Undertaking Community Engagement for a Controlled Human Malaria Infection Study in Kenya: Approaches and Lessons Learnt

Abstract

Human infection studies (HIS) involve deliberately infecting healthy volunteers with disease-causing pathogens under controlled conditions. These studies are “controlled” by way of using specific types of pathogens, including dose, and the availability of emergency medical facilities to research volunteers. Most HIS involve diseases whose treatment is known and are done to accelerate the development of novel therapeutics such as vaccines, to address emerging and existing infectious diseases. Traditionally, HIS have been conducted primarily in high-income countries (HICs) but are now increasingly being conducted in low-and-middle income countries (LMICs). In LMICs settings, HIS are likely to raise concerns among various stakeholders including participating populations and regulatory bodies, that are unfamiliar with this type of research. Deliberately infecting a healthy individual with a disease-causing pathogen seems to go against the normal practice of medicine of “do no harm”. Such types of studies can give rise to increased rumors and jeopardize research participation in study activities, including non-HIS research. Community engagement can be one approach to address particular issues that HIS studies raise through meaningfully engaging with communities, where views and voices inform the conduct of HIS studies. In addition, engagement can inform the ethical conduct and acceptability of HIS studies in LMICs settings and provide opportunities for sharing information, listening to, and responding to concerns and views from potential participants, and the larger community in which the study would be conducted. Despite community engagement being an important aspect to consider, very few published and gray literature cover the types of approaches that have been used, and lessons learnt in engagement for HIS. This article outlinesthe community engagement approaches that were used to engage stakeholders and communities for malaria HIS-controlled human malaria infection (CHMI), undertaken in Kilifi, Kenya. It outlines the engagement activities across the research cycle, from activities conducted during protocol development, to planning, and implementation of the study. We discuss the challenges experienced, lessons learnt, and provide some recommendations for engagement around HIS.

Community acceptance of a novel malaria intervention, Attractive Targeted Sugar Baits, in a ATSB Zambia phase III trial

“…Additional factors commonly explored include reported willingness to accept the intervention again in the future, and qualitative exploration of the sociocultural barriers and enablers of successful implementation (1,2,9). Inadequate consideration of community acceptance can undermine successful implementation or lead to unintended, negative consequences for new interventions (10).…”

Public engagement for the conduct of a controlled human infection study testing vaccines against Necator americanus (hookworm) in areas of active hookworm transmission in Brazil

“…Indeed, CHIS evolve controversial ethical issues considering that healthy participants are infected with pathogens which have deleterious effects. As a result, regulatory processes and specific ethical guidelines need to be discussed collectively, and actions to educate regulatory agents need to be implemented to guide these studies in the Brazilian context [ 8 , 11 , 12 ].…”

“…Public engagement is a potent pathway to study understanding of CHIS, developing participant autonomy in making decisions about study participation, and increasing trust and partnership between researchers and the public [ 12 , 15 – 17 ]. Paying attention to the public, particularly those potentially involved in the research, concerning their perceptions of the study and how it is developed, results in a more inclusive way to produce guidelines that consider the reality of developing countries and help researchers, members of Research Ethics Committees (RECs), and the public understand and engage with CHIS [ 4 , 18 ].…”