CATCH-UP Vaccines: Extension of Community - Engaged Approaches to Testing in Community and Healthcare Settings for Underserved Populations
Phase: NA
Conditions: COVID-19, Vaccine Refusal
Sponsor: University of Oklahoma

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RESEARCH PROTOCOL OUTLINE
Title of Project: CATCH-UP Vaccines: Extension of CATCH-UP (Community - 
engaged Approaches to Testing in Community and Healthcare Settings for Underserved 
Populations)
Principal Investigator: Judith James, MD, PhD, Oklahoma Medical Research 
Foundation
Co-Principal Investigator: Amanda Janitz, PhD, Biostatistics and Epidemiology
Abstract
Our proposal is an extension of the Oklahoma Shared Clinical Translational Resources 
(OSCTR) project CATCH-UP (Community-engaged Approaches to Testing in 
Community and Healthcare settings for Underserved Populations) in partnership with the 
Oklahoma State Department of Health, Southern Plains Tribal Health Board, Latino 
Community Development Agency, County Health Improvement Organizations, Public 
Health Institute of Oklahoma, and the Center for Applied Social Research. We will build 
on existing strengths and infrastructure to improve SARS-CoV-2 vaccine uptake in these 
highly susceptible populations. 
A.
Specific Aims
Aim 1 (Preparation). Identify SARS-CoV-2 vaccination barriers/facilitators and 
assess acceptability and feasibility of a suite of evidence-based vaccine intervention 
strategies among Oklahoma’s rural, minority, and high-risk populations to inform a 
targeted multicomponent intervention. 
We will conduct up to 10 focus groups including participants from communities with low 
levels of vaccine uptake and/or high levels of vaccine hesitancy and communities holding 
events where SARS-CoV-2 testing or vaccination is offered in partnership with the 
CATCH-UP program (IRB #12582). Focus groups will: (1) explore vaccine-related 
concerns and motivators, (2) evaluate NIH Community Engagement Alliance (CEAL) 
educational resources for local and cultural acceptability; and (3) examine outreach and 
communication intervention strategies detailed in the NIH COVID-19 Vaccination 
Communication for feasibility at later testing events. 
Aim 2 (Optimization). Develop and optimize a multicomponent intervention to 
improve SARS-CoV-2 vaccination among Oklahoman’s seeking SARS-CoV-2 
testing at CATCH-UP testing events.  
Aim 2.1. Pilot Implementation. In a pilot implementation, we will randomize 
participants to either receive a text message (yes/no) and an educational intervention 
through a tablet compared to a control message. We will also pilot messages for 
motivational interviewing in tandem with SARS-CoV-2 antibody test results and observe 
how participants respond to the messages. As part of this study, we will collect 
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information on demographics, COVID-19 testing, and vaccine status and hesitancy as 
required by NIH for the RADx-UP projects.
Aim 2.2. Full implementation. Participants will be randomized to a 2 x 2 x 2 fully crossed 
factorial design, creating eight conditions to evaluate the contribution of each intervention 
component. Feedback from Aim 1 and Aim 2.1 will inform the selection and development 
of three intervention components, which address three primary areas to improve 
vaccination uptake in the catchment area of the community: (1) process improvement; (2) 
teachable moment messaging; and (3) barrier elicitation and reduction. 
B.
Background and Significance
This proposal unites academic and community partners to solve a dire need for SARS-
CoV-2 vaccine uptake in rural, underserved minority, and at-risk populations. Oklahoma 
has high COVID-19 incidence, high vaccine hesitancy, and signs of a slowing SARS-
CoV-2 vaccine uptake. As of April 30, 2021, 448,305 cases of COVID-19 and 8,263 
deaths have occurred in Oklahoma.1 Oklahoma’s cumulative incidence is higher in rural 
(12,065 per 100,000) compared to urban (10,973 per 100,000) counties.2 AI people have 
a higher incidence of COVID-19 compared to white populations in Oklahoma (22% 
higher). In the US, Hispanic (100% higher), AI (48% higher), and Black (8% higher) 
populations have higher incidence rates compared to NH Whites, though non-white 
race/ethnicity is likely underestimated due to racial misclassification.2-4 Over one third 
(34%) of AI adults aged 18-64 years are at risk of serious illness from COVID-19 due to 
comorbidities, which is also elevated for Black (27%) and Native Hawaiian/Pacific 
Islander (23%) people, with lower percentages among White (21%), Hispanic (20%), 
Asian (12%) people.5, 6 
Despite high incidence, as of April 2021, an estimated 54% of Oklahomans who have not 
yet been vaccinated (approximately half of those surveyed) reported unwillingness to 
receive the SARS-CoV-2 vaccine.7 Vaccine hesitancy was even greater in AI people 
(62%).7 The most common concerns were vaccine side effects and safety (30%).8 Other 
reasons for hesitation included waiting for more data/information (15%), lack of trust in 
government (13%), and concerns about how rapidly vaccines were developed (10%).8 As 
of April 30, over 2.6 million SARS-CoV-2 vaccines have been administered in 
Oklahoma, with 38% of the population having received one dose and 30% fully 
vaccinated.2 Despite this early progress, all signs point to waning interest in receiving a 
vaccine, with many vaccine clinics unable to fill all available slots, particularly in tribal 
and rural areas.
