Community control strategies for scabies: A cluster randomised noninferiority trial.

<h4>Background</h4>Scabies is a neglected tropical disease hyperendemic to many low- and middle-income countries. Scabies can be successfully controlled using mass drug administration (MDA) using 2 doses of ivermectin-based treatment. If effective, a strategy of 1-dose ivermectin-based M...

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Autores principales:	Myra Hardy, Josaia Samuela, Mike Kama, Meciusela Tuicakau, Lucia Romani, Margot J Whitfeld, Christopher L King, Gary J Weil, Tibor Schuster, Anneke C Grobler, Daniel Engelman, Leanne J Robinson, John M Kaldor, Andrew C Steer
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R
Acceso en línea:	https://doaj.org/article/b24fed87401446ae87901a9b844bf36f
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spelling	oai:doaj.org-article:b24fed87401446ae87901a9b844bf36f2021-12-02T19:56:01ZCommunity control strategies for scabies: A cluster randomised noninferiority trial.1549-12771549-167610.1371/journal.pmed.1003849https://doaj.org/article/b24fed87401446ae87901a9b844bf36f2021-11-01T00:00:00Zhttps://doi.org/10.1371/journal.pmed.1003849https://doaj.org/toc/1549-1277https://doaj.org/toc/1549-1676<h4>Background</h4>Scabies is a neglected tropical disease hyperendemic to many low- and middle-income countries. Scabies can be successfully controlled using mass drug administration (MDA) using 2 doses of ivermectin-based treatment. If effective, a strategy of 1-dose ivermectin-based MDA would have substantial advantages for implementing MDA for scabies at large scale.<h4>Methods and findings</h4>We did a cluster randomised, noninferiority, open-label, 3-group unblinded study comparing the effectiveness of control strategies on community prevalence of scabies at 12 months. All residents from 35 villages on 2 Fijian islands were eligible to participate. Villages were randomised 1:1:1 to 2-dose ivermectin-based MDA (IVM-2), 1-dose ivermectin-based MDA (IVM-1), or screen and treat with topical permethrin 5% for individuals with scabies and their household contacts (SAT). All groups also received diethylcarbamazine and albendazole for lymphatic filariasis control. For IVM-2 and IVM-1, oral ivermectin was dosed at 200 μg/kg and when contraindicated substituted with permethrin. We designated a noninferiority margin of 5%. We enrolled 3,812 participants at baseline (July to November 2017) from the 35 villages with median village size of 108 (range 18 to 298). Age and sex of participants were representative of the population with 51.6% male and median age of 25 years (interquartile range 10 to 47). We enrolled 3,898 at 12 months (July to November 2018). At baseline, scabies prevalence was similar in all groups: IVM-2: 11.7% (95% confidence interval (CI) 8.5 to 16.0); IVM-1: 15.2% (95% CI 9.4 to 23.8); SAT: 13.6% (95% CI 7.9 to 22.4). At 12 months, scabies decreased substantially in all groups: IVM-2: 1.3% (95% CI 0.6 to 2.5); IVM-1: 2.7% (95% CI 1.1 to 6.5); SAT: 1.1% (95% CI 0.6 to 2.0). The risk difference in scabies prevalence at 12 months between the IVM-1 and IVM-2 groups was 1.2% (95% CI -0.2 to 2.7, p = 0.10). Limitations of the study included the method of scabies diagnosis by nonexperts, a lower baseline prevalence than anticipated, and the addition of diethylcarbamazine and albendazole to scabies treatment.<h4>Conclusions</h4>All 3 strategies substantially reduced prevalence. One-dose was noninferior to 2-dose ivermectin-based MDA, as was a screen and treat approach, for community control of scabies. Further trials comparing these approaches in varied settings are warranted to inform global scabies control strategies.<h4>Trial registration</h4>Clinitrials.gov NCT03177993 and ANZCTR N12617000738325.Myra HardyJosaia SamuelaMike KamaMeciusela TuicakauLucia RomaniMargot J WhitfeldChristopher L KingGary J WeilTibor SchusterAnneke C GroblerDaniel EngelmanLeanne J RobinsonJohn M KaldorAndrew C SteerPublic Library of Science (PLoS)articleMedicineRENPLoS Medicine, Vol 18, Iss 11, p e1003849 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R
