Bridges to Healing: Increasing Lakota Sioux Participation in Lupus Clinical Trials through Community-Based Outreach and the American Indian Clinical Trials Research Network Trial Site - Project Abstract Summary Black Hills Center for American Indian Health (BHCAIH), a nonprofit research organization based in Rapid City, South Dakota, requests funding to implement Bridges to Healing, a three-year project to increase participation of Lakota Sioux individuals in lupus clinical trials in western South Dakota. Target population and geographic area: The project's population of focus is Lakota Sioux individuals living with lupus — an autoimmune disease that disproportionately affects American Indian and Alaska Native populations, with higher prevalence, earlier onset, and greater severity than in non-Hispanic White populations. The project serves four communities in a medically underserved frontier region: the Pine Ridge, Rosebud, and Cheyenne River Sioux Tribe Reservations, and the urban American Indian community of Rapid City and the surrounding Black Hills area. An estimated 200 or more Lakota Sioux individuals with lupus live in this area, with no prior lupus clinical trial ever conducted there. Intervention approach: The project addresses the full clinical trial participation continuum — awareness, referral, screening, enrollment, and retention. It will train approximately 200 Community Health Representatives (CHRs) and 150 healthcare providers to build a culturally grounded education and referral pipeline. Trained CHRs and providers will identify and refer individuals with lupus to BHCAIH's American Indian Clinical Trials Research Network (AICTRN) site for screening and enrollment, supported by dedicated patient navigation to address transportation, scheduling, and other logistical barriers. The project incorporates newly developed and ratified Lakota-language terminology for lupus and clinical research, and applies the National CLAS Standards throughout, to address historical mistrust and improve health literacy and cultural relevance. Partnerships: The project is anchored in 25 years of active research partnerships with the Oglala Sioux Tribe, Rosebud Sioux Tribe, and Cheyenne River Sioux Tribe under BHCAIH's NARCH program project award, along with Oyate Health Center. AICTRN has an active, multi-trial relationship with a pharmaceutical sponsor, formalized through an executed Confidential Disclosure Agreement and three completed clinical trials, and will pursue lupus clinical trial site activation with this sponsor and other autoimmune-disease pipeline sponsors beginning in the first project quarter. Xcel Research Consulting, Inc. will serve as the independent process and outcomes evaluator. Measurable outcomes: By the end of the 36-month project period, the project will generate at least 200 documented referrals, complete at least 100 eligibility screenings, and enroll at least 50 (with an aspirational target of 75) Lakota Sioux individuals in lupus clinical trials, with a minimum 80% retention rate among enrolled participants.
