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Solar Water Disinfection Intervention Trial in Bolivia (SODIS_Bolivia)

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ClinicalTrials.gov Identifier: NCT00731497
Recruitment Status : Completed
First Posted : August 11, 2008
Last Update Posted : December 19, 2017
Sponsor:
Collaborators:
Swiss Tropical & Public Health Institute
Universidad de San Simon
Information provided by:
University of California, Berkeley

Tracking Information
First Submitted Date  ICMJE August 7, 2008
First Posted Date  ICMJE August 11, 2008
Last Update Posted Date December 19, 2017
Study Start Date  ICMJE September 2004
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2008)
Incidence of diarrhea [ Time Frame: weekly ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2008)
  • analysis of stool [ Time Frame: baseline and at diarreal episodes ]
  • water quality [ Time Frame: systematically ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Solar Water Disinfection Intervention Trial in Bolivia
Official Title  ICMJE Solar Water Disinfections: Randomized Intervention Trial
Brief Summary

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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Diarrhea
Intervention  ICMJE Device: Solar Water Disinfection (SODIS)
Intervention group has SODIS implemented at the household level as a way to disinfect drinking water
Other Name: SODIS
Study Arms  ICMJE
  • Active Comparator: 1
    children in households/villages using Solar Water Disinfection (SODIS) method of disinfecting household drinking water
    Intervention: Device: Solar Water Disinfection (SODIS)
  • No Intervention: 2
    children in households/villages where Solar Water Disinfection (SODIS) has not been implemented
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2008)
1163
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2006
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bolivia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00731497
Other Study ID Numbers  ICMJE R01AI50087_Register
R01AI050087 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John M. Colford, Jr., Professor, University of California, Berkeley
Study Sponsor  ICMJE University of California, Berkeley
Collaborators  ICMJE
  • Swiss Tropical & Public Health Institute
  • Universidad de San Simon
Investigators  ICMJE
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
PRS Account University of California, Berkeley
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP