Scaling and sustaining COVID-19 vaccination through meaningful community engagement and care coordination for underserved communities: hybrid type 3 effectiveness-implementation sequential multiple assignment randomized trial

Meaningful community engagement is an important factor in facilitating the uptake, implementation, and sustained use of interventions designed to address health inequities [28, 29]. Community engagement, however, is not a trivial task, especially when working with communities representing diverse cultural heritages and languages and whose voices have historically been silenced [30, 31]. In the creation of community-vetted solutions to inequitable vaccine distribution and uptake, as well as access to preventive services, it is critical to utilize approaches that acknowledge and address these historical patterns [32]. Community Weavers are individuals with lived experience as a member of an underserved community who serve as cultural brokers between communities, public health systems, and researchers to co-create community-driven, culturally sensitive public health solutions [33, 34]. Community Weavers can bridge the gap between the underserved community and the mainstream public health systems and support research and clinical partners in learning about the priorities, preferences, needs, and strengths of the community, which can lead to solutions that are culturally sensitive and responsive [34]. They can also support the engagement of community members in health care, including COVID-19 vaccination and other preventive services. The Global Action Research Center (ARC), a nonprofit social change organization with expertise conducting participatory action research to address public health needs and a trusted resource for many of the grassroots organizations, will be the key lead in identifying, training, and engaging our Community Weavers in this project. A key component in this process is to engage in co-creation of solutions with members of the community. Co-creationbuilds on the concepts of bidirectional learning and shared decision-making and relies on the expertise brought by all members of the team [35, 36]. Co-creation has been successfully used in diverse contexts, and programs that incorporate co-creation tend to have better uptake, more comprehensive implementation, and lead to more sustained positive outcomes [37‐39]. Co-creation has been at the heart of our prior community-engaged COVID-19 research with our community and clinical partners to meaningfully engage diverse community members in participatory methods.

Lessons addressing challenges with vaccine distribution and vaccine hesitancy can be drawn from decades of vaccine campaign research from low- or middle-income countries (LMICs) through reverse innovation. Reverse innovation involves replicating an innovation that was originally developed for use in LMIC settings and translating to a high-income country [40]. Traditionally in clinical research, innovation is scaled from high-resource settings to low-resource settings, resulting in predictable challenges with resource limitations impacting feasibility. Reverse innovation allows researchers to derive insights from LMIC implementation research and innovatively adapt for higher-income settings. Given the importance of trust in promoting vaccine uptake, the current study will amplify the voices of trusted local leaders within historically disadvantaged communities. Emerging research illustrates the popularity of mHealth interventions to extend service capacity and reach, promote healthcare engagement, reduce stigma, and promote vaccine acceptance [41]. The use of digital health products has significantly increased during the COVID-19 pandemic era [42]. Important considerations for the implementation of mHealth in real-world settings include technology literacy, personalization of interventions, and perceptions of health risk and status [43]. We will address these considerations to inform the appropriate selection of implementation strategies tailored for context and implementation phase [44].

In addition to information on vaccine effectiveness and access through mHealth strategies, additional support with more intense coordination might be needed for some community members. Care coordination is an evidence-based practice that is widely recognized as a core component of high-quality care [45]. It is also a pillar of the patient-centered medical home (PCMH), which is a model of primary care increasingly adopted by healthcare systems, including FQHCs, to meet the needs of diverse patients and to improve experiences, outcomes, safety, and system efficiency for patients, providers, and staff members [46, 47]. We define care coordination as “the deliberate organization of patient care activities between two or more participants involved in a patient’s care to facilitate the appropriate delivery of health care services” [48‐50]. Through personalized health education and care management and collaborative problem-solving, care coordinators will work with patients to develop and achieve a health action plan in collaboration with their primary care physician. The National Committee for Quality Assurance (NCQA) leads the most widely adopted evaluation program for PCMH accreditation, called the NCQA Recognition program [51]. Our FQHC healthcare partner has successfully obtained and maintained NCQA recognition, due, in part, to their care coordination program. This study will expand eligibility for care coordination to target reduction of outstanding preventive services, including but not limited to diabetes and cancer screenings, and influenza vaccination, and offer co-created enhancements to maximize cultural relevance to priority patient communities served by the FQHC.

Taken together, these three implementation strategies — co-creation led by Community Weavers, mHealth, and care coordination — have strong potential to accelerate efforts to sustain COVID-19 vaccination uptake and recommended use of preventive services. Research indicates that social determinants of health, such as low SES, educational level, and access to transportation, along with identifying as members of immigrant, refugee, Latino, and BIPOC communities, reduce one’s likelihood to engage in evidence-based preventive services [52, 53]. As a response to the COVID-19 pandemic, many preventive services were delayed, resulting in more members of underserved communities having overdue preventive service needs [54]. Through a multicomponent health program, COVID-19 vaccination will be coupled with engagement of members of underserved communities in broader preventive services. Engagement in preventive services will be addressed through all components of the program including co-creation of strategies, mHealth outreach, and care coordination. Combining care coordination with culturally relevant, linguistically appropriate, and co-created mHealth health promotion messages offer a powerful approach to both facilitating vaccine equity and preventive services engagement.

