Innovating for Inclusion
NIA Panel Discusses How to Diversify Dementia Trials
Be genuine. Listen. Engage with the community. These are among the ways clinical trial coordinators and investigators can build trust and recruit more underrepresented groups into their studies.
The National Institute on Aging (NIA) recently hosted a webinar to explore how to make Alzheimer’s disease and related dementia clinical trials more inclusive. Black/African-American and Hispanic/Latino populations have a higher risk of developing Alzheimer’s disease and other dementias than non-Hispanic Whites but are consistently underrepresented in dementia studies.
Traditionally, underrepresented populations have faced many challenges to participating in clinical trials. The hurdles can be daunting: Strict eligibility criteria. Time commitment. Inconvenient trial locations. Mistrust.
Yet their potential contributions are vast and critical to developing treatments and prevention strategies that work for all people. At the webinar, two investigators, a clinical trials coordinator and a study participant shared experiences and resources toward building more diverse cohorts.
Forging AHEAD
Two principal investigators working on diversity and inclusion for the NIH-funded AHEAD study discussed strategies for diversifying enrollment. Both PIs work with the University of Wisconsin’s Alzheimer’s Disease Research Center (WI-ADRC), a site for AHEAD—a multi-center prevention study aimed at delaying memory decline.
One of those PIs, Dr. Taryn James said most Black Americans recruited to WI-ADRC are in the African Americans Fighting Alzheimer’s in Midlife Study (AA-FAiM), a biomarker trial assessing Alzheimer’s disease risk reduction and treatment for African Americans. ADRC strategies to recruit and retain participants in AA-FAiM include brain health fairs, newsletters and social media, skills-based classes and other community events.
In addition, ADRC staff went inside the community, opening a field office equipped to do medical testing in a diverse neighborhood.
“To identify and remove barriers, we have to understand the needs of a community by forming relationships with them,” James said. Deep engagement involves developing community partnerships, such as the Black Leaders for Brain Health community advisory board consisting of local Black American leaders who understand community needs. “We listen to their feedback and incorporate that in our approaches.”
Building Bridges
Another AHEAD study PI, Dr. Shenikqua Bouges, is developing strategies to improve trust in research among Black Americans.
“Trust is a subjective term with a multitude of definitions and values, which significantly impacts an individual’s willingness to participate in a study,” said Bouges, an assistant professor at UW-Madison who specializes in dementia and geriatric medicine.
Building trust takes time. Their focus groups have shown that African Americans prefer interacting with doctors and staff of the same race. But, most importantly, the community wants to feel valued for their participation and seeks transparency from scientists.
Following up on the community’s request, Bouges said her team provides treats as a token of appreciation at community events, while sharing dementia and clinical trial information. They bring brain-healthy snacks and brain-stimulating activities such as culturally sensitive puzzles.
Bouges suggested clinical trials could become more inclusive by adjusting the exclusion criteria and providing genotyping for people at a higher risk for dementia.
A Champion and a ‘Shero’
“Being a person of color, we have stigma in the back of our minds,” said Jimmie Harris, a clinical trial participant at the Wake Forest Sticht Center for Healthy Aging and Alzheimer’s Prevention in North Carolina. “We do not trust research, because so many things have happened to people of color in research.”
Harris first discovered the Sticht Center several years ago when a friend invited him to participate in a brain study. “I enjoyed every minute of it,” he said, “and from that point on, I’ve been going for every brain study they’ve had.” He began sharing this positive experience with others and has become a passionate advocate in his community.
His recruitment tool? “I brought my ‘shero,’” he said of Deb Burcombe, who directs outreach programs at Sticht and helps bring programs to his community. “Even though she doesn’t look like [others in] my community, she was accepted because I told them ‘this is my angel.’”
Burcombe said she connects with diverse communities by being transparent and creating opportunities to share meaningful information. She created a monthly event on aging well focused on brain and body health. The now-virtual event includes fun prerecorded features, such as chefs sharing recipes and virtual road trips, and has expanded well beyond her state, with many more asking how to get involved.
In North Carolina, about 22% of the population is Black or African American. The Sticht Center’s clinical trials, with a 23.8% Black-American participation rate, exceeds the state average.
“I’m so proud of that,” said Burcombe, “not to check a box, but to say I feel like we’re working so hard to reach, to connect, to embrace a population that may not have been invited, or hesitated, to be a part before. I feel like we’re having an impact.”
Harris encourages Black Americans to join studies to help foster targeted research. He tells his friends that doctors “cannot design a medicine for a person of color if you’re not in the study. To get medication for your bloodline…you have to make sure you’re in there with that study.”
Further Outreach
NIA developed a free tool to help researchers generate recruitment materials for dementia trials. OutreachPro—available at https://outreachpro.nia.nih.gov/—offers customizable templates for developing locally targeted, culturally sensitive print and online materials such as handouts, posters and social media assets.
The tool was developed after gathering community input and conducting formative research such as expert listening sessions, national surveys and focus groups.
“We learned a lot from focus groups,” said NIA’s Jeanne Jarvis-Gibson, who moderated the webinar. “We got to see how terminology and imagery created an impact and how different audiences viewed a message or concept.”
The first step toward diversifying enrollment, though, is speaking with individual communities to discern their needs. Bouges said, “Then you’re able to provide a service to them, first and foremost, to help you build that trust.”