By Hannah Critchfield
Last week, Noshima Darden-Tabb logged onto Facebook for an informal research study.
“I was just doing my own little mini-research. I’d been out talking to people all day, and I was seeing a trend,” the 53-year-old said. “So I asked a handful of people online: Would they participate in a vaccine research study for COVID-19?
“I only had one person that said yes,” Darden-Tabb said.
It’s a question Darden-Tabb asks a lot these days.
She’s the community engagement manager for COVID-19 research at the University of North Carolina, a trial site for a potential vaccine developed by Moderna.
A little under a month ago, UNC Health and the School of Medicine announced they wanted to recruit 500 participants for their Phase 3 vaccine trial — with a particular emphasis on convincing the people most at risk for the novel coronavirus to participate in the study.
“We’ve prioritized enrolling Hispanics, African Americans, and we were shooting for people older than 65,” said Dr. Cynthia Gay, a physician and researcher from the School of Medicine’s infectious diseases division who’s leading the UNC study.
They’re the people who have disproportionately suffered the worst outcomes of the pandemic, locally and nationwide.
About 40 percent of North Carolina’s COVID-19 cases have been among Latino people, despite Latinos making up fewer than 10 percent of the state’s population. Black people account for 22 percent of the state’s population but represent a little over 30 percent of North Carolina’s pandemic deaths. And the virus has ravaged elderly people worldwide, who are at increased risk for severe illness from COVID-19.
“From whatever perspective you look at it from – ethics, efficacy, fairness – it doesn’t make sense not to have a significant portion of the people be those who could most benefit from a vaccine,” said Gay.
Yet many of the populations most impacted by the virus are also groups who have a deeply entrenched mistrust of the medical community. This is particularly true for studies in which the U.S. government is involved, such as the infamous Tuskegee syphilis study where Black men with syphilis were not treated for the disease so that researchers could study what happened to their bodies.
“It’s a challenge,” said Darden-Tabb, who is African American. “People bring up the Tuskegee study, they mention Henrietta Lacks. They say, ‘With the current administration, we definitely don’t trust it.’”
The recruitment process also comes as reports broke this month of alleged unnecessary hysterectomies performed on immigrant women, some of them Latinas, while they were incarcerated inside a federal Immigration and Customs Enforcement detention center.
“I think the concern and skepticism is understood and valid in a lot of ways,” said Gay. “The unfortunate thing is that we don’t have months or years to build additional trust, because of the urgent need to come up with solutions for COVID.”
North Carolina Health News spoke to experts involved in the UNC trial about how recruitment of diverse participants is going.
Lessons from HIV
Darden-Tabb began her career at UNC as a social worker supporting HIV patients, and eventually transitioned into doing community engagement work for HIV prevention studies at the university.
“I’ve been doing community engagement full-time for four-and-a-half years, and it’s a challenge,” she said. “We have stigma with HIV. And now I’m seeing a stigma with COVID-19.“
Still, Darden-Tabb said the strategies used in HIV outreach provide a model for recruiting volunteers of color for the COVID-19 vaccine trial.
UNC is reaching out to faith leaders, community organizations, and local health clinics on the ground to help them aid with messaging about the availability and safety of the study.
“There’s an African American church in Raleigh that allows me to come in and do outreach whenever they’re doing their community work around COVID-19,” said Darden-Tabb. “So I’m shadowing with them to share the COVID research message.”
“We’re also doing collaborations so we can better support agencies that are serving the Latino community,” she added.
These partners are holding their involvement in the vaccine study close to the chest. The organizations that UNC named declined to comment and asked not to be identified in this article.
One said they were still “sorting out their role” in the recruitment process.
As the principal investigator for the COVID-19 vaccine study, the school of medicine’s Gay said they’re attempting to build trust around the research process while racing against the pandemic’s ever-climbing death toll.
“For example, I want the public to know we have successfully and safely enrolled undocumented people into studies before and maintained their confidentiality,” she said. “We take that with the utmost concern.”
Many of the fears researchers and recruiters said they’re hearing from target participants concern the pace at which a COVID-19 vaccine is being developed.
“So we’re trying to educate: COVID is new, but research isn’t new,” said Darden-Tabb. “Yes, it does seem like it’s happening really fast, but no steps have been skipped.”
