Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00348478 |
| Other study ID # |
NA00001455 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
July 3, 2006 |
| Last updated |
October 27, 2011 |
| Start date |
December 2005 |
| Est. completion date |
January 2008 |
Study information
| Verified date |
November 2005 |
| Source |
Johns Hopkins University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Objectives
This study has the following objectives:
1. To determine the effect on clinical trachoma in a cohort of children from baseline to
one, two, and three years post-intervention with a village-based water and health
education program.
2. To determine the effect on ocular C. trachomatis infection in a cohort of children from
baseline to one, two, and three years post-intervention with a village-based water and
health education program.
3. A secondary outcome is the measure of under five years mortality in intervention
compared to control
Study Design:
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.
Design:
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:
1. A list of all villages with an estimated population between 900 and 2,100 in the
district of Kornaka West was generated. The total number of villages was 18
2. The Area Development Program (ADP) geographic area was stratified so that control
villages would not be within 5 KM of villages where there was a village with a well.
3. Each village was assigned a sequential number from a table of random numbers. The six
villages with the lowest numbers assigned in the "left" strata were selected as the
"intervention" villages, and the six villages with the lowest numbers in the "right"
strata were selected as the "control" villages. Four additional villages with the next
lowest numbers were selected as reserve villages, in case they are needed because a
village refuses to have the survey.
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.
Census
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:
- Explain the study to the village leadership so that they understand what is being asked
of the village residents.
- Explain that children in the survey sample found to have trachoma will be treated with
topical tetracycline during the surveys. However, not every child in every household is
part of the survey and antibiotics are restricted to just these survey children.
However, mass treatment for these communities where everyone is treated is planned by
the government at the end of two years.
- Secure permission of the village leadership to conduct the village survey, concession
survey, and trachoma survey on a sample of children age 1-5 years.
- Collect the village information
- Identify persons in the village who can lead the census team to all concessions in the
village for the information on the concession and the census.
- Supervise the team of census takers to carry out the census of the village.
- Certify that all households/concessions in the village have a census form at the end of
the village census
The census takers will be responsible for collecting the concession information and the
complete census on every concession/household in the village.
- Collect the data on each concession from the chef of the concession, and by
observation, on the "Questionniare Chef du Concession"
- Collect information on everyone in the
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:
1. Prior to the survey in the village, a member of the team will alert the village
leadership that the survey team is coming, which households are in the survey, and to
make sure that the sample children stay in the village for the days of the survey.
2. The day of the survey, the mothers will be asked to bring their sample children to a
survey site close by, for the examination. As they come, consent will be obtained by
the senior trachoma grader, and the name will be checked on the list, and a form and a
single specimen label filled out for the examiner and the laboratory technician.
3. The trachoma grader will be everting the eyelids. He must change gloves between each
child, even children in the same house, and even if the child does not appear to have
trachoma. The trachoma grader, wearing 2.5X loupes, will assess the trachoma status of
the tarsal plate, using the WHO Simplified grading scheme.
4. While the left eyelid is still everted, the laboratory technician, following careful
procedures described in the training manual, will roll the swab three times across the
tarsal plate to obtain a specimen.
5. If the child has TF or TI, the mother is given a tube of tetracycline and instructions
on proper use for that child.
6. At the end of each day in the field, all specimens are transferred to a freezer in
World Vision in Maradi, awaiting return to the freezer in Niamey. During the drive to
Niamey, specimens must be kept frozen as well, with ice packs.
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.
