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

Abstract

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.