spellingShingle	Medicine R Myra Hardy Josaia Samuela Mike Kama Meciusela Tuicakau Lucia Romani Margot J Whitfeld Christopher L King Gary J Weil Tibor Schuster Anneke C Grobler Daniel Engelman Leanne J Robinson John M Kaldor Andrew C Steer Community control strategies for scabies: A cluster randomised noninferiority trial.
description	<h4>Background</h4>Scabies is a neglected tropical disease hyperendemic to many low- and middle-income countries. Scabies can be successfully controlled using mass drug administration (MDA) using 2 doses of ivermectin-based treatment. If effective, a strategy of 1-dose ivermectin-based MDA would have substantial advantages for implementing MDA for scabies at large scale.<h4>Methods and findings</h4>We did a cluster randomised, noninferiority, open-label, 3-group unblinded study comparing the effectiveness of control strategies on community prevalence of scabies at 12 months. All residents from 35 villages on 2 Fijian islands were eligible to participate. Villages were randomised 1:1:1 to 2-dose ivermectin-based MDA (IVM-2), 1-dose ivermectin-based MDA (IVM-1), or screen and treat with topical permethrin 5% for individuals with scabies and their household contacts (SAT). All groups also received diethylcarbamazine and albendazole for lymphatic filariasis control. For IVM-2 and IVM-1, oral ivermectin was dosed at 200 μg/kg and when contraindicated substituted with permethrin. We designated a noninferiority margin of 5%. We enrolled 3,812 participants at baseline (July to November 2017) from the 35 villages with median village size of 108 (range 18 to 298). Age and sex of participants were representative of the population with 51.6% male and median age of 25 years (interquartile range 10 to 47). We enrolled 3,898 at 12 months (July to November 2018). At baseline, scabies prevalence was similar in all groups: IVM-2: 11.7% (95% confidence interval (CI) 8.5 to 16.0); IVM-1: 15.2% (95% CI 9.4 to 23.8); SAT: 13.6% (95% CI 7.9 to 22.4). At 12 months, scabies decreased substantially in all groups: IVM-2: 1.3% (95% CI 0.6 to 2.5); IVM-1: 2.7% (95% CI 1.1 to 6.5); SAT: 1.1% (95% CI 0.6 to 2.0). The risk difference in scabies prevalence at 12 months between the IVM-1 and IVM-2 groups was 1.2% (95% CI -0.2 to 2.7, p = 0.10). Limitations of the study included the method of scabies diagnosis by nonexperts, a lower baseline prevalence than anticipated, and the addition of diethylcarbamazine and albendazole to scabies treatment.<h4>Conclusions</h4>All 3 strategies substantially reduced prevalence. One-dose was noninferior to 2-dose ivermectin-based MDA, as was a screen and treat approach, for community control of scabies. Further trials comparing these approaches in varied settings are warranted to inform global scabies control strategies.<h4>Trial registration</h4>Clinitrials.gov NCT03177993 and ANZCTR N12617000738325.
format	article
author	Myra Hardy Josaia Samuela Mike Kama Meciusela Tuicakau Lucia Romani Margot J Whitfeld Christopher L King Gary J Weil Tibor Schuster Anneke C Grobler Daniel Engelman Leanne J Robinson John M Kaldor Andrew C Steer
author_facet	Myra Hardy Josaia Samuela Mike Kama Meciusela Tuicakau Lucia Romani Margot J Whitfeld Christopher L King Gary J Weil Tibor Schuster Anneke C Grobler Daniel Engelman Leanne J Robinson John M Kaldor Andrew C Steer
author_sort	Myra Hardy
title	Community control strategies for scabies: A cluster randomised noninferiority trial.
title_short	Community control strategies for scabies: A cluster randomised noninferiority trial.
title_full	Community control strategies for scabies: A cluster randomised noninferiority trial.
title_fullStr	Community control strategies for scabies: A cluster randomised noninferiority trial.
title_full_unstemmed	Community control strategies for scabies: A cluster randomised noninferiority trial.
title_sort	community control strategies for scabies: a cluster randomised noninferiority trial.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/b24fed87401446ae87901a9b844bf36f
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Community control strategies for scabies: A cluster randomised noninferiority trial.

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