Cargando…
Protocol for a cluster-randomised non-inferiority trial of one versus two doses of ivermectin for the control of scabies using a mass drug administration strategy (the RISE study)
INTRODUCTION: Scabies is a significant contributor to global morbidity, affecting approximately 200 million people at any time. Scabies is endemic in many resource-limited tropical settings. Bacterial skin infection (impetigo) frequently complicates scabies infestation in these settings. Community-w...
Autores principales: | , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7462236/ https://www.ncbi.nlm.nih.gov/pubmed/32868360 http://dx.doi.org/10.1136/bmjopen-2020-037305 |
_version_ | 1783576877283147776 |
---|---|
author | Lake, Susanna J Phelan, Sophie L Engelman, Daniel Sokana, Oliver Nasi, Titus Boara, Dickson Gorae, Christina Schuster, Tibor Grobler, Anneke C Osti, Millicent H Andrews, Ross Marks, Michael Whitfeld, Margot J Romani, Lucia Kaldor, John Steer, Andrew |
author_facet | Lake, Susanna J Phelan, Sophie L Engelman, Daniel Sokana, Oliver Nasi, Titus Boara, Dickson Gorae, Christina Schuster, Tibor Grobler, Anneke C Osti, Millicent H Andrews, Ross Marks, Michael Whitfeld, Margot J Romani, Lucia Kaldor, John Steer, Andrew |
author_sort | Lake, Susanna J |
collection | PubMed |
description | INTRODUCTION: Scabies is a significant contributor to global morbidity, affecting approximately 200 million people at any time. Scabies is endemic in many resource-limited tropical settings. Bacterial skin infection (impetigo) frequently complicates scabies infestation in these settings. Community-wide ivermectin-based mass drug administration (MDA) is an effective control strategy for scabies in island settings, with a single round of MDA reducing population prevalence by around 90%. However, current two-dose regimens present a number of barriers to programmatic MDA implementation. We designed the Regimens of Ivermectin for Scabies Elimination (RISE) trial to investigate whether one-dose MDA may be as effective as two-dose MDA in controlling scabies in high-prevalence settings. METHODS AND ANALYSIS: RISE is a cluster-randomised non-inferiority trial. The study will be conducted in 20 isolated villages in Western Province of Solomon Islands where population prevalence of scabies is approximately 20%. Villages will be randomly allocated to receive either one dose or two doses of ivermectin-based MDA in a 1:1 ratio. The primary objective of the study is to determine if ivermectin-based MDA with one dose is as effective as MDA with two doses in reducing the prevalence of scabies after 12 months. Secondary objectives include the effect of ivermectin-based MDA on impetigo prevalence after 12 and 24 months, the prevalence of scabies at 24 months after the intervention, the impact on presentation to health facilities with scabies and impetigo, and the safety of one-dose and two-dose MDA. ETHICS AND DISSEMINATION: This trial has been approved by the ethics review committees of the Solomon Islands and the Royal Children's Hospital, Australia. Results will be disseminated in peer-reviewed publications and in meetings with the Solomon Islands Ministry of Health and Medical Services and participating communities. TRIAL REGISTRATION DETAILS: Australian New Zealand Clinical Trials Registry: ACTRN12618001086257. Date registered: 28 June 2018. |
format | Online Article Text |
id | pubmed-7462236 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-74622362020-09-11 Protocol for a cluster-randomised non-inferiority trial of one versus two doses of ivermectin for the control of scabies using a mass drug administration strategy (the RISE study) Lake, Susanna J Phelan, Sophie L Engelman, Daniel Sokana, Oliver Nasi, Titus Boara, Dickson Gorae, Christina Schuster, Tibor Grobler, Anneke C Osti, Millicent H Andrews, Ross Marks, Michael Whitfeld, Margot J Romani, Lucia Kaldor, John Steer, Andrew BMJ Open Global Health INTRODUCTION: Scabies is a significant contributor to global morbidity, affecting approximately 200 million people at any time. Scabies is endemic in many resource-limited tropical settings. Bacterial skin infection (impetigo) frequently complicates scabies infestation in these settings. Community-wide ivermectin-based mass drug administration (MDA) is an effective control strategy for scabies in island settings, with a single round of MDA reducing population prevalence by around 90%. However, current two-dose regimens present a number of barriers to programmatic MDA implementation. We designed the Regimens of Ivermectin for Scabies Elimination (RISE) trial to investigate whether one-dose MDA may be as effective as two-dose MDA in controlling scabies in high-prevalence settings. METHODS AND ANALYSIS: RISE is a cluster-randomised non-inferiority trial. The study will be conducted in 20 isolated villages in Western Province of Solomon Islands where population prevalence of scabies is approximately 20%. Villages will be randomly allocated to receive either one dose or two doses of ivermectin-based MDA in a 1:1 ratio. The primary objective of the study is to determine if ivermectin-based MDA with one dose is as effective as MDA with two doses in reducing the prevalence of scabies after 12 months. Secondary objectives include the effect of ivermectin-based MDA on