The Lupus Foundation of America (LFA) announced today it has been awarded a new grant from the Office of Minority Health (OMH) at the U.S. Department of Health and Human Services to address the substantial disparities in lupus clinical trial participation. The grant will build upon the LFA’s commitment to reducing health disparities, improving care and ensuring an arsenal of safe and effective treatments for all people living with lupus.
Clinical trials with a diverse array of participants are essential for the development of new and effective lupus therapies, but racial and ethnic minority populations have been and continue to be underrepresented in lupus clinical trials. A review of the years 1997-2017 found that Blacks/African Americans made up 43% of lupus cases nationally, yet represent only 14% of participants in lupus clinical trials. Participation of Blacks/African Americans and other racial and ethnic minority groups in lupus clinical trials is imperative so that new treatments address their medical needs.
“The record is clear that more needs to be done to confront existing disparities in lupus clinical trial participation and help ensure that new lupus therapies are safe and effective for all those impacted by the disease,” said Stevan W. Gibson, president and CEO, Lupus Foundation of America. “The Lupus Foundation of America continues to be committed to tackling this challenging goal and will reach racial and ethnic minority groups through a strategic approach led by trained clinicians and patients, who know first-hand the barriers and obstacles that for too long have limited minority participation in trials.”
With support from the OMH grant, the LFA has launched a new program called Improving Minority Participation and Awareness in Clinical Trials (IMPACT+). Focused on Black/African American women who are disproportionately impacted by lupus, IMPACT+ involves a two-pronged strategy to educate healthcare providers, specifically, rheumatology nurses, and people with lupus about participation in clinical trials, barriers to clinical trial enrollment and best approaches to support racial and ethnic minority participation in trials. A complex and chronic autoimmune disease, lupus impacts an estimated 1.5 million Americans and there is no cure. Black/African American women are two to three times more likely to develop the disease.
Because nurses and advanced practice providers play a critical role in guiding and educating their patients, facilitating relationship-building between patients and providers, and fostering patient trust, IMPACT+ includes a robust training component for rheumatology nurses across the nation in partnership with the Rheumatology Nurses Society. Participants will be trained using the evidence-based Lupus Conversations Program (LCP), developed by researchers at Northwestern University Feinberg School of Medicine and Brigham and Women’s Hospital, and tailored to reach people with lupus, with a focus on Blacks/African Americans. The program includes four modules, an Introduction to Clinical Trials; Barriers, Facilitators, and Mediators in Clinical Trials Enrollment; and Clinical Trials and Racism.
IMPACT+ will also directly reach people with lupus through peer-to-peer education led by people with lupus who serve as volunteer members of the LFA’s Lupus Research Action Network (LRAN). Members of this network will be trained using the LCP, which is also based in part on the Centers for Disease Control’s Popular Opinion Leader model. The training of rheumatology nurses and people with lupus will be conducted in collaboration with physician advisors from Northwestern University and other experts from the lupus and health disparities fields.
During the IMPACT+ program, the LFA will also assess whether a clinical trial education component can be added to a newly established lupus patient navigator program to expand the educational reach of IMPACT+.
Launched in September 2021, IMPACT+ builds upon the LFA’s original IMPACT program developed in 2016 with support from the OMH. The LFA has championed efforts to break down barriers that have limited participation in clinical trials. More than a decade ago, the LFA and lupus advocates worked with Congress to help establish the OMH National Lupus Training, Outreach & Clinical Trial Program. Since that time, Congress has provided more than $20 million in funding to support minority participation in lupus clinical trials.