Vaccines need to work for everyone. It’s not a controversial idea, but it has proven historically difficult to achieve because of a lack of diversity in clinical research. As clinical trials for COVID-19 vaccines and treatments enroll this fall, some organizations have upped their efforts to ensure all populations are represented in those trials.
One of those groups, the COVID-19 Prevention Trials Network (COVPN), a task force convened by the federal government, began an advertising and education effort in September. The goal: to encourage underrepresented communities to participate in COVID-19 research.
Any such campaign must overcome structural barriers and years of distrust and misinformation among many communities of color and low-income communities. Still, COVPN is pushing a message that could resonate in these turbulent times: Help end the uncertainty.
“Not surprisingly, there is a human truth, a shared experience among those target populations that’s experienced by all of us right now: The most difficult thing is the uncertainty,” says Sally Bock, senior director of marketing for COVPN. “There’s uncertainty around if we will be safe and if our families will be safe. There’s uncertainty about how long the pandemic will last, but there are people who are doing something about it.”
The COVPN ads, slated to run nationally across TV, radio, digital and social outlets in both Spanish and English, push up against several ingrained obstacles. There’s the historical distrust of the medical system in communities of color as well as systemic issues that make participating in clinical trials more difficult for low-income and diverse communities. Then there’s the politicized nature of the country’s response to COVID-19.
One of the ads addresses this, with a voiceover intoning, “This pandemic is not red. This pandemic is not blue. This pandemic is Black, is brown, is white. It hits all colors and creeds.”
“In this particular time, there are many more misperceptions than there usually are, just because of the scale of the COVID-19 conversation,” Bock explains. “Some people see it through a political lens. There aren’t just a few barriers we need to knock down this time; there’s a very broad list of reasons and perspectives on COVID-19.”
The COVPN was formed in July by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The goal was to create a network to enroll thousands of volunteers in large-scale clinical trials for experimental COVID-19 drugs.
It unified several existing NIAID clinical trial networks, three of which were focused on HIV and AIDS and one on infectious diseases. These networks specialized in community outreach and education about clinical trials.
“Our country and our global partners need vaccines against SARS-CoV-2 that are demonstrated to be safe and effective for everyone. So it’s imperative that these vaccine trials be conducted at the highest scientific standards and are inclusive of the people who have been most impacted by COVID-19,” says Dr. Larry Corey, a virologist at the Fred Hutchinson Cancer Research Center and director of the COVPN Operations Program.
COVPN isn’t the only group racing to enroll trial participants. Clinical research organizations such as IQVIA are also running COVID-19 trials — and facing similar challenges. Because some communities have been disproportionately affected by the pandemic, ensuring they are represented in these clinical trials is critical to the success of a vaccine.
“If the hardest-hit populations can’t benefit from the vaccine,” says Erica Prowisor, global head of patient recruitment and retention at IQVIA, “I don’t know if there’s a greater miss than that.”
IQVIA has endeavored to ensure that people working on the trial reflect the participants. Sending researchers, doctors or nurses into communities to which they don’t belong can deter diverse patients from participating.
Workers at trial sites have also received extensive training about the challenges these individuals face and the history of people of color being used, sometimes against their will, for medical research. “Different populations may not know about research or may have heard horror stories of what was done in our country in terms of research that was unfavorable toward underrepresented communities,” Prowisor notes. “You have to ensure that you are transparent. You have to get real with stuff that has happened historically and not assume that people aren’t skeptical. You need to show why it’s important and what’s in it for the patient.”
Tailoring the outreach
The aforementioned skepticism notwithstanding, the best way to reach underrepresented communities is often to go right into them. To that end, COVPN has partnered with medical sites and community partners on the ground to do outreach and education. The overarching goal is to get information about vaccines or clinical trials to potential participants through people with whom they already have a relationship.
“This campaign is just one tool for having those conversations and truly engaging communities, but it’s not the only solution by any stretch,” Bock says. “If we could do that with a 30-second ad, we would’ve been done a long time ago.”
She adds that broad outreach remains an important goal. “We’re reaching out to people in places they already are and creating an awareness or a conversation about some of the widely held misbeliefs. Very few people really understand vaccines and how they work,” Bock continues. “Now that we’re in the middle of a pandemic, they’re much more interested in understanding that.”
COVPN is providing informational materials, presentations and educational videos to community influencers to increase the level of knowledge, both about vaccines and clinical trials. Similarly, IQVIA is conducting community outreach and running ads to recruit patients. Prowisor says the company’s team monitors performance every day and adjusts the messaging in accordance with what appears to be resonating with target audiences.
Some IQVIA ads show a person throwing off their mask, emphasizing the freedom that will eventually come with a vaccine. Other spots focus on altruism or protecting oneself and one’s family.
“We’ve designed ads that tap on different emotional triggers that vary by audience,” Prowisor explains.
She adds that the ads are customizable. “We can swap out each attribute. There are literally thousands of combinations that can come together.”
As for the future of efforts to bolster the diversity of clinical trial cohorts, Bock emphasizes the need to build something specifically for underrepresented communities, rather than altering a message meant for the general population. The recruitment of diverse participants needs to be built into the trial from the very beginning, in terms of site locations and the look and feel of ads.
“We need to be aware of what people are responding to and we need to use data to approach people in the right way,” Prowisor says. “This is something we can’t ignore, because representation in medical advances is so important. I love that there is a spotlight shining on this issue — and it’s about time.”