Water Uptake for Health in Amhara Pilot

NCT02373657 | Completed DMC

• 1 other identifier: 10-02169-B
• Study Type: interventional
• Target: 4,068
• Locations: 1 country
• Sites: 1

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.

Conditions

Trachoma

Keywords

trachoma; soil transmitted helminths; water; hand washing

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Study Arms (2)

WASH Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

instruction in soap-making and hygiene education BEHAVIORAL

WASH Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All residents residing in the state-teams which are randomly selected for this study.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

The Carter Center

Addis Ababa, Ethiopia

Location

MeSH Terms

Conditions

Trachoma

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Conjunctivitis, Bacterial; Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Chlamydia Infections; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Corneal Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Jeremy D Keenan, MD, MPH

  F.I. Proctor Foundation, University of California San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: February 27, 2015
• Study Start: April 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: June 29, 2021

Record last verified: 2021-06

Locations

ET (1)