C.
Preliminary Studies/Progress Report  
The OSCTR has extensive experience collaborating with clinical healthcare providers in 
Oklahoma and collaborating with tribal populations. As noted above, OSCTR is a grantee 
of the RADxSM-UP program to identify and improve upon barriers to obtain testing for 
COVID-19. Initial findings from our patient survey during testing events (n=96) found 
that of those that had not been vaccinated, more than 50% indicated they were unlikely to 
be vaccinated, while nearly 15% were unsure. The most common reason respondents 
would get a COVID-19 vaccine is to keep their family (77%) and community (71%) safe. 
The most common concern was side effects from the vaccine (51%) followed by lack of 
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knowledge about how well a COVID-19 vaccine works (34%) and lack of trust in 
vaccine safety (30%).
D.
Research Design and Methods (What, When, How, Where)
Aim 1 (Preparation). Identify SARS-CoV-2 vaccination barriers/facilitators and 
assess acceptability and feasibility of a suite of evidence-based vaccine intervention 
strategies among Oklahoma’s rural, minority, and high-risk populations to inform a 
targeted multicomponent intervention. 
Study Design. We will conduct up to 10 focus groups including participants from 
communities with low levels of vaccine uptake and/or high levels of vaccine hesitancy 
and communities holding events where SARS-CoV-2 testing or vaccination is offered in 
partnership with the CATCH-UP program (IRB #12582). We will recruit focus group 
participants in conjunction with testing events and through conversations with 
community leaders prior to testing events. Focus groups will: (1) explore vaccine-related 
concerns and motivators, (2) evaluate NIH Community Engagement Alliance (CEAL) 
educational resources for local and cultural acceptability; and (3) examine outreach and 
communication intervention strategies detailed in the NIH COVID-19 Vaccination 
Communication for feasibility to be implemented at later testing events. 
Focus Group Procedure. Focus groups will be conducted virtually (via 
teleconferencing/telephone) or in-person. The focus group guide will be developed in 
conjunction with our collaborative team. Focus groups will examine barriers and 
facilitators to vaccination within each community (e.g., perceptions of COVID-19 
severity, vaccine concerns, vaccine availability/accessibility, competing priorities, etc.).  
NIH Community Engagement Alliance (CEAL) educational resources will be examined 
for local and cultural acceptability. Participants will be presented with several vaccine 
interventions selected by the team for demonstrated efficacy as well as likely 
acceptability among Oklahoma communities. Responses to selected interventions will be 
elicited, with special attention to perceived effectiveness and acceptability within their 
respective communities, barriers to/facilitators of implementation, and needed 
modifications for local/cultural relevance. We will also have participants complete a brief 
demographic survey that will be completely de-identified. Although our goal is 6 
participants per focus group, only one participant is required for a focus group.  
We expect to enroll a maximum of 60 focus group participants.
Aim 2 (Optimization). Develop and optimize a multicomponent intervention to 
improve SARS-CoV-2 vaccination among Oklahoman’s seeking SARS-CoV-2 
testing at CATCH-UP testing events.  
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Overall Study Design: Interventions will 
address three primary areas to improve 
vaccination uptake: (1) process (text messages); 
(2) teachable moment messaging (motivational 
interviewing); and (3) barrier elicitation and 
reduction (electronic survey with tailored 
questions/prompts). In our selection of potential 
interventions, we will use the Community 
Preventive Services Task Force (CPSTF)9 and 
the NIH Behavior and Social Sciences Research-
Coordinating Committee Rapid Working Group 
on COVID-19 Vaccine Communication guide, among other resources.10 We will work 
with the NIH RADxSM-UP Coordination and Data Collection Center (CDCC) to ensure 
collection of Common Data Elements.
Outcome metrics characterizing SARS-CoV-2 vaccine uptake. Our primary outcome 
will be intention to receive a COVID-19 vaccine post-intervention. We will measure this 
with the question “How likely are you to get an approved COVID-19 vaccine?” and “If 
you have received 1 dose of the Janssen vaccine or 2 doses of the Moderna or Pfizer 
vaccine, how likely are you to get an approved booster shot?” We will compare intention 
to receive a COVID-19 vaccine or booster among those receiving the interventions 
compared to those not receiving the intervention (see details on analysis below). 
Our secondary outcome will be vaccine uptake, including self-report of receiving an 
initial dose of any approved vaccine, two doses of Pfizer or Moderna vaccines, or a 
booster of any approved vaccine. We will request the manufacturer of the vaccine and the 
approximate dates the vaccine was received from the participant.
Aim 2.1. Pilot Implementation.
Study Design. Participants at the pilot sites will be randomized to receive a text message 
and/or education message (detailed below) delivered through a tablet or no intervention. 
