Practical application of good participatory practices for trials of emerging pathogens: Developing materials for use in ACTIV-3, -3b, and ACTIV-associated COVID-19 trials

oleh: Paola del Carmen Guerra-de-Blas, Rubria Marines-Price, Olga Milman, Danae Deal, Jonathan Marchand, Jessica Linton, Sue Meger, John Rule, Thomas L. Holland, Jonathan Kitonsa, Yvette Delph, for the INSIGHT OTAC, ACTIV-3 TICO, ACTIV-3 substudy VATICO, and ACTIV-3b TESICO Study Groups

Format: Article
Diterbitkan: Cambridge University Press 2024-01-01

Deskripsi

The emergence of the COVID-19 pandemic required an immediate global clinical research response. The ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines)-3 trials and the ACTIV-associated Outpatient Treatment with Anti-Coronavirus Immunoglobulin trial used Good Participatory Practices (GPP) to develop materials for study implementation from a global network perspective. GPP guidelines offer a framework for engaging stakeholders throughout the research process. This paper provides an overview of the materials developed and their applicability in various settings, reports results from a survey of study site personnel on the materials’ usefulness, summarizes important lessons learned, and serves as a reference for networks eager to apply GPP. Survey results showed that flipbooks and overview videos were highly ranked. Stakeholder input was valuable in developing easily understandable participant-facing materials with culturally appropriate images. Materials should be available to submit with the initial protocol submissions to ethics committees, and in formats that accommodate a wide range of institutional resources, policies, and infection-control practices. This article emphasizes the importance of GPP, including stakeholder consultation, in developing materials that support clinical research and address language, cultural, and sociopolitical barriers during a pandemic. The findings will be used to optimize efforts and resource allocation for new and ongoing studies.