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-wi...
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BMJ Publishing Group
2020-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/8/e037305.full |
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| author | Michael Marks John Kaldor Oliver Sokana Tibor Schuster Ross Andrews Susanna J Lake Sophie L Phelan Daniel Engelman Titus Nasi Dickson Boara Christina Gorae Anneke C Grobler Millicent H Osti Margot J Whitfeld Lucia Romani Andrew Steer |
| author_facet | Michael Marks John Kaldor Oliver Sokana Tibor Schuster Ross Andrews Susanna J Lake Sophie L Phelan Daniel Engelman Titus Nasi Dickson Boara Christina Gorae Anneke C Grobler Millicent H Osti Margot J Whitfeld Lucia Romani Andrew Steer |
| author_sort | Michael Marks |
| collection | DOAJ |
| 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 | Article |
| id | doaj-art-fa2ebb19c472452fbde600b6636f09d8 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-08-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-fa2ebb19c472452fbde600b6636f09d82024-12-02T13:30:12ZengBMJ Publishing GroupBMJ Open2044-60552020-08-0110810.1136/bmjopen-2020-037305Protocol 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)Michael Marks0John Kaldor1Oliver Sokana2Tibor Schuster3Ross Andrews4Susanna J Lake5Sophie L Phelan6Daniel Engelman7Titus Nasi8Dickson Boara9Christina Gorae10Anneke C Grobler11Millicent H Osti12Margot J Whitfeld13Lucia Romani14Andrew Steer15Clinical Research Department, London School of Hygiene and Tropical Medicine, London, UKThe Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia6 Eye Health Department, Ministry of Health and Medical Services, Honiara, Solomon IslandsDepartment of Family Medicine, McGill University, Montreal, Quebec, CanadaGlobal and Tropical Health Division, Menzies School of Health Research, Charles Darwin University, Brisbane, Queensland, AustraliaTropical Disease Research Group, Murdoch Childrens Research Institute, Parkville, Victoria, AustraliaThe Kirby Institute, University of New South Wales, Sydney, New South Wales, AustraliaCentre for International Child Heath, The Royal Children`s Hospital Melbourne, Parkville, Victoria, AustraliaMinistry of Health and Medical Services, Honiara, Solomon IslandsMinistry of Health and Medical Services, Honiara, Solomon IslandsMinistry of Health and Medical Services, Honiara, Solomon IslandsClinical Epidemiology and Biostatistics Unit, Murdoch Childrens Research Institute, Parkville, Victoria, AustraliaTropical Disease Research Group, Murdoch Childrens Research Institute, Parkville, Victoria, AustraliaDepartment of Dermatology, St Vincent`s Hospital, Sydney, New South Wales, AustraliaThe Kirby Institute, University of New South Wales, Sydney, New South Wales, AustraliaDepartment of Paediatrics, The University of Melbourne, Melbourne, Victoria, AustraliaIntroduction 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.https://bmjopen.bmj.com/content/10/8/e037305.full |
| spellingShingle | Michael Marks John Kaldor Oliver Sokana Tibor Schuster Ross Andrews Susanna J Lake Sophie L Phelan Daniel Engelman Titus Nasi Dickson Boara Christina Gorae Anneke C Grobler Millicent H Osti Margot J Whitfeld Lucia Romani Andrew Steer 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) BMJ Open |
| 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 |
| url | https://bmjopen.bmj.com/content/10/8/e037305.full |
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