We will also conduct a pilot of motivational interviewing messages that are tailored 
based on antibody test results (or lack of testing if the participant declines an antibody 
test). 
We will collect a survey using Research Electronic Data Capture (REDCap) software 
(Nashville, TN) to allow for descriptive statistics, assessment of study outcomes, and 
ensure the randomization is balanced regarding these characteristics. 
Intervention Procedure
1. Screening Form to identify eligibility for the study. This will include age, ability to 
read and speak English, vaccine status and dose information (see eligibility criteria), 
and having symptoms of COVID-19 or positive test for COVID-19 infection in the 
previous 14 days. The screening form will include the following symptoms as having 
active COVID-19: fever, chills, cough, shortness of breath, difficulty breathing, lack 
of energy/general tired feeling, muscle or body aches, headache, new loss of taste or 
smell, sore throat/congestion/runny nose, nausea, vomiting, or diarrhea, abdominal 
pain, or skin rash.
Table 2. Experimental conditions in the 23 factorial design 
for the COVID-19 vaccine intervention
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2. Obtain consent and HIPAA authorization and allow an opportunity for questions.
3. Brief demographic questionnaire (race, ethnicity, sex, county of residence) and 
questions to assess intention to receive a COVID-19 vaccine.
4. Conduct interventions. All participants will have the opportunity to receive antibody 
testing using a finger stick (using the same methods as in the CATCH-UP Study, IRB 
#12582). After the antibody test is done and participants are waiting for the results 
(about 15 minutes), the participants will receive the interventions. If participants 
decline the antibody test, the interventions will begin once consent, HIPAA, and the 
brief demographic questionnaire are complete.
a.
Text message. Participants will be randomized to either receive 1) a text 
message encouraging COVID-19 vaccination (treatment) or no text message 
(control). This factor will last less than 1 minute. 
b. Tailored messaging. Participants will be randomized to receive 1) 
educational messaging about COVID-19 vaccines (treatment) or 2) an 
attention control educational message not related to COVID-19 (control). This 
will be delivered on a tablet through RedCap. This factor will last around 10 
minutes.
c.
Motivational interviewing. As part of CATCH-UP (IRB #12582), 
participants currently receive feedback on their antibody test results. Based on 
focus group findings, we will use a semi-structured script that encourages 
participants to take actions tailored to their individual test results. The 
procedure will be as such: Participants are given their test results in line with 
current CATCH-UP procedures. As part of this protocol, participants will be 
shown examples of anonymized antibody test results (e.g., results with low 
and high antibody tests). The key personnel will follow a script in REDCap to 
interpret the results (or address refusal to receive antibody testing). 
These interactions will be observed by key study personnel who will take 
notes on the participants’ reactions to the messages following a checklist 
directing them to note the antibody results, verbal and non-verbal reactions, as 
well as fidelity to the semi-structured script. In addition, we will observe the 
responses of the personnel delivering antibody test results to participants even 
if they are not using the semi-structured script. The study team will use this 
information to revise the messaging for full implementation in a future IRB 
modification. We expect this factor to last approximately 5 minutes.
5. Once the interventions are complete, the participants will complete a brief exit survey 
that includes questions about their intention to receive a COVID-19 vaccine or 
booster and to request their contact information for future follow-up surveys and 
mailing/distribution of gift card (if mailing or emailing is needed). Participants will 
also be asked to complete a survey required by NIH to report common data elements, 
with a link sent through text message or email, with follow-up daily for up to three 
days after the initial survey invitation is sent, and at 30 and 60 days post intervention 
if the participant has not responded (in tandem with the follow-up survey in #6 
below). This will complete the intervention.
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6. We will send participants a RedCap survey link through text message or email 30 
days and 60 days after the intervention to assess intent to be vaccinated for COVID-
19 and vaccine uptake, allowing time for both doses of the Pfizer and Moderna, single 
dose of Jansen’s COVID-19 vaccine, or boosters of vaccines to be delivered. We will 
also send up to three daily reminders to the participant to complete the common data 
elements survey if they did not complete it after the intervention.
7. For participants who agree, we will contact up to 60 participants to participate in an 
evaluation interview to help the personnel determine what did and did not work well 
during the intervention. This will be a 30 minute to one hour interview.
Aim 2.2. Full implementation.
Study Design. Participants will be randomized to a 2 x 2 x 2 fully crossed factorial design, 
creating 8 conditions to evaluate the contribution of each intervention component in an 
initial pilot/feasibility study. For each intervention site, we will collect a brief demographic 
survey through Research Electronic Data Capture (REDCap) software (Nashville, TN) to 
allow for descriptive statistics and ensure the randomization is balanced regarding these 
characteristics. 
Intervention Procedure
All interactions with participants will occur through a tablet or through verbal 
communication. 
