Effect of interventions to reduce malaria incidence among military personnel on active duty: study protocol for a cluster randomised controlled trial of the impact of etofenprox-treated uniforms, permethrin-treated uniforms and DEET insect repellent

Abstract Background While there is strong evidence that bite protection methods such as permethrin-treated clothing and topical insect repellents are protective against insect bites, there are few studies assessing the impact on malaria infection. This study will estimate the protective efficacy of...

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Autores principales:	Daniel Msellemu, Amanda Ross, Lucky Temu, Irene Moshi, Lorenz Hofer, Charles Mwanziva, Yadon M. Kohi, Sarah J. Moore
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Malaria Insecticide-treated clothing Military uniforms Etofenprox Permethrin Cluster randomised trial Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/fd6ca2927fb14769ba315d77dbd8933f
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spelling	oai:doaj.org-article:fd6ca2927fb14769ba315d77dbd8933f2021-11-28T12:28:18ZEffect of interventions to reduce malaria incidence among military personnel on active duty: study protocol for a cluster randomised controlled trial of the impact of etofenprox-treated uniforms, permethrin-treated uniforms and DEET insect repellent10.1186/s13063-021-05801-91745-6215https://doaj.org/article/fd6ca2927fb14769ba315d77dbd8933f2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05801-9https://doaj.org/toc/1745-6215Abstract Background While there is strong evidence that bite protection methods such as permethrin-treated clothing and topical insect repellents are protective against insect bites, there are few studies assessing the impact on malaria infection. This study will estimate the protective efficacy of treated uniforms and DEET insect repellent on the incidence of malaria infection among military personnel in an operational setting. Permethrin-treated uniforms used with DEET lotion will be compared to etofenprox-treated uniforms with DEET lotion. The effect of DEET lotion will be estimated by comparing permethrin-treated uniforms with DEET or placebo lotion. Method A cluster randomised double-blind placebo-controlled trial is planned to evaluate the effectiveness of the interventions on preventing malaria infections in soldiers on active duty at Mgambo National Service Camp in Tanga, Tanzania. The arms are (1) permethrin-treated uniform with 30% DEET liposome formula; (2) permethrin-treated uniform with placebo lotion; (3) candidate insect repellent system, i.e. etofenprox-treated uniform with 30% DEET liposome formula; and (4) placebo, i.e. untreated uniforms with placebo lotion. The primary outcome is the incidence of Plasmodium falciparum malaria infection detected by polymerase chain reaction (PCR) by active case detection using surveys every 2 weeks for 12 months. Rapid diagnostic tests will be used for the diagnosis of participants with symptoms. The unit of randomisation will be combania: companies formed by recruits aged 18 to 25 years; combania do activities together and sleep in the same dormitory. Unequal randomisation will be used to optimise statistical power for the primary comparison between permethrin-treated uniforms with DEET and etofenprox-treated uniforms with DEET. Discussion This trial will provide the estimate of the effects of permethrin with DEET compared to those of the new fabric treatment etofenprox with DEET and any additional effect of using DEET. The results will inform strategies to protect military personnel and civilians who have more outdoor or occupational malaria exposure than the general public. Trial registration ClinicalTrials.gov NCT02938975 .Daniel MsellemuAmanda RossLucky TemuIrene MoshiLorenz HoferCharles MwanzivaYadon M. KohiSarah J. MooreBMCarticleMalariaInsecticide-treated clothingMilitary uniformsEtofenproxPermethrinCluster randomised trialMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Malaria Insecticide-treated clothing Military uniforms Etofenprox Permethrin Cluster randomised trial Medicine (General) R5-920
spellingShingle	Malaria Insecticide-treated clothing Military uniforms Etofenprox Permethrin Cluster randomised trial Medicine (General) R5-920 Daniel Msellemu Amanda Ross Lucky Temu Irene Moshi Lorenz Hofer Charles Mwanziva Yadon M. Kohi Sarah J. Moore Effect of interventions to reduce malaria incidence among military personnel on active duty: study protocol for a cluster randomised controlled trial of the impact of etofenprox-treated uniforms, permethrin-treated uniforms and DEET insect repellent
