Water Uptake for Health in Amhara Pilot

Trachoma Clinical Trial

— WUHA  

Official title:

Water Uptake for Health in Amhara Pilot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373657
• Other study ID #: 10-02169-B
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: May 2017

Study information

• Verified date: June 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4068
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Trachoma

Intervention

Behavioral:
• instruction in soap-making and hygiene education

Locations

Country	Name	City	State
Ethiopia	The Carter Center	Addis Ababa

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of ocular chlamydia infection (0-5 year olds)		24 months
Primary	Nasopharyngeal macrolide resistance (0-5 year olds)		24 months
Primary	Prevalence of soil transmitted helminths (Ascaris, Trichuris trichiura, and hookworm) (0-5 year olds)		24 months
Secondary	Childhood growth (weight controlled for height among children aged 0-5 years at baseline)		24 months
Secondary	Clinically active trachoma in children aged 0-5, as determined by the WHO simplified grading system		24 months
Secondary	Prevalence of enteric viruses using PCR (0-5 year olds)		24 months
Secondary	Self report childhood morbidity		24 months