The multicomponent health program will be informed by an overarching ToC that was developed based on the team’s prior work with two CABs. The goal of the CO-CREATE CAB was to directly inform co-created implementation strategies for a tailored COVID-19 testing program and included 22 members representing community residents, public health researchers, and clinical partners. The goal of the STOP COVID-19 CA CAB was to inform materials and resources needed to support vaccine clinical trial participation and equity initiatives in underserved communities and included 11 community leaders representing ten local grassroots community organizations and two policy partners [23, 24]. ToCs have been broadly used to guide the planning, implementation, and evaluation of public health programs in low-resource settings and provide a comprehensive description of how and why a desired change is expected to happen in a particular context [55, 56]. In these two COVID-19 projects, a rigorous, multistep process was used to create a separate ToC for each CAB [24] which were overlaid to create an overarching, combined ToC. This combined ToC will be confirmed and refined and used to inform our strategy selection and implementation and evaluation planning.

The Practical, Robust Implementation, and Sustainability Model (PRISM) will guide the optimization, implementation, and evaluation of our multicomponent health program [57, 58]. PRISM allows for multi-level conceptualization of implementation efforts (context domains) and also provides guidance on how to measure relevant proximal implementation outcomes through integration of the RE-AIM measures (reach, effectiveness, adoption, implementation, maintenance) — one of the most widely used sets of implementation measures [59]. PRISM is ideal for guiding our real-world community-based research project because it accounts for multi-level effects; it builds on several implementation science frameworks and can guide development, implementation, and evaluation. Multiple levels of context will be considered: recipient characteristics (community members and delivery agents — Community Weavers and care coordinators), intervention characteristics (perceived by diverse partners), implementation and sustainability infrastructure within communities and clinics, and the external environment (national guidelines and regulations). These factors will be considered during the co-creation and optimization of the multicomponent health program and assessed dynamically across the lifetime of the study. Several studies show that the reach, adoption, implementation, and sustainment of interventions are related to how well the intervention is integrated into the local context [59‐61]. These factors will be assessed in addition to effectiveness, using the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework.

The multicomponent strategy will be developed and optimized using the team’s established co-creation approach with guidance from the Community Weavers and engagement of the community through CABs. Community Weavers will be hired and supervised by the study’s community partner, the Global ARC, based on their established relationships with ethnically based community organizations. Hiring criteria for Community Weavers include that they are fluent in English and at least one of the three priority languages (Spanish, Arabic, Vietnamese); are engaged with communities living near one of the three partnering FQHC clinics; have experience with community engagement, leading and organizing; and have the capacity to share back knowledge and information with their community as well as share the community’s perspectives and concerns with the CABs.

Community Weavers will have a critical role in developing and refining tailored mHealth messages [66]. 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 lead three CABs that include five members each inclusive of the three primary languages spoken by community members of our clinics of interest. CAB members will be compensated for their time. In addition to the five community members, we will include the two care coordinators, a mHealth Specialist, and two clinical investigators as nonvoting members in each CAB.

During the first year, each CAB will meet up to four times. These initial meetings will be tasked with co-creating culturally and linguistically appropriate content and frequency for mHealth outreach and identifying topics, strategies, and processes for the care coordination program. mHealth outreach messages will be developed in the native languages of the CABs, and we will use professional translation as needed. To facilitate mHealth message development, Community Weavers will use a storytelling/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 [67]. 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. 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 the team’s prior work with the community [24, 31] and the CAB members’ lived experience as members of their respective communities.

mHealth-related communications will include personalized short messaging service (SMS) and automated phone calls recorded by community leaders in their respective languages aligned with the language preferences of our target clinics. The content of mHealth outreach will include information such as how and where to get vaccinated, myths about COVID-19 and other vaccines, the importance, timing, and scheduling of priority preventive services, and provide reminders for clinical care appointments. The study team includes an expert consultant in health communications to guide message development. mHealth distribution frequency will be determined by each CAB to align with their community’s preferences and needs. New messages will be developed and added to the message library based on updated public health guidance and feedback from participants. The mHealth outreach system will be user tested and refined prior to launch. See Fig. 3 for a schematic of the mHealth outreach system.

A mHealth specialist will lead the development of the mHealth delivery system by consulting with programming experts through Twilio to design and build a fully integrated, Health Insurance Portability and Accountability Act (HIPAA) compliant communications platform to manage the distribution of SMS and voice communications. Twilio will allow customized communications, develop production-ready applications, and run serverless applications on one application programming interface-powered platform. A centralized study database connected with the mHealth delivery system will track the number and timing of text and voice messages sent to individual participants. User analytics will be captured such as individual reach, responsiveness, and engagement. Example messages may include the following: “Proteja a sus seres queridos con vacunarse contra el COVID-19”/ “Protect your loved ones by getting the COVID-19 vaccine” and “Recuerde pedir su vacuna contra la Influenza”/ “Remember to ask for your flu shot.”

The partnering FQHC has an established process to provide care coordination (see standard of care in Table 2). The partnering FQHC will identify study-specific care coordinators who are members of the three study communities. Care coordination for the intervention will be tailored to the needs and cultural preferences of the respective patient community through input from our CABs. The content of care coordination will include engagement of patients in preventive services, developing a patient health action plan, support with adhering to the health action plan, scheduling preventive and care management appointments, communicating with the patient’s care team to ensure continuity of care, and COVID-19 vaccination.