This is an adaptive intervention which utilizes a multi-component messaging and care
coordination to increase COVID19 vaccine uptake.

Aim 1: Optimize a multicomponent health program to promote COVID-19 vaccine uptake and
engagement in preventive healthcare using our established co-creation approach to address
multi-level (individual, community, systemic) barriers to vaccine uptake and preventive
care engagement.

Community engagement through Community Advisory Boards and Community Weavers. The
multicomponent health program will be developed and optimized using our established
co-creation approach with guidance from Community Weavers and engagement of the community
through Community Advisory Boards (CABs). Hiring criteria for Community Weavers will
include that they are fluent in at least one of the three priority languages (i.e.,
Spanish, Arabic, Vietnamese) and have at least six months of community organizing,
leading, or community engagement experience. Community Weavers will have a critical role
in developing and refining the tailored mHealth messages. They will also be instrumental
in facilitating the existing care coordination efforts at the FQHC by focusing on
immigrant and refugee communities that can be difficult to engage in care. The Community
Weavers will also lead three CABs that each include five members inclusive of the three
primary languages spoken by community members of our clinics of interest will be invited
to participate.

During the first year, each CAB will meet monthly or twice monthly up to four times (two
hours per meeting). These initial CAB meetings will be charged with co-creating content
and frequency for the mHealth outreach (SMS and voice messages) and identifying topics to
be covered in and strategies and processes for the care coordination program. To
facilitate mHealth message development, Cultural Weavers will use a story
telling/narrative framework approach inviting residents to join open dialogue and share
their journey through the decision-making process towards getting vaccinated, reflecting
on the anxieties they navigated, the misinformation they were confronted with, and any
structural or technological barriers they had to overcome to enhance the cultural
resonance and tailoring of the mHealth messages.90 In subsequent years, the CABs will
continue meeting quarterly to revise and update mHealth content and engage in an
Appreciative Inquiry Process to evaluate the implementation of the multicomponent health
program and determine when refinements for optimization are needed to both the mHealth
and care coordination components. The co-creation and optimization of the program
components will be guided by the contextual domains of PRISM (i.e., Intervention
characteristics, Recipient characteristics, Implementation and sustainability
infrastructure, External environment) and will build on our prior work with the community
and the CAB members' lived experience as members of the respective communities.

Throughout the project, the investigators will evaluate the quality and extent of
stakeholder engagement using a concurrent (QUAN + QUAL) mixed methods approach that the
investigators developed through our NIH funded COVID-19 projects. The investigators will
implement a stakeholder engagement survey completed via online distribution by all
stakeholders following each CAB meeting using the Goodman et al. 9-item measure inquiring
about how well and how frequently eight engagement principles were perceived during the
meeting and an open-ended reflection question. Ethnographic documentations of the CAB
process will be conducted by trained research staff and will use our structured
documentation form that identifies various aspects of engagement (e.g., topics covered,
interruptions, time spent contributing). Survey data will be summarized as simple
frequencies and text responses will be coded using an open coding approach. Data from the
documentation rubrics will be abstracted using a matrix approach the investigators
developed in our prior work and will be triangulated with information from the survey.
Survey information will be reviewed after each CAB meeting and used to support the
iterative improvement of the CAB processes.

mHealth Outreach. Specific mHealth messaging will include personalized SMS and automated
phone calls recorded by community leaders in their respective languages aligned with the
language preferences of our target SYH clinics. The content of the mHealth outreach will
include information about how and where to get COVID-19 vaccinated, COVID-19 vaccine side
effects, the importance of and timing of priority preventive services, and how to
schedule those services, as well as dispelling myths about vaccines and providing
reminders for appointments. mHealth content and distribution frequency will be determined
by each Community Advisory Board to align with their community's preferences and needs.
It is expected that 1-2 voice and/or SMS messages will be delivered weekly to the Aim 2
sample. New messages will be developed and added to our message library based on updated
public health guidance and feedback from our participants. Our mHealth outreach system
will be user tested and refined prior to Aim 2 launch.

