Improving Minority Participation and Awareness in Clinical Trials (IMPACT+) - Systemic lupus erythematosus (SLE), a complex, chronic autoimmune disease with no known cure, is more prevalent and most burdensome among Black/African Americans. Black/African American people with lupus (PWL) are more likely to have organ system involvement, more active disease, and lower levels of social support compared with White PWL. Despite Black/African Americans comprising 31% to 43% of lupus cases in the United States (US), they represent only 14% of clinical trial participants. This lack of representation has been an ongoing challenge in clinical trials conducted across the US. Given the impact of lupus on Black/African American populations, it is imperative they participate in trials so that new treatments address their medical needs. The Lupus Foundation of America (LFA), the nation’s leading organization dedicated to improving the lives of people with lupus, is proposing to continue its work via the Improving Minority Participation and Awareness of Clinical Trials Plus (IMPACT+) initiative to help address these challenges. IMPACT+ involves a two-pronged strategy to increase the participation and retention of Black/African American PWL in clinical trials in the US. By collaborating with partners in the lupus community, IMPACT+ will: 1) educate PWL about clinical trials to support trial participation through the existing peer-to-peer Lupus Research Action Network (LRAN) program and; 2) increasing Black/African American participation in Research Accelerated by You (RAY) registry. Through this work we aim to achieve tangible increase by conducting formative research to explore the barriers, motivations and preferences for clinical trials participation and using these findings to create culturally and linguistically relevant RAY marketing and recruiting strategies/materials. IMPACT+ has two overarching goals aimed at reducing barriers to clinical trials specifically for Black/African American (B/AA) PWL. These goals will be actualized through the development, refinement, and implementation of professional and community educational and outreach opportunities and tailored, culturally relevant and linguistically appropriate marketing and recruitment for the RAY registry and clinical trials. • Goal 1: By August 2025, build capacity amongst existing LRAN members and provide enhanced training for 60 highly engaged (enrolled in RAY and self-report as Black/African American) LRAN members for the expansion of outreach and engagement to increase Black/African American patient enrollment and retention in clinical trials and enrollment in RAY. • Goal 2: By August 2025; 1) explore B/AA motivations and preferences for registry and clinical trial participation, 2) translate motivations and preferences into targeted recruitment and communication strategies that are both culturally and linguistically appropriate, 3) pilot test newly developed strategies to examine effectiveness and acceptability within the target population, and 4) increase Black/African American enrollment in the RAY patient and caregiver registry by 200 new B/AA participants to ensure inclusive access to the adapted Lupus Conversations Program and clinical trial engagement opportunities sponsored by academic/industry partners using newly developed, multi-level communication strategies. Taken together, IMPACT+ represents a unique opportunity to make a difference in Black/African American participation in clinical trials. With support from the HHS Office of Minority Health, IMPACT+ will confront the needs of Black/African American population with an array of committed partners.
