Planning for a Group-Randomized Trial With American Indian Youth

AbstractPurposeTo describe lessons learned working with tribal communities in the Northern Plains to plan and implement a group randomized trial of multimedia Circle of Life (mCOL), a sexual risk reduction program designed for American Indian (AI) youth.MethodsProject records including emails, travel reports, and meeting minutes were reviewed and synthesized to describe participatory development of the project.ResultsSeveral challenges were identified including: discussing sexual health interventions for preteens with communities; developing a culturally appropriate research design; managing costs of conducting research in remote and culturally distinct tribal communities; and building research infrastructure of partner organizations. Opportunities for strengthening research partnerships included transparency, openness to bi-directional learning, planning for change, flexibility, and strategic use of technology.ConclusionsFindings suggest that meaningful AI community participation in research trials is achievable and a critical step towards generating evidence for interventions in settings where they are most needed. Substantial investments in time, resources, and relationship-building are necessary