Solar Water Disinfection Intervention Trial in Bolivia (SODIS_Bolivia)

This study has been completed.
Sponsor:
Collaborators:
Swiss Tropical & Public Health Institute
Universidad de San Simon
Information provided by:
University of California, Berkeley
ClinicalTrials.gov Identifier:
NCT00731497
First received: August 7, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

The importance of waterborne gastrointestinal illness throughout the developing world, the existence of a cheap and effective intervention (SODIS), the concurrent limited dissemination program for SODIS, the need for a controlled evaluation of the effectiveness of SODIS under actual field conditions, and the experience of our tri-national collaborative research team in successfully conducting large scale drinking water intervention and observational studies in both the United States and the developing world encourage us to propose the following randomized controlled trial in which our specific aims are to:

  • Evaluate the hypothesis that SODIS reduces the incidence of gastrointestinal illness in 660 children under the age of five years in rural Bolivia that are randomly selected from 22 villages ;
  • Define, through an extensive microbiologic testing component, the baseline rates of pathogen-specific diarrheal illnesses and the pathogens responsible for the differences in diarrheal illness between active and control groups;
  • Document the actual use and acceptance of SODIS by participants in the study;
  • Assess the cost-effectiveness of SODIS and the social and economic impact of SODIS at household level;
  • Examine through mathematical disease modelling the effects of the presence of multiple transmission pathways within a village on the preventable fraction estimate due to the introduction of SODIS.

Condition Intervention Phase
Diarrhea
Device: Solar Water Disinfection (SODIS)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Solar Water Disinfections: Randomized Intervention Trial

Resource links provided by NLM:


Further study details as provided by University of California, Berkeley:

Primary Outcome Measures:
  • Incidence of diarrhea [ Time Frame: weekly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • analysis of stool [ Time Frame: baseline and at diarreal episodes ] [ Designated as safety issue: No ]
  • water quality [ Time Frame: systematically ] [ Designated as safety issue: No ]

Enrollment: 1163
Study Start Date: September 2004
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
children in households/villages using SODIS method of disinfecting household drinking water
Device: Solar Water Disinfection (SODIS)
Intervention group has SODIS implemented at the household level as a way to disinfect drinking water
Other Name: SODIS
No Intervention: 2
children in households/villages where SODIS has not been implemented
Device: Solar Water Disinfection (SODIS)
Intervention group has SODIS implemented at the household level as a way to disinfect drinking water
Other Name: SODIS

Detailed Description:

More than one third of the population in rural and in peri-urban areas of developing countries has no access to sufficient or clean drinking water free of pathogens. Thus, waterborne gastroenteritis remains a major infrastructural and public health problem particularly, as effective treatment (filtration, chlorination, treatments plants) is often beyond financial means or environmental resources used for water purification (fire-boiling, burning carbon-based fuels) become scarce in those communities. In this context solar disinfection of drinking water is especially appealing using a combination of irradiation by direct sunlight and solar heating to kill the water-borne patho¬gens in contaminated drinking water. To date, the efficacy of the SODIS technology as a home-based, low-cost intervention to provide safe drinking water in low income countries is well established, and a large-scale promotion and dissemination program is under way in seven Latin American countries. The principal objective of this study is to evaluate the effectiveness of home-based solar water disinfection (SODIS) in reducing the burden of gastrointestinal illness in children under 5 years in rural villages participating in a country-wide Bolivian SODIS program. We will conduct a community (cluster)-randomized controlled trial following a cohort of children <5 in each community. Totally, 22 communities will be selected from among those districts designated by the country-program to receive the SODIS intervention. A pair-matched design will be employed where communities are first ranked according to their baseline incidence of diarrheal disease and the intervention then assigned within each of the 11 consecutive pairs of communities randomly to one of them. In each cluster, 30 children (660 in total) will be enrolled and followed up for 12 months. Data on diarrheal illness will be obtained from morbidity diaries kept by mothers and validated through weekly home visits. Stool samples will be collected during the baseline morbidity surveys and at times of a diarrheal episode in a child during follow-up. Water quality monitoring of raw water sources used for drinking water and of water samples after treatment with the SODIS device will be conducted systematically. Mothers of participating children will be interviewed at baseline and during the trial with regard to current water use, behavioral and environmental exposures of their child in the home and within the community. This study will specifically estimate; i.) how much of the efficacy of the SODIS technology established in laboratory experiments and in two tightly control¬led phase-III trials can be retained as effectiveness i.e. under program conditions, ii.) the preventive fraction of all-cause child-diarrhea attributable to SODIS. In addition, pathogen-specific attributable risks of diarrheal illness will be calculated. The project is organised by the University of California, Berkeley, with its substantial experience in water intervention trials in US and it benefits from the tradition of North-South collaboration in public health research of the Swiss Tropical Institute, Basel, Switzerland. It is run jointly with the Universidad Mayor de San Simon which coordinates the Bolivian SODIS program.

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Consent of Community Leadership
  • Permanent residence in village
  • Consent of both parents and all other adult household members
  • Age 6 months to 5 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731497

Locations
Bolivia
Universidad de San Simon
Cochabamba, Bolivia
Water and Stool Lab
Totora, Bolivia
Sponsors and Collaborators
University of California, Berkeley
Swiss Tropical & Public Health Institute
Universidad de San Simon
Investigators
Principal Investigator: John M Colford, M.D., Ph.D. U.C. Berkeley
Principal Investigator: Daniel Mausezahl, Ph.D. Swiss Tropical & Public Health Institute
Study Director: Andri Christen Bolivia
  More Information

No publications provided by University of California, Berkeley

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John M. Colford, Jr., Professor, University of California, Berkeley
ClinicalTrials.gov Identifier: NCT00731497     History of Changes
Other Study ID Numbers: R01AI50087_Register, R01AI50087
Study First Received: August 7, 2008
Last Updated: August 7, 2008
Health Authority: United States: Institutional Review Board
Switzerland: Ethikkommission
Bolivia: Ethics Committee

Keywords provided by University of California, Berkeley:
SODIS
Drinking Water
Disinfection
Intervention Trial

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014