Browsing by Author "Kunda-Ng'andu EM"

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Community Engagement Strategy for Building Trust in Human Challenge Studies Using Participatory and Creative Methods: An Ethical Imperative.
(2025-Sep-12) Kunda-Ng'andu EM; Chirwa M; Muzazu S; Laban N; Chisenga C; Simuyandi M; Mwale S; Chilengi R; Sharma A
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.
Engagement of ethics and regulatory authorities on human infection studies: Proceedings of an engagement workshop in Zambia.
(2021) Kunda-Ng'andu EM; Simuyandi M; Kapulu M; Chirwa-Chobe M; Mwanyungwi-Chinganya H; Mwale S; Chilengi R; Sharma A
Human infection studies (HIS) have generally been used as a tool in the pathway for vaccine development in high income settings. Over the last decade, this model has been implemented in LMICs with the aim of accelerating development of next generation vaccines that would perform better in these settings. However, in most LMICs, the ethics and regulatory framework for the conduct of these studies are not in place. In Zambia, these studies are yet to be conducted and thus we conducted a stakeholder engagement workshop in October 2019. We engaged with bioethicists, regulatory authority officials, and scientists from within Zambia and other African countries to anticipate and address foreseeable ethical and regulatory issues when conducting HIS in Zambia for the first time. The workshop largely focused on sensitizing the stakeholders on the benefits of these studies with the following main points for consideration on the implementation of these studies in Zambia: need for in-country legal framework and guidelines; need for adequate informed consent based on comprehensive understanding of the concept of HIS and study requirements; and requirements for heightened vigilance to assure participant safety including good ethical and clinical practice with regulatory, ethical, data safety, and community oversight. Additionally, the workshop emphasized the need for rigorous health screening prior to enrolment; suitable infrastructure for containment; and personnel to provide appropriate treatment including emergency resuscitation and evacuation if indicated. Specific recommendations included compensation for burden of participation; access to care and provision for study related injury (e.g. no-fault insurance); and withdrawal and exit procedures to preserve individual and community safety. Finally, the meeting concluded that researchers should actively engage key gate keepers including civic leaders such as parliamentarians, universities, researchers, potential participants and laypersons to avoid circulation of misinformation.