Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201710002676407 Date of Approval: 09/10/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of a 20-Litre Transparent Jerrycan for SODIS in the Tigray Region, Ethiopia
Official scientific title Water Sustainable point of use treatment technologies (WATERSPOUTT)- Ethiopia
Brief summary describing the background and objectives of the trial For the past 20 years SODIS has been promoted to communities without access to safe drinking water on the basis that 2-3L PET bottles are the ideal SODIS container since they are already in use within the community and therefore accessible. Also volumes larger than this were not thought to be effective for pathogen inactivation. However, one of the most frequently cited reasons for cessation of use or prevention of adoption of SODIS is the workload associated with daily management (filling, exposure, subsequent storage and use) of the PET bottles. A solution to this would be to increase the volume of the solar disinfection containers. WATERSPOUTT researchers from Royal College of Surgeons (RCSI), National University of Ireland Maynooth (NUIM) and CIEMAT-PSA have already demonstrated that 20L transparent polycarbonate water dispenser bottles, identical to the water cooler bottles found in many office environments, are just as effective for SODIS purposes as 2L PET plastic bottles (Keogh et al; 2015). Armed with this knowledge, SODIS using these 18-20L dispensers has been introduced into Ugandan Primary schools in Lwengo and Nakasongola districts.The plastic jerrycan is the universally accepted container for water collection and transport throughout Sub-Saharan Africa. At least one, if not more, can be found in most rural households.Standard jerrycans used for water collection are typically made of opaque polycarbonate plastic and cannot be used for SODIS. The main objective of this study will be to design, develop, pilot and bring to market, an innovative large volume (20L) SODIS transparent jerrycan. The design will be made in consultation with the end users for ease of acceptability. The other specific objective will be to scale up SODIS as a household water treatment technology for the prevention of diarrhea and other GI complications related to unsafe drinking water.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TJC
Disease(s) or condition(s) being studied Diarrhea, Gastro-intestinal complaints,,Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/05/2017
Actual trial start date 01/06/2017
Anticipated date of last follow up 20/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 800
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
ERC 0844/2016 Mekelle University Health Research Ethics Review Committee (HRERC)
ERC 0844/2016 Mekelle University Health Research Ethics Review Committee (HRERC)
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off-site Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off-site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Transparent Jerrycan This group will use the Transparent 20 Litre Jerrycan for SODIS treatment of their drinking water at home 12 monhts The participants in this arm of the study rely on unsafe drinking water sources such as open wells, rivers and ponds. They will be provided with transparent Jerrycan for treatment of their water using SODIS. The Jerrycan will have undergone prior evaluations/trials to ascertain suitability for SODIS. The water will be monitored for microbial quality and health impact assessments will be done. 400
Control Group Standard Solar water disinfection PET bottles This group will use the standard 2L transparent PET bottles for SODIS 12 monhts The participants in this arm also rely on unsafe sources such as open wells, rivers and ponds for their drinking water needs. They will be given the standard 2 Litre PET bottles for treatment of drinking water using SODIS technology. Water quality monitoring, acceptability and Health impact assessments will also be done 400 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Use of an unprotected water source for drinking water needs Presence of at least one child below 5 years in the household. willingness to provide consent to participate in the study. None as long as the above inclusion criteria are met. 0 Year(s) 5 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/10/2016 Mekelle University College of Health Sciences, Health Research Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Mekelle University, College of Health Sciences Mekelle P.O.Box 231 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Development and design of transparent Jerry can which can be used to treat at least 20 litres of water using the SODIS method By June 2018
Primary Outcome Reduction of Diarrhea episodes among children under five in the participating households. Monthly from baseline to end-line using diarrhea diaries.
Secondary Outcome Improved microbial quality of drinking water using E. Coli as an indicator. Fortnightly from baseline to end-line through laboratory analysis.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mekelle University College of Health Sciences Mekelle P.O.Box 231 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
EU Horizon2020 Genevestraat Brussels 1,1 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Royal College of Surgeons in Ireland 123 St. Stephen's Green Dublin 2 Ireland University
COLLABORATORS
Name Street address City Postal code Country
Mekelle University College of Health Sciences Mekelle P.O.Box 231 Ethiopia
Centro de Investigaciones Energeticas, Medioambientales y Tecnologicas- Plataforma Solar de Almería (CIEMAT- PSA) Carretera Senés s/n Almeria 04200 Spain
Rey Juan Carlos University (UJRC Calle tulipán s/n Mostoles 28933 Spain
National University of Ireland, Maynooth Co Kildare Maynooth Ireland
Buckinghamshire New University (BNU), Queen Alexandra Rd High Wycombe HP11 2JZ United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kevin McGuigan kmcguigan@rcsi.ie +353 1 4022207 123 St. Stephen's Green
City Postal code Country Position/Affiliation
Dublin 2 Ireland Associate Professor of Medical Physics
Role Name Email Phone Street address
Public Enquiries Fabio Ugolini f.ugolini@innova-eu.net +39 06 40040358 Via Giacomo Peroni, 386
City Postal code Country Position/Affiliation
Rome 00131 Italy
Role Name Email Phone Street address
Scientific Enquiries Tsehay Asmelash Dejene tsehaye.asmelash@mu.edu.et 0914316004 Mekelle University, College of Health Sciences
City Postal code Country Position/Affiliation
Mekelle P.O. Box 231 Ethiopia
REPORTING
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