WUHA: Water Uptake for Health in Amhara Pilot

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT02373657

Collaborator

(none)

4,068

Enrollment

Location

Arms

Duration (Months)

110

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Trachoma	Behavioral: instruction in soap-making and hygiene education	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

4068 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Water Uptake for Health in Amhara Pilot

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

May 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Carter Center	Addis Ababa		Ethiopia

Sponsors and Collaborators

University of California, San Francisco

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT02373657

Other Study ID Numbers:

10-02169-B

First Posted:

Feb 27, 2015

Last Update Posted:

Jun 29, 2021

Last Verified:

Jun 1, 2021

Keywords provided by University of California, San Francisco

trachoma

soil transmitted helminths

water

hand washing

Additional relevant MeSH terms:

Trachoma

Study Results

No Results Posted as of Jun 29, 2021