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

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ClinicalTrials.gov Identifier: NCT00348478
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : October 28, 2011
World Vision
Information provided by:
Johns Hopkins University

Brief Summary:
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 or disease Intervention/treatment Phase
Trachoma Behavioral: water and health education program to improve hygiene Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Determination of the Impact of Water and Health Education on Trachoma and Ocular C. Trachomatis in Niger
Study Start Date : December 2005
Estimated Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. trachoma
  2. ocular C. trachomatis infection

Secondary Outcome Measures :
  1. under five years mortality

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 65 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348478

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

ClinicalTrials.gov Identifier: NCT00348478     History of Changes
Other Study ID Numbers: NA00001455
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: October 28, 2011
Last Verified: November 2005

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

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