Impact of Water and Health Education Programs on Trachoma and Ocular C. Trachomatis in Niger
|First Received Date ICMJE||July 3, 2006|
|Last Updated Date||October 27, 2011|
|Start Date ICMJE||December 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00348478 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||under five years mortality|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Impact of Water and Health Education Programs on Trachoma and Ocular C. Trachomatis in Niger|
|Official Title ICMJE||Determination of the Impact of Water and Health Education on Trachoma and Ocular C. Trachomatis in Niger|
|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.|
This study has the following objectives:
Population: We are proposing to evaluate trachoma over time in a sample of children age 1-5 years at baseline in villages in Niger where World Vision is planning immediate water and health education services delivery, compared to a sample of children in villages where services will be implemented after two years.
Services: World Vision plans water wells to serve a population of about 300, in villages of about 300-5,000 persons. Thus each village has around 1-17 wells. The goal is to provide water within 500 meters with a wait time of less than 15 minutes. Health education on use of water and hygiene practices is also part of services delivery. A World Vision Area Development Program officer establishes and trains a water and sanitation committee to provide health education for their village. Villages who are randomly selected to be part of these services will be classified as "intervention" villages. In addition, there are other villages where the planning process has just started and wells would not be drilled for over two years. Villages who are randomly selected to be in the group where services will not be available immediately, will be classified as "control" villages.
Overview The design is a three-year longitudinal study of trachoma and infection with ocular Chlamydia trachomatis in a cohort of children age 1-5 at baseline. From a list of villages in Maradi region that are intended to have a water program within the next three years, we will randomly select six villages to be the "intervention" villages and six villages to be the "control" villages. We will aim to include 360 children, randomly selected from the 6 "intervention" villages (one per mother for a total of up to 60 in each village) and 360 children randomly selected from 6 "control" villages. Surveys for trachoma and infection will be carried out at baseline, one, two, and three years from baseline. Details are described below.
Villages The 1995 census of Maradi was the basis for selecting villages in the Kornaka West district of Maradi, Niger, where World Vision is planning their intervention. The villages in the study should be of comparable size (between 900-2,100 [estimated] persons), as village size may be an important predictor of trachoma status at 12 months.
The villages were selected as follows:
This selection process means that World Vision will plan to work first in the six villages designated as "intervention villages", so they have wells and health education programs within the first year. World Vision will not implement water and health education programs in the "control" villages until after two years. The rest of the villages not selected as either intervention or controls can have programs implemented as decided by World Vision to suit their needs with the understanding that wells will not be implemented in villages within 5 KM of control villages until after two years. The reserve villages will be released if not needed as soon as the census is completed.
Once the villages have been selected, a team of trained census-takers will do three things: gather minimal data on the village, minimal data on each compound or "concession", and do a complete census of everyone in the concession. Every concession must have a census to provide an accurate count of the number of persons and number of children age 1-5 years old.
The senior census taker will do the following:
The census takers will be responsible for collecting the concession information and the complete census on every concession/household in the village.
Selection of Sample of Children
Once the census of all concessions is completed, the random sample of up to 60 children age 1 to 5 years and 5 months in each village can be selected. A stratified random sampling strategy will be developed that limits the selection to no more than one children per mother, with preference for 0 to 1 child age 1 to 5 and 5/12 months for a total of 60 per village. This strategy minimizes clustering of children within households, which is possible if a simple random sample is used.
Survey for Trachoma
Baseline surveys for trachoma in the sample of children age 1-5 5/12 years will take place prior to any water or health education intervention.
The surveys will consist of the following steps:
By 6 months into the first year, the water and health education program in the "intervention" villages should be underway, and the well completed. This assures at least 6 months exposure to the intervention before the next survey at one year.
The same sample of children will be surveyed for trachoma at one, two, and three years. No additional children will be added to the sample to replace any who have died or moved away. The procedures for the follow up surveys are exactly the same as for the baseline survey.
Mass Treatment will be provided by the Ministry of health after the Second Year Survey; control villages will receive water and sanitation programs at that time.
The "intervention villages" continue with water and sanitation, and undergo mass treatment after two year survey. The "control villages, where implementation of water and health education are planned for implementation after the second year survey, also receive mass treatment of azithromycin. For the third year, we can compare the prevalence of trachoma after three years of water and health education plus mass treatment, to mass treatment plus shorter exposure to water and health education.
At the same time as the other surveys, the complete census list of all children age five and under will be updated for new children added , and children who were deceased in the previous year. These data will be used to determine the under five mortality for the villages in the previous year. A comparison of under five years mortality for the intervention and control villages will be done at the end of the three year surveys.
Comparison of trachoma and ocular C. trachomatis infection in sentinel children resident in intervention villages compared to sentinel children resident in control villages at one and two years post baseline will be done. A secondary comparison is to determine the under five years mortality at two and three years post baseline in intervention versus control villages.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
|Intervention ICMJE||Behavioral: water and health education program to improve hygiene|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||January 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||6 Months to 65 Months (Child)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00348478|
|Other Study ID Numbers ICMJE||NA00001455|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Johns Hopkins University|
|PRS Account||Johns Hopkins University|
|Verification Date||November 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP