Water Uptake for Health in Amhara Pilot

Study Overview
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Brief Summary
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Trachoma is a blinding disease caused by ocular strains of Chlamydia trachomatis. The Carter Center and Proctor Foundation have been jointly conducting trachoma research in the Goncha Siso Enese woreda of Amhara for the past 8 years, through a series of clinical trials. We have found that repeated mass administration of oral azithromycin can greatly reduce the prevalence of trachoma, but mass antibiotics have been unable thus far to eliminate infection. The World Health Organization recommends not only antibiotics for control of trachoma, but an entire SAFE strategy (Surgery for in-turned eyelids, Antibiotics, Facial hygiene promotion, and Environmental improvements such as latrines and water points). Trachoma is more common in villages and households with poor access to water and latrines, so improving the public health infrastructure is thought to be important for limiting transmission of trachoma. However, there is very little evidence to support the efficacy of installing new water points for trachoma. There has been only one previous attempt to study the role of hand dug well installation for trachoma control, and this study, conducted in Niger, found that installing wells was not effective. We now propose a project to improve the public health infrastructure of Goncha Siso Enese woreda by helping with the construction of water points (e.g., hand-dug wells) and providing hygiene education, in order to determine whether improving access to water and hygiene information will be effective for control of trachoma and soil-transmitted helminths.

Official Title
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Water Uptake for Health in Amhara Pilot

Conditions
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Trachoma

Intervention / Treatment
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* Behavioral: instruction in soap-making and hygiene education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All residents residing in the state-teams which are randomly selected for this study. Exclusion Criteria: Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WASH Intervention<br>In these seven communities we built a well in a central location for all state team residents. We plan on providing tippy-taps (water and soap dispensers), instruction in soap-making, and hygiene education to these communities. We will also put fly traps in the communities to see if wells reduce flies. We plan on performing monitoring visits at 12 months and 24 months, in order to assess clinically active trachoma, ocular chlamydia infection, nasopharyngeal macrolide resistance, soil transmitted helminths, and childhood growth (height and weight). We will also perform assessments of the adequacy of the intervention, by conducting household surveys to assess hygiene behavior, access to water and latrines, and fly density. | Behavioral: instruction in soap-making and hygiene education<br> <br> |
| No Intervention: Control<br>In these seven communities, we plan to perform monitoring visits at 12 months and 24 months, in order to assess clinically active trachoma, ocular chlamydia infection, nasopharyngeal macrolide resistance, soil transmitted helminths, and childhood growth (height and weight). We will also perform assessments of the adequacy of the intervention, by conducting household surveys to assess hygiene behavior, access to water and latrines, and fly density. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of ocular chlamydia infection (0-5 year olds) |  | 24 months | 
| Nasopharyngeal macrolide resistance (0-5 year olds) |  | 24 months | 
| Prevalence of soil transmitted helminths (Ascaris, Trichuris trichiura, and hookworm) (0-5 year olds) |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Childhood growth (weight controlled for height among children aged 0-5 years at baseline) |  | 24 months | 
| Clinically active trachoma in children aged 0-5, as determined by the WHO simplified grading system |  | 24 months | 
| Prevalence of enteric viruses using PCR (0-5 year olds) |  | 24 months | 
| Self report childhood morbidity |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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water, trachoma, soil transmitted helminths, hand washing