Federal grant aims to get more Black patients into lupus clinical trials
Lupus Foundation of America awarded 3-year grant worth $500K per year
The Lupus Foundation of America (LFA) will use a three-year federal grant — worth up to $500,000 per year — to continue efforts to increase the number of Black lupus patients in the U.S. who participate in clinical trials.
The grant, which runs from September 2023 to September 2026, was awarded by the Office of Minority Health (OMH) at the U.S. Department of Health and Human Services.
It builds upon a 2021 OMH grant to the LFA that led to creation of the foundation’s Improving Minority Participation and Awareness in Clinical Trials program, dubbed IMPACT+. That program focuses primarily on Black women, who are disproportionately affected by lupus.
“Diversity in lupus clinical trials is not just a matter of representation, but a critical factor in ensuring the efficacy and safety of treatments, which is why programs like the Lupus Foundation of America’s IMPACT+ supported by OMH is so important,” Mary Crimmings, the LFA’s interim CEO and senior vice president for marketing and communications, said in a press release.
This the third time in the last seven years the OMH has awarded the LFA a grant aimed at addressing health disparities in the autoimmune disorder and improving care.
New award seeks to build on LFA’s IMPACT+ program
The aim of the IMPACT+ program is to erode barriers to enrollment in clinical studies and to educate patients and healthcare providers about clinical trial participation, and its impediments. In particular, the program seeks to engage rheumatology nurses, who typically are frontline care providers and, as such, play a key role in educating and taking care of patients.
A review spanning 1997 through 2017 found that Black individuals comprised 43% of U.S. lupus patients yet represented 14% of participants in clinical studies. According to the LFA, about 1 in 537 Black females are affected by lupus. Compared with cases involving white females, lupus is 2-3 times more prevalent among Black, Hispanic, Asian American, Native American, Alaska Native, Native Hawaiian, and other Pacific Islander women.
“Each individual brings a unique genetic makeup and lived experience, influencing how they respond to therapies. Embracing diversity in trials is imperative for advancing lupus research and improving outcomes for all,” Crimmings said.
With grant funds, IMPACT+ will seek to use formative evaluation methods to identify the most effective ways to communicate to Black lupus patients the importance of clinical trial participation, and to boost interest in them. The aim is to assure that the patient voice is integrated throughout the establishment of the education portion of the program as well as the recruitment process.
This approach includes gaining an understanding of the chief concerns Black lupus patients have when presented with information about clinical research and studies. It also seeks to better assess their priorities.
The hope is that such an understanding will provide more “culturally congruent and relevant” insight into how best to communicate with this patient population around clinical trial education and trial recruitment, according to the press release.
Each individual brings a unique genetic makeup and lived experience, influencing how they respond to therapies. Embracing diversity in trials is imperative for advancing lupus research and improving outcomes for all.
In addition, IMPACT+ will use grant funds to seek to expand the participation of Black patients in the LFA’s Lupus Research Action Network (LRAN), a nationwide peer-to-peer clinical study education and training program.
Members learn more about clinical trials — and how to communicate about participation — within their communities and networks to increase enrollment in RAY, the LFA’s patient registry. The overarching goal is to ultimately increase participation among Black patients in lupus research.
LRAN’s training portion is based on the Lupus Conversions program, which employs the Popular Opinion Leader model. So far, 102 patients have been training using this model.
The LFA has long sought to eradicate obstacles to participation in clinical studies. More than a decade ago, the organization, along with lupus advocates, worked with U.S. lawmakers to establish the OMH National Lupus Training, Outreach & Clinical Trial Program.