Clinical trial NCT02373657: Water Uptake for Health in Amhara Pilot
Official title: Water Uptake for Health in Amhara Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trachoma
Keywords: trachoma
soil transmitted helminths
water
hand washing
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 4068
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: Prevalence of ocular chlamydia infection (0-5 year olds)
timeFrame: 24 months
measure: Nasopharyngeal macrolide resistance (0-5 year olds)
timeFrame: 24 months
measure: Prevalence of soil transmitted helminths (Ascaris, Trichuris trichiura, and hookworm) (0-5 year olds)
timeFrame: 24 months
Secondary outcomes:
measure: Childhood growth (weight controlled for height among children aged 0-5 years at baseline)
timeFrame: 24 months
measure: Clinically active trachoma in children aged 0-5, as determined by the WHO simplified grading system
timeFrame: 24 months
measure: Prevalence of enteric viruses using PCR (0-5 year olds)
timeFrame: 24 months
measure: Self report childhood morbidity
timeFrame: 24 months
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: The Carter Center
Study officials:
affiliation: F.I. Proctor Foundation, University of California San Francisco
name: Jeremy D Keenan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: