Accrombessi, Manfred; Cook, Jackie; Ngufor, Corine; Sovi, Arthur; Dangbenon, Edouard; Yovogan, Boulais; Akpovi, Hilaire; Hounto, Aurore; Thickstun, Charles; Padonou, Gil G; +6 more... Tokponnon, Filemon; Messenger, Louisa A; Kleinschmidt, Immo; Rowland, Mark; Akogbeto, Martin C; Protopopoff, Natacha; Bio-efficacy, , , , , , , , , , Interceptor, Tanzania, Textile durability, Malaria vectors, Insecticide resistance, Pyriproxyfen, Chlorfenapyr, Piperonyl butoxide, Royal Guard, Interceptor G2; (2021) Assessing the efficacy of two dual-active ingredients long-lasting insecticidal nets for the control of malaria transmitted by pyrethroid-resistant vectors in Benin: study protocol for a three-arm, single-blinded, parallel, cluster-randomized controlled trial. BMC Infectious Diseases, 21 (1). 194-. DOI: https://doi.org/10.1186/s12879-021-05879-1
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Abstract
BACKGROUND: Long-lasting insecticidal nets (LLINs) are currently the primary method of malaria control in sub-Saharan Africa and have contributed to a significant reduction in malaria burden over the past 15 years. However, this progress is threatened by the wide-scale selection of insecticide-resistant malaria vectors. It is, therefore, important to accelerate the generation of evidence for new classes of LLINs. METHODS: This protocol presents a three-arm superiority, single-blinded, cluster randomized controlled trial to evaluate the impact of 2 novel dual-active ingredient LLINs on epidemiological and entomological outcomes in Benin, a malaria-endemic area with highly pyrethroid-resistant vector populations. The study arms consist of (i) Royal Guard® LLIN, a net combining a pyrethroid (alpha-cypermethrin) plus an insect growth regulator (pyriproxyfen), which in the adult female is known to disrupt reproduction and egg fertility; (ii) Interceptor G2® LLIN, a net incorporating two adulticides (alpha-cypermethrin and chlorfenapyr) with different modes of action; and (iii) the control arm, Interceptor® LLIN, a pyrethroid (alpha-cypermethrin) only LLIN. In all arms, one net for every 2 people will be distributed to each household. Sixty clusters were identified and randomised 1:1:1 to each study arm. The primary outcome is malaria case incidence measured over 24 months through active case detection in a cohort of 25 children aged 6 months to 10 years, randomly selected from each cluster. Secondary outcomes include 1) malaria infection prevalence (all ages) and prevalence of moderate to severe anaemia in children under 5 years old, measured at 6 and 18 months post-intervention; 2) entomological indices measured every 3 months using human landing catches over 24 months. Insecticide resistance intensity will also be monitored over the study period. DISCUSSION: This study is the second cluster randomised controlled trial to evaluate the efficacy of these next-generation LLINs to control malaria transmitted by insecticide-resistant mosquitoes. The results of this study will form part of the WHO evidence-based review to support potential public health recommendations of these nets and shape malaria control strategies of sub-Saharan Africa for the next decade. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03931473 , registered on 30 April 2019.
Item Type | Article |
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Faculty and Department |
Faculty of Infectious and Tropical Diseases > Dept of Disease Control Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology |
Research Centre | Malaria Centre |
PubMed ID | 33607958 |
Elements ID | 156997 |
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Filename: Accrombessi 2021 Assessing the efficacy of two dual AI LLINs for control of malaria transmitted by pyrethroid resistant vectors in Benin RCT protocol.pdf
Licence: Creative Commons: Attribution 3.0
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