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

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.

Timeline

Start

2022-01-08

Primary completion

2022-06-21

Completion

2023-12-01

Publications

• Baker K, Aide P, Bonnington CA, Rassi C, Richardson S, Roca-Feltrer A, Rodrigues M, Sitoe M, Pulido Tarquino IA, Enosse S, McGugan C, de Carvalho EA, Saute F, Mayor Aparicio AG, Candrinho B. Feasibility, Acceptability, and Protective Efficacy of Seasonal Malaria Chemoprevention Implementation in Nampula Province, Mozambique: Protocol for a Hybrid Effectiveness-Implementation Study. JMIR Res Protoc. 2022 Sep 23;11(9):e36403. doi: 10.2196/36403.

Drugs

Indications