Increasing Black, Indigenous and People of Color participation in clinical trials through community engagement and recruitment goal establishment.

Longstanding social and economic inequities elevate health risks and vulnerabilities for Black, Indigenous and People of Color (BIPOC) communities. Engagement of BIPOC communities in infectious disease research is a critical component in efforts to increase vaccine confidence, acceptability, and uptake of future approved products. Recent data highlight the relative absence of BIPOC communities in vaccine clinical trials. Intentional and effective community engagement methods are needed to improve BIPOC inclusion. We describe the methods utilized for the successful enrollment of BIPOC participants in the U.S. Government (USG)-funded COVID-19 Prevention Network (CoVPN)-sponsored vaccine efficacy trials and analyze the demographic and enrollment data across the efficacy trials to inform future efforts to ensure inclusive participation. Across the four USG-funded COVID-19 vaccine clinical trials for which data are available, 47% of participants enrolled at CoVPN sites in the US 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. Despite robust fiscal resources and a longstanding collaborative and collective effort, enrollment of White persons outpaced that of BIPOC communities. With appropriate resources, commitment and community engagement expertise, the equitable enrollment of BIPOC individuals can be achieved. To ensure this goal, intentional efforts are needed, including an emphasis on diversity of enrollment in clinical trials, establishment of enrollment goals, ongoing robust community engagement, conducting population-specific trials, and research to inform best practices.

Opioid-related deaths before and after COVID-19 stay-at-home orders in Los Angeles County.

BACKGROUND: Opioid-related morbidity and mortality has increased during the COVID-19 pandemic, yet specific information about the communities most affected remains unknown. Our objective is to evaluate decedent-level associations with an opioid-related death following the implementation of stay-at-home orders in Los Angeles County. METHODS: This retrospective cohort study used data from the L.A. County Medical Examiner-Coroner to identify opioid-related deaths in 2019 and 2020. We used logistic regression to analyze the change in opioid-related deaths following a 30-day washout period after the start of stay-at-home orders. Independent variables included decedent age, gender, race and ethnicity, heroin or fentanyl present at the time of death, census tract-level education, and a scheduled drug prescription in the year before death. RESULTS: Opioid-related deaths in L.A. County are most common in census tracts where a small percentage of the population has a Bachelor's degree. Following stay-at-home orders, Non-Hispanic Caucasian individuals had significantly more opioid-related deaths than Hispanic individuals (risk ratio (RR): 1.82 [95 % CI, 1.10-3.02]; P < 0.05) after adjusting for age, gender, and heroin or fentanyl use. Racial and ethnic differences in mortality were not explained by census tract-level education or recent scheduled drug prescriptions. DISCUSSION: There has been an alarming rise in opioid-related deaths in L.A. County during 2020. The increase in opioid-related overdose deaths following the onset of COVID-19 and related policies occurred most often among Non-Hispanic Caucasian individuals. Further research on this trend's underlying cause is needed to inform policy recommendations during these simultaneous public health crises.