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Water Uptake for Health in Amhara Pilot (WUHA)

Primary Purpose

Trachoma

Status
Completed
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
instruction in soap-making and hygiene education
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Trachoma focused on measuring trachoma, soil transmitted helminths, water, hand washing

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • The Carter Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

WASH Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Prevalence of ocular chlamydia infection (0-5 year olds)
Nasopharyngeal macrolide resistance (0-5 year olds)
Prevalence of soil transmitted helminths (Ascaris, Trichuris trichiura, and hookworm) (0-5 year olds)

Secondary Outcome Measures

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

Full Information

First Posted
February 23, 2015
Last Updated
June 23, 2021
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02373657
Brief Title
Water Uptake for Health in Amhara Pilot
Acronym
WUHA
Official Title
Water Uptake for Health in Amhara Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trachoma
Keywords
trachoma, soil transmitted helminths, water, hand washing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4068 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WASH Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
instruction in soap-making and hygiene education
Primary Outcome Measure Information:
Title
Prevalence of ocular chlamydia infection (0-5 year olds)
Time Frame
24 months
Title
Nasopharyngeal macrolide resistance (0-5 year olds)
Time Frame
24 months
Title
Prevalence of soil transmitted helminths (Ascaris, Trichuris trichiura, and hookworm) (0-5 year olds)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Childhood growth (weight controlled for height among children aged 0-5 years at baseline)
Time Frame
24 months
Title
Clinically active trachoma in children aged 0-5, as determined by the WHO simplified grading system
Time Frame
24 months
Title
Prevalence of enteric viruses using PCR (0-5 year olds)
Time Frame
24 months
Title
Self report childhood morbidity
Time Frame
24 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy D Keenan, MD, MPH
Organizational Affiliation
F.I. Proctor Foundation, University of California San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Carter Center
City
Addis Ababa
Country
Ethiopia

12. IPD Sharing Statement

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