JMIR Publications

ABSTRACT

Background:

Malaria is a significant cause of morbidity and mortality in children under five in Mozambique. The World Health Organization recommends seasonal malaria chemoprevention (SMC); the administration of four monthly courses of sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) (SPAQ), to children aged 3–59 months during the rainy season. Because resistance to SP is widespread in East and Southern Africa, SMC has so far only been implemented across the Sahel in West Africa.

Objective:

This protocol describes the first phase of a pilot project, which aims to assess the protective effect of SPAQ when used for SMC and investigate levels of molecular markers of resistance of Plasmodium falciparum to the antimalarial medicines in the study districts. Plus, understand whether SMC is a feasible and acceptable intervention in the context of Nampula province, Mozambique.

Methods:

This study will adopt a hybrid effectiveness-implementation design to conduct a mixed methods evaluation with six objectives: a molecular marker study, a non-randomised controlled trial, an analysis of reported malaria morbidity indicators, a documentation exercise of the contextual SMC adaptation, an acceptability and feasibility assessment and a coverage and quality assessment.

Results:

Ethical approval for this study was granted by the Mozambican Ministry of Health National Bioethics Committee on 15 September 2020. Data collection began on in October 2020 and is expected to be completed by August 2021.

Conclusions:

This research will make a unique contribution to our understanding of whether SPAQ, when used for SMC, can confer a protective effect against malaria in children aged 3–59 months in a region where malaria transmission is seasonal and SP resistance is expected to be high. If successful, subsequent phases are expected to provide a more comprehensive assessment of SMC’s effectiveness and sustainability. Clinical Trial: Not applicable.