Design
DISEASE
We will optimize, implement, and test the impact of a multicomponent health program that includes three implementation strategies: co-creation led by Community Weavers, mHealth outreach, and care coordination (described earlier). A participatory approach will be used to engage community members in co-creating and optimizing mHealth outreach and care coordination program components (Aim 1). A hybrid type 3 effectiveness-implementation SMART design will assess the impact of the multicomponent health program on implementation and clinical outcome measures (Aim 2) [Conceptual modelThrough the team’s ongoing community-engaged COVID-19 studies and guided by PRISM, determinants that underlie COVID-19 testing and vaccine disparities in underserved communities (immigrant, refugee, BIPOC, and Latino families) were identified. These determinants include unique explanatory models of health and COVID-19 (intervention PRISM domain), structural and systemic challenges to vaccination and preventive services engagement (implementation and sustainability infrastructure PRISM domain), FDA-approved or authorized COVID-19 vaccines available to all adults (external environment PRISM domain), and the varying needs and characteristics of underserved communities located in our target geographic regions (recipients PRISM domain). It is hypothesized that the selected implementation strategies will exert their impact on implementation and clinical outcomes through vaccine confidence and service navigation support (mechanisms). Implementation outcomes are based on RE-AIM and expected to affect our clinical outcomes (effectiveness).Clinical outcomes are based on the Office of Disease Prevention and Health Promotion’s Healthy People 2020 objectives [The multicomponent strategy is an adaptive approach that utilizes tailored mHealth messaging and care coordination to increase COVID-19 vaccine uptake. The SMART assignment arms are described in Table Sequential, multiple assignment randomized trial (SMART) design