Lupus is a complex, chronic autoimmune disease impacting an estimated 1.5 million Americans and for which there is no cure. Lupus also disproportionately affects women of color. Black/African American, Hispanic/Latino, Asian American, and Native American women are two to three times more likely to develop lupus. There also are substantial disparities in lupus clinical trial participation. Minorities are far less likely to participate in clinical trials than their White counterparts. Given the impact of lupus on minority 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 leading the Improving Minority Participation and Awareness of Clinical Trials Plus (IMPACT+) initiative to help address these challenges.
IMPACT+ involves a two-pronged strategy to educate healthcare providers--specifically, rheumatology nurses--and people with lupus about participation in clinical trials. The training is built around three specific modules from the evidence-based Lupus Conversations Program: 1) Introduction to Clinical Trials; 2) Barriers, Facilitators, and Mediators in Clinical Trials Enrollment; and 3) Clinical Trials and Racism. This training is tailored to reach minority audiences, with a focus on Black/African American women, in collaboration with Northwestern University and the IMPACT+ physician advisors.
Nurses play a critical role in guiding and educating their patients, developing relationships between patients and providers, and building patient trust. IMPACT+ trains rheumatology nurses in partnership with the Rheumatology Nurses Society. Training sessions take place at the RNS annual summit and via webinars. Participating nurses are eligible to receive Continuing Nursing Education credit. Nurses who complete the training will be provided resources to share with their lupus patients to help the latter learn about clinical trials.
IMPACT + also reaches people with lupus through peer-to-peer education by members of the Lupus Research Action Network (LRAN). Members of this network are trained using the Lupus Conversations model at the 2022 and 2023 National Lupus Advocacy Summit. People with lupus who are contacted by LRAN participants are encouraged to join LFA’s Research Accelerated by You (RAY) registry where they can access and receive information on clinical trial opportunities through on-demand resources and targeted information shared with them.
IMPACT+ activities focus on active lupus clinical trials and on Black/African American women who are disproportionately impacted by lupus. The project has nationwide reach and LFA will dedicate resources to recruiting participants from targeted areas with a high proportion of Black/African American residents. LFA works with its national network of affiliated chapters and regional offices to conduct outreach to these targeted areas.
During the IMPACT+ program, LFA also will assess whether a newly-established lupus patient navigator program can serve to expand IMPACT+ educational reach. The aim of the program is to have trained patient navigators conduct outreach to people with lupus to improve overall disease management and drive better health outcomes. A feasibility analysis conducted under IMPACT+ will determine whether a clinical trial education component can be added to the navigator program as part of a sustained clinical trial diversity initiative.
Taken together, IMPACT+ represents an unique opportunity to make a difference in minority participation in clinical trials for potential lupus therapies. The record is clear that progress in this challenging goal requires tailored, intensive education and training for both clinicians and patients. With support from the HHS Office of Minority Health, IMPACT+ will confront these needs with an array of committed partners.