National Lupus Outreach and Clinical Trail Education Program - Lupus is an autoimmune disease that disproportionately affects populations often underrepresented in clinical trials, including Black/African American, Hispanic/Latino, rural, and lower-income communities. Although many people living with lupus are willing to consider clinical trial participation, barriers can prevent them from moving from interest to referral, screening, and enrollment. These barriers include limited awareness of trial opportunities, distance from trial sites, transportation and cost concerns, limited provider referral pathways, and the need for trusted support. From October 1, 2026, to September 29, 2029, the Lupus Foundation of America (LFA) will implement the Building Engagement through Advocacy, Community Outreach, and Navigation program, known as BEACON. BEACON will increase lupus clinical trial awareness, readiness, referral, screening, and enrollment among underrepresented people living with lupus, with a focus on the South Atlantic region. The program will combine the LFA’s national reach, community engagement infrastructure, Research Accelerated by You (RAY) lupus registry, and partnerships with the Medical University of South Carolina and MedStar Georgetown University Hospital to connect interested individuals with relevant trial opportunities. BEACON will use a two-part approach. First, the program will implement targeted education and communication to increase clinical trial awareness, trial literacy, and RAY registry engagement. Activities will include training Lupus Research Advocacy Network members for peer-to-peer lupus research outreach; delivering culturally appropriate virtual and in-person education; partnering with academic medical centers to share registry information; and disseminating culturally and linguistically relevant digital ads and communications, social media, and web-based materials. By the end of the project period, these activities are expected to increase enrollment of underrepresented populations in RAY by 20% over baseline and increase awareness of clinical trial representativeness, interest in trial information and participation, and awareness of tools to identify trial opportunities and eligibility criteria. Second, BEACON will implement a telephone- and virtual-based nurse-led clinical trial navigation model for eligible and interested RAY participants in the South Atlantic region. The nurse navigator will identify and prescreen potentially eligible participants, provide plain-language trial education, assess barriers such as transportation, cost, language, and scheduling, support informed decision-making, and facilitate warm handoffs to trial coordinators at partner academic medical centers. By September 29, 2029, BEACON aims for at least 85% of navigated, interested participants to receive warm-handoff referrals, at least 90% of referred participants to complete eligibility screening, and at least 15% of screened participants to enroll in a lupus clinical trial. The program also aims for at least 80% of navigated participants to complete trial knowledge modules and for at least 70% of identified barriers to be resolved or mitigated. Expected deliverables include clinical trial education and outreach materials, community and academic medical center partnerships, a nurse-led navigation workflow, referral and tracking processes, interim and final analyses, participant satisfaction surveys, a replication toolkit, at least one scientific abstract and one peer-reviewed manuscript submission, and a national scale-up feasibility brief with potential partners and sustainability strategies. The primary beneficiaries of BEACON are underrepresented people living with lupus, particularly those in the South Atlantic region who face barriers to clinical trial participation. The program will also benefit trial sites, researchers, and the broader lupus community by supporting more representative participation and evidence that better reflects the populations most affected.
