Last Updated

06 Jul 2021

Boosting the impact of Seasonal Malaria Chemoprevention (SMC) through simultaneous screening and treatment of SMC-children's roommates in Burkina Faso

Objectives

The goal of the study is to improve the impact of Seasonal Malaria Chemoprevention (SMC) intervention in terms of reducing malaria morbidity and mortality in children under five years.

Primary objectives include:

  • to assess whether SMC + children's roommates screening and treatment with dihydro-artemisinin-piperaquine (DHAPPQ) is more effective than current routine implementation of SMC alone.
  • to assess the tolerance and safety of AQSP and DHAPPQ.


Secondary objectives include:

  • to assess the impact of the new strategy on the circulating parasite population in terms of selection of resistant strains.
  • to assess implementation determinants such as adherence and acceptability of the strategy.
Principal Investigator
Study Design

Study Type: Interventional (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)

The study will be carried out in the Nanoro health district catchment area in Burkina Faso. This will be a randomized superiority trial. The unit of randomization will be the household and all eligible children from a household will be allocated to the same study group to avoid confusion. Households with 3 - 59 months old children will be assigned to either (i) control group (SMC alone) or (ii) intervention (SMC + roommates screening with standard HRP2-RDT and treatment if positive) or (iii) intervention (SMC + roommates screening with highly sensitive RDT and treatment if positive). The sample size will be 789 isolated households per arm, i.e. around 1,578 children and 2,630 roommates expected. They will be followed-up for 24 months to fully cover two consecutive malaria transmission seasons and then two SMC cycles. Children will be actively followed-up during the malaria transmission seasons while in the dry seasons the followed-up will be passive.