Community Engagement Strategy for Building Trust in Human Challenge Studies Using Participatory and Creative Methods: An Ethical Imperative

Abstract

Human Infection Challenge studies (HICs) are crucial for advancing global understanding of disease pathogenesis, immune responses, and accelerating vaccine and drug development. Explorations on willingness to participate among medical students revealed the need to ensure full understanding of HIC requirements, for example, for residency, by the broader community. This raised the question of 'How could we ensure informed and understood consent for the ethical conduct of HIC?' We employed iterative participatory discovery and creative design methods, including three Zoom meetings and discussions with university students and community leaders. Neighbourhood Health Committee leaders further refined suggested creatives of a future mass-media campaign for building trust in HICs. Deliberative focus group discussions and workshops were conducted on communication strategies on HICs' requirements, risks, requirements, and benefits. The final creative brief suggested (1) using a pyramid approach utilizing existing community structures, to introduce HIC concepts progressively to larger groups, (2) engaging communities through theatre for development, community dialogue, and engagement meetings, and wide society through social and mass media advertisements, and (3) preference for the term 'Human Challenge Studies' over 'Human Infection Challenge Studies'. We learned that community engagement, if properly conducted, can create systems of ownership of research and build communication strategies to achieve an accurate understanding of HICs and use informed participation that results in trustworthy data. We need further research, including in rural areas, pilot testing of evaluation strategies, and continued engagement with diverse stakeholders to create products that can be adapted by future HIC studies in settings such as Zambia.

Keywords: clinical trials; community engagement; ethical review; human challenge studies; human infection studies; informed consent; vaccine research.