Last Updated: 25/07/2024
Initial study to assess the feasibility, acceptability and impact of seasonal malaria chemoprevention in Nampula province, Mozambique
Objectives
- To determine the baseline prevalence of sulfadoxine-pyrimethamine and amodiaquine (SPAQ) resistance and any increase in resistance prevalence after one annual round of SMC
- To determine whether receipt of SPAQ is associated with a reduction in the odds of clinically significant malaria outcomes
- To assess the change in reported malaria morbidity indicators through routine data
- To document the adaptation of seasonal malaria chemoprevention (SMC) implementation to the Mozambican context
- To explore the feasibility and acceptability of SMC among stakeholders
- To evaluate the process of SMC implementation in terms of distribution quality and coverage.
Background
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. 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.
Objective
This 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.
Methods
This 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.
Results
Ethical 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.
Conclusions
This 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.
Type 2 hybrid effectiveness-implementation study design that evaluates the effects of a clinical intervention on relevant outcomes while collecting information on implementation
Oct 2020 — Aug 2021
$570,000
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