Evaluation of the protective efficacy of OlysetPlus ceiling nets for reduction of malaria incidence in children in Homa Bay County, Kenya: a cluster-randomised controlled study protocol

Introduction Malaria is still a major health problem in sub-Saharan Africa, where 98% of global malaria mortality occurs. In addition, the spread of Plasmodium falciparum with partial artemisinin resistance in East Africa and beyond is a great concern. The establishment of more effective vector cont...

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Main Authors: Daisuke Yoneoka, Jesse Gitaka, James Kongere, Wataru Kagaya, Akira Kaneko, Yura K Ko, Chim W Chan, Mariko Kanamori, Bernard N Kanoi, Gordon Odhiambo Okomo, Protus Omondi, Kelvin B Musyoka, Takatsugu Okai, Victor Opiyo, Jared Oginga, Samuel Mungai, Kibor K Keitany, Elijah Songok, Noboru Minakawa
Format: Article
Language:English
Published: BMJ Publishing Group 2025-01-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/1/e087832.full
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author Daisuke Yoneoka
Jesse Gitaka
James Kongere
Wataru Kagaya
Akira Kaneko
Yura K Ko
Chim W Chan
Mariko Kanamori
Bernard N Kanoi
Gordon Odhiambo Okomo
Protus Omondi
Kelvin B Musyoka
Takatsugu Okai
Victor Opiyo
Jared Oginga
Samuel Mungai
Kibor K Keitany
Elijah Songok
Noboru Minakawa
author_facet Daisuke Yoneoka
Jesse Gitaka
James Kongere
Wataru Kagaya
Akira Kaneko
Yura K Ko
Chim W Chan
Mariko Kanamori
Bernard N Kanoi
Gordon Odhiambo Okomo
Protus Omondi
Kelvin B Musyoka
Takatsugu Okai
Victor Opiyo
Jared Oginga
Samuel Mungai
Kibor K Keitany
Elijah Songok
Noboru Minakawa
collection DOAJ
description Introduction Malaria is still a major health problem in sub-Saharan Africa, where 98% of global malaria mortality occurs. In addition, the spread of Plasmodium falciparum with partial artemisinin resistance in East Africa and beyond is a great concern. The establishment of more effective vector control, in addition to the current long-lasting insecticide-treated net distribution programme, is an urgent task in these areas. One novel vector control candidate is the pyrethroid-PBO ceiling nets (OlysetPlus ceiling nets) which can overcome the problems of variations in net use behaviours and metabolic resistance to insecticide in vectors. Our preliminary study suggests the protective efficacy and high acceptability of this tool. With this proposed second trial, we aim to evaluate the impact of this tool in a different eco-epidemiological setting in the lake endemic region of Kenya.Methods A cluster-randomised controlled trial is designed to evaluate the impact of pyrethroid-PBO ceiling nets in Ndhiwa Sub-County, Homa Bay County, Kenya. A total of 44 clusters will be randomly assigned in a 1:1 ratio to the intervention group (pyrethroid-PBO ceiling nets) and the control group. The assignment will be accomplished through covariate-constrained randomisation of clusters. For the primary outcome of clinical malaria incidence, 38 children from each cluster will be enrolled in a cohort and followed for 18 months. We will also evaluate the effects of the intervention on entomological indicators as well as its acceptance by communities and cost-effectiveness.Ethics and dissemination Ethics approvals were provided by the Mount Kenya University Institutional Scientific Ethics Review Committee and the Ethics Committee Osaka Metropolitan University. Study results will be shared with study participants and communities, the Homa Bay County government and the Kenya National Malaria Control Programme. Results will also be disseminated through publications, conferences and workshops to help the development of novel malaria control strategies in other malaria-endemic countries.Trial registration number UMIN000053873.
