At a glance
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A Phase III Cluster-randomized, Open-label, Clinical Trial to Study the Safety and Efficacy of Ivermectin Mass Drug Administration to Reduce Malaria Transmission in Two African Settings
In Brief
A Phase 3 clinical trial evaluating Albendazole Pill, Ivermectin Pill, and 1 other intervention for Malaria. Completed, enrolled 48,145 participants across 2 sites in 2 countries.
Detailed Summary
The BOHEMIA program consists of a combination of studies organized around a central community prevention mass drug administration protocol and four sub-studies (i.e.; social science, entomology, health economics, and environmental), each written as an individual protocol. The protocol is central but used in two separate, individually powered trials in Mozambique and Kenya. The trials have been powered on the efficacy outcome and designed to meet the requirements of World Health Organization's (WHO) preferred product characteristics (PPC) for endectocides.
Study Details
Timeline
Interventions
Using a MDA approach, fieldworkers will administer albendazole using directly observed treatment methodology to participants
Using a MDA approach, fieldworkers will administer ivermectin using directly observed treatment methodology to participants
Veterinary ivermectin injectable will be given to livestock in the relevant cluster