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.: PACTR202401489970145 Date of Approval: 23/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Determinants of Diarrhea among Under Five Children and Intervention Using Solar Water Disinfection in Communities of Gambella along the Baro River, Southwestern Ethiopia.
Official scientific title Solar Water Disinfection to Preventing Under Five Children Diarrhea in Communities of Gambella along the Baro River, Western Ethiopia.
Brief summary describing the background and objectives of the trial Introduction: The quality of drinking water is a powerful environmental determinant of health and continues to be the foundation for the prevention and control of waterborne diseases. The majority of population in developing countries has no access to clean water and any form of sanitation services. Consequently, sub-Saharan Africa remains the region with the largest disease burden from inadequate WASH. Studies in different parts of Ethiopia found that water related diseases specially the prevalence of diarrhea in the community reported high in different regions. In addition to this in Gambella region repeated diarrheal diseases outbreaks including acute watery diarrhoea were recorded at different times along the Baro River. Now a days, solar water disinfection (SODIS) is a very simple and new water treatment to be applied at household (HH) level with a great potential to reduce diarrhoea incidence of users. Objective: The general objective of this study is to assess the status of Baro River pollution, identify determinants of childhood diarrhea, examining the efficiency of SODIS and evaluate the effectiveness of SODIS intervention among under five children. Methods: Mixed methods of a laboratory based experimental study, cross-sectional survey, cluster randomized controlled trial (CRCT) and case study design will be used. The study will be conducted to assess the status of Baro River pollution through water quality analysis and to identify potential determinant factors of diarrhoea for under five children. As an intervention, examining the efficiency of SODIS on different water sources and evaluate its effectiveness on reducing diarrhea among under five children in the up and downstream areas of Gambella town along the Baro River catchments in Gambella region will also be another area of concern. Four kebeles and 1168 HHs will be selected randomly for cross-sectional survey while a total of 14 clusters with 462 children will be selected for CRCT.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/01/2023
Actual trial start date 01/04/2023
Anticipated date of last follow up 24/08/2023
Actual Last follow-up date 31/08/2023
Anticipated target sample size (number of participants) 462
Actual target sample size (number of participants) 462
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Solar Water Disinfection daily from April to July2023 Solar water disinfection (SODIS) where raw water is filled into polyethylene terephthalate (PET) bottles is one of the potential alternative HWT technologies that relies on the germicidal effects of sunlight and heat. 231
Control Group health education weekly 4 months As the name indicates a control group is a group which receives no treatment or intervention during actual trial period, instead the group receives the SODIS intervention after accomplishing the community trial. Health education indicates a type of intervention based on the need of the control group during data collection to assess whether the child have diarrhea or not every week within the time frame. Furthermore, your format obliged to mention some sort of an intervention for control group. 231 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Households having at least one child aged six months to less than five years of age and lived in the study area for six months prior to data collection will be included in the study. . Households with mothers/caregivers who will be severely ill and unable to respond to the questionnaire, households having under-five children with persistent diarrhea during data collection time will be excluded from the study. In SODIS trial, children under six months of age will be excluded due to the rule of exclusive breast feeding. Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 6 Month(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 11/10/2022 Addis Ababa University Ethiopian Institute of Water Resources institutional review committee
Ethics Committee Address
Street address City Postal code Country
Addis Ababa University Addis Ababa 150461 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome reduction of diarrhea The pre intervention period January to March, the actual or during intervention time from April 01 to July 31, 2023. whereas August and plus a post intervention period.
Secondary Outcome behavior change 1 months, August 2023
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gambella Peoples National Regional State Health Bureau rural villages Gambella Gambella 109 Ethiopia
upsteam and downstream areas of rural Gambella along the baro river Gambella Gambella 109 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
research grant Addis Ababa university Addis Ababa 150461 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Gambella Peoples National Regional State Health Bureau Gambella Gambella 109 Ethiopia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tamru Tadesse tamrutadesse@gmail.com +251911762812 Addis Ababa university
City Postal code Country Position/Affiliation
Addis Ababa 150461 Ethiopia coordinator
Role Name Email Phone Street address
Public Enquiries Ephrem Tefera epesol@gmail.com +251944055445 Haramaya University
City Postal code Country Position/Affiliation
Harar 138 Ethiopia Dr
Role Name Email Phone Street address
Scientific Enquiries argaw anbelu aambelu@yahoo.com +251911826218 Addis Ababa university
City Postal code Country Position/Affiliation
Addis Ababa 150461 Ethiopia professor chairman and also my advisor.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the SODIS trial will be shared. Informed Consent Form,Statistical Analysis Plan The individual participant data of the SODIS trial will be shared immediately following publication or within 12 months of the study completion date. Individual participant data collected during the SODIS trial will be shared to anyone who wishes to access the data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information