Evaluation of Safe-Water Programs in Baja California Sur, Mexico

NCT01637389 | Completed

• 1 other identifier: UCB_CPHS_2009-1-47
• Study Type: interventional
• Target: 1,731
• Locations: 1 country
• Sites: 1

Brief 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 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. 1.To evaluate the impact the implementation of the safe drinking-water programs has on rates of gastrointestinal events in rural BCS communities;
2. 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. 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. 4.To identify household, program and system design characteristics that affect user compliance with the disinfection strategies.

Conditions

Diarrhea

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

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.

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.

Other: Enhanced Safe Water Program

Interventions

Basic Safe Water Program OTHER

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.

Basic Safe Water Program

Enhanced Safe Water Program OTHER

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.

Enhanced Safe Water Program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Berkeley: lead
• Fundacion Cantaro Azul: collaborator

Study Sites (1)

Fundacion Cantaro Azul

La Paz, Baja California Sur, Mexico

Location

Related Publications (1)

• 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.

  PMID: 17998607 BACKGROUND

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joshua S Gruber, MPH

  University of California, Berkeley

  STUDY DIRECTOR

• Fermin Reygadas, MA

  University of California, Berkeley

  STUDY DIRECTOR

• John M Colford Jr, MD PHD MPH

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Epidemiology

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 11, 2012
• Study Start: July 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 11, 2012

Record last verified: 2012-07

Locations

ME (1)