Address Medical Mistrust to Recruit Minorities to COVID-19 Trials

To end HIV and control COVID-19, medicine must earn back the trust of people in Black, Latinx, and Native American communities, said Jonathan Mermin, MD, MPH, director of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention at the CDC.

During the closing plenary of the United States Conference on HIV/AIDS October 21, Mermin laid out four principles behind those actions to the audience of USCHA:

  • Actively work with communities most affected by health inequities

  • Make plans to address them transparent

  • Work with community members on those plans and listen to their feedback

  • Do a good job

“Trust will come with proof of action,” he told the audience, watching virtually from their homes and offices.

But clinicians can take action in the exam room and during clinical trial recruitment to help the process along, said Russell Campbell, MA, deputy director of the Office of HIV/AIDS Network Coordination at the Fred Hutchinson Cancer Research Center, Seattle, Washington.

“Distrust in the medical and research establishment has deep roots,” he said during a presentation earlier in the week. To address this, clinicians must learn “culturally appropriate and meaningful engagement to influence the participation of historically underrepresented communities in healthcare and research.”

From Slavery to HeLa to Clinical Practice

Medical mistrust doesn’t stem only from the denial of treatment to the men who were part of the Tuskegee Syphilis Study. It also includes reckonings with the racist abuse of study participants by some of science’s most acclaimed leaders. Take, for instance, J. Marion Sims, MD, the so-called father of gynecology, who gained much of that information by experimenting without anesthesia on enslaved women; or Cornelius Rhoads, MD, whose name was removed from an award at the American Association for Cancer Research when objections grew concerning racist remarks Rhoads made about Puerto Rican patients in the 1930s. Or consider the story of Henrietta Lacks, the originator of the HeLa genes that have guided oncology research. Her genetic material was being mined for oncological insights without her permission and without compensation.

“The groups that have been systematically and intentionally denied treatment and known cures for diseases on behalf of research have just really taken the brunt,” Campbell said during a session role-playing best practices for addressing medical mistrust among potential clinical trial participants, conducted earlier in the conference.

“African Americans, American Indians, Puerto Ricans, Guatemalans, and others really still are heavily impacted by these abuses of research.”

And it shows in clinical outcomes. Research into HIV antiretroviral treatment adherence has found that medical mistrust was associated with a 76% likelihood that Black Americans living with HIV would be nonadherent to their treatments. But race-based medical mistrust drew into question the necessity of treatment at all.

A 2016 study in the journal AIDS Care found that although White gay men in Boston and primarily Black gay men in Jackson, Mississippi both reported concerns about side effects and lack of culturally appropriate care, it was the Black gay men in Jackson who expressed stronger medical mistrust

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Attacks on Obamacare threaten coverage gains among minorities

Threats to Obamacare could deal a new blow to communities of color that have been disproportionately ravaged by the coronavirus pandemic as the nation is reckoning with generations of inequity.

The Affordable Care Act’s insurance subsidies, its expansions of Medicaid eligibility and its protections for preexisting conditions have especially helped Americans of color, narrowing historic disparities in access to health insurance and affordable care. The coverage gains are among the most significant since the passage of Medicare and Medicaid and the desegregation of American hospitals more than 50 years ago.

Now, President Donald Trump is again threatening to replace the law if he’s reelected. And exactly one week after the election, the Supreme Court, with its new 6-3 conservative majority, will hear oral arguments in a case brought by conservative states seeking to overturn the entire Affordable Care Act. If the law is dismantled, the communities it aided the most stand to lose the most.

“Health care could be ripped away from millions and the numbers of uninsured Americans of color could skyrocket—aggravating the health care disparities that already exist in this country,” said Sen. Tammy Duckworth (D-Ill.). “It’s especially infuriating that this is happening in the middle of a deadly pandemic that is disproportionately devastating so many seniors, Black, Brown and Native Americans and those with pre-existing conditions.”

Between 2013, the year before the Obamacare markets opened and Medicaid expansion began, and 2018, the rate of Latinx adults without health insurance plummeted from 40 percent to 25. The uninsured rate for Black adults fell from 24 percent to 14. For white adults, it dropped from 15 percent to 9, according to the Commonwealth Fund.

“There is no doubt that the Affordable Care Act, though it left millions uninsured, narrowed the racial gap in health insurance coverage and that’s a good thing,” said Mary Bassett, the former New York City health commissioner who is now a professor at Harvard’s School of Public Health. “Having millions suddenly lose their health insurance seems very likely to have an adverse impact.”

If the health law disappeared, the Urban Institute estimated that the gaps would widen once again, almost back to 2013 levels. And that assessment was in 2019 — before the devastation wrought by the coronavirus which is exacerbating inequality, in both health and the economy overall.

Especially affected would be people of color living in one of the 38 states that expanded Medicaid, the joint federal-state health program for low-income people. Without health coverage, many would lose access to much-needed care for chronic health conditions — and become more vulnerable to serious complications from Covid-19.

Trump says he wants a health system that will give people more choice, at less cost. “It’s in court, because Obamacare is no good,” he said at his second and last debate with Democratic challenger Joe Biden.

Even the Affordable Care Act’s backers admit it was not a panacea. Health inequities, some driven by generations of systemic racism, persist. Private insurance remains out of reach

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Moderna’s coronavirus vaccine trial is fully enrolled, 37 percent of participants are minorities

“I think that we have done quite well — I think the demographics of the Moderna trial have markedly changed,” Larry Corey, a virologist at Fred Hutchinson Cancer Research Center said in an interview last week. Corey is heading up the clinical trials under Operation Warp Speed, the federal effort to speed vaccine development.

“We hope that we continue to improve upon that, this is the first trial,” Corey said. ‘There are two others in the field, and two more scheduled to go — so our journey in covid-19 vaccines is just starting.”

Pharmaceutical giant Pfizer’s coronavirus vaccine trial is also nearing completion. Pfizer’s trial, which is not part of Operation Warp Speed, has enrolled 39,862 of its planned 44,000 participants. Of those, 34,601 have received their second, booster dose.

Half the participants in both trials receive the study vaccine and half receive a placebo, and more than 25,000 of Moderna’s participants have already received their second dose.

More than half of the volunteers in Moderna’s trial are healthy and not at high risk of severe covid-19, the disease caused by coronavirus. But 25 percent are at elevated risk due to age and 17 percent are younger, but have conditions such as diabetes or obesity that put them in a high risk group.

Moderna has projected having early data in the next month that may show whether its vaccine is effective. The company will determine whether that data is sufficient to apply for regulatory authorization once it has accumulated two months of safety follow-up on half the study participants, a milestone anticipated slightly before Thanksgiving.

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