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Water Uptake for Health in Amhara Pilot (WUHA)

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ClinicalTrials.gov Identifier: NCT02373657
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Jeremy Keenan, Francis I. Proctor Foundation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Trachoma Behavioral: instruction in soap-making and hygiene education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4068 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : April 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: WASH Intervention
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
No Intervention: Control
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.



Primary Outcome Measures :
  1. Prevalence of ocular chlamydia infection (0-5 year olds) [ Time Frame: 24 months ]
  2. Nasopharyngeal macrolide resistance (0-5 year olds) [ Time Frame: 24 months ]
  3. Prevalence of soil transmitted helminths (Ascaris, Trichuris trichiura, and hookworm) (0-5 year olds) [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Childhood growth (weight controlled for height among children aged 0-5 years at baseline) [ Time Frame: 24 months ]
  2. Clinically active trachoma in children aged 0-5, as determined by the WHO simplified grading system [ Time Frame: 24 months ]
  3. Prevalence of enteric viruses using PCR (0-5 year olds) [ Time Frame: 24 months ]
  4. Self report childhood morbidity [ Time Frame: 24 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373657


Locations
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Ethiopia
The Carter Center
Addis Ababa, Ethiopia
Sponsors and Collaborators
Francis I. Proctor Foundation
Investigators
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Principal Investigator: Jeremy D Keenan, MD, MPH F.I. Proctor Foundation, University of California San Francisco
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Responsible Party: Jeremy Keenan, Associate Professor, Francis I. Proctor Foundation
ClinicalTrials.gov Identifier: NCT02373657    
Other Study ID Numbers: 10-02169
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Keywords provided by Jeremy Keenan, Francis I. Proctor Foundation:
trachoma
soil transmitted helminths
water
hand washing
Additional relevant MeSH terms:
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Trachoma
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Infection
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Corneal Diseases