Effectiveness of Seasonal Malaria Chemoprevention in Nampula Province, Mozambique: Type Two Hybrid Implementation Study

• Status: Not yet recruiting
• Trial end date: 2022-06-01

Summary

We describe a Type II hybrid effectiveness-implementation study design which evaluates the effects of a clinical intervention on relevant outcomes whilst collecting information on implementation. It is designed to determine feasibility and effectiveness of an innovative intervention, as well as the protective efficacy of the drugs used. The study consists of three components: 1) Conducting a cluster randomized controlled trial (cRCT) through household surveys establishing confirmed malaria cases in children; 2) Conducting a prospective cohort study to determine the chemoprevention efficacy of sulfadoxine-pyrimethamine and amodiaquine (SPAQ) and whether drug concentrations or parasite resistance influence the duration of protection; and 3) Conducting a resistance markers study in children 3-59 months to measure changes in resistance marker prevalence over time.

• Phase: Phase 4

Details

• Lead Sponsor: Malaria Consortium
• Treatments: Amodiaquine; Fanasil, pyrimethamine drug combination; Pyrimethamine; Sulfadoxine