description	Abstract Background While there is strong evidence that bite protection methods such as permethrin-treated clothing and topical insect repellents are protective against insect bites, there are few studies assessing the impact on malaria infection. This study will estimate the protective efficacy of treated uniforms and DEET insect repellent on the incidence of malaria infection among military personnel in an operational setting. Permethrin-treated uniforms used with DEET lotion will be compared to etofenprox-treated uniforms with DEET lotion. The effect of DEET lotion will be estimated by comparing permethrin-treated uniforms with DEET or placebo lotion. Method A cluster randomised double-blind placebo-controlled trial is planned to evaluate the effectiveness of the interventions on preventing malaria infections in soldiers on active duty at Mgambo National Service Camp in Tanga, Tanzania. The arms are (1) permethrin-treated uniform with 30% DEET liposome formula; (2) permethrin-treated uniform with placebo lotion; (3) candidate insect repellent system, i.e. etofenprox-treated uniform with 30% DEET liposome formula; and (4) placebo, i.e. untreated uniforms with placebo lotion. The primary outcome is the incidence of Plasmodium falciparum malaria infection detected by polymerase chain reaction (PCR) by active case detection using surveys every 2 weeks for 12 months. Rapid diagnostic tests will be used for the diagnosis of participants with symptoms. The unit of randomisation will be combania: companies formed by recruits aged 18 to 25 years; combania do activities together and sleep in the same dormitory. Unequal randomisation will be used to optimise statistical power for the primary comparison between permethrin-treated uniforms with DEET and etofenprox-treated uniforms with DEET. Discussion This trial will provide the estimate of the effects of permethrin with DEET compared to those of the new fabric treatment etofenprox with DEET and any additional effect of using DEET. The results will inform strategies to protect military personnel and civilians who have more outdoor or occupational malaria exposure than the general public. Trial registration ClinicalTrials.gov NCT02938975 .
format	article
author	Daniel Msellemu Amanda Ross Lucky Temu Irene Moshi Lorenz Hofer Charles Mwanziva Yadon M. Kohi Sarah J. Moore
author_facet	Daniel Msellemu Amanda Ross Lucky Temu Irene Moshi Lorenz Hofer Charles Mwanziva Yadon M. Kohi Sarah J. Moore
author_sort	Daniel Msellemu
title	Effect of interventions to reduce malaria incidence among military personnel on active duty: study protocol for a cluster randomised controlled trial of the impact of etofenprox-treated uniforms, permethrin-treated uniforms and DEET insect repellent
title_short	Effect of interventions to reduce malaria incidence among military personnel on active duty: study protocol for a cluster randomised controlled trial of the impact of etofenprox-treated uniforms, permethrin-treated uniforms and DEET insect repellent
title_full	Effect of interventions to reduce malaria incidence among military personnel on active duty: study protocol for a cluster randomised controlled trial of the impact of etofenprox-treated uniforms, permethrin-treated uniforms and DEET insect repellent
title_fullStr	Effect of interventions to reduce malaria incidence among military personnel on active duty: study protocol for a cluster randomised controlled trial of the impact of etofenprox-treated uniforms, permethrin-treated uniforms and DEET insect repellent
title_full_unstemmed	Effect of interventions to reduce malaria incidence among military personnel on active duty: study protocol for a cluster randomised controlled trial of the impact of etofenprox-treated uniforms, permethrin-treated uniforms and DEET insect repellent
title_sort	effect of interventions to reduce malaria incidence among military personnel on active duty: study protocol for a cluster randomised controlled trial of the impact of etofenprox-treated uniforms, permethrin-treated uniforms and deet insect repellent
publisher	BMC
publishDate	2021
url	https://doaj.org/article/fd6ca2927fb14769ba315d77dbd8933f
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Effect of interventions to reduce malaria incidence among military personnel on active duty: study protocol for a cluster randomised controlled trial of the impact of etofenprox-treated uniforms, permethrin-treated uniforms and DEET insect repellent

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