Design and Baseline Data of a Randomized Trial to Evaluate Coverage and Frequency of Mass Treatment with Azithromycin: The Partnership for Rapid Elimination of Trachoma (PRET) in Tanzania and The Gambia


Stare, D; Harding-Esch, E; Munoz, B; Bailey, R; Mabey, D; Holland, M; Gaydos, C; West, S; (2011) Design and Baseline Data of a Randomized Trial to Evaluate Coverage and Frequency of Mass Treatment with Azithromycin: The Partnership for Rapid Elimination of Trachoma (PRET) in Tanzania and The Gambia. Ophthalmic epidemiology, 18 (1). pp. 20-29. ISSN 0928-6586 DOI: https://doi.org/10.3109/09286586.2010.545500

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Abstract

Methods: The Partnership for the Rapid Elimination of Trachoma supervises 2 randomized, community-based clinical trials in Tanzania and The Gambia. Although each trial is a stand-alone effort, protocols, data collection, and analytic approaches have been harmonized to permit generalizations. Communities in each site were randomized using a 2X2 factorial design to standard (80%--90.0%) versus high (over 90.0%) treatment coverage; communities were further randomized to annual treatment for 3 years versus a ""graduation"" rule where evidence indicates an absence of follicular trachoma or infection and annual treatment is halted. Results: Average prevalence of follicular trachoma in children age less than 5 years was 32.2% in Tanzania and 5.96% in The Gambia. Randomization appeared to be effective, as prevalence was not statistically different between the arms within each country. Conclusions: There are challenges in harmonizing 2, large trials in Africa. Study outcomes will provide critical data to national trachoma control programs on treatment methodology and resource allocation toward elimination of the disease.

Item Type: Article
Keywords: CHLAMYDIA-TRACHOMATIS, INFECTION, COMMUNITY, EYE
Faculty and Department: Faculty of Infectious and Tropical Diseases > Dept of Clinical Research
Research Centre: Neglected Tropical Diseases Network
PubMed ID: 21275593
Web of Science ID: 286928600002
URI: http://researchonline.lshtm.ac.uk/id/eprint/1220

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