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Impact of Water and Health Education Programs on Trachoma and Ocular C. Trachomatis in Niger

This study has been completed.
Sponsor:
Collaborators:
World Vision
CONRAD
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00348478
First received: July 3, 2006
Last updated: October 27, 2011
Last verified: November 2005
History of Changes
  Purpose

There are no specific trials addressing the benefit of water provision and health education on prevalence of trachoma and infection with ocular Chlamydia trachomatis over time, despite considerable effort to provide water resources in trachoma endemic areas. Such information is sorely needed, to advance the Global Alliance agenda for the Elimination of Blinding Trachoma. This community-based clinical trial will randomize ten communities in Maradi Niger, half to receive delivery of water and health education services, and half for delivery of services at a later date. We hypothesize that the intervention communities will have lower rates of trachoma and C. trachomatis one and two years after delivery of services compared to communities without such services. This trial will provide, for the first time, solid evidence of the effect of such services on trachoma, as well as the added benefit following antibiotic provision by the Ministry of Health on sustaining reductions in trachoma and infection.


Condition Intervention Phase
Trachoma
 Behavioral: water and health education program to improve hygiene
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Determination of the Impact of Water and Health Education on Trachoma and Ocular C. Trachomatis in Niger

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • trachoma
  • ocular C. trachomatis infection

Secondary Outcome Measures:
  • under five years mortality

Estimated Enrollment: 720
Study Start Date: December 2005
Estimated Study Completion Date: January 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 65 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • villages size between 900-2100 residents as of 1995 census in Kornaka West district of Niger
  • village leadership approval of entry of village in the study
  • sentinel children ages 6 months to 5 years and five months

Exclusion Criteria:

  • village already has health education program for hygiene
  • village within 5 km of a well
  • child already has a sibling in the study population
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00348478

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
World Vision
CONRAD
Investigators
Principal Investigator: Sheila K West Johns Hopkins University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00348478     History of Changes
Other Study ID Numbers: NA00001455
Study First Received: July 3, 2006
Last Updated: October 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
trachoma
chlamydia trachomatis
water
health education
face washing

Additional relevant MeSH terms:
Trachoma
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
 Eye Infections
Infection
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Corneal Diseases

ClinicalTrials.gov processed this record on May 23, 2013