NIH Develops Ads to Bolster Minority Participation in COVID-19 Vaccine Trials: But are Ads Enough to Develop Trust?

Sep 12, 2020 | Blacks, Coronavirus, COVID-19, Hispanic, Latinos, Minorities, News, Patient Recruitment

NIH Develops Ads to Bolster Minority Participation in COVID-19 Vaccine Trials: But are Ads Enough to Develop Trust?

Do advertisements work? Well, there’s a long-running debate that’s well beyond the scope of this snippet. The National Institutes of Health (NIH), via the COVID-19 Prevention Network led by a renowned HIV/AIDS investigator, produced recent ads appealing to Blacks and Latinos to step up, roll up their sleeves and contribute to clinical research: starting with COVID-19 vaccine trials. COVID-19 hits communities of color harder than others due to the social determinants of health. The federal government, via the NIH/NIAID, correctly sought more minority participation to ensure health equity. But due to a number of factors, Blacks and Latinos don’t participate in research proportionally to the population size. For example, Latinos represent nearly 20% of the U.S. population, yet only about 1% of the population participates in research. Blacks represent 13% of America’s population, and only about 5% regularly participate in trials. Hence part of a consolidated effort to combat COVID-19, NIH’s COVID-19 Protection Network, via advertisement, appeals to communities of color to participate in these important trials. But are ads enough? Or put another way, could they create even more distrust in some communities?

An Appeal to Participate

The news surfaced recently, thanks to Elizabeth Cohen, CNN’s Senior Medical Correspondent. The ads depict Blacks and Latinos “pointing to their upper arms, where an injection would be given, and then a nurse appears to roll down a Black man’s sleeve after giving him a shot,” writes Ms. Cohen. The ad finishes with a reference to the COVID-19 Prevention Network called preventCOVID.org.

In another ad CNN points references the narrator:

“When everything looks bleak, we know that someone somewhere is full of hope and strength and wants to take action,” depicting different Black people. It continues, “Walking the walk, and rolling their sleeves to go to normal sooner.”

Another ad shows Hispanic grandparents viewing a video of their baby grandson. The camera then points to the baby’s mom–the grandparent’s daughter: she stares directly at the viewer and asks all, “I wonder when they’re going to get to see him” in Spanish.

The Challenge

The message here is that Blacks and Latinos need to contribute more to fight the vaccine. And the sooner they do, the sooner all of society can go back to normal. With three ongoing COVID-19 vaccine trials in America (Moderna, Pfizer/BioNTech, AstraZeneca), all are falling woefully short of minority participation targets despite enormous sums of federal dollars allocated into such outcomes. 

According to the CNN account, NIAID’s Dr. Anthony Fauci urges that 37% of the volunteers be Latino and 27% Black. The government-driven effort has fallen short—TrialSite has reported many accounts of this dynamic. CNN reported thus far 16% of Moderna’s new volunteers were Latino, while by August 31, 11% of Pfizer’s volunteers were Latino and only 8% Black. Although TrialSite did report that NIH-backed studies produce more diversified outcomes than purely industry-driven studies.

Nationwide, about 20% of the population is Latino/Hispanic, and 13% is Black. COVID-19 disproportionately impacts Black and Latinos and other groups at risk (e.g., elderly Whites in lower economic demographic groups with comorbidities). Based on some reports, Blacks, for example, were dying at far higher rates.

The Producer

The ads are produced by Dr. Larry Corey, a superstar in the world of HIV/AIDS research and infectious disease. This principal investigator doesn’t work solely in a privileged research bubble; quite the contrary, as head of the HIV Vaccines Trials Network, for example, he and colleagues developed models for global, collaborative, and inclusive research. He has actively engaged with communities of color around the United States and the world in an ongoing battle against HIV/AIDS.

Dr. Corey acknowledges the ads won’t instantly boost participation, but he can’t help but hope that they make a difference, reported CNN. Dr. Corey lead’s the COVID-19 Prevention Network and points out that the ads were developed at the Fred Hutchinson Cancer Center in Seattle, where the network is headquartered. 

NIH’s decision to leverage Dr. Corey and the team in Seattle was a smart move. Based on the development of HIV/AIDS trial networks worldwide, this group has developed a deep understanding of how to reach at-risk communities of color. This understanding can manifest in small details, such as hiring minority-owned ad firms Socialisssima and Sam Bonds Creative to produce the ads. These ads air on major television networks, not to mention BET, the Oprah Winfrey Network, Univision, and more, and will certainly have some impact.