1. Screening Form to identify eligibility for the study. This will include age, ability to 
read and speak English, vaccine status and dose information (see eligibility criteria), 
and having symptoms of COVID-19 or positive test for COVID-19 infection in the 
previous 14 days. The screening form will include the following symptoms as having 
active COVID-19: fever, chills, cough, shortness of breath, difficulty breathing, lack 
of energy/general tired feeling, muscle or body aches, headache, new loss of taste or 
smell, sore throat/congestion/runny nose, nausea, vomiting, or diarrhea, abdominal 
pain, or skin rash.
2. Obtain consent and HIPAA authorization and allow an opportunity for questions.
3. Brief demographic questionnaire (race, ethnicity, sex, county of residence) and 
questions to assess intention to receive a COVID-19 vaccine.
4. Conduct interventions. Participants will be randomized to receive or not receive each 
of the interventions described below. Participants may be randomized to receive all 
three factors (treatment), all three control factors, or any combination of 
treatment/control as defined below (see Table 2). All participants will have the 
opportunity to receive antibody testing using a finger stick (using the same methods as 
in the CATCH-UP Study, IRB #12582). After the antibody test is done and participants 
are waiting for the results (about 15 minutes), the participants will receive the 
interventions. 
a.
Text message. Participants will be randomized to either receive 1) a text 
message encouraging COVID-19 vaccination (treatment) or no text message 
(control). This factor will last less than 1 minute. 
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a.
Tailored messaging. Participants will be randomized to receive 1) 
educational messaging about COVID-19 vaccines (treatment) or 2) attention 
control educational message not related to COVID-19 (control). This will be 
delivered on a tablet through RedCap. This factor will last around 10 minutes.
b. Motivational interviewing. Participants will be randomized to receive 
feedback on their antibody tests in these two methods: 1) receive a motivational 
interview following the 5A’s strategy (Ask, Advise, Assess, Assist, Arrange) 
following a semi-structured format (treatment) or 2) interpretation of antibody 
test results and encouragement of vaccine uptake (as per usual standard 
practice) (control). Personnel will make notes regarding any deviations from 
the semi-structure script or assigned treatment arm (e.g., some participants may 
decline to discuss the vaccine). This factor will last around 5 minutes.
5. Once the interventions are complete, the participants will complete a brief exit survey 
that includes questions about their intention to receive a COVID-19 vaccine or 
booster and to request their contact information for future contact and 
mailing/distribution of gift card (if mailing or emailing is needed). Participants will 
also be asked to complete a survey required by NIH to report common data elements, 
with a link sent through text message or email, with follow-up daily for up to three 
days after the initial survey invitation is sent, and at 30 and 60 days post intervention 
if the participant has not responded (in tandem with the follow-up survey in #6 
below). This will complete the intervention.
6. We will send participants a RedCap survey link through text message or email 30 
days and 60 days after the intervention to assess intent to be vaccinated for COVID-
19 and vaccine uptake, allowing time for both doses of the Pfizer and Moderna, single 
dose of Jansen’s COVID-19 vaccine, or boosters of vaccines to be delivered. We will 
also send up to three daily reminders to the participant to complete the common data 
elements survey if they did not complete it after the intervention. 
7. For participants who agree, we will contact up to 60 participants to participate in an 
evaluation interview to help the personnel determine what did and did not work well 
during the intervention. This will be a 30 minute to one hour interview.
At all events, key personnel will also conduct a field observation of how the events flow, 
including external factors such as weather or logistical problems and where challenges to 
implementing the study or recruiting participants occurred. We will also conduct 
evaluation focus groups with event site staff to determine what did and did not work 
during the event.
We expect to recruit 2000 participants over the entire study period (Aim 2.1 and 2.2).
Factorial design. In a factorial research design, two or more independent variables are 
concurrently examined within the same trial. The three factors are crossed with one another 
to create a total of eight experimental conditions. An equal number of participants are 
randomly assigned to each condition, using a random number generator. This is not an 8-
arm randomized controlled trial, but instead allows for an efficient examination of main 
effects for each variable in a sample of 2000 participants (including Aim 2.1 and Aim 2.2). 
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This approach allows examination of three key treatment development questions in a much 
more time-efficient and economical manner by simultaneously performing three studies 
within the single trial. This achieves power to detect between-group differences that is 
equivalent to performing three separate randomized trials. Investigators who are providing 
the intervention and conducting analysis will be not be masked to study assignment due to 
challenges in maintaining the masking in an educational intervention. For all sites, 
including Aims 2.1 and 2.2, we expect to recruit 2000 participants.
Identifiers might be removed and the de-identified information may be used for future 
research without additional informed consent from the subject.
Evaluation. Global questions will be explored in the program evaluation, including: 1) 
What are potential barriers and facilitators to “real-world” implementation of the 
interventions?; 2) What problems are associated with delivering the interventions, and how 
might they translate to improving implementation processes?; 3) What potential 
modifications to the interventions could be made to maximize implementation?; and 4) 
Among the interventions that were implemented, which appeared most promising? 
