Diarrhea Clinical Trial
Official title:
A Stepped Wedge, Cluster-randomized Impact Evaluation of a Household UV-treatment and Safe Storage Drinking Water Intervention in Rural Baja California Sur, Mexico
Fundacion Cantaro Azul (FCA) is a non-profit organization in Baja California Sur, Mexico
(BCS). Since 2006 FCA has piloted a safe drinking-water program in rural regions of BCS. The
premise of their safe drinking-water programs has been the installation of household
drinking-water disinfection systems which utilize an ultra-violet technology (UV) developed
at the University of California, Berkeley. While the systems have been tested for safety and
effectiveness at inactivating waterborne pathogens, FCA is interested in rigorously
evaluating the impact of their safe drinking-water program at the population level. FCA is
looking to expand their safe-water program during 2009 and 2010 to newly identified
communities that lack safe-drinking water. In order to evaluate the community level
effectiveness of their program FCA has agreed to randomize the timing of this expansion
which will allow the lead investigators and key personal in this protocol to conduct a
meaningful, scientific evaluation of the impact of their program through a randomized
stepped wedge design.
The research described in this protocol has four (4) primary objectives:
1. To evaluate the impact the implementation of the safe drinking-water programs has on
rates of gastrointestinal events in rural BCS communities;
2. To evaluate the impact of the safe drinking-water programs on concentrations of fecal
contamination in household drinking-water in rural BCS communities;
3. To evaluate other-health and non-water impacts on communities where the safe-water
programs are implemented, including school and work absenteeism, and health care costs;
4. To identify household, program and system design characteristics that affect user
compliance with the disinfection strategies.
The investigators hypothesize that households that receive an UV based drinking-water
disinfection system through the safe-water program will have reduced prevalence of
gastrointestinal illness, and reductions in fecal contamination of household drinking-water,
measured as concentrations of Escherichia Coli per 100 ml of water. Similarly, the
investigators hypothesize that these communities will also have reduced health care costs,
and school and work absenteeism due to the implementation of the safe drinking-water
programs. The investigators further hypothesize that household level characteristics and
specific program characteristics will differentially impact user compliance, measured as the
sustained use of the systems over the course of the study. In order to evaluate the last
hypothesis (Objective 4) two program variations will be rolled out to inform future
programmatic decisions. A priori the investigators do not anticipate that these program
variations will impact population measures for Objectives 1 and 2, but the investigators
will explore these assumptions during analysis.
Status | Completed |
Enrollment | 1731 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: Communities: 1. are within the La Paz and Los Cabos counties of Baja California Sur, Mexico; 2. lack access to centrally treated drinking water distribution; 3. access drinking water sources (i.e. wells and springs) year round for household purposes Exclusion Criteria: Community source water: 1. contains levels arsenic that are below Mexican limits; 2. has taste characteristics (e.g. salinity) that are acceptable for drinking among community members. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Mexico | Fundacion Cantaro Azul | La Paz | BCS |
Lead Sponsor | Collaborator |
---|---|
University of California, Berkeley | Fundacion Cantaro Azul |
Mexico,
Brownell SA, Chakrabarti AR, Kaser FM, Connelly LG, Peletz RL, Reygadas F, Lang MJ, Kammen DM, Nelson KL. Assessment of a low-cost, point-of-use, ultraviolet water disinfection technology. J Water Health. 2008 Mar;6(1):53-65. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Household Microbial Drinking Water Quality | We measure household drinking water quality using Escherichia Coli concentrations measured through standard techniques. Each household is visited a maximum of 7 times over 15 months. Water is collected from household drinking water storage containers by a household respondent as though they were going to take a drink, and a 100 ml sample is taken and processed. We use multiple definitions of water contamination risk based World Health Organization classifications (>1 E.coli (low), >10 E.coli (medium), >100 E.coli (high) | 15 months | No |
Primary | Diarrhea | We measure the 7-day prevalence of diarrhea symptoms (3 or more loose/watery stools in a 24 hour period, or one with blood or mucus) through household interviews. Each household is visited a maximum of 7 times (every 2 months) over the 15 month study period for a total possible of 49 days of recall. | 15 months | No |
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