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Table 1 Study objectives and populations

From: The PRIME trial protocol: evaluating the impact of an intervention implemented in public health centres on management of malaria and health outcomes of children using a cluster-randomised design in Tororo, Uganda

Objective

Study population and sample size

1. To compare the impact of the PRIME intervention to current standard of care on key population-based indicators, including the prevalence of anaemia in children under five

Cross-sectional community surveys in children under five and aged 5 to 15 years randomly selected from households in each cluster (8,766 children total); surveys will be conducted at baseline and then annually for two years (three surveys in total)

2. To compare the impact of the PRIME intervention to current standard of care on key longitudinal indicators, including treatment incidence density, in a prospectively followed cohort of children under five

Cohort of children under five recruited from 25 households randomly selected from each cluster (500 total) and followed for approximately 18 months in total, 12 months following the implementation of the intervention; all children of appropriate age from each household will be eligible to participate

3. To compare the impact of the PRIME intervention to current standard of care on key indicators of case management for malaria and other illnesses, including the risk of inappropriate antimalarial treatment, in children under five treated at health centres

Exit interviews in patients attending public health centres (20 HC IIs and IIIs) in the study area (three surveys in total). In the first two surveys, including 10 patients per health facility (200 patients per survey). In the final survey, including 50 patients per health facility (1,000 patients in survey, 1,400 patients overall)