Implementation process metrics will be assessed by conducting a process evaluation for 
deployment of interventions to increase vaccine uptake. To organize process findings, we 
will generate a comprehensive list of patient and community implementation outcomes 
aggregated through the common taxonomy of the Proctor et al. evaluation framework.11, 12 
The evaluation also will incorporate measures from CFIR,13 which has been shown to be 
effective for guiding successful implementation.14, 15
Research team members will visit the community sites or meet through videoconference 
to conduct five additional focus groups with multiple respondents, including the 
community members involved in the intervention, to assess acceptability, cultural 
relevance, and possible barriers. We will also interview participants who agreed to an 
interview in the consent form for evaluation of the intervention. Findings will help clarify 
processes of care and perceptions of barriers and facilitators. The focus group guide will 
prompt participants to discuss their practice context as it relates to their experiences with 
implementing each of the intervention components, and participants will be probed 
regarding challenges and facilitators they face when implementing each component. To 
evaluate whether the selected intervention(s) improved vaccine uptake in the pilot study, 
our team will evaluate aggregate vaccination data for the catchment area of the community 
site through the Oklahoma State Department of Health. The final product will summarize 
barriers and facilitators for implementation and provide a thorough picture of the 
implementation process, including feasibility, acceptability, and fidelity of intervention 
implementation that can inform future large-scale research.
For the community site evaluation, we will have participants complete a brief 
demographic survey that will be completely de-identified. Although our goal is 6 
participants per focus group and one focus group per intervention site, only one 
participant is required for a focus group.  We expect to enroll a maximum of 60 focus 
group participants.
We expect to interview up to 60 Aim 2 participants for an evaluation interview.
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E.
Inclusion / Exclusion Criteria
Aim 1.
The following inclusion criteria will apply:
1. 18 years of age and older 
2. Leadership/membership role in community organization or staff at 
CATCH-UP testing event (IRB #12582)
3. English speaking
Aim 2.1 and Aim 2.2.
The following inclusion criteria will apply:
1. 18 years of age and older
2. Must be eligible to receive a COVID-19 vaccine dose at the time of consent 
based on the following criteria:
a.
Eligible for one bivalent mRNA vaccine
i. No previous doses of any COVID-19 vaccine
ii. At least 8 weeks since a previous vaccine dose of any 
manufacturer
b. Eligible for second bivalent mRNA vaccine
i. Adults 65 year of age and older can receive one additional 
bivalent mRNA vaccine at least 4 months after the first dose of 
a bivalent mRNA vaccine.
ii. Those who are immunocompromised can receive one 
additional bivalent mRNA vaccine at least 2 months after the 
first dose of a bivalent mRNA vaccine.
3. Ability to read and speak English
Exclusion criteria:
1. Those who have received all eligible doses of any approved COVID-
19 vaccine.
2. Those with active COVID-19 disease (either through self-reported 
positive test within the last 10 days or viral test at the event if 
available).
Vaccine criteria are based on CDC recommendations as of April 13, 2023 obtained here: 
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-
date.html#recommendations 
Evaluation of Aim 2 (focus group with intervention site staff or volunteer)
The following inclusion criteria will apply:
1. 18 years of age and older
2. Community volunteer or staff at a CATCH-UP Vaccines intervention 
site.
F.
Gender/Minority/Pediatric Inclusion for Research
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Both men and women will be included in the focus groups (Aim 1) and in the 
intervention (Aim 2). 
We will enroll adults 18 years of age and older for Aim 1 and Aim 2. Focus groups will 
include community leaders who are adults working/volunteering in a leadership role or at 
CATCH-UP testing events. The intervention will only include adults 18 years of age and 
older.
G.
Recruitment and Enrollment
Aim 1.
Recruitment: Focus groups will include community leaders and staff/volunteers involved 
in community events. Included participants will be able to provide insights into the 
barriers faced within their communities in Oklahoma in partnership with the CATCH-UP 
program (IRB #12582). We will work with Laura Ross at Public Health Institute of 
Oklahoma to assist with recruitment of focus group participants. We will recruit focus 
group participants through emails and advertisements to the community organizations 
and will use REDCap to register interested potential participants. If a participant 
recommends including other potential participants in future focus groups, we will provide 
the participant with the study team’s contact information to allow any potential 
participants to obtain more information about the study while maintaining confidentiality 
between participants.
We will advertise for the focus groups through social media, websites, email, and flyers. 
Testing event partners will disseminate flyers during community team meetings and at 
CATCH-UP testing events and in partnership with Public Health Institute of Oklahoma. 
Potential participants will be directed to contact the study team listed on the flyer for 
questions or interest in participating in the focus groups. At the time of contact, we will 
explain the purpose of the project and the nature of the study. Participants will receive a 
$40 gift card as compensation for their participation. We expect the focus groups to last 
one hour.
Consent Procedures: We will obtain oral consent from participants prior to beginning the 
focus groups by reading a consent script. Once we have identified key informants who 
are eligible and agree to participate, we will schedule a meeting virtually through 
Zoom/conference call or in-person. The informed consent process will include the audio 
and/or video recording of the interview. 
