Assessment of the Feasibility, Acceptability, and Impact of Implementing Seasonal Malaria Chemoprevention in Nampula Province, Mozambique: Protocol for a Hybrid Effectiveness-Implementation Study.

Alexandra Wharton-Smith,Pedro Aide,Christian Rassi,Sol Richardson,Baltazar Candrinho,Eusebio Macete,Craig A Bonnington,Arantxa Roca-Feltrer,Kevin Baker,Maria Rodrigues,Francisco Saute,Madeleine Marasciulo,Sonia Enosse

doi:10.2196/27855

Abstract

BackgroundMalaria is a significant cause of morbidity and mortality in children aged under 5 years in Mozambique. The World Health Organization recommends seasonal malaria chemoprevention (SMC), the administration of four monthly courses of sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ), to children aged 3-59 months during rainy season. However, as resistance to SP is widespread in East and Southern Africa, SMC has so far only been implemented across the Sahel in West Africa.ObjectiveThis protocol describes the first phase of a pilot project that aims to assess the protective effect of SP and AQ when used for SMC and investigate the levels of molecular markers of resistance of Plasmodium falciparum to antimalarial medicines in the study districts. In addition, it is important to understand whether SMC is a feasible and acceptable intervention in the context of Nampula Province, Mozambique.MethodsThis study will adopt a hybrid effectiveness-implementation design to conduct a mixed methods evaluation with six objectives: a molecular marker study, a nonrandomized 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.ResultsEthical approval for this study was granted by the Mozambican Ministry of Health National Bioethics Committee on September 15, 2020. Data collection began in October 2020, and data analysis is expected to be completed by August 2021.ConclusionsThis research will make a unique contribution to our understanding of whether the combination of SP and AQ, 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 the project is successful, subsequent phases are expected to provide a more comprehensive assessment of the effectiveness and sustainability of SMCs.International Registered Report Identifier (IRRID)DERR1-10.2196/27855

Highlights

BackgroundAn estimated 409,000 people die from malaria each year worldwide, and children aged under 5 years are vulnerable, comprising 67% of all malaria deaths in 2019 [1]
This research will make a unique contribution to our understanding of whether the combination of SP and AQ, when used for seasonal malaria chemoprevention (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
The high burden to high impact approach, supported by the World Health Organization (WHO), the Roll Back Malaria Partnership to End Malaria and other partners, aims to prevent disease and save lives through strategies targeted to the contextual needs of 11 countries that together account for more than 70% of the world’s malaria burden [2]

Summary

Introduction

BackgroundAn estimated 409,000 people die from malaria each year worldwide, and children aged under 5 years are vulnerable, comprising 67% of all malaria deaths in 2019 [1]. Malaria causes 29% of all deaths and 42% of deaths among children aged under 5 years in Mozambique, rendering it the most significant national public health threat [4]. Mozambique has adopted the high burden to high impact approach, and the National Malaria Control Programme is working with partners toward the global vision of a malaria-free world. Malaria is a significant cause of morbidity and mortality in children aged under 5 years in Mozambique. The World Health Organization recommends seasonal malaria chemoprevention (SMC), the administration of four monthly courses of sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ), to children aged 3-59 months during rainy season. As resistance to SP is widespread in East and Southern Africa, SMC has so far only been implemented across the Sahel in West Africa

Methods

Discussion

Conclusion