Water Uptake for Health in Amhara Pilot (WUHA)

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.

Study Overview

• Status: Completed
• Conditions: Trachoma
• Intervention / Treatment: Behavioral: instruction in soap-making and hygiene education

• Study Type: Interventional
• Enrollment (Actual): 4068
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ethiopia
  • Addis Ababa, Ethiopia
    • The Carter Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Jeremy D Keenan, MD, MPH, F.I. Proctor Foundation, University of California San Francisco

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (ACTUAL): May 1, 2017
• Study Completion (ACTUAL): May 1, 2017

Study Registration Dates

• First Submitted: February 23, 2015
• First Submitted That Met QC Criteria: February 26, 2015
• First Posted (ESTIMATE): February 27, 2015

Study Record Updates

• Last Update Posted (ACTUAL): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: water; soil transmitted helminths; trachoma; hand washing
• Additional Relevant MeSH Terms: Infections; Eye Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Conjunctivitis; Conjunctival Diseases; Corneal Diseases; Chlamydiaceae Infections; Eye Infections, Bacterial; Eye Infections; Chlamydia Infections; Conjunctivitis, Bacterial; Trachoma
• Other Study ID Numbers: 10-02169-B