Effectiveness of repellent delivered through village health volunteers on malaria incidence in villages in South-East Myanmar: a stepped-wedge cluster-randomised controlled trial protocol

Abstract Background To combat emerging drug resistance in the Greater Mekong Sub-region (GMS) the World Health Organization and GMS countries have committed to eliminating malaria in the region by 2030. The overall approach includes providing universal access to diagnosis and treatment of malaria, a...

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Main Authors: Win Han Oo, Julia C. Cutts, Paul A. Agius, Kyaw Zayar Aung, Poe Poe Aung, Aung Thi, Nyi Nyi Zaw, Htin Kyaw Thu, Wai Yan Min Htay, Ricardo Ataide, Katherine O’Flaherty, Ai Pao Yawn, Aung Paing Soe, James G. Beeson, Brendan Crabb, Naanki Pasricha, Freya J. I. Fowkes
Format: Article
Language:English
Published: BMC 2018-12-01
Series:BMC Infectious Diseases
Subjects:
Online Access:http://link.springer.com/article/10.1186/s12879-018-3566-y
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author Win Han Oo
Julia C. Cutts
Paul A. Agius
Kyaw Zayar Aung
Poe Poe Aung
Aung Thi
Nyi Nyi Zaw
Htin Kyaw Thu
Wai Yan Min Htay
Ricardo Ataide
Katherine O’Flaherty
Ai Pao Yawn
Aung Paing Soe
James G. Beeson
Brendan Crabb
Naanki Pasricha
Freya J. I. Fowkes
author_facet Win Han Oo
Julia C. Cutts
Paul A. Agius
Kyaw Zayar Aung
Poe Poe Aung
Aung Thi
Nyi Nyi Zaw
Htin Kyaw Thu
Wai Yan Min Htay
Ricardo Ataide
Katherine O’Flaherty
Ai Pao Yawn
Aung Paing Soe
James G. Beeson
Brendan Crabb
Naanki Pasricha
Freya J. I. Fowkes
author_sort Win Han Oo
collection DOAJ
description Abstract Background To combat emerging drug resistance in the Greater Mekong Sub-region (GMS) the World Health Organization and GMS countries have committed to eliminating malaria in the region by 2030. The overall approach includes providing universal access to diagnosis and treatment of malaria, and sustainable preventive measures, including vector control. Topical repellents are an intervention that can be used to target residual malaria transmission not covered by long lasting insecticide nets and indoor residual spraying. Although there is strong evidence that topical repellents protect against mosquito bites, evidence is not well established for the effectiveness of repellents distributed as part of malaria control activities in protecting against episodes of malaria. A common approach to deliver malaria services is to assign Village Health Volunteers (VHVs) to villages, particularly where limited or no services exist. The proposed trial aims to provide evidence for the effectiveness of repellent distributed through VHVs in reducing malaria. Methods The study is an open stepped-wedge cluster-randomised controlled trial randomised at the village level. Using this approach, repellent (N,N-diethyl-benzamide – 12% w/w, cream) is distributed by VHVs in villages sequentially throughout the malaria transmission season. Villages will be grouped into blocks, with blocks transitioned monthly from control (no repellent) to intervention states (to receive repellent) across 14 monthly intervals in random order). This follows a 4-week baseline period where all villages do not receive repellent. The primary endpoint is defined as the number of individuals positive for Plasmodium falciparum and Plasmodium vivax infections diagnosed by a rapid diagnostic test. Secondary endpoints include symptomatic malaria, Polymerase Chain Reaction (PCR)-detectable Plasmodium spp. infections, molecular markers of drug resistance and antibodies specific for Plasmodium spp. parasites. Discussion This study has been approved by relevant institutional ethics committees in Myanmar and Australia. Results will be disseminated through workshops, conferences and peer-reviewed publications. Findings will contribute to a better understanding of the optimal distribution mechanisms of repellent, context specific effectiveness and inform policy makers and implementers of malaria elimination programs in the GMS. Trial registration Australian and New Zealand Clinical Trials Registry (ACTRN12616001434482). Retrospectively registered 14th October 2016.
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spelling doaj.art-d922c66800fb4e0ea47e22f44d2610322022-12-21T19:07:08ZengBMCBMC Infectious Diseases1471-23342018-12-0118111010.1186/s12879-018-3566-yEffectiveness of repellent delivered through village health volunteers on malaria incidence in villages in South-East Myanmar: a stepped-wedge cluster-randomised controlled trial protocolWin Han Oo0Julia C. Cutts1Paul A. Agius2Kyaw Zayar Aung3Poe Poe Aung4Aung Thi5Nyi Nyi Zaw6Htin Kyaw Thu7Wai Yan Min Htay8Ricardo Ataide9Katherine O’Flaherty10Ai Pao Yawn11Aung Paing Soe12James G. Beeson13Brendan Crabb14Naanki Pasricha15Freya J. I. Fowkes16Burnet InstituteBurnet InstituteBurnet InstituteBurnet InstituteBurnet InstituteDepartment of Public Health, Myanmar Ministry of Health and SportBurnet InstituteBurnet InstituteBurnet InstituteBurnet InstituteBurnet InstituteBurnet InstituteBurnet InstituteBurnet InstituteBurnet InstituteBurnet InstituteBurnet InstituteAbstract Background To combat emerging drug resistance in the Greater Mekong Sub-region (GMS) the World Health Organization and GMS countries have committed to eliminating malaria in the region by 2030. The overall approach includes providing universal access to diagnosis and treatment of malaria, and sustainable preventive measures, including vector control. Topical repellents are an intervention that can be used to target residual malaria transmission not covered by long lasting insecticide nets and indoor residual spraying. Although there is strong evidence that topical repellents protect against mosquito bites, evidence is not well established for the effectiveness of repellents distributed as part of malaria control activities in protecting against episodes of malaria. A common approach to deliver malaria services is to assign Village Health Volunteers (VHVs) to villages, particularly where limited or no services exist. The proposed trial aims to provide evidence for the effectiveness of repellent distributed through VHVs in reducing malaria. Methods The study is an open stepped-wedge cluster-randomised controlled trial randomised at the village level. Using this approach, repellent (N,N-diethyl-benzamide – 12% w/w, cream) is distributed by VHVs in villages sequentially throughout the malaria transmission season. Villages will be grouped into blocks, with blocks transitioned monthly from control (no repellent) to intervention states (to receive repellent) across 14 monthly intervals in random order). This follows a 4-week baseline period where all villages do not receive repellent. The primary endpoint is defined as the number of individuals positive for Plasmodium falciparum and Plasmodium vivax infections diagnosed by a rapid diagnostic test. Secondary endpoints include symptomatic malaria, Polymerase Chain Reaction (PCR)-detectable Plasmodium spp. infections, molecular markers of drug resistance and antibodies specific for Plasmodium spp. parasites. Discussion This study has been approved by relevant institutional ethics committees in Myanmar and Australia. Results will be disseminated through workshops, conferences and peer-reviewed publications. Findings will contribute to a better understanding of the optimal distribution mechanisms of repellent, context specific effectiveness and inform policy makers and implementers of malaria elimination programs in the GMS. Trial registration Australian and New Zealand Clinical Trials Registry (ACTRN12616001434482). Retrospectively registered 14th October 2016.http://link.springer.com/article/10.1186/s12879-018-3566-yMalariaRepellentMosquitoPlasmodium
spellingShingle Win Han Oo
Julia C. Cutts
Paul A. Agius
Kyaw Zayar Aung
Poe Poe Aung
Aung Thi
Nyi Nyi Zaw
Htin Kyaw Thu
Wai Yan Min Htay
Ricardo Ataide
Katherine O’Flaherty
Ai Pao Yawn
Aung Paing Soe
James G. Beeson
Brendan Crabb
Naanki Pasricha
Freya J. I. Fowkes
Effectiveness of repellent delivered through village health volunteers on malaria incidence in villages in South-East Myanmar: a stepped-wedge cluster-randomised controlled trial protocol
BMC Infectious Diseases
Malaria
Repellent
Mosquito
Plasmodium
title Effectiveness of repellent delivered through village health volunteers on malaria incidence in villages in South-East Myanmar: a stepped-wedge cluster-randomised controlled trial protocol
title_full Effectiveness of repellent delivered through village health volunteers on malaria incidence in villages in South-East Myanmar: a stepped-wedge cluster-randomised controlled trial protocol
title_fullStr Effectiveness of repellent delivered through village health volunteers on malaria incidence in villages in South-East Myanmar: a stepped-wedge cluster-randomised controlled trial protocol
title_full_unstemmed Effectiveness of repellent delivered through village health volunteers on malaria incidence in villages in South-East Myanmar: a stepped-wedge cluster-randomised controlled trial protocol
title_short Effectiveness of repellent delivered through village health volunteers on malaria incidence in villages in South-East Myanmar: a stepped-wedge cluster-randomised controlled trial protocol
title_sort effectiveness of repellent delivered through village health volunteers on malaria incidence in villages in south east myanmar a stepped wedge cluster randomised controlled trial protocol
topic Malaria
Repellent
Mosquito
Plasmodium
url http://link.springer.com/article/10.1186/s12879-018-3566-y
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