Seasonal Malaria Chemoprevention with Dihydroartemisin Piperaquin vs. Sulfadoxine-pyrimethamin+Amodiaquin
The proposed study will examine the effect of seasonal malaria chemoprevention (SMC) with Sulfadoxine+Amodiaquine (SP+AQ) extension to older age, the efficacy of Dihydroartemisinin-Piperaquine (DHA-PQ) when used for SMC, social, cultural, economic and health systems factors associated with effective implementation of SMC.
The specific aims of this study are to:
- Assess the effect of SMC (SP+AQ) on malaria incidence and infection prevalence in different age groups across sites;
- Study the effect of SMC (DHA-PQ) compared to SMC (SP-AQ) among children less than 10 years;
- Determine the cost-effectiveness for each treatment regimen; )
- Explore factors determining effective SMC implementation including coverage of children targeted to receive treatment by community distributors, receipt of a full course of treatment, perception of medications by parents and health care providers, and sustainability; and
- Establish a district-based system to identify severe cases.
Seasonal Malaria Chemoprevention (SMC) for children less than five years old is one of the high impact interventions against malaria in sub-Saharan Africa (SSA). Since 2016, the Government of Mali and partners through the National Malaria Control Program has deployed SMC countrywide during high malaria transmission season with a total of four rounds per year. Sulfadoxine-Pyrimethamine (SP) with Amodiaquine (AQ) are the drugs used for SMC. However, SP is also used for Intermittent preventative treatment (IPTp) for pregnant women while AQ has been used for decades for treatment of uncomplicated malaria.
Study Type: Interventional
Study Phase: Phase 1
Intervention Model: Crossover Assignment
Intervention Model Description: A cluster-randomized design will be used.
Masking: None (Open Label)
Masking Description: Any
Primary Purpose: Prevention
ClinicalTrials.gov Identifier: NCT04149106