Location where consent/interviews will take place: Focus groups will be held in-person 
or virtually through telephone or Zoom using a password-protected meeting that requires 
a free Zoom account to ensure privacy. In-person focus groups will take place at Tabitha 
Baptist Church in Oklahoma City, OK; Sertoma Center in Pryor, OK; and OUHSC 
campus at the OSCTR.
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Recruitment of non-English speaking participants: We will only recruit English-speaking 
participants.
Measures to decrease participant coercion: The study personnel conducting interviews 
will not be supervisors of the focus group participants. Participants will be informed that 
they have the opportunity to leave the focus group or skip questions at any time.
Aim 2.1. 
Recruitment: We will recruit participants through the community health events in 
partnership with the Public Health Institute of Oklahoma. We will recruit through flyers, 
emails, and direct contact during events. Participants will be eligible for a $20 gift card at 
the completion of the study, which will either be given to participants on-site, mailed to 
the participants, or emailed as an e-gift card.
Consent Procedures: After completing a screening form, eligible participants who are 
interested in the study will review and sign the consent and HIPAA authorization form if 
they decide to participate in the study. The consent form will include questions about 
sharing zip code with the Duke Clinical Research Institute and contact for future research 
studies. Study staff will review the consent form and answer any questions. Consent and 
HIPAA authorization will be conducted either with paper forms or electronically through 
REDCap.
Location where consent and intervention will take place: The pilot events will occur in 
partnership with community organizations in Oklahoma. The events will be at a public 
location selected by the community organization in partnership with PHIO.
Measures to decrease participant coercion: Potential participants will be notified through 
the consent process that participating is optional and withdrawing from the study any 
time is allowed. Study personnel will not be supervisors of any potential participants. 
Aim 2.2. 
Recruitment: We will recruit sites through the CATCH-UP program testing events and as 
requested through community partnerships in collaboration with the Public Health 
Institute of Oklahoma. We will recruit through flyers, emails, and direct contact during 
events. Participants will be eligible for a $20 gift card at the completion of the study, 
which will either be given to participants on-site, mailed to the participants, or emailed as 
an e-gift card.
Consent Procedures: After completing a screening form, eligible participants who are 
interested in the study will review and sign the consent and HIPAA authorization form if 
they decide to participate in the study. The consent form will include questions about 
sharing zip code with the Duke Clinical Research Institute and contact for future research 
studies. Study staff will review the consent form and answer any questions. Consent and 
HIPAA authorization will be conducted either with paper forms or electronically through 
REDCap.
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Location where consent and intervention will take place: We will conduct the 
intervention at multiple community events, which will be open to the public, as identified 
by community organizations as they are scheduled in partnership with PHIO.
Measures to decrease participant coercion: Potential participants will be notified through 
the consent process that participating is optional and withdrawing from the study any 
time is allowed. Study personnel will not be supervisors of any potential participants. 
Aim 2 Evaluation with intervention event staff/volunteers
Recruitment: Focus groups will include community leaders and staff/volunteers involved 
in community events where CATCH-UP Vaccines interventions were held. We will work 
with Laura Ross at Public Health Institute of Oklahoma to assist with recruitment of 
focus group participants. We will recruit focus group participants through emails and 
advertisements to the community organizations and will use REDCap to register 
interested potential participants. If a participant recommends including other potential 
participants in future focus groups, we will provide the participant with the study team’s 
contact information to allow any potential participants to obtain more information about 
the study while maintaining confidentiality between participants.
We will advertise for the focus groups through social media, websites, email, and flyers. 
Testing event partners will disseminate flyers during community team meetings and at 
CATCH-UP testing events. Potential participants will be directed to contact the study 
team listed on the flyer for questions or interest in participating in the focus groups. At 
the time of contact, we will explain the purpose of the project and the nature of the study. 
We expect the focus groups to last one hour.
Consent Procedures: We will obtain oral consent from participants prior to beginning the 
focus groups by reading a consent script. Once we have identified key informants who 
are eligible and agree to participate, we will schedule a meeting virtually through 
Zoom/conference call or in-person. The informed consent process will include the audio 
and/or video recording of the interview. 
Location where consent/interviews will take place: Focus groups will be held in-person 
or virtually through telephone or Zoom using a password-protected meeting that requires 
a free Zoom account to ensure privacy.
Recruitment of non-English speaking participants: We will only recruit English-speaking 
participants.
Measures to decrease participant coercion: The study personnel conducting interviews 
will not be supervisors of the focus group participants. Participants will be informed that 
they have the opportunity to leave the focus group or skip questions at any time.
H.
Risks and Benefits
Potential Risks
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The potential risks to the participants in this study should be minimal. It is possible that 
participants may feel psychological stress associated with completing the focus groups.  
There is also a slight risk of a breach in data confidentiality. For those participating in the 
serology study, it remains a minimal risk study, where possible risks associated with 
blood draws include: occasional slight discomfort associated with blood drawing and 
occasional hematoma (bruise) or infection at the blood drawing site. Rarely, a participant 
may experience fainting or dizziness. Procedures will be implemented to minimize these 
potential risks as described below.
