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Abstract
Background Most of the reduction in malaria prevalence seen in Africa since 2000 has been attributed to vector control interventions. Yet increases in the distribution and intensity of insecticide resistance and higher costs of newer insecticides pose a challenge to sustaining these gains. Thus, endemic countries face challenging decisions regarding the choice of vector control interventions.
Methods A cluster randomised trial is being carried out in Mopeia District in the Zambezia Province of Mozambique, where malaria prevalence in children under 5 is high (68% in 2015), despite continuous and campaign distribution of long-lasting insecticide-treated nets (LLINs). Study arm 1 will continue to use the standard, LLIN-based National Malaria Control Programme vector control strategy (LLINs only), while study arm 2 will receive indoor residual spraying (IRS) once a year for 2 years with a microencapsulated formulation of pirimiphos-methyl (Actellic 300 CS), in addition to the standard LLIN strategy (LLINs+IRS). Prior to the 2016 IRS implementation (the first of two IRS campaigns in this study), 146 clusters were defined and stratified per number of households. Clusters were then randomised 1:1 into the two study arms. The public health impact and cost-effectiveness of IRS intervention will be evaluated over 2 years using multiple methods: (1) monthly active malaria case detection in a cohort of 1548 total children aged 6–59 months; (2) enhanced passive surveillance at health facilities and with community health workers; (3) annual cross-sectional surveys; and (4) entomological surveillance. Prospective microcosting of the intervention and provider and societal costs will be conducted. Insecticide resistance status pattern and changes in local Anopheline populations will be included as important supportive outcomes.
Discussion By evaluating the public health impact and cost-effectiveness of IRS with a non-pyrethroid insecticide in a high-transmission setting with high LLIN ownership, it is expected that this study will provide programmatic and policy-relevant data to guide national and global vector control strategies.
Trial registration number NCT02910934.
- malaria
- cluster randomised trial
- health economics
- health policy
- medical entomology
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Footnotes
CJC, SA, RZ, MR and FS contributed equally.
Handling editor Alberto L Garcia-Basteiro
Contributors BC, RZ, AS, MR, CLC, JW and FS conceived the study. CJC, CLC, MR, JW and JB planned the cluster design and calculated the sample size. CJC, SA, JW, RZ, KV, MR and FS wrote the first draft of the protocol. CJC, SA, JW, RZ, MR and FS wrote the data collection and informed consent forms. BC, EM and HK contributed to study design and assessed emerging issues during planning and initial implementation. SA planned and wrote the costing methods. CS designed and implemented the census. KV, LL and CF planned and wrote the entomological methods and are responsible for entomological data collection. JB delineated and randomised the clusters and produced the maps and implementation lists. All authors contributed to, read and approved the final manuscript.
Funding Funding for this study was provided by PATH, through a grant from UNITAID primed by the Innovative Vector Control Consortium (IVCC), and by USAID through the US President’s Malaria Initiative. CJC is supported by a Ramón Areces Fellowship. JB is supported by an Erasmus Mundus Joint Doctorate Fellowship, Specific Grant Agreement 2016-1346. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
Competing interests None declared.
Patient consent Obtained.
Ethics approval This protocol has been approved by the Institutional Review Board of the CISM (CIBS-CISM), the National Bioethical Committee (Comité Nacional de bioética para a Saúde de Moçambique (CNBS), the PMI Operational Research Committee and PATH’s Research Ethics Committee (REC). This study was reviewed by the Centers for Disease Control and Prevention (CDC) and determined to be human subjects research with non-engagement by CDC staff.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The full protocol is available from the corresponding author upon reasonable request.
Author note Some members of the sponsor institutions participated in study design (MR, JW, RZ, AS, CLC and CF). The primary data collection, management and analysis remain the responsibility of the CISM, with other investigators contributing to secondary analysis, in coordination with CISM. Writing of the report will be a joint effort of the participating institutions.