This program, based on a two-year, $500,000 grant, combines the ACR’s Materials to Increase Minority Involvement in Clinical Trials (MIMICT) model with its Community Health Worker Lupus Clinical Trials Training model. Its goal is to enhance collaboration among practicing rheumatologists, nephrologists, dermatologists and community health workers who serve Black and Latinx patients and break down barriers to participation in lupus clinical trials. The program aims to increase providers’ knowledge about these barriers to participation, positively influence attitudes about referring under-represented patients to trials, support providers’ belief that they can competently discuss clinical trial opportunities with patients and increase providers’ intentions to begin referring patients to clinical trials.
The key educational resources used in the TIMELY program include online modules tailored to the learning needs of rheumatologists, nephrologists and dermatologists, and modules for community health workers. These materials are designed to prepare participants to conduct outreach and education on clinical trials with Black and Latinx patients. The program is currently being employed and evaluated in North Carolina and western New York under the leadership of Dr. Sheikh and Allen P. Anandarajah, MD, MBBS, professor of medicine, Division of Allergy/Immunology and Rheumatology, University of Rochester, New York.
The U.S. South
Pamela Payne-Foster, MD, MPH, professor of community and population health, University of Alabama, Tuscaloosa, discussed the Deep South Health Equity Lupus Education Project (DS HELP), which seeks to increase the participation of patients with lupus, primary care providers and health disparity researchers and clinicians who are Black in clinical trials for lupus. The interventions for these groups include existing resources, such as the online Lupus Conversations program and the MIMICT program from the ACR. Other new resources include a conference using innovative approaches to disseminate information and a lupus research development program for both clinicians and biosocial researchers who work in predominantly Black communities.
Although the recruitment of participants for DS HELP was challenging, Dr. Payne-Foster noted that interesting lessons were learned through discussions in the program. Concerns about the distances between clinical trial sites and patients’ homes, fear of side effects from experimental medications and unease about the possibility of increased disease activity resulting from participating in trials were all raised.
Nurses
Finally, Joy Buie, PhD, MSCR, RN, director of research, Lupus Foundation of America, Charleston, S.C., discussed the Increasing Minority Participation and Awareness in Clinical Trials (IMPACT+) initiative. The goals of this program are threefold:
- To use an accredited curriculum to increase the knowledge of nurses about clinical trials and use the Popular Opinion Leader model to encourage the participation of Black patients in lupus trials;
- To educate people with lupus about clinical trials and the barriers to enrollment; and
- To determine the feasibility of using patient navigator-led clinical trial educational initiatives to increase Black participation in trials.
The training was built on the Rheumatology Nurses Society Lupus Conversations course and was delivered at a virtual summit in April 2022. The program taught nurses about lupus health disparities, outreach to geographically and demographically at-risk communities, and treatment options, including clinical trial participation. (View the online program for continuing nursing education credit until April 2024.)
