To be blunt, Rob Newells isn’t really optimistic about getting high rates of Black and Brown people to enroll in COVID-19 vaccine trials, even though such a goal is indisputably important: Federal data shows that Black and Latinx people are three times as likely as white people to get COVID and twice as likely to die from it.
Newells, a Black gay man living with HIV who just became director of national programs at the Black AIDS Institute, was until recently the head of AIDS Project of the East Bay in Oakland, California. He’s spent many years working to engage people of color, including gay Black men, in HIV vaccine trials—and he says that, even with his and others’ best efforts, he was only ever able to convince about 5% of them.
“People would still always bring up Tuskegee and Henrietta Lacks,” he says, referring first to the infamous study between the 1930s and 1970s in which white researchers deliberately withheld syphilis treatment from Black men in order to observe the natural course of the disease, and secondly to the Black woman whose cells were used, without her knowledge or consent, to create one of the most important cell lines in cancer-research history.
“We have to explain what Tuskegee would look like today if somebody tried to do a study like that,” says Newells, “because people don’t really understand the changes that have since been made, like [regulations demanding that trials have] independent review boards [IRBs] and community advisory boards [CABs].” When Black people hear “clinical trial,” says Newells, “they still see Tuskegee in their minds, so we have to bring the story into the 21st century and demonstrate what’s different.”
But even with the right people initiating those conversations—meaning people who look like the people they’re talking to—it’s still an uphill climb, he says.
And that may be the case now more than ever when it comes to the herculean task of making sure that the roughly 30,000 people needed for each of several upcoming COVID-19 vaccine trials sufficiently includes Black and Latinx people, whose higher risk for COVID is driven by many factors, from higher rates of underlying conditions such as diabetes and asthma to more such folks working “essential” jobs, such as in factories and grocery stores, where COVID risk is higher.
Not only is there historical mistrust among Black people, but there is broad sentiment against taking a COVID-19 vaccine in the general population. Recent polls show that between only half to two-thirds of Americans say they would get a vaccine if made available. Some of that reluctance comes from an anti-science, anti-vaccine movement that has been gaining traction for many years, while some comes from fear of what the scientifically unreliable Trump administration has been touting as “Operation Warp Speed”—a federal public-private partnership intent on getting Food and Drug Administration (FDA) approval for at least one COVID-19 vaccine by the end of this year, or early in the next one.
“They’re trying to compress a five-year timeline [for development of most vaccines] into 13 months,” says Matthew Rose, director of U.S. policy and advocacy at Health GAP, a global health advocacy group with an HIV focus. “You’re going to be delivering a product faster than ever, and you have to be able to answer people’s fears and concerns about that.”
All Systems Go
But many of the folks responsible for making sure the COVID trials have sufficient Black and Brown representation just so happen to be researchers and advocates of color themselves who’ve long worked at engaging diverse communities in HIV treatment and prevention trials—and they’re confident that, despite a mountain of mistrust out there, they can break through.
One such person is Michele Andrasik, Ph.D., a honcho at the HIV Vaccine Trials Network (HVTN), a nationwide web of trial sites that is being used as the backbone for COVID vaccine trials that various drugmakers—including Moderna, Johnson & Johnson, AstraZeneca, and Pfizer—will launch in the coming weeks and months. (The Moderna trial just started enrolling a few weeks ago.) The “front door” for the effort, where folks can learn more and register to be contacted about COVID trials down the line, is the COVID-19 Prevention Network website.
Andrasik says that it’s possible to get good rates of Black and Brown folks in trials, if community engagement is done right, as it has been in recent decades for HIV. (Research shows that Black and Latinx participation in HIV vaccine trials rose from 17% between 1988 and 2002 to 33% between 2002 and 2016.)
“We’re doing with the COVID trials what we’ve done with the HIV trials, which is building trust, focusing on relationships, ensuring that people have the information they need, and explaining how we are expediting these trials without cutting corners or compromising safety,” she says.
That’s happening, she says, through “reaching out to community groups on all levels—grassroots, community-based, faith-based.” With Stephaun Wallace, Ph.D., M.S., HVTN’s director of external relations, she’s been “engaging for months now in fact-finding in terms of communities we don’t have a strong history of working with, like essential workers,” as well as “reaching out to organizations we have longstanding relationships with, identifying ways we can partner with them to facilitate [virtual] town halls, listening sessions, webinars. I recently had a call with some of my contacts at the local YWCA and YMCA, talking about how we might get information out to their multiple housing units”—populated, she says, with those at heightened risk for COVID-19.
Additionally, says Andrasik, they are working with the large trial networks of entities including Veterans Affairs and the National Heart, Lung, and Blood Institute, as well as with “all the historically Black medical colleges.” And the Prevention Network website will soon debut short, animated videos in English and Spanish that address people’s most common concerns, “the biggest being the perceived speed of the trials. The other is, Black and Brown people asking, ‘Why are you targeting my community? Why are we considered priority populations?’ There’s a long legacy of institutions not being trustworthy, so we need to focus on that.”
