Engaging communities in therapeutics clinical research during pandemics: Experiences and lessons from the ACTIV COVID-19 therapeutics research initiative
David A Wohl, Stacey J Adam, Kevin W Gibbs, Ari L Moskowitz, Thomas L Ortel, Upinder Singh, Nikolaus Jilg, Teresa H Evering, William A Fischer II, Babafemi O Taiwo, Eric S Daar, Christopher J Lindsell, Susanna Naggie, Russell L Rothman, Sarah E Dunsmore, M Patricia Mcadams, Julia Vail, Dushyantha Jayaweera
Journal of Clinical and Translational Science, doi:10.1017/cts.2024.561
This manuscript addresses a critical topic: navigating complexities of conducting clinical trials during a pandemic. Central to this discussion is engaging communities to ensure diverse participation. The manuscript elucidates deliberate strategies employed to recruit minority communities with poor social drivers of health for participation in COVID-19 trials. The paper adopts a descriptive approach, eschewing analysis of data-driven efficacy of these efforts, and instead provides a comprehensive account of strategies utilized. The Accelerate COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership launched early in the COVID-19 pandemic to develop clinical trials to advance SARS-CoV-2 treatments. In this paper, ACTIV investigators share challenges in conducting research during an evolving pandemic and approaches selected to engage communities when traditional strategies were infeasible. Lessons from this experience include importance of community representatives' involvement early in study design and implementation and integration of well-developed public outreach and communication strategies with trial launch. Centralization and coordination of outreach will allow for efficient use of resources and the sharing of best practices. Insights gleaned from the ACTIV program, as outlined in this paper, shed light on effective strategies for involving communities in treatment trials amidst rapidly evolving public health emergencies. This underscores critical importance of community engagement initiatives well in advance of the pandemic.
Competing interests. None.
Lessons Learned Topic • Undertaking community messaging about research importance to individuals, communities, and national well-being during in-between periods is the best time to prepare for a future infectious disease crisis. • Research networks, clinical investigators, and study teams that had regularly engaged with communities in preparation of a PHE allowed for rapid engagement and implementation of protocols. • Flexible infrastructure with mobile study sites and/or preparations for deployment to affected communities executed protocols efficiently. • Networks with existing distribution methods for study material and samples showed great efficiency. • Investing in on-going dialogue with respected influencers is necessary to cultivate awareness and understanding of infectious disease threats and the role of healthcare and research responses can combat issues with mistrust in government and academic institutes.
Critical Pre-PHE Preparations • Utilization of a registry allows for rapid enrollment and focused outreach to registrants from underrepresented and highly impacted groups. • Effective use of social media as a recruitment tool should be explored as many participants reported they first became aware of ACTIV through social media advertisements.
Public Messaging and Research Marketing • Sites are critically important in increasing enrollment, especially among historically underrepresented populations. • Incorporating feedback from all..
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