Ads Aren’t Enough

TrialSite sponsored the African American Clinical Research Disparity Survey in southeast Texas at the end of 2018 with the launch of the new website. The TrialSite survey results emphasize that the traditional “patient recruitment” approaches such as advertisements or even intricate and elaborate social network outreach schemes aren’t nearly enough to initiate, build, and nurture trust between pharmaceutical sponsors (whether that be company, government, or academic medical center) and minority groups around the United States. In fact, the same mistrust exists with many Whites.

One of TrialSite’s founders, Daniel O’Connor, emphasizes that when he was involved with Omnicom Group/MMG, many of the patient recruitment challenges occurring nearly twenty years ago remain just as relevant today, although social networks have opened up enormous potential for developing new cross-cultural communication channels. 

O’Connor emphasizes, however, that the true problems lie in the underlying health and social systems themselves, but that plenty can be done to change this for the better. In fact, O’Connor and TrialSite are working with a health system today to develop a clinical research as a care option process model with accompanying technology-driven workflow, part of an underlying research hub with multiple connections points to community groups, universities, and local providers, including research sites. All this in a metropolitan area of about 3 million people.

The Key: The Healthcare System

There is much positive that can be done, but it necessitates the transformation of the healthcare system as known today. For example, clinical research must become more seamlessly integrated into community healthcare workflows. As the American healthcare system morphs from one that exists to take care of sick people to one that prevents sickness in the first place, community participation, including community navigators, along with intelligent matching of the right research to the right patient will open up heretofore not contemplated advanced research as care options: participation in research will become far more seamless. All will be involved, including, importantly, the payers.

Participation

With the COVID-19 pandemic raging, the National Institutes of Health (NIH) announced the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership to develop a coordinating research strategy for prioritizing and accelerating the development of what was deemed the most promising treatments and vaccines. 

Backed by the Foundation’s coordination efforts for the National Institutes of Health (FNIH), ACTIV represented the entire U.S. federal government research and health apparatus, including the NIH with its sibling agencies in the Department of Health and Human Services (including BARDA, CDC, and FDA). Other stakeholders include the Department of Defense (DoD), Department of Veterans Affairs (VA), and others as well as representation from academia, philanthropic organizations, and a number of pharmaceutical companies.

TrialSite review of the leadership, as well as participation in the “Fast Track” areas of focus, revealed the underlying systemic bias that helps contribute to the continuous recreation and reproduction of mistrust in the system. 

Participation in the true leadership of what COVID-19 drugs and trials are funded comes down to a few federal government players, large pharmaceutical firms, and prestigious academic medical centers. Of course, it is these very groups that understand drug development the most. But a more vibrant, dynamic, and healthy tomorrow necessitates diverse participation at all levels.

Completely missing from the picture: state and local healthcare systems, community providers, entrepreneurial biotech ventures, and leadership and participation that reflects a true demographic cross-section of America. That research needs to become more inclusive, transparent, and “democratized” represents an important, albeit controversial theme.

Positive Outlook

Although the ads were produced by a superstar researcher and a truly talented and committed team in Seattle, with the support of minority-owned creatives—all with the best of intentions–lots of money has already been poured into these federally-backed vaccine studies—billions of dollars. An attempt to bolster participation in the middle of the trial reminds TrialSite’s Daniel O’Connor of the “troubled trials” contracts he uncovered as part of supporting Omnicom Group nearly twenty years ago. O’Connor told this author, “The amount a sponsor was willing to pay for a subject in a troubled Phase 3 trial was staggering back then.” But the underlying problem, the root cause of mistrust, lies in the health and social systems themselves. 

TrialSite’s outlook is quite upbeat, however, for broad-based progress—with the transformation of a fee for service healthcare system to one truly driven by value and prevention–with an emphasis on deterrence of sickness in the first place. The COVID-19 pandemic and associated public health crisis point to the need for reform and intelligent transformation of the healthcare system. With a move to value in health comes a need for more educated health consumers and, of course, informed participation. That research can improve quality of life—even save lives—is recognized by architects of an evolved healthcare system presently unfolding. In the not too distant future, research as a care option feature, seamlessly part of the healthcare system itself, could render the current discussion of trust and participation an irrelevant point.

Source: CNN

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