Firstly, participants will be randomly allocated to intervention groups via concealed allocation.
The trial was a multi-centred randomised controlled pilot trial using a parallel design with participants allocated to intervention or control on a 1 1 allocation ratio.
Eleven centres were allocated to intervention group, and 13 centres were allocated to standard care.
One hundred three chemotherapy-naïve patients were recruited, stratified by treatment regimen, and randomly allocated to intervention or usual care.
One class in each school was randomly allocated to intervention (n= 5, 111 children) or control (n= 5, 104 children).
Between January 2012 and April 2015, 3036 patients were included in the trial, 1518 patients in 11 clusters allocated to intervention group and 1518 patients in 13 clusters allocated to standard care.
Fifty-one kebeles (with a total population of 296, 811) were randomly allocated to intervention and control groups.
Two divisions in Kwale (Matuga and Kinango) had been randomly allocated to intervention area, while two others (Msambweni and Samburu) acted as controls [16].
Sites were randomly allocated to intervention initiation dates.
101 patients were allocated to intervention and 100 to control.
Participants will be randomly allocated to intervention or control conditions.
