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DiarrheaPhase 3SODIS_BoliviaNCT00731497

Solar Water Disinfection Intervention Trial in Bolivia

A Phase 3 study testing Solar Water Disinfection (SODIS) in people with Diarrhea, run by University of California, Berkeley at 2 sites in Bolivia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 months to 5 yearsHealthy volunteers can take part
Conditions the study is for
Diarrhea
What is being tested?
Solar Water Disinfection (SODIS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,163 participants
Where
2 sitesBolivia
Study dates
Sep 2004to Jun 2006
Phase
Phase 3
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 6 months to 5 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Consent of Community Leadership
  • Permanent residence in village
  • Consent of both parents and all other adult household members
  • Age 6 months to 5 years

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

Bolivia2 sites
  • Universidad de San Simon

    Cochabamba

  • Water and Stool Lab

    Totora

Other trials in Bolivia

About this study

Official title: 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.
Read the 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.

Conditions
Diarrhea
Being tested
Solar Water Disinfection (SODIS)
Keywords
SODIS, Drinking Water, Disinfection, Intervention Trial
Medical subject headings
Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Solar Water Disinfection (SODIS)Device

    Also called SODIS

    Intervention group has SODIS implemented at the household level as a way to disinfect drinking water

Study groups in NCT00731497
Study groupRoleWhat they receive
1Active comparatorchildren in households/villages using Solar Water Disinfection (SODIS) method of disinfecting household drinking water
Receives: Device: Solar Water Disinfection (SODIS)
2No interventionchildren in households/villages where Solar Water Disinfection (SODIS) has not been implemented

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of diarrhea

    Measured: weekly

Secondary outcomes (2)
  1. analysis of stool

    Measured: baseline and at diarreal episodes

  2. water quality

    Measured: systematically

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2008 (estimated)
  2. Study startSep 2004
  3. Primary completionJun 2006
  4. Study completionJun 2006

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00731497
Sponsor's protocol ID
R01AI50087_Register
Other IDs
R01AI050087
Acronym
SODIS_Bolivia
Status last verified
Dec 2017
First submitted
7 Aug 2008
Last updated
19 Dec 2017
Results posted
No
Data monitoring committee
No

Publications

  • Christen A, Duran Pacheco G, Hattendorf J, Arnold BF, Cevallos M, Indergand S, Colford JM, Mausezahl D. Factors associated with compliance among users of solar water disinfection in rural Bolivia. BMC Public Health. 2011 Apr 4;11:210. doi: 10.1186/1471-2458-11-210.

    PubMed 21463508
  • Mausezahl D, Christen A, Pacheco GD, Tellez FA, Iriarte M, Zapata ME, Cevallos M, Hattendorf J, Cattaneo MD, Arnold B, Smith TA, Colford JM Jr. Solar drinking water disinfection (SODIS) to reduce childhood diarrhoea in rural Bolivia: a cluster-randomized, controlled trial. PLoS Med. 2009 Aug;6(8):e1000125. doi: 10.1371/journal.pmed.1000125. Epub 2009 Aug 18.

    PubMed 19688036

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Solar Water Disinfection (SODIS) in people with Diarrhea, run by University of California, Berkeley at 2 sites in Bolivia.

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 0 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 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Bolivia. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Incidence of diarrhea (time frame: weekly). 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 NCT00731497, which also lists 2 linked publications.

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 19 Dec 2017.

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