Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05841810 |
| Other study ID # |
R01MD017222 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 10, 2024 |
| Est. completion date |
June 30, 2027 |
Study information
| Verified date |
May 2024 |
| Source |
University of California, San Diego |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will optimize, implement, and test the impact of our multicomponent health program
that includes three primary implementation strategies (Cultural Weavers and co-creation,
mHealth strategies using culturally meaningful text and voice messages, and care
coordination). The investigators will use a participatory approach to engage community
members in co-creating and optimizing our mHealth outreach and enhanced care coordination
program components. The investigators will use a hybrid type 3 effectiveness-implementation
sequential multiple assignment randomized trial (SMART) design to assess the impact of our
multicomponent health program on implementation and outcome measures.
Description:
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.
