
Declaration of Investigator 
 
I confirm that I have read the above-mentioned protocol and its attachments. I agree to conduct the 
described trial in compliance with all stipulations of the protocol, regulations and ICH E6 Guideline for 
Good Clinical Practice (GCP). 
 
  
 
Principal Investigator Name:  
 Ken Resnicow, Ph.D.  
 
 
Principal Investigator Signature:   
 
                                                          
 
Date:  2/26/24