Using Community-Based Participatory Research to Design, Conduct, and Evaluate Randomized Controlled Trials with American Indian Communities.

Purpose And Objectives: Academic literature indicates a need for more integration of Indigenous and colonial research systems in the design, implementation, and evaluation of randomized controlled trials (RCTs) with American Indian communities. In this article, we describe ways to implement RCTs with Tribal Nations using community-based participatory research (CBPR) principles and practices.

Intervention Approach: We used a multiple case study research design to examine how Tribal Nations and researchers collaborated to develop, implement, and evaluate CBPR RCTs.

Evaluation Methods: Discussion questions within existing tribal-academic partnerships were developed to identify the epistemologic, methodologic, and analytic strengths and challenges of 3 case studies.

Results: We identified commonalities that were foundational to the success of CBPR RCTs with Tribal Nations. Long-standing community-researcher relationships were critical to development, implementation, and evaluation of RCTs, although what constituted success in the 3 CBPR RCTs was diverse and dependent on the context of each trial. Respect for the importance of diverse knowledge systems that account for both Indigenous knowledge and colonial science also contributed to the success of the RCTs.

Implications For Public Health: Tribal-academic partnerships using CBPR RCTs must include 1) establishing trusted CBPR partnerships and receiving tribal approval before embarking on RCTs with Tribal Nations; 2) balancing tribal community interests and desires with the colonial scientific rigor of RCTs; and 3) using outcomes that include tribal community concepts of success as well as outcomes found in standard colonial scientific research practices to measure the success of the CBPR RCTs.