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

NCT00348478 | Completed Phase 4

• 1 other identifier: NA00001455
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

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.

Conditions

Trachoma

Keywords

trachoma; chlamydia trachomatis; water; health education; face washing

Outcome Measures

Primary Outcomes (2)

• trachoma

• ocular C. trachomatis infection

Secondary Outcomes (1)

• under five years mortality

Interventions

water and health education program to improve hygiene BEHAVIORAL

Eligibility Criteria

• Age: 6 Months - 65 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• village already has health education program for hygiene
• village within 5 km of a well
• child already has a sibling in the study population

Sponsors & Collaborators

• Johns Hopkins University: lead
• World Vision: collaborator
• CONRAD: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Trachoma; Health Education

Interventions

Water

Condition Hierarchy (Ancestors)

Conjunctivitis, Bacterial; Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Chlamydia Infections; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Corneal Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Sheila K West

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 3, 2006
• First Posted: July 4, 2006
• Study Start: December 1, 2005
• Study Completion: January 1, 2008
• Last Updated: October 28, 2011

Record last verified: 2005-11

Locations

US (1)