Solar Water Disinfection Intervention Trial in Bolivia (SODIS_Bolivia)

December 15, 2017 updated by: University of California, Berkeley

Solar Water Disinfections: Randomized Intervention Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

1163

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bolivia
      • Cochabamba, Bolivia
        • Universidad de San Simon
      • Totora, Bolivia
        • Water and Stool Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 5 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
children in households/villages using Solar Water Disinfection (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 Names:
  • SODIS
NO_INTERVENTION: 2
children in households/villages where Solar Water Disinfection (SODIS) has not been implemented

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of diarrhea
Time Frame: weekly
weekly

Secondary Outcome Measures

Outcome Measure
Time Frame
analysis of stool
Time Frame: baseline and at diarreal episodes
baseline and at diarreal episodes
water quality
Time Frame: systematically
systematically

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Berkeley

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (ACTUAL)

June 1, 2006

Study Completion (ACTUAL)

June 1, 2006

Study Registration Dates

First Submitted

August 7, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (ESTIMATE)

August 11, 2008

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2017

Last Update Submitted That Met QC Criteria

December 15, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AI50087_Register
  • R01AI050087 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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