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.: PACTR201710002624161 Date of Approval: 14/09/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title ASSESSING SOLAR WATER DISINFECTION AND CERAMIC WATER FILTRATION IN RURAL HOUSEHOLDS IN CHIKWAWA DISTRICT, SOUTHERN MALAWI
Official scientific title Water sustainable point of use treatment technologies (WATERSPOUTT) Malawi
Brief summary describing the background and objectives of the trial In 2015, 663 million people around the world remained without sustainable access to safe drinking water (JMP, 2015). The majority of these live in rural areas with no realistic hope in the foreseeable future of access to distributed treated water systems. To combat safe water access problems especially in areas where centralized supply is expensive, the WHO advocates for simple and inexpensive approaches to treat and store water safely at the household level. Solar water disinfection (SODIS) is one such approach used to provide safe drinking water at household level. Approved by WHO since 2005, SODIS is a household water treatment technology that uses freely available solar energy to inactivate pathogens in water stored in transparent containers placed in direct sunlight for a period of 2-6 hours or more (Dejung et al., 2007). Although SODIS has been proven to be effective, one of the most important limitations is the small batch volume of standard SODIS treated water (>3L). This often results in heavy workloads for household members to be able to disinfect sufficient volumes of water to meet drinking water needs. As such, one of the main challenges of SODIS for developing countries is to increase in a cheap and viable way the total batch volume of water to cater for standard rural household domestic requirements. This is often compounded by the limited belief that simply placing water in the sun can make water of a dirty appearance safe to consume. The 3 year study will take place in Chikwawa District, as this has some of the worst access to safe drinking water coverage in Malawi (<50%). The study will have 2 main aims: 1. To assess the current water resource issues, governance, gender, and local water conflicts and perceptions and experiences of water interventions in the study area, and 2. To pilot a household water treatment system (HWTS) technology which combines the basic principles of both SODIS and ceramic water filtration
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Diarrhoeal disease,Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 03/07/2017
Actual trial start date
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 750
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
17/05/1823 Malawi National Health Sciences Research Committee
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 randomisation using a randomisation table created by a computer software programme Allocation was determined by the holder of the sequence who is located offsite Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Combined solar ceramic system This arm will use a prototype solar ceramic design for household water treatment 14 months Group are currently using unprotected water source for drinking water. They will be provided with the prototype combined solar-ceramic system which has been tested and approved under controlled conditions. The intervention will measure health impact assessment (centred on diarrhoea disease) , user acceptability and water quality (microbiological) 250
Experimental Group SODIS only These households will use a traditional SODIS treatment in a 20 litre transparent container 14 months This group of households will be provided with a 20 litre transparent container which will be subject to traditional solar water disinfection. The households currently use drinking water from unprotected water sources. The household will be subject to a health impact assessment, user acceptability assessment and water quality testing 250
Control Group Control Not applicable 14 months This group of households collect their drinking water from an unprotected source but will not be provided with any water treatment intervention. The will be monitored for health impact assessment, user challenges and water quality. 250 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Use of unprotected water sources for drinking water. Presence of a pit latrine. Presence of at least one child below 2 years of age in the household. Willingness to provide consent to participate in the study. Collecting drinking water from a safe protected water source No toilet/pit latrine No child under the age of 2 years in the household 0 Year(s) 2 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 11/08/2017 Malawi National Health Sciences Research Committee
Ethics Committee Address
Street address City Postal code Country
Ministry of Health, Box 30377 Lilongwe 3 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome reduction of diarrhoeal disease Baseline Monthly(diary) End point
Secondary Outcome Reduction in E coli and coliforms in drinking water Baseline Quarterly End point
Secondary Outcome Reduce incidence of acute respiratory infections Baseline Monthly End point
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
WASHTED Polytechnic, Chimpembere Highway Blantyre 3 Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
EU Horizon 2020 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Royal College of Surgeons Ireland 123 St. Stephen's Green Dublin 2 Ireland University
COLLABORATORS
Name Street address City Postal code Country
University of Strathclyde Level 5 James Weir Building 75 Montrose Street Glasgow G1 1XJ United Kingdom
University of Malawi - Polytechnic Private Bag 303 Blantyre 3 Malawi
New University of Buckinghamshire United Kingdom
CIEMAT Plataforma Solar de Almería (CIEMAT-PSA) 04200 Tabernas Almeria Spain
Universidad Rey Juan Carlos 28933 Móstoles Madrid Spain
Maynooth University Collegeland Maynooth Ireland
Dublin City University Glasnevin Dublin Ireland
University of Santiago de Compostela 15782 Santiago de Compostela Santiago Spain
New University of Buckinghamshire Queen Alexandra Rd High Wycombe United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kevin McGuigan kmcguigan@rcsi.ie +35301-402-2207 123 St Stephens 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 Tracy Morse tracy.thomson@strath.ac.uk +265 999945779 Box 30376
City Postal code Country Position/Affiliation
Blantyre 3 Malawi
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information