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Community involvement in HIV trials leads to fairness in COVID-19 vaccine research

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Women Vaccinated with COVID-19 in Tampa, Florida
The Bible-based Fellowship Church, based in Tampa, Florida, encouraged members of the African-American community to receive the COVID-19 vaccine and worked with the County Health Department to organize a clinic.
Photo by Octavio Jones / Getty Images

For more than a decade, psychologist Dr. Michele Andrasik has been working in Seattle to increase the chances of an undervalued minority at risk for HIV participating in clinical trials of vaccines and drugs to prevent it. It was.

Her focus at the Fred Hutchinson Cancer Research Center was on testing coronavirus vaccines as COVID-19 began destroying American cities last spring, affecting the color community disproportionately. Focused on the important task of involving the same community.

“Unfortunately, if this happens in the United States or around the world, the devaluation, marginalization and deprivation of individuals will be the greatest burden,” he said. Andrasik, Senior Staff Scientist, Director of Hatch-based Social and Behavioral Sciences and Community Engagement HIV Vaccine Testing Network, Or HVTN.

Statistics edited by Centers for Disease Control and Prevention Of the 350,000 people who died of COVID-19 in the United States last year, whites accounted for only 63% of the deaths.However, according to the latest census data, whites 76% Of the US population. Blacks make up 15% of the dead and less than 14% of the population.

“It is not surprising to any of us that the disparities in COVID-19 results reflect the disparities found in other illnesses,” Andrasik said. These disparities have long been reflected in the underestimation of minority groups in clinical trials of new vaccines and drugs.

Last June, Dr. Tony Fauci leveraged his expertise in vaccine trials at HVTN to help coordinate planned large-scale clinical trials of the COVID-19 vaccine.Staff have shifted their allocation to work because of the newly formed Covid-19 Prevention Network, Or CoVPN — An operations center headed by HVTN co-founder and hatch virologist Dr. Larry Corey.

Fauci provides HVTN for behavioral health professionals such as Andrasik, who have a deep understanding of the barriers that limit the participation of members of marginalized communities, as well as a network of vaccine trial designers and vaccine research sites. I was looking for it.

Andrasik applies behavioral health science to address community questions and fears such as: Historical reason Don’t trust medical research. The same community, with no access to quality medical care and feeling that health concerns are routinely dismissed by doctors, has infectious diseases such as HIV and COVID-19 for several reasons. Most vulnerable to.

The work to address these structural inequality begins at the beginning of the clinical trial process. At this time, the protocol for setting research goals is sketched and the procedure is designed.

“We need colored races that look like us and are trusted by the community to check these protocols and check their consents,” Andrasik said.

From there, outreach activities are trying to prove that the researcher deserves the trust of the community. Here, the years of working to involve marginalized or stigmatized populations in HIV testing show efforts to reach those at highest risk for COVID-19.

“Most of what I learned about engaging with the community was through experience and building relationships,” she said. “Relationships characterized by trust are at the core of our work.”

New research highlights poor performance

Decades of US efforts to increase the participation of women and minorities in clinical trials of vaccines have been unsatisfactory. In 1993, the National Institutes of Health Revitalization ACT called for the “appropriate” inclusion of women and minorities in clinical trials.However, a study published in an online journal today JAMA network open It shows that these efforts are inadequate.

Researchers in the study, including Andrasik and Dr., a doctor of Hutch infections. Stephen PurgumOf the 230 vaccine trials conducted between 2011 and 2018, only 58% actually reported the race of participants and only 34% reported ethnicity. understood.

On average, women were underestimated in the 10-year study (56% of participants vs. 51% of the U.S. population), but the study included data on race and ethnicity. , It turns out that minorities are significantly underestimated. For example, blacks in 2018 accounted for 13.9% of the US population, but only 10.6% of study participants during the study period. Researchers found that Hispanics accounted for 18.5% of the population, but only 11.6% of the participants.

“The fundamental problem is that we need to do a better job with these populations,” said study co-author Pergam. “It opened my eyes a lot. I expected it to be much better than we saw.”

The mandatory racial and ethnic data reporting gaps are particularly troublesome, Pergam said. The authors of the study concluded that the “diversity registration goal” should be included in all vaccine trials.

“To support inclusion, you need to invest in clinical trials. You can’t be a lip service,” Pergam said in an interview. “It must be something that needs to provide support to promote diversity. If you need to delay your trial to make sure your registration is correct, do so.”

Dr. Stephen Wallace
Dr. Stephen Wallace is Director of External Relations for the Fred Hutchin-based HIV Vaccine Testing Network.
Photo courtesy of Robert Hood / Fred Hutch News Service

One of the reasons researchers emphasize the importance of promoting diversity in vaccine trials is that racial inequality in the composition of these studies will later become apparent in approved vaccine allocation methods. I am concerned that it may become.

Dr. Stephen WallaceHVTN’s director of external affairs said support for the COVID-19 vaccine trial increased the participation of undervalued minorities, reducing vaccine hesitation in these communities as vaccine supply increased. I hope that.

A Recent research by the Kaiser Family Foundation Using state-reported COVID-19 data, “a nearly consistent pattern of black and Hispanic people having lower vaccination rates compared to the total population and cases and mortality rates” Found. We found that the immunization rate for whites (10%) was more than three times that of Hispanics (3%) and twice that of blacks (5%).

Wallace hopes that participation in the trial and vaccine allocation will be consistent with the demographics of those at highest risk of the disease.

“There is always room for improvement,” he said. “We are approaching the proportion of people of color in the population, but ideally we are approaching the proportion of disease burden.”

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