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spelling doaj-art-648da0417a3849b0a43e6dcdf56d06b42025-02-11T08:00:08ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-087832Evaluation of the protective efficacy of OlysetPlus ceiling nets for reduction of malaria incidence in children in Homa Bay County, Kenya: a cluster-randomised controlled study protocol 0Daisuke Yoneoka1Jesse Gitaka2James Kongere3Wataru Kagaya4Akira Kaneko5Yura K Ko6Chim W Chan7Mariko Kanamori8Bernard N Kanoi9Gordon Odhiambo Okomo10Protus Omondi11Kelvin B Musyoka12Takatsugu Okai13Victor Opiyo14Jared Oginga15Samuel Mungai16Kibor K Keitany17Elijah Songok18Noboru Minakawa19Kenya National Bureau of Statistics, Nairobi, Nairobi, KenyaNational Institute of Infectious Diseases, Shinjuku-ku, Tokyo, JapanResearch and Innovation, Mount Kenya University, Thika, KenyaOsaka Metropolitan University, Osaka, Osaka, JapanNagasaki University, Nagasaki, Nagasaki, JapanDepartment of Microbiology, Tumor and Cell Biology (MTC), Karolinska Institute, Stockholm, SwedenDepartment of Microbiology, Tumor and Cell Biology (MTC), Karolinska Institute, Stockholm, SwedenOsaka Metropolitan University, Osaka, Osaka, JapanKyoto University, Kyoto, JapanMount Kenya University, Thika, KenyaMinistry of Health, Homa Bay, KenyaOsaka Metropolitan University, Osaka, Osaka, JapanOsaka Metropolitan University, Osaka, Osaka, JapanOsaka Metropolitan University, Osaka, Osaka, JapanCenter for Research in Tropical Medicine and Community Development, Nairobi, KenyaCenter for Research in Tropical Medicine and Community Development, Nairobi, KenyaMount Kenya University, Thika, KenyaKenya National Malaria Control Program, Nairobi, Nairobi, KenyaKenya Medical Research Institute, Nairobi, KenyaNagasaki University, Nagasaki, Nagasaki, JapanIntroduction Malaria is still a major health problem in sub-Saharan Africa, where 98% of global malaria mortality occurs. In addition, the spread of Plasmodium falciparum with partial artemisinin resistance in East Africa and beyond is a great concern. The establishment of more effective vector control, in addition to the current long-lasting insecticide-treated net distribution programme, is an urgent task in these areas. One novel vector control candidate is the pyrethroid-PBO ceiling nets (OlysetPlus ceiling nets) which can overcome the problems of variations in net use behaviours and metabolic resistance to insecticide in vectors. Our preliminary study suggests the protective efficacy and high acceptability of this tool. With this proposed second trial, we aim to evaluate the impact of this tool in a different eco-epidemiological setting in the lake endemic region of Kenya.Methods A cluster-randomised controlled trial is designed to evaluate the impact of pyrethroid-PBO ceiling nets in Ndhiwa Sub-County, Homa Bay County, Kenya. A total of 44 clusters will be randomly assigned in a 1:1 ratio to the intervention group (pyrethroid-PBO ceiling nets) and the control group. The assignment will be accomplished through covariate-constrained randomisation of clusters. For the primary outcome of clinical malaria incidence, 38 children from each cluster will be enrolled in a cohort and followed for 18 months. We will also evaluate the effects of the intervention on entomological indicators as well as its acceptance by communities and cost-effectiveness.Ethics and dissemination Ethics approvals were provided by the Mount Kenya University Institutional Scientific Ethics Review Committee and the Ethics Committee Osaka Metropolitan University. Study results will be shared with study participants and communities, the Homa Bay County government and the Kenya National Malaria Control Programme. Results will also be disseminated through publications, conferences and workshops to help the development of novel malaria control strategies in other malaria-endemic countries.Trial registration number UMIN000053873.https://bmjopen.bmj.com/content/15/1/e087832.full
spellingShingle Daisuke Yoneoka
Jesse Gitaka
James Kongere
Wataru Kagaya
Akira Kaneko
Yura K Ko
Chim W Chan
Mariko Kanamori
Bernard N Kanoi
Gordon Odhiambo Okomo
Protus Omondi
Kelvin B Musyoka
Takatsugu Okai
Victor Opiyo
Jared Oginga
Samuel Mungai
Kibor K Keitany
Elijah Songok
Noboru Minakawa
Evaluation of the protective efficacy of OlysetPlus ceiling nets for reduction of malaria incidence in children in Homa Bay County, Kenya: a cluster-randomised controlled study protocol
BMJ Open
title Evaluation of the protective efficacy of OlysetPlus ceiling nets for reduction of malaria incidence in children in Homa Bay County, Kenya: a cluster-randomised controlled study protocol
title_full Evaluation of the protective efficacy of OlysetPlus ceiling nets for reduction of malaria incidence in children in Homa Bay County, Kenya: a cluster-randomised controlled study protocol
title_fullStr Evaluation of the protective efficacy of OlysetPlus ceiling nets for reduction of malaria incidence in children in Homa Bay County, Kenya: a cluster-randomised controlled study protocol
title_full_unstemmed Evaluation of the protective efficacy of OlysetPlus ceiling nets for reduction of malaria incidence in children in Homa Bay County, Kenya: a cluster-randomised controlled study protocol
title_short Evaluation of the protective efficacy of OlysetPlus ceiling nets for reduction of malaria incidence in children in Homa Bay County, Kenya: a cluster-randomised controlled study protocol
title_sort evaluation of the protective efficacy of olysetplus ceiling nets for reduction of malaria incidence in children in homa bay county kenya a cluster randomised controlled study protocol
url https://bmjopen.bmj.com/content/15/1/e087832.full
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