DiarrheaNCT01637389
Evaluation of Safe-Water Programs in Baja California Sur, Mexico
A study testing Basic Safe Water Program and Enhanced Safe Water Program in people with Diarrhea, run by University of California, Berkeley at 1 site in Mexico.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- Basic Safe Water Program and Enhanced Safe Water Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,731 participants
- Where
- 1 siteMexico
- Study dates
- Jul 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Communities:
- are within the La Paz and Los Cabos counties of Baja California Sur, Mexico;
- lack access to centrally treated drinking water distribution;
- access drinking water sources (i.e. wells and springs) year round for household purposes
Who cannot join
- Community source water:
- contains levels arsenic that are below Mexican limits;
- has taste characteristics (e.g. salinity) that are acceptable for drinking among community members.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
Read the detailed description
Twenty-five to thirty communities (400-600 households) have been identified by Fundacion Cantaro Azul (FCA) as communities that are appropriate for their safe water program. These communities were identified based on their sources of water (chemical and taste characteristics) and resource availability (access to electricity and lack of access to piped water). Fundacion Cantaro Azul is planning to expand their safe-drinking water programs to all 600 households in these communities. In order to allow for a meaningful evaluation of the impact of their program the organization has agreed to randomize the timing of implementation of the safe drinking-water program to eligible communities. This will allow independent researchers (the lead investigator and key personal in this protocol) to make household visits during the implementation of the programs and will further allow for a valid evaluation of the programs' impact using a stepped wedge study design. Through the stepped-wedge study design all communities, over a 12-15 month, period will be approached by Fundacion Cantaro Azul for promotional meetings; since no community will have received the intervention they will be acting as their own controls until the time they are approached by the organization. Randomizing the time at which a community is approached reduces bias and allows for meaningful evaluation of differences in outcomes due to the safe drinking-water program. As part of this study design a randomly assigned, predetermined number of rural BCS communities will be approached every two-months for enrollment in the safe water program by Fundacion Cantaro Azul, and thus 'cross-over' from the comparison group to the safe-water group. Within each of these crossover groups half of the clusters will receive a "Basic" program variation, and half will receive an "Enhance" program variation. This process will continue until all consenting households in the 25-30 communities have received a UV disinfection system, and related support through the safe drinking-water program. Field teams, trained and supervised by the lead investigator and key personal listed in this protocol, will conduct independent (from Fundacion Cantaro Azul) household visits to collect data on the outcomes of interest. During household visits structured interviews and water-quality sampling will be used to measure these outcomes (prevalence of gastrointestinal events, concentrations of E.coli in household drinking-water, school and work absenteeism and compliance with the disinfection strategy.) The stepped-wedge design will allow for evaluation of the impacts of the safe drinking-water programs while allowing the relatively small organization to manage the logistics of installing 600 household disinfection systems, in a manner consistent with their mission, commitments to regional governmental collaborators, and fiscal restraints.
- Conditions
- Diarrhea
- Being tested
- Basic Safe Water Program, Enhanced Safe Water Program
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Safe Water ProgramOther
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.
Enhanced Safe Water ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | 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. |
| Basic Safe Water Program | Experimental | 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. Receives: Other: Basic Safe Water Program |
| Enhanced Safe Water Program | Experimental | 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. Receives: Other: Enhanced Safe Water Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 15 months
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.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJul 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,731 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion Cantaro Azul
- Responsible party
- Principal investigator, John M. Colford, Jr., University of California, Berkeley
- Investigators
- Joshua S Gruber, MPH, Study director, University of California, BerkeleyFermin Reygadas, MA, Study director, University of California, BerkeleyJohn M Colford Jr, MD PHD MPH, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637389
- Sponsor's protocol ID
- UCB_CPHS_2009-1-47
- Status last verified
- Jul 2012
- First submitted
- 6 Jul 2012
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.2166/wh.2007.015.
PubMed 17998607
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01637389
- Acronym / sponsor ID
- UCB_CPHS_2009-1-47
- Conditions
- Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,731 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- Fundacion Cantaro Azul
- Study start
- Jul 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Twenty-five to thirty communities (400-600 households) have been identified by Fundacion Cantaro Azul (FCA) as communities that are appropriate for their safe water program. These communities were identified based on their sources of water (chemical and taste characteristics) and resource availability (access to electricity and lack of access to piped water). Fundacion Cantaro Azul is planning to expand their safe-drinking water programs to all 600 households in these communities. In order to allow for a meaningful evaluation of the impact of their program the organization has agreed to randomize the timing of implementation of the safe drinking-water program to eligible communities. This will allow independent researchers (the lead investigator and key personal in this protocol) to make household visits during the implementation of the programs and will further allow for a valid evaluation of the programs' impact using a stepped wedge study design. Through the stepped-wedge study design all communities, over a 12-15 month, period will be approached by Fundacion Cantaro Azul for promotional meetings; since no community will have received the intervention they will be acting as their own controls until the time they are approached by the organization. Randomizing the time at which a community is approached reduces bias and allows for meaningful evaluation of differences in outcomes due to the safe drinking-water program. As part of this study design a randomly assigned, predetermined number of rural BCS communities will be approached every two-months for enrollment in the safe water program by Fundacion Cantaro Azul, and thus 'cross-over' from the comparison group to the safe-water group. Within each of these crossover groups half of the clusters will receive a "Basic" program variation, and half will receive an "Enhance" program variation. This process will continue until all consenting households in the 25-30 communities have received a UV disinfection system, and related support through the safe drinking-water program. Field teams, trained and supervised by the lead investigator and key personal listed in this protocol, will conduct independent (from Fundacion Cantaro Azul) household visits to collect data on the outcomes of interest. During household visits structured interviews and water-quality sampling will be used to measure these outcomes (prevalence of gastrointestinal events, concentrations of E.coli in household drinking-water, school and work absenteeism and compliance with the disinfection strategy.) The stepped-wedge design will allow for evaluation of the impacts of the safe drinking-water programs while allowing the relatively small organization to manage the logistics of installing 600 household disinfection systems, in a manner consistent with their mission, commitments to regional governmental collaborators, and fiscal restraints.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –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. |
| Basic Safe Water Program | Experimental | Other: Basic Safe Water ProgramThe 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. |
| Enhanced Safe Water Program | Experimental | Other: Enhanced Safe Water ProgramThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- are within the La Paz and Los Cabos counties of Baja California Sur, Mexico;
- lack access to centrally treated drinking water distribution;
- access drinking water sources (i.e. wells and springs) year round for household purposes
Key exclusion criteria (3 listed)
- contains levels arsenic that are below Mexican limits;
- has taste characteristics (e.g. salinity) that are acceptable for drinking among community members.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic Safe Water ProgramThe 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. | Other | Basic Safe Water Program |
| Enhanced Safe Water ProgramThe 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. | Other | Enhanced Safe Water Program |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2012.
- Background: PubMed 17998607Brownell 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. doi: 10.2166/wh.2007.015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua S Gruber, MPH study director
University of California, Berkeley
Fermin Reygadas, MA study director
University of California, Berkeley
John M Colford Jr, MD PHD MPH principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic Safe Water Program and Enhanced Safe Water Program in people with Diarrhea, run by University of California, Berkeley at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Household Microbial Drinking Water Quality (time frame: 15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01637389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2012.