New Study Demonstrates Community Engagement Efforts Are Critical to Ensuring the Equitable Inclusion of BIPOC Communities in Vaccine Clinical Trials

A team of research experts from the COVID-19 Prevention Network (CoVPN), headquartered at Fred Hutchinson Cancer Research Center, has demonstrated that through robust community engagement, equitable inclusion in vaccine clinical trials can make a powerful impact in the health of underrepresented communities.

Recent data highlights the absence of Black, Indigenous, and people of color (BIPOC) communities in vaccine clinical trials. The new study, published in the journal PLOS ONE, discusses the need for engagement of BIPOC communities in infectious disease research as a critical component in efforts to increase vaccine confidence, acceptability and uptake of future approved products.

“There has been discourse stating that it is challenging and there are too many barriers to engaging with BIPOC communities,” said Dr. Michele Andrasik, a senior staff scientist at Fred Hutch and lead author of the study. “We are hoping that this shows these are surmountable barriers, and it is possible to overcome them through long-term investments in relationships within the community and by building reputations of trustworthiness as researchers and institutions.”

The study analyzed demographic and enrollment data across the Phase 3 COVID-19 vaccine efficacy trials to inform future efforts to ensure inclusive participation. Across the four U.S. government-funded COVID-19 vaccine clinical trials for which data are available, 47% of participants enrolled at CoVPN sites in the U.S. were BIPOC. White enrollment outpaced enrollment of BIPOC participants throughout the accrual period, requiring the implementation of strategies to increase diverse and inclusive enrollment. Trials opening later benefitted considerably from strengthened community engagement efforts, and greater and more diverse volunteer registry records.

“Misinformation and distrust of science are important barriers to research participation,” said Dr. George Mensah, director, Center for Translation Research and Implementation Science (CTRIS) at the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH) and one of the authors of the study. “This study showed us that if you take the time to engage communities and use promising practices to address misinformation and distrust, you can be successful in increasing BIPOC community participation in clinical research.”

US diverse enrollment across the NIH-funded Moderna, AstraZeneca, J&J, and Novavax trials.

Four methods for engaging with BIPOC communities included:

  • Increasing community awareness and knowledge to address and correct misperceptions, misinformation and myths required the utilization of Community-Based Participatory Research (CBPR) approaches and working with partners such as the NIH Community Engagement Alliance (CEAL) Against COVID-19 Disparities.
  • Working in partnership with institutions and organizations, such as social service providers, advocacy organizations, physician and medical professional associations, media, academic institutions, local/state/national government partners and faith-based organizations, particularly those who serve BIPOC communities with whom longstanding trusting relationships have been established.
  • Leveraging the breadth of established relationships from the HIV Vaccine Trials Network’s (HVTN) history of successful engagement in faith communities, the CoVPN Faith Initiative established a faith-based advisory council to provide guidance and direction for community engagement efforts with faith-based groups, and to implement a national faith-focused CoVPN education program that used anti-racism, anti-homophobic, anti-transphobic and other principles to ensure that the activities and messages reached broad audiences.
  • Integrating in-language and in-culture marketing into the outreach strategy, the CoVPN launched a cross-platform campaign focused on Latino/a/Hispanic and Black/African American communities. The campaign, “Help End the Uncertainty,” was developed from audience insights gathered through consumer research with priority audiences and helped deliver nearly 600,000 volunteer signups on the CoVPN study registry.

“These results show that equitable inclusion of BIPOC communities is possible. We have known that it is necessary given the long standing social, structural and economic inequities that BIPOC communities face,” Andrasik said. “We have to invest in connecting with the community and ensuring meaningful community involvement in every step of the research.”

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