How NIH Uses Community Health Partnership for Participant Engagement

The National Institutes of Health (NIH) is looking to change the paradigm for medical research participation, working toward better participant engagement and diversity by leveraging strong community health partnerships and promoting transparency.

In fact, that’s the entire crux of the All of Us Research Program, according to Justin Hentges, the chief financial and management officer and acting chief engagement officer for the All of Us Research Program. NIH relies on a diverse breadth of clinical data from participants to make All of Us run. Participants volunteer anything from their electronic health records to some biospecimens—like getting an extra vial of blood drawn—to the larger data repository.

The end goal: more targeted therapeutics to advance precision medicine.

NIH takes the title of the initiative, All of Us, very seriously, asserting that it literally includes “all of us”—even the most underrepresented of populations. The challenge, however, is that those underrepresented populations—BIPOC, members of the LGBTQ+ community, women, people from rural areas, or those with disabilities—haven’t historically been represented in clinical research.

In 2019, researchers reported in JAMA Oncology that the typical cancer clinical trial was about 76 percent White. Meanwhile, Asian patients usually represented about 18 percent of trial populations, Hispanic patients 6 percent, and Black patients 3 percent.

This comes even as Black and Hispanic patients comprise 22 and 44 percent of the cancer incidence in the US, the study authors noted.

And that’s not to mention the participant engagement once someone joins a study. Anecdotal evidence has outlined an ivory tower in medical research, with limited participant engagement and transparency.

For Hentges, it is personal. As someone who identifies as a gay man, Hentges told PatientEngagementHIT he’s participated in a few clinical trials in his life, but he hasn’t ever felt particularly engaged.

“I identify as gay. And so, I've been in a number, I think now two or three, clinical trials, and in those clinical trials, they were for important things and I'm really happy I participated, but I didn't feel part of the program,” he said in an interview.

“I felt like, ‘Okay, I'm giving my blood, I'm getting a test vaccine, et cetera,’” but Hentges suggested that was the extent to his engagement.

The All of Us program feels different, Hentges added, also identifying himself as a participant. He said that his community has not only been brought to the table, but also asked to speak at the table and has gotten respect at that table.

The proof is the in the pudding. Although the figures for the number of All of Us program participants change daily, Hentges reported that NIH has about 388,000 people who have started the enrollment process. About 284,000 have completed the first steps, including providing their consent, completing some surveys, sharing their EHRs, and providing bio samples.

“With those folks that have completed the initial stages of our program, about 80 percent of those participants are from communities that we consider underrepresented in biomedical research,” he added. “That includes racial or ethnic minority communities, and of our 284,000, about 50 percent of those folks identify as from a racial or ethnic minority community.”

And that’s nearly entirely the credit of NIH’s community health partnerships, Hentges said. After all, generating patient or participation engagement in anything health-related largely hinges on trust. And when it comes to working with traditionally marginalized groups, that trust isn’t automatic.

“In some ways when you say it, it sounds really simple,” Hentges said. “We'll build trust with folks, but that is obviously a very long and, it can be a complex process.”

In some ways, NIH is fighting an uphill battle. Decades of institutional inequality and discrimination have had measurable impacts on patient trust for traditionally marginalized populations. Medical atrocities performed on Black and Indigenous peoples, members of the LGBTQ+ community, and those with a disability have tainted the image of the medical establishment. That’s not to mention the incidents of implicit bias that might still be eroding patient trust to this day.

Community health partnerships, as well as being committed to its principles, has helped NIH overcome those barriers.

For example, it’s been essential for NIH to view All of Us participants as its partners, not as subjects or patients.

“We refer to them as participants,” Hentges said, emphasizing this underlying principle. “And that's important for us because we really feel that our participants are our partners in this journey. What the program itself is trying to do is build a community of a million or more diverse people from across the United States that are with us for the long-term, that are with this program over the course of a decade or decades or longer.”

That means NIH needs to view participants as partners and “build that relationship based on respect for them and the gift that they’re giving us,” Hentges added.

And to get to that relationship, NIH relies on community partners.

“The biggest factor here is trust, and trust is something that you can't build overnight,” Hentges acknowledged. “We've really taken an approach of working with community organizations, trusted partners within different communities, to talk about why biomedical research is important, why it's important for these communities to participate. Even more importantly is, we don't just talk, we listen.”

All of Us builds out community health partnerships via two main avenues. Foremost, the program fosters relationships with five big nationwide community engagement partners.

“These are organizations, like the National Alliance for Hispanic Health, which are national organizations that have reach into a variety of different communities,” Hentges explained. “They may be focused on, for example, Latinx folks, but they, maybe have organizations that really can relate to folks living in a rural environment or folks living in an urban environment.”

That intersectionality—Latinx people living in rural areas—is a very important piece of the puzzle because it allows NIH to view participants as a whole person, as opposed to one piece of a participant’s persona.

All of Us also works with 55 smaller community health partnerships across more regional groups. One size doesn’t fit all, and especially doesn’t fit such a vast nation, so NIH needs to lean on smaller organizations with deeper relationships with the people of a certain region or population.

“We have a competitive award process that we use,” Hentges said. “What we look for is a track record of engagement, partners working with communities and in communities for a while that can show that they live up to and practice the values that we want to have. That they treat their communities as partners in this journey, that they respect and value the contribution that these folks are making to their communities.”

NIH rounds this out by making its own overtures to build trust as part of the All of Us program. For example, All of Us has recently started returning ancestry and trait reports to program participants to establish a culture of transparency. The group consulted with community partners to understand the best and most receptive way for program participants to receive these reports and has since been giving that data back to them.

Ultimately, this will be integral to NIH’s mission of not just getting all of us to the table, but letting participants speak. This bidirectional communication is the basis to inform the rest of the program’s efforts to support engagement.

“As we build these relationships with these participants, we work to bring these diverse folks together, to show them respect for the time and the data that they're providing, and to really build that long-lasting foundation for the program,” Hentges concluded.