The aim of the proposed project is to determine whether a comprehensive water and sanitation package is a cost-effective strategy to hasten trachoma elimination. Mass azithromycin distributions are effective in clearing the ocular strains bf chlamydia that cause trachoma, but do not eliminate trachoma in the most severely affected areas. Moreover, mass antibiotic treatments have the disadvantage of selecting for resistance among commensal organisms. Because poor hygiene is thought to be an important risk factor for trachoma, the World Health Organization recommends non-antibiotic hygiene improvements for trachoma (e.g., latrines, water supply, and promotion of face washing). However, no randomized clinical trial has ever demonstrated that any of these measures prevent transmission of ocular chlamydia, and no trials have even been conducted in which the entire package of WHO-recommended interventions are implemented together. The current submission attempts to fill that gap, by randomizing communities in Ethiopia to either a package of hygiene interventions, or to standard of care. In the trial, all communities will receive a singe dose of oral azithromycin. Communities randomized to the hygiene package will receive wells, latrines, and education on face washing. Communities randomized to standard of care will receive the current hygiene promotion services provided by the government. The co-primary outcomes of the trial will be improvement in clinical trachoma and the prevalence of ocular chlamydia at 36 months after the baseline visit. Secondary outcomes will include chlamydial load from quantitative PCR and nasopharyngeal pneumococcal macrolide resistance. A cost-effectiveness analysis will be performed to allow trachoma programs to better decide how to use their limited resources.

Public Health Relevance

Trachoma remains the leading infectious cause of blindness worldwide. Trachoma is most common in areas of poverty, with poor hygiene thought to be a contributing factor. However, there have been no clinical trials demonstrating that improvements in public health and hygiene are effective for trachoma. This trial seeks to provide a stronger evidence base to guide decisions on non-antibiotic measures for trachoma control.

National Institute of Health (NIH)
National Eye Institute (NEI)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Special Emphasis Panel (ZEY1)
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Everett, Donald F
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University of California San Francisco
Schools of Medicine
San Francisco
United States
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Aiemjoy, Kristen; Aragie, Solomon; Gebresillasie, Sintayehu et al. (2018) Defining Diarrhea: A Population-Based Validation Study of Caregiver-Reported Stool Consistency in the Amhara Region of Ethiopia. Am J Trop Med Hyg 98:1013-1020
Morberg, Daniel P; Alemayehu, Wondu; Melese, Muluken et al. (2018) A Longitudinal Analysis of Chlamydial Infection and Trachomatous Inflammation Following Mass Azithromycin Distribution. Ophthalmic Epidemiol :1-8
Porco, Travis C; Keenan, Jeremy D; Enanoria, Wayne T A et al. (2016) The permuted locus trial--Well suited for emerging pathogens? Contemp Clin Trials 47:72-3