Water, sanitation, and hygiene for control of trachoma in Ethiopia (WUHA): a two-arm, parallel-group, cluster-randomised trial.

BACKGROUND: WHO promotes the SAFE strategy for the elimination of trachoma as a public health programme, which promotes surgery for trichiasis (ie, the S component), antibiotics to clear the ocular strains of chlamydia that cause trachoma (the A component), facial cleanliness to prevent transmission of secretions (the F component), and environmental improvements to provide water for washing and sanitation facilities (the E component). However, little evidence is available from randomised trials to support the efficacy of interventions targeting the F and E components of the strategy. We aimed to determine whether an integrated water, sanitation, and hygiene (WASH) intervention prevents the transmission of trachoma. METHODS: The WASH Upgrades for Health in Amhara (WUHA) was a two-arm, parallel-group, cluster-randomised trial in 40 rural communities in Wag Hemra Zone (Amhara Region, Ethiopia) that had been treated with 7 years of annual mass azithromycin distributions. The randomisation unit was the school catchment area. All households within a 1·5 km radius of a potential water point within the catchment area (as determined by the investigators) were eligible for inclusion. Clusters were randomly assigned (at a 1:1 ratio) to receive a WASH intervention either immediately (intervention) or delayed until the conclusion of the trial (control), in the absence of concurrent antibiotic distributions. Given the nature of the intervention, participants and field workers could not be masked, but laboratory personnel were masked to treatment allocation. The WASH intervention consisted of both hygiene infrastructure improvements (namely, construction of a community water point) and hygiene promotion by government, school, and community leaders, which were implemented at the household, school, and community levels. Hygiene promotion focused on two simple messages: to use soap and water to wash your or your child's face, and to always use a latrine for defecation. The primary outcome was the cluster-level prevalence of ocular chlamydia, measured annually using conjunctival swabs in a random sample of children aged 0-5 years from each cluster at 12, 24, and 36 month timepoints. Analyses were done in an intention-to-treat manner. This trial is ongoing and is registered at ClinicalTrials.gov, NCT02754583. FINDINGS: Between Nov 9, 2015, and March 5, 2019, 40 of 44 clusters assessed for eligibility were enrolled and randomly allocated to the trial groups (20 clusters each, with 7636 people from 1751 households in the intervention group and 9821 people from 2211 households in the control group at baseline). At baseline, ocular chlamydia prevalence among children aged 0-5 years was 11% (95% CI 6 to 16) in the WASH group and 11% (5 to 18) in the control group. At month 36, ocular chlamydia prevalence had increased in both groups, to 32% (24 to 41) in the WASH group and 31% (21 to 41) in the control group (risk difference across three annual monitoring visits, after adjustment for prevalence at baseline: 3·7 percentage points; 95% CI -4·9 to 12·4; p=0·40). No adverse events were reported in either group. INTERPRETATION: An integrated WASH intervention addressing the F and E components of the SAFE strategy did not prevent an increase in prevalence of ocular chlamydia following cessation of antibiotics in an area with hyperendemic trachoma. The impact of WASH in the presence of annual mass azithromycin distributions is currently being studied in a follow-up trial of the 40 study clusters. Continued antibiotic distributions will probably be important in areas with persistent trachoma. FUNDING: National Institutes of Health-National Eye Institute. TRANSLATION: For the Amharic translation of the abstract see Supplementary Materials section.

Changing hygiene behaviours: a cluster-randomized trial, Ethiopia.

OBJECTIVE: To determine whether a water, sanitation and hygiene intervention could change hygiene behaviours thought to be important for trachoma control. METHODS: We conducted a cluster-randomized trial in rural Ethiopia from 9 November 2015 to 5 March 2019. We randomized 20 clusters to an intervention consisting of water and sanitation infrastructure and hygiene promotion and 20 clusters to no intervention. All intervention clusters received a primary-school hygiene curriculum, community water point, household wash station, household soap and home visits from hygiene promotion workers. We assessed intervention fidelity through annual household surveys. FINDINGS: Over the 3 years, more wash stations, soap and latrines were seen at households in the intervention clusters than the control clusters: risk difference 47 percentage points (95% confidence interval, CI: 41-53) for wash stations, 18 percentage points (95% CI: 12-24) for soap and 12 percentage points (95% CI: 5-19) for latrines. A greater proportion of people in intervention clusters reported washing their faces with soap (e.g. risk difference 21 percentage points; 95% CI: 15-27 for 0-5 year-old children) and using a latrine (e.g. risk difference 9 percentage points; 95% CI: 2-15 for 6-9 year-old children). Differences between the intervention and control arms were not statistically significant for many indicators until the programme had been implemented for at least a year; they did not decline during later study visits. CONCLUSION: The community- and school-based intervention was associated with improved hygiene access and behaviours, although changes in behaviour were slow and required several years of the intervention.

