BMJ open · 2024
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.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Last Anna R, Shafi Abdurahman Oumer, Greenland Katie, Robinson Ailie, Collin Claire, Czerniewska Alexandra, Etu Edao Sinba, Versteeg Bart, Butcher Robert, Guye Meseret, Legesse Demitu, Nuri Kedir Temam, Shuka Gemeda, Haji Mohammed Yousuf Munira, Dheressa Gaddisa, Dumessa Gebeyehu, Akalu Melesse, Tadesse Mesfin, Adugna Kumsa Dereje, Seife Gebretsadik Fikre, Abashawl Aida, Habtamu Esmael, Sarah Virginia, Alemayehu Wondu, Solomon Anthony, Weiss Helen Anne, Logan James G, Macleod David, Burton Matthew J
Аннотация
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.
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.