impetigo prevalence after 12 and 24 months, the prevalence of scabies at 24 months after the intervention, the impact on presentation to health facilities with scabies and impetigo, and the safety of one-dose and two-dose MDA. ETHICS AND DISSEMINATION: This trial has been approved by the ethics review committees of the Solomon Islands and the Royal Children's Hospital, Australia. Results will be disseminated in peer-reviewed publications and in meetings with the Solomon Islands Ministry of Health and Medical Services and participating communities. TRIAL REGISTRATION DETAILS: Australian New Zealand Clinical Trials Registry: ACTRN12618001086257. Date registered: 28 June 2018. BMJ Publishing Group 2020-08-30 /pmc/articles/PMC7462236/ /pubmed/32868360 http://dx.doi.org/10.1136/bmjopen-2020-037305 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Global Health Lake, Susanna J Phelan, Sophie L Engelman, Daniel Sokana, Oliver Nasi, Titus Boara, Dickson Gorae, Christina Schuster, Tibor Grobler, Anneke C Osti, Millicent H Andrews, Ross Marks, Michael Whitfeld, Margot J Romani, Lucia Kaldor, John Steer, Andrew Protocol for a cluster-randomised non-inferiority trial of one versus two doses of ivermectin for the control of scabies using a mass drug administration strategy (the RISE study) |
title | Protocol for a cluster-randomised non-inferiority trial of one versus two doses of ivermectin for the control of scabies using a mass drug administration strategy (the RISE study) |
title_full | Protocol for a cluster-randomised non-inferiority trial of one versus two doses of ivermectin for the control of scabies using a mass drug administration strategy (the RISE study) |
title_fullStr | Protocol for a cluster-randomised non-inferiority trial of one versus two doses of ivermectin for the control of scabies using a mass drug administration strategy (the RISE study) |
title_full_unstemmed | Protocol for a cluster-randomised non-inferiority trial of one versus two doses of ivermectin for the control of scabies using a mass drug administration strategy (the RISE study) |
title_short | Protocol for a cluster-randomised non-inferiority trial of one versus two doses of ivermectin for the control of scabies using a mass drug administration strategy (the RISE study) |
title_sort | protocol for a cluster-randomised non-inferiority trial of one versus two doses of ivermectin for the control of scabies using a mass drug administration strategy (the rise study) |
topic | Global Health |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7462236/ https://www.ncbi.nlm.nih.gov/pubmed/32868360 http://dx.doi.org/10.1136/bmjopen-2020-037305 |
work_keys_str_mv | AT lakesusannaj protocolforaclusterrandomisednoninferioritytrialofoneversustwodosesofivermectinforthecontrolofscabiesusingamassdrugadministrationstrategytherisestudy AT phelansophiel protocolforaclusterrandomisednoninferioritytrialofoneversustwodosesofivermectinforthecontrolofscabiesusingamassdrugadministrationstrategytherisestudy AT engelmandaniel protocolforaclusterrandomisednoninferioritytrialofoneversustwodosesofivermectinforthecontrolofscabiesusingamassdrugadministrationstrategytherisestudy AT sokanaoliver protocolforaclusterrandomisednoninferioritytrialofoneversustwodosesofivermectinforthecontrolofscabiesusingamassdrugadministrationstrategytherisestudy AT nasititus protocolforaclusterrandomisednoninferioritytrialofoneversustwodosesofivermectinforthecontrolofscabiesusingamassdrugadministrationstrategytherisestudy AT boaradickson protocolforaclusterrandomisednoninferioritytrialofoneversustwodosesofivermectinforthecontrolofscabiesusingamassdrugadministrationstrategytherisestudy AT goraechristina protocolforaclusterrandomisednoninferioritytrialofoneversustwodosesofivermectinforthecontrolofscabiesusingamassdrugadministrationstrategytherisestudy AT schustertibor protocolforaclusterrandomisednoninferioritytrialofoneversustwodosesofivermectinforthecontrolofscabiesusingamassdrugadministrationstrategytherisestudy AT groblerannekec protocolforaclusterrandomisednoninferioritytrialofoneversustwodosesofivermectinforthecontrolofscabiesusingamassdrugadministrationstrategytherisestudy AT ostimillicenth protocolforaclusterrandomisednoninferioritytrialofoneversustwodosesofivermectinforthecontrolofscabiesusingamassdrugadministrationstrategytherisestudy AT andrewsross protocolforaclusterrandomisednoninferioritytrialofoneversustwodosesofivermectinforthecontrolofscabiesusingamassdrugadministrationstrategytherisestudy AT marksmichael protocolforaclusterrandomisednoninferioritytrialofoneversustwodosesofivermectinforthecontrolofscabiesusingamassdrugadministrationstrategytherisestudy AT whitfeldmargotj protocolforaclusterrandomisednoninferioritytrialofoneversustwodosesofivermectinforthecontrolofscabiesusingamassdrugadministrationstrategytherisestudy AT romanilucia protocolforaclusterrandomisednoninferioritytrialofoneversustwodosesofivermectinforthecontrolofscabiesusingamassdrugadministrationstrategytherisestudy AT kaldorjohn protocolforaclusterrandomisednoninferioritytrialofoneversustwodosesofivermectinforthecontrolofscabiesusingamassdrugadministrationstrategytherisestudy AT steerandrew protocolforaclusterrandomisednoninferioritytrialofoneversustwodosesofivermectinforthecontrolofscabiesusingamassdrugadministrationstrategytherisestudy |