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

INTRODUCTION: Facial 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 ANALYSIS: Forty 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 DISSEMINATION: Study 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

Objective To investigate vaccine hesitancy leading to underimmunization and a measles outbreak in Rwanda and to develop a conceptual, community-level model of behavioural factors. Methods Local immunization systems in two Rwandan communities (one recently experienced a measles outbreak) were explored using systems thinking, human-centred design and behavioural frameworks. Data were collected between 2018 and 2020 from: discussions with 11 vaccination service providers (i.e. hospital and health centre staff); interviews with 161 children's caregivers at health centres; and nine validation interviews with health centre staff. Factors influencing vaccine hesitancy were categorized using the 3Cs framework: confidence, complacency and convenience. A conceptual model of vaccine hesitancy mechanisms with feedback loops was developed. Findings: A comparison of service providers' and caregivers' perspectives in both rural and peri-urban settings showed that similar factors strengthened vaccine uptake: (i) high trust in vaccines and service providers based on personal relationships with health centre staff; (ii) the connecting role of community health workers; and (iii) a strong sense of community. Factors identified as increasing vaccine hesitancy (e.g. service accessibility and inadequate follow-up) differed between service providers and caregivers and between settings. The conceptual model could be used to explain drivers of the recent measles outbreak and to guide interventions designed to increase vaccine uptake. Conclusion :The application of behavioural frameworks and systems thinking revealed vaccine hesitancy mechanisms in Rwandan communities that demonstrate the interrelationship between immunization services and caregivers' vaccination behaviour. Confidence-building social structures and context-dependent challenges that affect vaccine uptake were also identified.

Objectif Déterminer si une intervention au niveau de l'eau, de l'assainissement et de l'hygiène pourrait avoir une influence sur les comportements en la matière, considérés comme importants dans la lutte contre le trachome. Méthodes Nous avons mené un essai randomisé par grappes dans les régions rurales d'Éthiopie entre le 9 novembre 2015 et le 5 mars 2019. Nous avons réparti aléatoirement 20 échantillons où l'intervention consistait à développer les infrastructures d'assainissement et d'approvisionnement en eau et à promouvoir l'hygiène, et 20 échantillons n'ayant fait l'objet d'aucune intervention. Tous les échantillons du groupe d'intervention ont suivi une formation sur l'hygiène à l'école primaire, disposaient d'un point d'eau communautaire, d'un poste de lavage par ménage, de savon à domicile, et recevaient des visites de la part de travailleurs chargés d'enseigner les bonnes pratiques en matière d'hygiène. Nous avons évalué le niveau d'observance des mesures en effectuant des enquêtes annuelles au sein des foyers. Résultats En l'espace de 3 ans, le nombre de postes de lavage, de savons et de latrines dans les ménages a davantage augmenté dans le groupe d'intervention que dans le groupe de contrôle: la différence de risque s'élevait à 47 points de pourcentage (intervalle de confiance de 95%, IC: 41­53) pour les postes de lavage, à 18 points de pourcentage (IC de 95%: 12­24) pour le savon et à 12 points de pourcentage (IC de 95%: 5­19) pour les latrines. La proportion de gens déclarant se laver le visage au savon était plus grande dans le groupe d'intervention (différence de risque de 21 points de pourcentage; IC de 95%: 15­27 pour les enfants de 0 à 5 ans), tout comme celle mentionnant l'usage de latrines (différence de risque de 9 points de pourcentage; IC de 95%: 2­15 pour les enfants de 6 à 9 ans). Pour de multiples indicateurs, il a fallu attendre minimum un an après l'instauration du programme pour que les variations observées entre les groupes d'intervention et de contrôle deviennent statistiquement significatives; ces variations se sont ensuite maintenues lors des visites ultérieures. Conclusion Intervenir à l'école et au sein de la communauté a permis d'améliorer l'accès à l'hygiène et les comportements en la matière. Néanmoins, cette évolution prend du temps et plusieurs années d'intervention sont nécessaires.