Protecting Native Families from COVID-19: Implementation and Lessons Learned from a Community-Based Approach to Collecting Evidence to Support Uptake of Health Behaviors During the COVID-19 Pandemic.

The COVID-19 pandemic highlighted longstanding health inequities, particularly among American Indian/Alaska Native (AIAN) communities, which experienced disproportionately high morbidity and mortality. This manuscript documents the implementation, adaptation, and lessons learned from a randomized controlled trial (RCT) conducted during a rapidly evolving pandemic context. The RCT tested two public health interventions: (1) a motivational interviewing strategy to promote COVID-19 testing and preventive behaviors, and (2) a symptom monitoring tool to assess COVID-related symptoms. As the public health landscape shifted with the introduction of vaccines and evolving guidance, protocols required frequent adaptation to remain relevant. Four major amendments were made to adapt the study to evolving conditions, including changes to inclusion criteria, the addition of community-prioritized content such as vaccine hesitancy, and adjustments to accommodate mixed vaccination statuses within households. Delays in multiple IRB approvals often rendered changes outdated by the time they could be implemented. Recruitment was limited, and intervention delivery faced challenges including low survey completion and technological barriers. Nonetheless, strong collaboration with tribal partners and respect for tribal sovereignty enabled culturally grounded, community-responsive adaptations throughout the study. Lessons from the implementation process underscore the need for flexible, adaptive research approaches that maintain rigorous community and tribal oversight. Future research on urgent, ongoing health issues can be strengthened through streamlined regulatory pathways and sustained partnerships with AIAN communities in future emergencies like the COVID-19 pandemic. ClinicalTrials.gov Identifier: NCT04765475.