Cluster randomised controlled trial of double-dose azithromycin mass drug administration, facial cleanliness and fly control measures for trachoma control in Oromia, Ethiopia: the stronger SAFE trial protocol
Introduction Trachoma is caused by the bacterium Chlamydia trachomatis (Ct). The WHO recommends the SAFE strategy for trachoma elimination: Surgery for trichiasis, Antibiotics, Facial cleanliness and Environmental improvement. Multiple rounds of SAFE implementation have proven insufficient to elimin...
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2024-12-01
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| author | Robert Butcher David Macleod Helen Anne Weiss Matthew J Burton Esmael Habtamu Bart Versteeg Virginia Sarah Anthony Solomon James G Logan Anna R Last Alexandra Czerniewska Oumer Shafi Abdurahman Katie Greenland Ailie Robinson Claire Collin Edao Sinba Etu Meseret Guye Demitu Legesse Kedir Temam Nuri Gemeda Shuka Munira Haji Mohammed Yousuf Gaddisa Dheressa Gebeyehu Dumessa Melesse Akalu Mesfin Tadesse Dereje Adugna Kumsa Fikre Seife Gebretsadik Aida Abashawl Wondu Alemayehu |
| author_facet | Robert Butcher David Macleod Helen Anne Weiss Matthew J Burton Esmael Habtamu Bart Versteeg Virginia Sarah Anthony Solomon James G Logan Anna R Last Alexandra Czerniewska Oumer Shafi Abdurahman Katie Greenland Ailie Robinson Claire Collin Edao Sinba Etu Meseret Guye Demitu Legesse Kedir Temam Nuri Gemeda Shuka Munira Haji Mohammed Yousuf Gaddisa Dheressa Gebeyehu Dumessa Melesse Akalu Mesfin Tadesse Dereje Adugna Kumsa Fikre Seife Gebretsadik Aida Abashawl Wondu Alemayehu |
| author_sort | Robert Butcher |
| collection | DOAJ |
| description | Introduction Trachoma is caused by the bacterium Chlamydia trachomatis (Ct). The WHO recommends the SAFE strategy for trachoma elimination: Surgery for trichiasis, Antibiotics, Facial cleanliness and Environmental improvement. Multiple rounds of SAFE implementation have proven insufficient to eliminate trachoma in Ethiopia, where over 50% of the global trachoma burden remains. More effective antibiotic treatment schedules and transmission-suppressing approaches are needed. The aim of stronger SAFE is to evaluate the impact of a novel package of interventions to strengthen the A, F and E of SAFE on the prevalence of ocular Ct and trachoma in Oromia, Ethiopia.Methods and analysis 68 clusters were randomised in a 1:1:1:1 ratio to one of (1) standard A/standard F&E (standard SAFE), (2) standard A/enhanced F&E, (3) enhanced A/standard F&E or (4) enhanced A/enhanced F&E (stronger SAFE). Enhanced A includes two height-based doses of oral azithromycin (equivalent to 20 mg/kg) given as single doses 2 weeks apart, as mass drug administration, annually. Enhanced F&E includes fly control measures (permethrin-treated headwear and odour-baited traps) and face-washing hygiene behaviour change implemented at household level in selected communities. The interventions will be implemented and reinforced over 3 years.The primary outcome is the prevalence of ocular Ct by quantitative PCR in children aged 1–9 years at 36 months. A key secondary outcome is the prevalence of active (inflammatory) trachoma in the same children, assessed by validated trachoma graders and conjunctival photography. Laboratory technicians and photo-graders are masked to treatment allocation. Other important secondary analyses include process evaluations, assessment of behaviour change, fly indicators, adherence and coverage of interventions and a cost analysis.Ethics and dissemination Study protocols have been approved by the National Research Ethics Review Committee of the Ethiopian Ministry of Science and Higher Education and the London School of Hygiene & Tropical Medicine Ethics Committee. An independent data safety and monitoring board oversees the trial. Results will be disseminated through peer-reviewed publications, presentations and reports.Trial registration number ISRCTN40760473. |
| format | Article |
| id | doaj-art-e04176485ede40678c6a1b59dc898997 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-e04176485ede40678c6a1b59dc8989972025-08-20T02:55:49ZengBMJ Publishing GroupBMJ Open2044-60552024-12-01141210.1136/bmjopen-2024-084478Cluster randomised controlled trial of double-dose azithromycin mass drug administration, facial cleanliness and fly control measures for trachoma control in Oromia, Ethiopia: the stronger SAFE trial protocolRobert Butcher0David Macleod1Helen Anne Weiss2Matthew J Burton3Esmael Habtamu4Bart Versteeg5Virginia Sarah6Anthony Solomon7James G Logan8Anna R Last9Alexandra Czerniewska10Oumer Shafi Abdurahman11Katie Greenland12Ailie Robinson13Claire Collin14Edao Sinba Etu15Meseret Guye16Demitu Legesse17Kedir Temam Nuri18Gemeda Shuka19Munira Haji Mohammed Yousuf20Gaddisa Dheressa21Gebeyehu Dumessa22Melesse Akalu23Mesfin Tadesse24Dereje Adugna Kumsa25Fikre Seife Gebretsadik26Aida Abashawl27Wondu Alemayehu281 Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK17 Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK15 Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK15 Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK12 London School of Hygiene & Tropical Medicine, London, UK8 Knowledge Institute of the Dutch Association of Medical Specialists, Utrecht, The Netherlands13 The Fred Hollows Foundation UK, London, UK14 Global Neglected Tropical Diseases Program, World Health Organization, Geneva, Switzerland6 Department of Disease Control, London School of Hygiene & Tropical Medicine, London, UK1 Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK6 Department of Disease Control, London School of Hygiene & Tropical Medicine, London, UK1 Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK3 Department for Disease Control, London School of Hygiene and Tropical Medicine, London, UK4 Department of Infection Biology, London School of Hygiene & Tropical Medicine, London, UK5 Department for Disease Control, London School of Hygiene & Tropical Medicine, London, UK7 Berhan Public Health Consultancy, Addis Ababa, Ethiopia2 The Fred Hollows Foundation, Addis Ababa, Ethiopia2 The Fred Hollows Foundation, Addis Ababa, Ethiopia2 The Fred Hollows Foundation, Addis Ababa, Ethiopia2 The Fred Hollows Foundation, Addis Ababa, Ethiopia2 The Fred Hollows Foundation, Addis Ababa, Ethiopia2 The Fred Hollows Foundation, Addis Ababa, Ethiopia2 The Fred Hollows Foundation, Addis Ababa, Ethiopia2 The Fred Hollows Foundation, Addis Ababa, Ethiopia2 The Fred Hollows Foundation, Addis Ababa, Ethiopia10 Oromia Regional Health Bureau, Addis Ababa, Ethiopia11 Ethiopia Ministry of Science and Technology, Addis Ababa, Ethiopia7 Berhan Public Health Consultancy, Addis Ababa, Ethiopia7 Berhan Public Health Consultancy, Addis Ababa, EthiopiaIntroduction Trachoma is caused by the bacterium Chlamydia trachomatis (Ct). The WHO recommends the SAFE strategy for trachoma elimination: Surgery for trichiasis, Antibiotics, Facial cleanliness and Environmental improvement. Multiple rounds of SAFE implementation have proven insufficient to eliminate trachoma in Ethiopia, where over 50% of the global trachoma burden remains. More effective antibiotic treatment schedules and transmission-suppressing approaches are needed. The aim of stronger SAFE is to evaluate the impact of a novel package of interventions to strengthen the A, F and E of SAFE on the prevalence of ocular Ct and trachoma in Oromia, Ethiopia.Methods and analysis 68 clusters were randomised in a 1:1:1:1 ratio to one of (1) standard A/standard F&E (standard SAFE), (2) standard A/enhanced F&E, (3) enhanced A/standard F&E or (4) enhanced A/enhanced F&E (stronger SAFE). Enhanced A includes two height-based doses of oral azithromycin (equivalent to 20 mg/kg) given as single doses 2 weeks apart, as mass drug administration, annually. Enhanced F&E includes fly control measures (permethrin-treated headwear and odour-baited traps) and face-washing hygiene behaviour change implemented at household level in selected communities. The interventions will be implemented and reinforced over 3 years.The primary outcome is the prevalence of ocular Ct by quantitative PCR in children aged 1–9 years at 36 months. A key secondary outcome is the prevalence of active (inflammatory) trachoma in the same children, assessed by validated trachoma graders and conjunctival photography. Laboratory technicians and photo-graders are masked to treatment allocation. Other important secondary analyses include process evaluations, assessment of behaviour change, fly indicators, adherence and coverage of interventions and a cost analysis.Ethics and dissemination Study protocols have been approved by the National Research Ethics Review Committee of the Ethiopian Ministry of Science and Higher Education and the London School of Hygiene & Tropical Medicine Ethics Committee. An independent data safety and monitoring board oversees the trial. Results will be disseminated through peer-reviewed publications, presentations and reports.Trial registration number ISRCTN40760473.https://bmjopen.bmj.com/content/14/12/e084478.full |
| spellingShingle | Robert Butcher David Macleod Helen Anne Weiss Matthew J Burton Esmael Habtamu Bart Versteeg Virginia Sarah Anthony Solomon James G Logan Anna R Last Alexandra Czerniewska Oumer Shafi Abdurahman Katie Greenland Ailie Robinson Claire Collin Edao Sinba Etu Meseret Guye Demitu Legesse Kedir Temam Nuri Gemeda Shuka Munira Haji Mohammed Yousuf Gaddisa Dheressa Gebeyehu Dumessa Melesse Akalu Mesfin Tadesse Dereje Adugna Kumsa Fikre Seife Gebretsadik Aida Abashawl Wondu Alemayehu Cluster randomised controlled trial of double-dose azithromycin mass drug administration, facial cleanliness and fly control measures for trachoma control in Oromia, Ethiopia: the stronger SAFE trial protocol BMJ Open |
| title | Cluster randomised controlled trial of double-dose azithromycin mass drug administration, facial cleanliness and fly control measures for trachoma control in Oromia, Ethiopia: the stronger SAFE trial protocol |
| title_full | Cluster randomised controlled trial of double-dose azithromycin mass drug administration, facial cleanliness and fly control measures for trachoma control in Oromia, Ethiopia: the stronger SAFE trial protocol |
| title_fullStr | Cluster randomised controlled trial of double-dose azithromycin mass drug administration, facial cleanliness and fly control measures for trachoma control in Oromia, Ethiopia: the stronger SAFE trial protocol |
| title_full_unstemmed | Cluster randomised controlled trial of double-dose azithromycin mass drug administration, facial cleanliness and fly control measures for trachoma control in Oromia, Ethiopia: the stronger SAFE trial protocol |
| title_short | Cluster randomised controlled trial of double-dose azithromycin mass drug administration, facial cleanliness and fly control measures for trachoma control in Oromia, Ethiopia: the stronger SAFE trial protocol |
| title_sort | cluster randomised controlled trial of double dose azithromycin mass drug administration facial cleanliness and fly control measures for trachoma control in oromia ethiopia the stronger safe trial protocol |
| url | https://bmjopen.bmj.com/content/14/12/e084478.full |
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