Rise Above COVID on the Importance of Clinical Trials.

Rise Above COVID is raising awareness of ACTIV-2, a nationwide clinical trial conducted by the AIDS Clinical Trials Group (ACTG) to evaluate treatments for early COVID-19. ACTIV-2 is working to enroll people of color to ensure that the nation’s diverse population is represented in the trial.

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The U.S. Black population has experienced 10 percent more COVID-19 cases, nearly 300 percent more hospitalizations, and 90 percent more deaths (CDC, March 2021) than non-Hispanic whites. Historically, the Black community has had the lowest clinical trial participation rates of any racial group and only 8 percent participation in clinical trials of drugs that were approved last year (FDA, 2020).

“Historical events like Tuskegee have understandably left many feeling that clinical trials shouldn’t be trusted,” said Lance Okeke, M.D., Assistant Professor of Medicine in the Division of Infectious Diseases and ACTIV-2 Principal Investigator, Duke University. “However, the National Research Act was signed into law in 1974 to ensure the highest ethical standards, conduct, and standards are met during clinical research. From my view on the frontlines of COVID-19 research, it is vitally important that we ensure treatments are safe and effective for the communities most impacted by this pandemic. Diverse clinical trial participation is a key to this.”

“My entire household tested positive, including my children, and we all experienced different symptoms,” said Mike McDaniel, a Black ACTIV-2 clinical trial participant in Los Angeles. “The impact on my family was painful. Participating in this clinical trial allowed me to make a valuable contribution to my community and I encourage others to do the same.”

While some in the Black community mistrust clinical trials, many deeply trust their barbershops and beauty salons. Rise Above COVID is partnering with more than 300 Black barbershops and beauty salons across New York City, Chicago, Raleigh, and Durham to engage patrons in “real talk” about COVID-19 and raise awareness of the ACTIV-2 clinical trial (which has multiple sites in each locale). These community-based safe spaces, which have long been epicenters of honest dialogue, are the ideal settings to candidly discuss topics ranging from the historical mistrust of clinical trials to the present-day devastation COVID-19 has had on the Black community. Customers receive detailed information about the study, along with complimentary facemasks and hand sanitizers from Rise Above COVID.

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ACTIV-2 is being conducted to identify therapeutics that can prevent people who get COVID-19 from progressing to severe disease and hospitalization. The clinical trial is taking place across 134 sites including Detroit, Atlanta, New Orleans, Houston, Chicago, New York, Baltimore, Philadelphia, Los Angeles, and others. The study is enrolling adults within eight days of experiencing symptoms and 10 days of their positive COVID-19 test result.

“I lost five family members to COVID-19 in 14 days and personally feel the devastation our Black community is experiencing,” said Tony Wafford, member of the Rise Above COVID Community Advisory Board. “Our community is being hit hard, and we need research that reflects our population. The time to join this movement is now.”

ACTIV-2 is sponsored by the National Institute of Allergy and Infectious Diseases (part of the National Institutes of Health) with support from the Federal COVID Response – Therapeutics, the U.S. government’s multi-agency effort to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

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