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CTRI Number  CTRI/2017/09/009640 [Registered on: 05/09/2017] Trial Registered Retrospectively
Last Modified On: 04/09/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Cluster Randomized Trial 
Public Title of Study   SODIS Water Treatment Intervention to reduce childhood diarrhea:A Clustered Randomized Controlled Trial in Northwest Ethiopia 
Scientific Title of Study   Household water treatment by solar disinfection as a method of diarrhoeal disease prevention among under five children in Dabat district, northwest Ethiopia  
Trial Acronym  SODIS-HWT  
Secondary IDs if Any  
Secondary ID  Identifier 
N/A  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bikes Destaw Bitew 
Designation  Assistant professor  
Affiliation  University of Gondar 
Address  University of Gondar, College of Medicine and Health Sciences, Institute of Public Health, Ethiopia
Azezo


196
Other 
Phone  918785876  
Fax    
Email  bikesdestaw2004@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Gashaw Andargie Biks 
Designation  Associate Professor 
Affiliation  University of Gondar 
Address  Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Ethiopia
Gondar


196
Other 
Phone  913385423  
Fax  581116221  
Email  gashawab@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Yigzaw Kebede Gete 
Designation  Professor 
Affiliation  University of Gondar 
Address  Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Ethiopia
Gondar


196
Other 
Phone  911522831  
Fax  581116221  
Email  gkyigzaw@yahoo.com  
 
Source of Monetary or Material Support  
University of Gondar, Vice president for Research and community service. Email:kasuamare@gmail.com Phone:581141236 P.O.Box:196 Gondar, Ethiopia  
 
Primary Sponsor  
Name  University of Gondar  
Address  Gondar, Ethiopia  
Type of Sponsor  Other [Government University ] 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     Ethiopia  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Takele Tadesse Adafirie  Dabat DHSS site, in 28Villages, Dabat district, Northwest Ethiopia  Dabat research Center, Dabat District, North Gondar Administrative Zone, Amhara Administrative Regional Sate, Northwest Ethiopia P.O.Box. 196

 
920256715

takeletadesse1627@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Review Board of University of Gondar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  at the base line they were healthy. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group: Non SODIS water treatment user  Households with under five children in the 14 clusters(Villages) enrolled for non SODIS user for drinking water treatment for consecutive 6months.  
Intervention  SODIS water treatment intervention   Households with under five children in the 14 clusters(Villages) enrolled for household water treatment intervention group for consecutive 6months.  
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  59.00 Month(s)
Gender  Both 
Details  Inclusion criteria:(i) geographical accessibility of a cluster area throughout the year; (ii) the average size of cluster was 28-30 children under five years; (iii) reliance only on untreated drinking water sources and (iv) no other special water quality management intervention  
 
ExclusionCriteria 
Details  Exclusion criteria of Participants:
Children less than 6 months of age, and children who were received special diarrhea prevention/control programs in the study area.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Childhood diarrhoea incidence   Data assessed biweekly bases:
week1:24/01/2016
week2:08/02/2016
week3:23/02/2016
week4:09/03/2016
week5:24/03/2016
week6:08/04/2016
week7:23/04/2016
week8:08/05/2016
Week9:23/05/2016
week10:07/06/2016
week11:22/06/2016
week12:07/07/2016  
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable   Not applicable 
 
Target Sample Size   Total Sample Size="797"
Sample Size from India="0" 
Final Enrollment numbers achieved (Total)= "766"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  10/01/2016 
Date of Study Completion (Global) 07/07/2016 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   du Preez M, Conroy RM, Ligondo S, Hennessy J, Elmore-Meegan M, Soita A, McGuigan KG: Randomized intervention study of solar disinfection of drinking water in the prevention of dysentery in Kenyan children aged under 5 years. Environmental science & technology 2011, 45(21):9315-9323. McGuigan KG, Samaiyar P, du Preez M, Conroy RM: High compliance randomized controlled field trial of solar disinfection of drinking water and its impact on childhood diarrhea in rural Cambodia. Environmental science & technology 2011, 45(18):7862-7867. Mausezahl D, Christen A, Pacheco GD, Tellez FA, Iriarte M, Zapata ME, Cevallos M, Hattendorf J, Cattaneo MD, Arnold B: Solar drinking water disinfection (SODIS) to reduce childhood diarrhoea in rural Bolivia: a cluster-randomized, controlled trial. PLoS medicine 2009, 6(8):882.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The magnitude of diarrhoeal disease is high in developing countries where an estimated 801,000 children under five die due to diarrhea each year. Consumption of water from unimproved sources is a potential contributor of diarrhoeal diseases and their transmission. In sub-Saharan Africa, safe water coverage is less than 50% where about 319 million people lack access to improved water sources and an estimated 1.9 billion people rely on faecally contaminated drinking-water.

 In Ethiopia, nearly 40 million people, most of them in rural areas, didn’t have access to safe drinking water. Even water safe at the source can be easily contaminated during collection, transport, and storage. However; more than 90% of households do not treat their drinking water at home.  Such a situation would pose high public health risks of diarrhea to unsafe water users unless prompt intervention is implemented. Evidences revealed in different parts of Ethiopia indicated that the two-week period prevalence of diarrhea among under-five children ranged from 22.5 to 30.5%. 

   Installation of large scale water treatment plants in rural Ethiopia is difficult due to the scarcity of resources including poor infrastructure Therefore, the situation demands implementation of alternative strategies such as easily applicable low-cost and environmental friendly household water treatment such as solar water disinfection (SODIS). Solar water disinfection (SODIS) where raw water is filled in polyethylene terephthalate (PET) bottles is one of the potential alternative household water treatment technologies that rely on the germicidal effects of sunlight and heat. However, SODIS is still largely unknown as a method of household water treatment technology in rural Ethiopia. So, evidence based health effect of SODIS intervention at household level is limited.  The main purpose of this study is to examine the   effect of SODIS intervention in reducing the burden of diarrhoeal disease among under-five children in rural community of northwest Ethiopia. 

 A community based clustered randomized controlled trial was conducted among children under five years of age in each community from January 10 to July 7, 2016. The SODIS intervention was designed according to the Swiss Federal Institute for Environmental Science and Technology (EWAG) published guideline.  Initially, the study area was divided into two blocks (“block A” and “block B”) with an adequate buffering zone between them.   Potential clusters in the study area were exhaustively listed and sorted out the eligible clusters based on the preset selection criteria within the two blocks.  Intervention and control blocks/arms were randomly assigned through lottery systems. Clusters were also selected in each block based on lottery methods. In the eligible 28 clusters (villages), households with under-five children were randomly allocated to the intervention and control groups and then assigned within each of the 14 pairs of communities randomly to one of them. In each cluster, 28-30 children (778 in total) were enrolled within 568 households and followed up for 6 consecutive months.   Nineteen data collectors with 6 supervisors approached the mother-child pairs in the selected households and completed the baseline survey with regard to socio-demographic, environmental, and   behavioral characteristics of each household in the community and follow up study.

The primary outcome of the study is childhood diarrhea   which is defined by WHO as “three or more loose or watery stools over the past 24 hours (or more frequently than it is normal for the individual).    It was computed as the number of under five children (U5C) who are new cases of a diarrhoeal disease over a six months of follow up period divided into person-weeks observation at risk during the similar period of time.  Data were collected biweekly bases.     

This research is operated under the aegis of Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Ethiopia.

  Clinical trial protocol registry system is not available in Ethiopia.  
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