Care Coordination. Care coordination will be focused on collaborative problem-solving and
case management to help patients schedule and attend recommended annual preventive health
care, including a routine physical exam, recommended preventive screenings (e.g.,
mammograms, A1c screening, colorectal cancer screening), and COVID-19 vaccination. SYH
has an established process to provide care coordination and the investigators will refine
these processes (e.g., eligibility, health education topics, duration of care
coordination) through input from our Community Advisory Board. For this study, SYH will
hire study-specific care coordinators who are members of the three communities
represented by the Community Advisory Board. Care coordination will be tailored to the
needs and cultural preferences of the respective patient community. The content of care
coordination will include initial engagement and re-engagement of patients in preventive
care services, developing a patient health action plan, support with adhering to the
health action plan, scheduling preventive care appointments, and communicating with the
patient's care team to ensure continuity of care.

Aim 2: Evaluate the implementation, effectiveness, and sustainment of the multicomponent
COVID-19 vaccine and preventive care engagement program using a hybrid type 3
implementation-effectiveness sequential multiple assignment randomized trial design
across immigrant, refugee, Latino, and BIPOC communities in Central and East San Diego.

A total of 300 patients (100 per clinic), from a sampling frame of approximately 5000
patients, will be recruited to participate in the study. Recruitment will be from all
language groups, and the investigators will work with CABs to develop culturally
appropriate recruitment methods to ensure participation from all three language groups
(i.e., Spanish, Arabic, and Vietnamese). The investigators will consider a weighted
sampling approach if patient volume varies considerably between the three clinics during
the baseline period. While these language groups are broad, they are all connected with
the partnering FQHC, which helps frame the target populations for this research project.
Furthermore, to understand reach for our program, the investigators will document the
characteristics of those participating in the study and compare it to the population in
each of the three geographic regions recruited into the study (Community Heights, El
Cajon, Escondido).

Patient recruitment will occur at each of the three participating SYH clinics through
collaborative efforts between the SYH Care Coordinators, Global ARC Cultural Weavers, and
UC San Diego Health and Technology Specialists. This is an adaptive intervention which
utilizes a multi-component messaging and care coordination to increase COVID19 vaccine
uptake. Both randomization and analysis will be conducted at the individual participant
level. The hybrid type 3 trial will span 4 years inclusive of two years of active
implementation and 2 years of sustainment/maintenance. At enrollment, participants will
be stratified by current COVID-19 vaccination status, then randomized into the first
stage intervention (mHealth outreach or standard of care). Response or lack of response
after the completion of the first stage intervention will determine if participants
continue in their initial first stage intervention or re-randomized to increased
intensity intervention. Non-responders in the standard of care arm will be equally
re-randomized into either mHealth outreach or enhanced care coordination for stage 2.
Non-responders in mHealth outreach will be re-randomized into mHealth or mHealth plus
enhanced care coordination for stage 2. Non-response will be defined as not being up to
date on COVID-19 vaccination OR having at least one outstanding preventive care need.

Data collection and measures. Data will be collected using multiple sources to represent
diverse perspectives using a QUANT+QUAL concurrent (mixed method design approach). Data
sources include data from delivery of the core components of the program, data from
participants, and EHR clinical outcomes data. Surveys and interviews with participants
will be conducted in the participant's preferred language. Interviews will be led by
Community Weavers. Study databases for mHealth message delivery, care coordination, and
Community Weavers will be in REDCap surveys allowing for the entry of real time
information. Periodic reflections will be collected as weekly diary entries from
different members of the research team and notes from monthly meetings reviewing these
entries. Participant surveys will be drafted with input from the CABs and pilot tested
prior to full implementation. A combination of electronic and paper-based surveys based
on the preference of the participants will be used.. Interviews will be conducted by the
Community Weavers using a semi-structured interview guide reflecting PRISM domains
adapted from prior studies and vetted by the CAB.

This 5-year R01 NIMHD proposal capitalizes on the unique and complementary methods from
community engagement, implementation science, health equity, health communication,
infectious disease, and public health to co-create a multicomponent health program to
promote sustained COVID-19 vaccination and preventive care engagement for underserved
communities in San Diego. This proposal extends current work using a generalizable
co-creation approach and funded by NIH CEAL and RADx-UP initiatives to focus on scaling
and sustaining COVID-19 and broader health equity for immigrant, refugee, and BIPOC
communities. Limited research exists on sustainment strategies so the explicit focus on
scaling and sustaining will add to the field of implementation science by adding evidence
to health equity-promoting sustainment strategies. Results from this study will be used
to develop a multi-site scaling out study in a subsequent NIH R01 application.