Recruitment, capacity building and community engagement
After almost two years of careful preparation, the first trial participants (infants under 18 months of age) were recruited on 17 March in Tonkolili, a district of the Northern Province. By late 2021, 20% of the 20,560 participants needed for the trial had already been recruited. “This is the first individually randomised placebo-control design to evaluate the effect of IPTi together with azithromycin,” says Menéndez. The innovative aspect of the approach is to deliver the drugs through the immunisation programme, which now includes an additional visit at 15 months of age for a booster of the measles vaccine.
But recruitment is not everything. “In addition to starting the clinical trial, this year we have continued to build and reinforce capacities among local healthcare workers and staff in different aspects of a trial, such as data management, administration, human resources, good clinical practices and monitoring of drug resistance,” says project manager Anna Lucas. “And we also have been busy with another vital activity in this kind of project: engaging with local communities,” she adds. All this is possible thanks to valuable help from local partners: the College of Medicine and Allied Health Sciences at the University of Sierra Leone and the Ministry of Health and Sanitation.
ICARIA’s approach has the potential to save many lives. Whether it works, is feasible, and can be scaled up to other countries in Africa, the next few years will tell.