Discussion
ICH, deaths
DISEASE, CHOLERA
Implementing such a large trial under GCP-ICH standards in remote rural settings in Mozambique is challenging at several levels:ICH standards have been developed primarily for hospital-based work in high-income countries and they do not always take into consideration the environmental or cultural context of rural Africa. A clear example is the legal guardianship of minors. Can the primary caretaker (an “auntie”) provide consent for a child if both parents are absent or dead even if this primary caretaker does not have written proof of legal guardianship?There is a need to have community buy-in by involving local personnel in the field work, yet the scarcity of trained personnel increases the costs and length of trainingCluster randomization brings additional complexities as community engagement and early handling of rumours requires a fully dedicated teamMalaria is a seasonal disease, and implementing a mass drug administration program during the rainy season carries enormous logistical challenges including degraded roads, floodings, and general supply constringentThe Mozambican team faced five cyclones and severe floodings followed by a cholera outbreak. This means a surge in the number of deaths in study participants. This put a serious strain on the local team in order to keep the strict reporting timelines required by ICH. Appropriate resources were put in place including the procurement of satellite phones for usage in areas with no cell phone networkCollecting large amounts of data from the field with limited connectivity requires complex logistical operations such as physically transporting tablets to an area with 3G coverage for upload and refresh