Due to the nature of the intervention and the minimal risks, we will not establish Data 
Safety Monitoring Board (DSMB) to monitor this study.  Study data are accessible at all 
times for the Project Directors (PDs) to review. Dr. James will review the study conduct 
weekly and the investigators will review the study conduct on a monthly basis. Study 
conduct will include accrual, drop-outs, and protocol deviations. The PDs will review 
adverse events individually in real-time and in aggregate on a weekly basis. The PI, PD, 
and co-investigators will review serious adverse events in real-time.  The PI and PD 
ensure all protocol deviations, AEs, and SAEs are reported to the NIH and IRB according 
to the applicable regulatory requirements. 
Protection Against Risk 
Psychological Stress:  This stress will be minimized as focus group and intervention 
participants will be informed through the consent process that they do not have to 
participate, do not have to answer all questions, and do not have to complete the focus 
group or intervention if they are uncomfortable.  The voluntary nature of the study will be 
emphasized and participants will have the option to participate in only some aspects of 
the study.  Participants will have the option to withdraw from the study at any time.
  
Data confidentiality: Any written notes taken during the focus groups or at intervention 
sites and any paper forms will be stored in a locked filing cabinet in the office of the 
study personnel. 
Blood draws: We will use a low-risk method of finger sticks to collect serum for the 
serology study. Participants will have access to bandages if needed and have the option to 
withdraw from the study at any time.
Potential Benefits of the Proposed Research to the Subjects and to Others
Subjects often experience a sense of satisfaction with their participation in research; 
however, the most obvious benefits of this work will be to others. 
Importance of the Knowledge to be Gained
Oklahoma’s IDeA-CTR, the OSCTR, and its long-standing community-engaged research 
programs and partnerships will contribute to the knowledge base necessary to improve 
SARS-CoV-2 vaccine uptake in underserved and vulnerable populations. We have 
developed robust community partnerships through the OSCTR Community Engagement 
and Outreach (CEO) Core and investment in the development of community-driven and 
responsive organizations developed primarily in rural counties. Oklahoma has high 
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COVID-19 incidence, particularly among underserved minority and rural Oklahomans. 
Oklahoman’s are also reporting SARS-CoV-2 vaccine hesitancy and signs of slowing 
vaccine uptake, with increased hesitancy among American Indian and rural populations. 
The project aims to work with ongoing community testing events to implement 
interventions to improve vaccine uptake among Oklahoma’s underserved populations. 
I.
Statistical Methods  
Aim 1 Analysis. Digitally recorded focus groups will be securely uploaded to protected 
servers and transcribed using NVivo Transcription. Transcriptions will be team coded for 
conceptual themes using QSR NUDIST Vivo12 Pro for Windows.16 Investigators will 
develop a code book. Throughout the coding process, qualitative data will be categorized, 
connections made between categories, and core categories identified and systematically 
linked to other categories.  Focus group data will inform intervention selection and 
needed modifications for community acceptability/relevance.  
Aim 2 Analysis. All analyses are intent-to-treat. Outcome measures will be assessed at 
baseline, 30 days, and 60 days follow-up. At the outset, we will examine the frequency 
distributions of all variables. We will compare the baseline characteristics to assess 
whether randomization distributed covariates evenly. We will determine whether there is 
differential dropout and consider developing probability-of-completion weights to obtain 
unbiased estimates of treatment effect. 
The primary analysis will assess the effects of each intervention component in terms of 
its association with the primary outcome (intent to receive a COVID-19 vaccine 
immediately after the interventions are completed). Cross-sectional analyses will be 
conducted for outcomes assessed at 30 and 60 days. For binary outcomes, chi-square tests 
will be used to compare the outcomes between groups. For continuous outcomes, two-
sample t-tests or Wilcoxon rank sum tests, whichever is more appropriate, will be used to 
compare between groups. A longitudinal analysis using Generalized Estimating 
Equations (GEE) techniques will also assess the overall impact of the intervention by 
including data from all follow-up time points. 
As a secondary analysis, we will compare vaccine coverage among counties with an 
intervention compared to counties without intervention to see whether coverage increased 
in the study counties using a chi-square test. We will use publicly available data from the 
Oklahoma State Department of Health and/or Centers for Disease Control and Prevention 
for this analysis.
Sample size and power calculations. Power calculations are based on our primary 
analysis, which is to assess the effect of each intervention component on increased 
intention to receive a COVID-19 vaccine immediately after the intervention. This is a 
two-sample comparison between participants that receive one intervention component 
and those that receive the control. Our pilot implementation will include a single site with 
an estimated 500 participants. 
Our outcome of interest is also assessed at 30 and 60 days follow-up to measure intention 
to receive a COVID-19 vaccine, which allows us to use a longitudinal generalized 
estimating equations approach wherein power is proportional to the within-site 
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correlation. Using PASS v16, we assume the intra-cluster correlation within each site is 
0.01. Our power analysis is based on data from both pilot and full implementation of the 
study results. Assuming a minimum n=167 participants per site for a minimum of sites, a 
Type 1 error rate of 0.05, and an estimated standard deviation of 5, we have over 80% 
power to detect a mean difference of 20. 
