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101 Participation of Racial and Ethnic Minorities in Decentralized Trials: The ACTIV-6 Experience

Published online by Cambridge University Press:  03 April 2024

Maximilian Rohde
Affiliation:
Vanderbilt University Medical Center
Dushyantha Jayaweera
Affiliation:
Department of Medicine, Miller School of Medicine, University of Miami
Olveen Carrasquillo
Affiliation:
Department of Medicine, Miller School of Medicine, University of Miami
Thomas Stewart
Affiliation:
School of Data Science, University of Virginia
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Abstract

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OBJECTIVES/GOALS: Racial and ethnic minority populations have been historically underrepresented in clinical trials, which limits the external validity of study findings. We analyze data from the ACTIV-6 trial to assess whether inclusion efforts were effective in increasing participation from minority groups. METHODS/STUDY POPULATION: ACTIV-6 is a decentralized randomized placebo-controlled platform trial investigating repurposed drugs for the treatment of mild to moderate COVID-19. Study participants could either self-refer online or be recruited through a study site. Two inclusion efforts were introduced to increase participation from racial or ethnic minority populations: targeted advertising and outreach, and strategic selection of study sites that serve diverse populations. We assessed the effectiveness of these interventions by analyzing enrollment trends over time. We also assessed whether participants from racial or ethnic minority populations experienced higher loss to follow-up. RESULTS/ANTICIPATED RESULTS: At the start of the trial, enrollment of non-Hispanic White participants outpaced enrollment from racial or ethnic minority populations. At 4 months, only 108 participants (20.5%) were from racial or ethnic minority populations, but greatly increased by 28 months to 3,544 participants (46.4%), nearly half of all participants. This increase was predominantly due to recruitment through study sites rather than self-referral. In particular, certain sites recruited large numbers of minority participants. We also observed that participants from racial or ethnic minority populations were more likely to drop out of the study before receiving the study drug (3% vs 1%). DISCUSSION/SIGNIFICANCE: Our results suggest that strategic site selection is an effective strategy for recruiting a study population that represents racial and ethnic populations. The benefits of targeted advertising and outreach were less clear. Retention efforts remain important to reduce loss to follow-up.

Type
Diversity, Equity, Inclusion and Accessibility
Creative Commons
Creative Common License - CCCreative Common License - BYCreative Common License - NCCreative Common License - ND
This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work.
Copyright
© The Author(s), 2024. The Association for Clinical and Translational Science