Point of Contact
But even if people and communities are first approached by folks who “look like them,” there’s still the matter of whom they interface with at actual trial sites. “Black people can talk to Black people all day,” says Newells, but, in most cases, “you’re still going to the clinic and seeing a white doctor. There need to be more people of color who are [trial] principle investigators—otherwise, there’s still that feeling of being under the white gaze, Black people being studied as ‘subjects’ and not ‘participants,’ and the whole power dynamic between doctor and patient.”
There’s also the fact that, ultimately, drugmakers aren’t required to meet demographic quotas as they enroll studies, as much as they are told—and even understand—the importance of doing so. “There’s an inbuilt need for companies to recruit the right quotas,” says Mitchell Warren, who heads AVAC, which has long helped develop and guide HIV vaccine and other prevention trials. “If you have to stop a trial because you’re in the wrong place”—in other words, drawing too much from communities not at high risk for COVID—“that’s a waste of time and money.”
TheBody reached out to the best-known drugmakers set to launch COVID vaccine trials—Moderna, Johnson & Johnson, Pfizer, and AstraZeneca—to ask if they would set hard quotas for people of color, and what they were doing so far to ensure diverse recruitment.
A rep for AstraZeneca wrote back: “Our Phase III trial in the U.S. will include 30,000 participants across a broad age range and will be drawn from diverse populations. Our clinical trial sites are focusing on areas where there is a high amount of disease present and where we know the vaccine disproportionately impacts populations that are typically underrepresented in clinical trials. More specifically, we are working to recruit and enroll participants in communities where there is a strong minority representation, including African American, Hispanic, and Native American populations. We also have targeted recruitment materials for minority populations. We do anticipate that there may be some hesitancy among minority communities; however, we are working closely with sites that have strong ties in these communities. Additionally, the trial will operate in collaboration with NIH’s new clinical trials network, whose extensive community engagement framework emphasizes that communities most vulnerable to COVID-19’s severe outcomes will be critical to successful research.”
However, the rep did not answer a follow-up question as to whether the trial would be setting racial or ethnic quotas, or at least targets.
A rep for Pfizer wrote that the company was “committed to making our COVID-19 trial accessible to diverse participants and also to ensure that any potential COVID-19 vaccine we develop is accessible to individuals who may benefit in the future.” They understood that “conducting studies in locations with diverse communities is instrumental in recruiting and retaining underrepresented participants,” and said that, for phases II and III of the trial, “site selection criteria included locations with diverse communities that have been disproportionately affected by COVID-19. Key considerations are to provide diverse individuals the opportunity to enroll in the study at a rate that is reflective of the diversity among those who may use the vaccine and to enroll participants in areas where there is sufficient SARS-CoV-2 transmission to determine if the vaccine is effective at preventing COVID-19.”
The email also said that Pfizer was putting out informational material in many languages, “working with sites that have established community networks and engagement strategies for diverse networks,” and “working closely with our advocacy partners in local communities, who are trusted voices and resources and share our commitment to equity in clinical trial recruitment.”
Again, the rep did not say whether Pfizer would set hard quotas or targets. As with previous queries from TheBody, Moderna did not reply, although Andrasik said that she had been on calls with the company over the issue of trial diversity.
How Important?
It’s a given in the research world that when highly impacted groups are represented in clinical trials, the results are stronger and more reliable. “It’s incredibly important that we have diverse communities in these trials,” says Andrasik. “At the end of the day, if people have the information they need, they can make informed decisions, so we have to be incredibly innovative and collaborative to ensure” that diverse communities are represented.
And, says Warren, all this must happen fast. “If people are not enrolling [in available trials] in the next month or so, we’re gonna have a huge problem. But I think that because most of these trials are happening through the Coronavirus Prevention Network, we’re in good shape.”
But Newells flat-out doesn’t think that the trials have the necessary lead time to properly engage high levels of recruitment from communities of color—and says that the effort should be on building trust in those communities so people actually get vaccines once they’re FDA-approved.
“When it comes to effective recruitment efforts for the trials, the train is already out of the station,” he says. “The focus should be on having the right people use it once it’s approved. The general public doesn’t really care who vaccines are tested on. It’s a second-line question for most. We’ve been coming up with effective medications [for a variety of things] without [robust levels of] Black folks in trials for years.”
But once vaccines are approved, he says, things like community town halls over Zoom will be essential to educate people about the basics of how the vaccines were developed, and how they work. “A lot of this is being built of this HIV research infrastructure that already exists, but a challenge for many HIV/AIDS community groups will be how to get the knowledge out to” communities beyond HIV, he says. “Agencies will have to partner with other organizations, like Black Lives Matter chapters or the Poor People’s Campaign.”
Rose, on the other hand, is more sanguine, saying that, on a scale of one to 10, he thinks the chances of decent enrollment of color in the trials is at about a five.
“There are already a lot of people at the trial sites who’ve done a lot of work on racial inclusion and diversity,” he says. “True, the drivers at the top just care about numbers and it’s easier to get white people in trials. But we’re also in a moment where a lot of people are confronting racial underrepresentation and trying to think about how to do better. So I’ll take the glass-half-full view for now.”