Data and Safety Monitoring Plan 
Drs. James and Janitz assure that oral informed consent is obtained prior to conducting 
the focus groups (Aim 1) and written informed consent and HIPAA authorization are 
obtained for the intervention (Aim 2) prior to performing any research procedures, that all 
subjects meet eligibility criteria, and that the study is conducted according to the IRB-
approved research plan.  
Study data are accessible at all times for the PI/PD to review. Dr. James will review the 
study conduct weekly and the PI/PD will review the study conduct on a monthly basis.  
Study conduct will include accrual, drop-outs, and protocol deviations.  The PI/PD will 
review adverse events individually in real-time and in aggregate on a weekly basis.  
COLLECTION AND REPORTING OF SAEs AND AEs
For this study, the following standard AE definitions are used:
Adverse event:  Any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom or disease temporally associated with the use of a 
medical treatment or procedure, regardless of whether it is considered related to the 
medical treatment or procedure.
Serious Adverse Event:  Any AE that results in any of the following outcomes:
•
Death
•
Life-threatening 
•
Event requiring inpatient hospitalization or prolongation of existing 
hospitalization
•
Persistent or significant disability/incapacity
AEs are graded according to the following scale:
Mild:  An experience that is transient, & requires no special treatment or 
intervention.  The experience does not generally interfere with usual daily 
activities.  This includes transient laboratory test alterations.
Moderate:  An experience that is alleviated with simple therapeutic treatments.  
The experience impacts usual daily activities.  Includes laboratory test alterations 
indicating injury, but without long-term risk.
Severe:  An experience that requires therapeutic intervention.  The experience 
interrupts usual daily activities. If hospitalization (or prolongation of 
hospitalization) is required for treatment it becomes an SAE.
The study uses the following AE attribution scale:
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Not related:  The AE is clearly not related to the study procedures (i.e., another 
cause of the event is most plausible and/or a clinically plausible temporal 
sequence is inconsistent with the onset of the event).  
Possibly related:  An event that follows a reasonable temporal sequence from the 
initiation of study procedures, but that could readily have been produced by a 
number of other factors.
Related:  The AE is clearly related to the study procedures.  
AEs are identified by the study coordinator during weekly visits or by phone call 
throughout the study duration, and AEs will be assessed at time of study follow-up visits.
SAEs and specific procedure-associated AEs are reported to the PDs within 24 hours.  In 
addition, all AEs are reported according to the University of Oklahoma Health Sciences 
Center Institutional Review Board AE reporting guidelines. 
MANAGEMENT OF RISKS TO SUBJECTS
Expected AEs
There are no expected AEs as a result of this study, as the intervention components will 
be standard and evidence-based strategies and non-therapeutic. Potential interventions 
strategies are educational in nature with a minimal risk finger stick for serology tests and 
are not anticipated to have AEs.
Expected SAEs
There are no expected SAEs as a result of this study, as the intervention components will 
be standard and evidence-based methods, primarily educational in nature with a minimal 
risk finger stick for serology tests.
AE and SAE Management
The research coordinator will monitor outcomes and make adjustments to the protocol if 
unanticipated problems arise.
J.
Data Sharing
Sharing of primary epidemiological data that is generated as part of this project will occur 
as allowed by the University of Oklahoma Health Sciences Center IRB. 
Aggregate data will be submitted to clinicaltrials.gov as required by NIH. 
Identifiable data will be uploaded, with participant consent, to the RADx-UP data 
repository as required by the NIH grant terms and conditions. A data transfer agreement 
will be fully executed prior to sharing data with NIH. If participants decline to share their 
identifiers, including all identifiable information or zip code with the Duke Clinical 
Research Institute, only de-identified information will be shared for these participants.
Specifically, only aggregate data that cannot be linked back to individual people will be 
shared upon request in accordance with IRB. We will adhere to NIH Policy on sharing 
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biomedical research resources. We will make de-identified data available for users under 
a data-sharing agreement that requires the user to (1) agree to use the data for research 
purposes only; (2) have a plan in place to secure the data using appropriate computer 
technology; and (3) agree to destroy or return the data after analyses are completed.
K.
Confidentiality 
No one will have access to the data files and servers except the investigators. All data 
will be stored on Redcap or an OUHSC secured drive behind a firewall that requires a 
log-in and password. When the drive is not in use, the user will log off. The server is 
stored in a locked location. To transfer de-identified, aggregate data between OU Norman 
and OUHSC for development of research products (i.e., posters, manuscripts, 
dissertation), we will use a secure file transfer system/method. This will help safeguard 
the confidentiality and integrity of sensitive data in compliance with HIPAA and other 
regulatory requirements. We will encrypt the data prior to sending through the secure file 
transfer system. Published reports and presentations will not include any individually 
identifiable data and only aggregate statistics will be reported. 
L.
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