When the November 2020 news broke that two vaccines had proven to be highly effective in preventing COVID-19 or minimizing its impact, people everywhere began talking about seeing a light at the end of the tunnel.
But many public health experts were talking, too, about another bright spot – the vast numbers of participants from racial and ethnic minorities who helped test those vaccines in clinical trials. Some 37% of the 30,000 volunteers in the NIH-Moderna vaccine trial and 42% of the almost 45,000 volunteers in the Pfizer-BioNTech trial came from communities of color.
Just a few months ago, the prospect of drawing numbers that large seemed almost inconceivable. Headlines blared about minorities’ historic lack of participation in medical research, as well as their mistrust of the scientific community in charge of it. Worse, people of color were bearing the brunt of COVID-related illnesses and deaths, but seemed the most reluctant to test treatments and vaccines—and actually use them once approved.
So what explained the surge of diversity in enrollment? The credit, experts say, goes not only to the individuals who stepped up, but to the public health professionals, researchers, and community advocates who engaged with them where they live and work.
“Community engagement is critical,” explained Tiffany Powell-Wiley, M.D., M.P.H., a tenure-track intramural investigator in NHLBI’s Cardiovascular Branch. And she should know: Powell-Wiley leads a research project called Step It Up, that works primarily with African American women who live in lower income and high risk areas of Washington, D.C. Her experiences underscore why community engagement matters, especially for studies focused on the highest risk populations.
Simply, she said, “it builds trust.”
It is an ongoing process, not a one shot deal. The Presidential Commission for the Study of Bioethical Issues underscored the importance of the ongoing process this way: “Although research can move forward without participation from the community, ethical and practical reasons compel community input.” Engagement entails the active inclusion and participation of community members. It could take many forms, from outreach and sharing of information, all the way to consulting, collaborating and sharing leadership on the research projects themselves.
“Beneficial relationships between researchers and communities can foster trust in scientific research and can lead to greater acceptance of scientific findings,” the Commission wrote in 2016.
All that work builds respect, Powell-Wiley agreed, and respect builds trust. Indeed, for her, respect is the foundation for any meaningful engagement with communities, and it has to be demonstrated in concrete, practical ways. Her own project has made that plain. “Working with the women throughout the process of developing an initiative, and getting their input at each step of the process allowed the work to happen,” Powell-Wiley said.
“I think if we had come in with something already put together, packaged and ready to go, there would have been a lot of skepticism about why they should participate,” she explained. “What’s really in it for them? There would have been questions: ‘Are you trying to experiment on us?’”
These questions did come up in the beginning, but after more than seven years working together, Powell-Wiley said, “they are much less frequent.”
Trusted relationships helped the COVID-19 response
It is no surprise, then, that during the pandemic, engagement with communities worked best where it has worked the longest. For example, when COVID-19 hit, Powell-Wiley shifted gears and capitalized on her strong community ties to become a source of reliable information about the virus, prevention measures, treatments, testing, research, and more. Her voice was known. She had their backs.
Drawing on these kinds of ongoing relationships between other NIH-funded researchers and the communities they serve, in fact, is the idea behind the NIH Community Engagement Alliance (CEAL) Against COVID-19 Disparities. Through these local connections, communities hard hit by the double whammy of the pandemic and the onslaught of misinformation about it are learning the truth about COVID-19 from leaders they trust. They are also learning about the importance of inclusion in research studies that seek effective treatments and vaccines. A greater understanding of the scientific process, researchers believe, will bolster community members’ trust and equip individuals to make informed decisions about participating in research.
The CEAL Alliance also funds community engaged research teams in counties within Alabama, Arizona, California, Florida, Georgia, Louisiana, Michigan, Mississippi, North Carolina, Tennessee and Texas.
“Having a strategic plan to conduct a culturally tailored community engagement program that addresses issues of historical disadvantage, low health literacy, and mistrust is really important,” said Venus Ginés, M.A., President and Founder of Día de la Mujer Latina® Inc, a nonprofit organization that is part of the CEAL research team in Texas. “It allows us to build the type of framework for all research studies moving forward, not just for COVID-19.”
Ginés, who also is a Promotora —Spanish for Community Health Worker—said people like her play a big role in that effort. “Promotores and Community Health Workers (P/CHWs) will be crucial, since they are trusted members of the community,” she said. “They are trained to use effective strategies to motivate, inform, navigate and educate vulnerable populations.”
Minority and marginalized communities have long faced the twin problems of exclusion and involuntary inclusion in medical research done without consent, oversight, or consequences. Ginés points to two notable cases, both occurring between the 1930s and 1970s, as causes of heightened distrust. One was the infamous Tuskegee Syphilis Study, in which researchers with the U.S. Public Health Services let syphilis go untreated in a group of Black men, without their consent, to observe the effects of the disease in the body; the other was the coercive sterilization of Puerto Rican and Mexican women.
But “compelling inequalities”—from lack of transportation and child care to economic scarcity and illness—also limit their full participation in research. “COVID-19 exposed that,” Ginés said.
A lesson in true inclusion and participation
Anna Maria Siega-Riz, Ph.D., dean of the School of Public Health and Health Sciences at the University of Massachusetts Amherst, understands more than most the practical impact those kinds of inequities can have on efforts to engage communities in research. In 2015, when she moved from North Carolina to her new post as professor of nursing and associate dean for research at the University of Virginia School of Nursing, she knew next to nothing about the community.
But Siega-Riz wanted to implement a program to help pregnant women and new mothers learn about nutrition. So to better understand the local landscape, she became involved with the health department, the Women, Infants, and Children (WIC) Program, and various community based organizations. Soon, her team was able to conduct a demonstration project in Charlottesville.
“I can’t tell you how impactful it was for me, as a researcher, to have that understanding, that input from the local community members,” said Siega-Riz, a former member of the NHLBI Advisory Council. She quickly geared up to put her idea into action: provide the women with wholesome foods, host a cooking demonstration, and gather some data about the women’s body measurements and food consumption , to see what impact the intervention would have on the diets of the mothers and their children.
“And what I found out, much to our dismay, was that these women had such complicated lives that they couldn’t come to the designated areas to pick up the food and attend the food demonstration,” Siega-Riz said.
In short order, she and her team realized they needed to go to the women, not require they come to them. And it worked. The women came forth. “But I would have never gotten that information if I hadn’t engaged with community members,” Siega-Riz concluded. Not only did the research become more relevant to the women, she said, it increased their commitment to participating and made them trust the research enough to share its findings with others."
“We need cultural humility to understand that when we approach a community with a research interest, their priorities might be different,” Siega-Riz said.
Deepening the engagement for COVID-19 and beyond
Through CEAL, the NIH is taking these lessons in inclusion and engagement to heart, and expanding community engagement efforts already underway by NIH COVID-19 trial networks.
“Black and brown people in the United States continue to suffer severe illness and die from COVID-19, but we don’t have reliable data because of how it is collected, analyzed, and reported,” Ginés, from Texas CEAL research team, said. Through the work with community and faith-based organizations, the CEAL program will try to address these gaps," she added.
The CEAL research teams' activities focus on COVID-19 awareness and education research, especially among African Americans, Hispanics/Latinos, and American Indians —populations that account for over half of all reported COVID-19 cases in the United States. They will also promote and facilitate the inclusion and participation of these groups in vaccine and therapeutic clinical trials to prevent and treat the disease.
To reduce health literacy barriers and promote good health and wellness, the Texas team also plans to develop a Clinical Trial Community Navigation training program for P/CHWs in both English and Spanish.
“It all starts with dispelling myths, rumors, and misinformation,” Ginés concluded.