Evaluation of Safe-Water Programs in Baja California Sur, Mexico
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|ClinicalTrials.gov Identifier: NCT01637389|
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : July 11, 2012
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:
- To evaluate the impact the implementation of the safe drinking-water programs has on rates of gastrointestinal events in rural BCS communities;
- To evaluate the impact of the safe drinking-water programs on concentrations of fecal contamination in household drinking-water in rural BCS communities;
- 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;
- 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.
|Condition or disease||Intervention/treatment|
|Diarrhea||Other: Basic Safe Water Program Other: Enhanced Safe Water Program|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1731 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2009|
|Primary Completion Date :||December 2010|
|Study Completion Date :||December 2010|
No Intervention: Control Arm
All communities (independent units/clusters) start in the control and have no intervention. All control communities cross-over to the intervention in a randomized sequence over the course of 12-15 month study.
Experimental: Basic Safe Water Program
The Basic program represents a variation in the implementation of the overall intervention: a community level safe-water program that is initiated with promotional meetings and followed by the offer to install Mesita Azul disinfection systems at the household level. Communities (independent units/cluster) cross-over from the control group to the intervention group in a randomized stepped-wedge fashion -- within each crossover group of 4 clusters, 2 are randomized to the Basic program.
Other: Basic Safe Water Program
The intervention is community promotional meetings followed by household installations of a UV-based drinking water disinfection system (Mesita Azul). Households can opt-in at the meetings, or when the organization returns for installations in that community (~2 weeks later). Mesita Azul utilizes a 15-watt UV lamp to disinfect water and a closed mouth collection container for safe storage. The system utlizes UV-Tube technology developed as a method to disinfect water in low- and middle-income communities. The Basic Safe Water Program receives: the community meeting; installation of a Mesita Azul; a six month technical guarantee; one safe-storage container; training of one household member in operation and basic maintenance of the technology; training of at least one local resident in repair and system maintenance; and follow up after four to six months of the installation date.
Experimental: Enhanced Safe Water Program
The Enhanced program represents a variation in the implementation of the overall intervention: a community level safe-water program that is initiated with promotional meetings and followed by the offer to install Mesita Azul disinfection systems at the household level. Communities (independent units/cluster) cross-over from the control group to the intervention group in a randomized stepped-wedge fashion -- within each crossover group of 4 clusters, 2 are randomized to the Enhanced program.
Other: Enhanced Safe Water Program
The intervention is community promotional meetings followed by household installations of a UV-based drinking water disinfection system (Mesita Azul). Households can opt-in at the meetings, or when the organization returns for installations in that community (~2 weeks later). Mesita Azul utilizes a 15-watt UV lamp to disinfect water and a closed mouth collection container for safe storage. The system utlizes UV-Tube technology developed as a method to disinfect water in low- and middle-income communities. The Enhanced program complements the Basic version with: a water quality analysis and presentation of results to households at the community meeting; a six-month money back guarantee; the provision of two safe-storage containers to facilitate access to disinfected water at different locations within the household; training of two household members in operation and basic maintenance of the technology; an additional follow up visit about two weeks after the installation date.
- Household Microbial Drinking Water Quality [ Time Frame: 15 months ]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)
- Diarrhea [ Time Frame: 15 months ]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.
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): NCT01637389
|Fundacion Cantaro Azul|
|La Paz, BCS, Mexico|
|Study Director:||Joshua S Gruber, MPH||University of California, Berkeley|
|Study Director:||Fermin Reygadas, MA||University of California, Berkeley|
|Principal Investigator:||John M Colford Jr, MD PHD MPH||University of California, Berkeley|