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.: PACTR201711002625297 Date of Approval: 17/09/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Scaling up Solar Water Disinfection (SODIS) and Harvested Rain Water in Uganda
Official scientific title Water Sustainable point of use treatment technologies (WATERSPOUTT)- Uganda
Brief summary describing the background and objectives of the trial In Uganda, a large section of the rural population meets their water needs from surface water such as shallow wells, springs, lakes, streams and boreholes (Rugumayo, 2008). Rain water harvesting (RWH) is currently being promoted by the government as alternative water source. Although rural access to improved water sources has increased from 49.8% in 2000 to the current 64% (MWE, 2012), rapid population growth (3.3%/annum) and environmental degradation threaten to derail the successes recorded. Poverty assessment of Uganda shows that lack of access to clean drinking water is still one of the top ten community priority problems (MoFPED, 2012). In fact 75% of the country¿s disease burden is attributed to poor sanitation and hygiene all of which are related to insufficient safe water access and supply (MoH, 2010). Water borne diseases such as diarrhoea, gastro-intestinal complaints, and other water-related diseases including malaria and skin diseases are reported to be very common in the population, especially in children less than five years (MWE, 2004). 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. It is estimated that such approaches would reduce the world disease burden by 4% (WHO, 2014). Solar water disinfection (SODIS) is one such approach used to provide safe drinking water at household level. Objective of the study The two major objectives of this study are: (i). To develop new prototype solar reactors based on SODIS for disinfection of harvested rainwater. These will provide up to 125 liters/day of treated harvested rainwater of suitable microbiological standards. (ii). To scale up rain water harvesting as an alternative fresh water source in rural Uganda.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
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 01/01/2018
Actual trial start date
Anticipated date of last follow up 31/12/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 1200
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
REC 1400 Research Ethics Committee, Royal College of Surgeons in Ireland
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 Non-randomised Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Prototype Solar Water Disinfection Reactor Pupils in the selected intervention schools will drink disinfected water from the reactor. 12 Months The reactors will be located in two primary schools in the study area. Pupils in these schools have no access to safe drinking water and normally rely on unsafe sources such as open wells and ponds .The reactors installed at the schools will provide sufficient safe water for the pupils. Pupils will also be provided with standard 2-Litre PET bottles to continue with SODIS while at home. 600
Control Group Solar Water Disinfection using standard 2 litre PET bottles Pupils in the selected control schools will drink water treated using the standard SODIS procedure using 2-3 Litre PET bottles for water disinfection. 12 Months Pupils in control schools also rely on unsafe sources for their drinking water needs. They will be provided with four standard 2-3 litre PET for SODIS while at school and home for provision of safe water.This will be the water they will drink throughout the trial. 600 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All pupils in the selected intervention and control schools will be legible to participate in the study as long as they and their parents/caregivers consent. Selection of schools will be done in consultation with community members who will. be end users All pupils in the selected schools will be included as long as there is willingness and consent to participate in the study. There is therefore no exclusion. 6 Year(s) 13 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 25/05/2017 Research Ethics Committee (REC)
Ethics Committee Address
Street address City Postal code Country
121 St. Stephen's Green D2 Dublin 2 Ireland
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 08/08/2017 National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6, Kimera Road, Ntinda Kampala Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Increased access to improved drinking water sources by pupils in both the intervention and control schools through provision of rain water harvesting tanks. January 2018
Primary Outcome Access to safe drinking water by pupils in both the intervention and control schools January 2018
Secondary Outcome Increased community awareness and uptake of SODIS as a household water treatment technology for safe drinking water February 2019
Primary Outcome Reduced incidences of waterborne/related disease and hence reduced absenteeism among the pupils as result of sicknesses related to insufficient and unsafe drinking water February 2019
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nakatete Primary School Nanywa Subcounty Lwengo Uganda
Kabuyoga Primary school Ndagwe Subcounty Lwengo Uganda
Makerere University Department of Food Technology and Nutrition Kampala P.O.Box 7062 Uganda
Arise and Shine Primary School Nanywa Subcounty Lwengo Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
HORIZON 2020 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 D2 Dublin Ireland University
COLLABORATORS
Name Street address City Postal code Country
Makerere University, Kampala School of Food Technology, Nutrition and Bio-engineering Kampala Uganda
Centro de Investigaciones Energeticas, Medioambientales y Tecnologicas- Plataforma Solar de Almería (CIEMAT- PSA) Almería Spain
Rey Juan Carlos University (UJRC) Calle tulipán s/n Mostoles 28933 Spain
Ecosystem Environmental Services (EES) Travesía Turo d¿en Lull, 12 Sant Andreu de Llavaneres Barcelona Spain
Universidad De Santiago De Compostela (USC) Praza do Obradoiro, s/n Santiago de Compostela 15782 Spain
Centro de Investigaciones Energeticas, Medioambientales y Tecnologicas- Plataforma Solar de Almería (CIEMAT- PSA) Carretera Senés s/n Almería 04200 Spain
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kevin McGuigan kmcguigan@rcsi.ie +353 1 4022207 123 St. Stephens Green D2
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 Charles Muyanja ckmuyanja@gmail.com +256 772 577708 Department of Food & Nutrition, Makerere University
City Postal code Country Position/Affiliation
Kampala 7062 Uganda Professor of Food Safety
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information