WASH Upgrades for Health in Amhara (WUHA): study protocol for a cluster-randomised trial in Ethiopia

Abstract

IntroductionFacial hygiene promotion and environmental improvements are central components of the global trachoma elimination strategy despite a lack of experimental evidence supporting the effectiveness of water, sanitation and hygiene (WASH) measures for reducing trachoma transmission. The objective of the WUHA (WASH Upgrades for Health in Amhara) trial is to evaluate if a comprehensive water improvement and hygiene education programme reduces the prevalence of ocular chlamydia infection in rural Africa.Methods and analysisForty study clusters, each of which had received at least annual mass azithromycin distributions for the 7 years prior to the start of the study, are randomised in a 1:1 ratio to the WASH intervention arm or a delayed WASH arm. The WASH package includes a community water point, community-based hygiene promotion workers, household wash stations, household WASH education books, household soap distribution and a primary school hygiene curriculum. Educational activities emphasise face-washing and latrine use. Mass antibiotic distributions are not provided during the first 3 years but are provided annually over the final 4 years of the trial. Annual monitoring visits are conducted in each community. The primary outcome is PCR evidence of ocular chlamydia infection among children aged 0–5 years, measured in a separate random sample of children annually over 7 years. A secondary outcome is improvement of the clinical signs of trachoma between the baseline and final study visits as assessed by conjunctival photography. Laboratory workers and photo-graders are masked to treatment allocation.Ethics and disseminationStudy protocols have been approved by human subjects review boards at the University of California, San Francisco, Emory University, the Ethiopian Food and Drug Authority, and the Ethiopian Ministry of Innovation and Technology. A data safety and monitoring committee oversees the trial. Results will be disseminated through peer-reviewed publications and presentations.Trial registration number(http://www.clinicaltrials.gov): NCT02754583; Pre-results.

Changing hygiene behaviours: a cluster-randomized trial, Ethiopia

“…The trial protocol is reported elsewhere. 11 Briefly, 20 clusters were randomized to a comprehensive water, sanitation and hygiene intervention and 20 control clusters were randomized to no intervention (clinicaltrials.gov NCT02754583). The control group will receive the same water, sanitation and hygiene intervention at the end of the trial.…”

“…The water, sanitation and hygiene intervention consisted of improvements in water and sanitation infrastructure and hygiene promotion, implemented in both community-based and school-based settings. 11 We developed the study messaging and materials with input from government officials, school and community leaders, and community members, and organized our hypothesized causal pathway of desired hygiene behaviour changes in a logic model (i.e. a graphic representation of shared relationships).…”

“…We report uptake of a hygiene intervention administered in the WASH Upgrades for Health in Amhara trial, a cluster-randomized trial in rural Ethiopia. 11 A series of focus group discussions held before the trial showed variability in hygiene practices. 12 , 13 Focus group participants reported that a main barrier to face-washing was the high cost of soap and that schoolchildren were key hygiene facilitators since they brought attitudes and perceptions gained in the classroom back home.…”

Predicting future ocular Chlamydia trachomatis infection prevalence using serological, clinical, molecular, and geospatial data

“…This work was designed as a secondary analysis of data from the WASH Upgrades for Health in Amhara (WUHA) community-randomized trial, one of the trials in the Sanitation, Water, and Instruction in Face-Washing for Trachoma (SWIFT) (NCT02754583) series. Details of study methodology and implementation are described in the published protocol (19). WUHA was conducted in the Gazgibella, Sekota Zuria (i.e.…”

“…We also hypothesized that seroprevalence would be a more accurate and stable predictor of Ct infections compared to clinical disease and that communities with high levels of infection would be geographically clustered in stable foci of transmission ("hotspots"). We tested our hypotheses using data from the WASH Upgrades for Health in Amhara (WUHA) randomized controlled trial (NCT02754583) (19).…”