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Community engagement in HIV trials guides equity for COVID-19 vaccine studies

New study highlights longstanding barriers to diversity in prior decade of vaccine trials, despite federal guidelines
A women getting COVID-19 vaccination in Tampa, Florda
The Tampa, Florida-based Bible-Based Fellowship Church encouraged members of the African American community to receive COVID-19 vaccines, organizing clinics in partnership with the county health department. Photo by Octavio Jones / Getty Images

Editor's update: On March 31, the New England Journal of Medicine published an editorial co-authored by Andrasik about addressing vaccine hesitancy in communities of color and the efforts of the COVID-19 Prevention Network.

For more than a decade, psychologist Dr. Michele Andrasik has been working in Seattle on ways to increase opportunities for underrepresented minorities at risk for HIV to participate in clinical trials of vaccines and drugs to prevent it.

Last spring, as COVID-19 began to tear through American cities and was disproportionately affecting communities of color, her focus at Fred Hutchinson Cancer Research Center pivoted to the vital work of engaging these same communities in trials of coronavirus vaccines.

“Unfortunately when anything like this hits in the U.S. or in the world, it’s going to be the individuals who have devalued identities, who are marginalized and disenfranchised, who will bear the greatest burden,” said Andrasik, a senior staff scientist who is director of social and behavioral sciences and community engagement at the Hutch-based HIV Vaccine Trials Network, or HVTN.

Statistics compiled by the Centers for Disease Control and Prevention show that, among 350,000 who perished from COVID-19 in the U.S. last year, whites accounted for only 63% of deaths. Yet most recent census data show whites comprise 76% of the U.S. population. Blacks accounted for 15% of deaths, while representing less than 14% of the population.

“It is no surprise to any of us that disparities in COVID-19 outcomes mirror disparities we see in other diseases,” Andrasik said. Those disparities have long been reflected in underrepresentation of minority groups in clinical trials of new vaccines and drugs.

Fred Hutch's Drs. Steven Pergam (left) and Michele Andrasik (right) are co-authors of a JAMA Network Open study showing that African Americans, Latinos/Hispanics and other people of color were underrepresented in clinical trials of vaccines in the U.S. from 2011-2018.
Fred Hutch's Drs. Steven Pergam (top) and Michele Andrasik (below) are co-authors of a JAMA Network Open study showing that African Americans, Latinx people and other people of color were underrepresented in clinical trials of vaccines in the U.S. from 2011-2018.

Photos by Robert Hood / Fred Hutch News Service

Last June, Dr. Tony Fauci tapped the vaccine trial expertise at HVTN to help coordinate planned massive clinical trials of COVID-19 vaccines. Staff shifted their assignments to work for the newly formed Covid-19 Prevention Network, or CoVPN — its operations center led by HVTN co-founder and Hutch virologist Dr. Larry Corey.

Fauci was looking to HVTN not only because of its network of vaccine trial designers and vaccination study sites, but also for its behavioral health experts like Andrasik, people with a deep understanding of the barriers that limit participation by members of marginalized communities.

Andrasik applies behavioral health science to address the questions and fears of communities who have historical reasons to distrust medical research. The same communities who lack access to quality health care and feel their health concerns are routinely dismissed by doctors are, for some of those same reasons, most vulnerable to infectious diseases like HIV and COVID-19.

The work to address these structural inequalities starts at the very beginning of the clinical trial process, when the protocols that set out the goals of the study are sketched out and its procedures are designed.

“We need to have people of color who look like us and are trusted by their communities to review these protocols and review consent forms,” Andrasik said.

From there, the outreach effort seeks to prove its researchers are worthy of the communities’ trust. Here, the years of working to involve marginalized or stigmatized populations in HIV trials informs efforts to reach those who are most at risk for COVID-19.

“Most of what I’ve learned about engaging communities has been through experience and through building relationships,” she said. “Relationships that are characterized by trust are at the very core of what we do.”

New study highlights poor track record

U.S. efforts to increase participation among women and minorities in vaccine clinical trials span decades, but the track record is not impressive. In 1993, the National Institutes of Health Revitalization ACT required “appropriate” inclusion of women and minorities in clinical trials. But a study released today in the online journal JAMA Network Open shows these efforts have fallen short.

Researchers for that study, including Andrasik and Hutch infectious diseases physician Dr. Steven Pergam, found that among 230 vaccine trials carried out from 2011-2018, only 58% actually reported the race of participants and only 34% reported ethnicity.

While women on average were overrepresented during that decade of trials (56% of participants v. 51% of U.S. population), the study found that — among the trials that provided data on race and ethnicity — minorities were significantly underrepresented. For example, Blacks were 13.9% of the U.S. population in 2018, but accounted for only 10.6% of trial participants during the study period; Hispanics were 18.5% of the population but were only 11.6% of participants, the researchers found.

“The fundamental issue is that we need to do a better job of targeting these populations,” said study co-author Pergam. “It opened my eyes quite a bit. I was expecting much better than we saw.”

The gap in reporting racial and ethnic data as mandated is particularly troubling, Pergam said. The study authors concluded that “diversity enrollment targets” should be included for all vaccine trials.

“There needs to be investment in clinical trials to support inclusion. It can’t be lip service,” Pergam said in an interview. “It’s got to be something where you have to provide support to encourage diversity, and if you have to slow the trial down to make sure enrollment is appropriate, so be it.”

Dr. Stephaun Wallace
Dr. Stephaun Wallace is director of external relations for the Fred Hutch-based HIV Vaccine Trials Network . Photo by Robert Hood / Fred Hutch News Service

One reason researchers are stressing the importance of promoting diversity in vaccine trials is concern that the racial inequities in the composition of these studies can play out later in how approved vaccines are allocated.

Dr. Stephaun Wallace, HVTN director of external relations, said that outreach effort in the COVID-19 vaccine trials has increased participation from underrepresented minorities, and he hopes that will reduce vaccine hesitancy in these communities as vaccine supplies increase.

A recent study by the Kaiser Family Foundation using state-reported COVID-19 data found “a largely consistent pattern of Black and Hispanic people receiving smaller shares of vaccinations compared to their share of cases and deaths compared to the total population.” It found the vaccination rate for white people (10%) was more than three times higher than that for Hispanics (3%) and twice as high as the rate for Blacks (5%).

Wallace would like to see participation in trials and allocation of vaccines match the demographics of people who are most at risk for the disease.

“There is always room for improvement,” he said. “While we are getting closer to the proportion of people of color in the population, getting closer to the percentage of disease burden would be ideal.”

Sabin Russell is a staff writer at Fred Hutchinson Cancer Research Center. For two decades he covered medical science, global health and health care economics for the San Francisco Chronicle, and wrote extensively about infectious diseases, including HIV/AIDS. He was a Knight Science Journalism Fellow at MIT, and a freelance writer for the New York Times and Health Affairs. Reach him at srussell@fredhutch.org.

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Last Modified, September 21, 2021