Planning for a group-randomized trial with American Indian youth.

Purpose: To 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.

Methods: Project records including emails, travel reports, and meeting minutes were reviewed and synthesized to describe participatory development of the project.

Results: Several 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.

Conclusions: Findings 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.