Improving Minority Participation and Awareness in Clinical Trials

“Beloved, I wish above all things that thou mayest prosper and be in health, even as thy soul prospereth.” —3 John 1:2

Through Improving Minority Participation and Awareness in Clinical Trials (IMPACT) for Lupus, the Lupus Foundation of America and local faith communities have partnered to shine a light on clinical trials and to educate about lupus. Lupus is a disease that affects African Americans, particularly women, at much higher rates than others. In fact, about 1 in 250 African American women will develop lupus. Not only is lupus more common in African Americans, but fewer African Americans participate in clinical trials than any other racial group.

Clinical trials are studies that can help doctors and scientists learn more about different diseases and discover better treatments.

As an African American, participation in clinical trials is very important because:

• African American participation in clinical trials is historically low.
• African Americans may respond differently to certain treatments than other racial groups.
• Many of the current medications and procedures used to treat lupus have not been fully studied in African Americans.
• Participation allows you to take an active role in your own health now and for future generations.

The IMPACT for Lupus model was developed to create an awareness and education program to help inform you about clinical trials and lupus. It was created in partnership with family physician experts, clinical research participation experts, key lupus researchers, community experts, and lupus patients. IMPACT for Lupus was also developed using an extensive literature review and information gathered by surveying the faith community.

The model features a navigator as a connector among physicians, patients and clinical trial teams within local faith communities. Faith teaches us to think of others and leave a legacy of good works — participation in clinical trials is one way we can do just that.

IMPACT for Lupus Overview

Lupus is a devastating and complicated disease that knows no racial or ethnic boundaries, but is especially severe in African Americans. It is devastating because African American women develop lupus at a younger age with more complications. It is severe because the rate of kidney failure, degree of organ damage and prevalence of cardiovascular disease is unacceptably high in African Americans with lupus. 

Right now, there are not enough African Americans participating in lupus clinical trials. Clinical trials are supposed to help us understand how treatments affect all people, but they can’t do that unless all groups are represented. There is a need for more drugs to treat lupus and to understand how treatment affects different subset populations of those with lupus. The way to study those things is through clinical trials.

Awareness is a critical and necessary first step for anyone considering participation in clinical trials. IMPACT for Lupus is a one-year grant awarded to the Lupus Foundation of America by the Office of Minority Health as part of a larger federal initiative, the National Health Education Lupus Program. The goal of IMPACT for Lupus is to develop and test an innovative education model, within faith-based communities, to raise awareness of lupus clinical trials among African Americans impacted by lupus.

From August 2016 to June 2017, the Lupus Foundation of America and its partners developed a faith-based education model and materials for African Americans with lupus. The model features a navigator as a connector among physicians, patients and clinical trial teams within local faith communities. The model was implemented and evaluated from September 2017 to December 2017 in three sites:

• Atlanta, Georgia in collaboration with the Georgia Chapter of the Lupus Foundation of America
• Charleston, South Carolina in collaboration with the Medical University of South Carolina
• Fort Washington, Maryland in collaboration with CARLDEN, Inc.

The IMPACT for Lupus Action Partnership, as of September 1, 2017, includes the following representatives:

• A lupus patient
• Clinical trial, lupus, and industry experts
  • Richard Furie, MD
  • Sue Manzi, MD
  • Brad Rovin, MD
• The American Academy of Family Physicians (AAFP)
• The Center for Information and Study on Clinical Research Participation (CISCRP) 

For additional support, please contact the Lupus Foundation of America’s health educators. Questions are answered in English and Spanish.

This project is supported by Grant Number 1 CPIMP161122-01-00 from the U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the HHS, OMH.