“It’s important to make a distinction between what is being accelerated and what is not,” added Gay. “All of the same steps that always need to happen have been followed. The thing that’s being really accelerated is the ask of the people involved — from the sponsor to the Food and Drug Administration who reviews the process to the people involved with drafting the protocols and creating all the documents that go with that, to a site like our own, where you need the staff trained and ready and everything in place.
“Everyone is doing that at a faster pace, and the way that they’re doing that is by working on Saturdays and into the evenings, and bringing on new staff. “
The numbers/recruitment so far
As of this week, UNC has recruited 131 people for the vaccine trial.
About 20 percent of them are Hispanic, according to Gay, and 16 percent are African Americans.
One percent have identified as Indian Americans — one percentage point less than their proportion within overall COVID-19 cases — and 3 percent Asian American — one percent higher than their proportion within the case count. However, their representation mirrors their ratio within the overall North Carolina population.
Four percent of the participants identify as more than one race.
“We’re very pleased about our progress,” said Gay. “But it’s about maintaining that ratio as we continue.”
COVID-19 vaccine trials at other sites have been criticized for oversampling white people.
No nursing home residents
There’s one group that will be left out.
A limitation of the study, according to Gay, is that all research will take place on-site at UNC. It means members of the Black and Latino community who have limited access to transportation or time to travel long distances won’t have the opportunity to participate.
This population includes many people who have been deemed essential workers during the pandemic, leading to increased exposure to the virus, such as farmworkers, who may live in nearby housing on-site, and those who labor in meat-processing plants.
“It’s more logistically challenging to do enrollments at what we would call a ‘satellite site’ — a place away from the pharmacy where you’re storing the product,” said Gay. “UNC opened a bit later than some of the other sites, so we had a shorter amount of time to really be able to work through some of those challenges.”
That limitation also affects elderly people living in nursing homes and other long-term care facilities.
“We had reached out to three retirement communities and were hopeful in the beginning that we were going to do study visits on-site, so they wouldn’t have to travel to UNC,” said Gay. “But the logistics of the study just did not allow it in time. It was a huge disappointment for us. We had a plan for how to make participation easier for those communities — we just weren’t allowed to execute it.”
Gay said this fallout is once again due to the somewhat competing goals of a COVID-19 vaccine study: There needs to be adequate representation, but the process must also be carried out quickly. Moderna, the sponsor, ultimately opted to open the UNC site without approving satellite sites.
“To make a blanket statement: if the sponsors of the studies are committed [to diversity], they need to make participation available to those communities,” she said. “They need to build that emphasis into the conduct of the study early on.
“I guess in some fairness, the desire to have these studies get started and recruited quickly is a little bit in contrast to that, right?” Gay added. “Because it takes more time and effort to do those things.”
When it stops
The overall Moderna trial, including the UNC site, will close recruitment after they enroll 30,000 participants nationwide.
Amid the challenges of her job, Darden-Tabb said she focuses on the long-term goals of her outreach work.
“It may not change somebody’s mind to participate in the study, but at a minimum, what I hope is that people will be more open to research and will not discourage someone else who may have an interest in participating,” she said, noting several people who initially expressed interest in the trial ultimately opted not to enroll after speaking to concerned family members.
Gay echoed this. She hopes the education efforts will make people more likely to take a vaccine when it does become available.
“At the end of the day, I have no particular investment in any company, including any of the ones that are making these vaccines,” she said. “I do, however, want as many effective vaccines as we can possibly have.”
I am an 82 year old woman with MS and chronic kidney disease
I am presently well but still in a high risk category
Good article, but I understand the anxiety of testing out a Warp Speed Vaccine. If the vaccine causes adverse reactions, things would appear that they could go bad for a participant in so many ways. If we had Medicaid for All, there would be fewer long term financial risks, in my opinion. Unfortunately, NC is ranked about 50th(worst) in healthcare costs and access to care with few preventable adverse events resulting in compensation (WalletHub 2019 & National Practioner Database). I admire anyone participating in a trial, but it seems scary to me.
Moderna has come up with a genetically engineered experimental nucleic acid (RNA) vaccine. The RNA vaccine is a far cry from the traditional type of vaccines made from whole microbes.
Because RNA vaccine is an alien entity that the body has never seen before, one would expect toxicity and potential severe hypersensitive reaction when injected into the body.
Furthermore, how is it possible that vaccine makers are not held liable should vaccine injury arise from taking the vaccines?
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