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.: PACTR201807815961394 Date of Approval: 16/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of improving Microbial Water Quality and Hygiene on reducing diarrhea of under-fives in rural Dire Dawa, Eastern Ethiopia
Official scientific title Effect of single and combined interventions of Point-of-use Water Treatment and Handwashing on diarrhea among under-five children in rural Dire Dawa, Eastern Ethiopia: A cluster randomized controlled trial
Brief summary describing the background and objectives of the trial Background: Worldwide, diarrhea is a serious global public health problem, particularly in low-income and middle-income countries. It is the second leading cause of death in children under five years old, and is responsible for killing around 525,000 children every year mostly results from contaminated food, water sources and poor hygiene. Evidence shows that interventions such as drinking water treatment and handwashing are effective in reducing diarrhea in children under the age of five years. However, there is a major gap in the literatures addressing the effect of single as well as combined interventions of water treatment and handwashing on diarrhea of under-fives with measurements for study participants compliance with the interventions. General Objective: The general objective of this study is to assess effect of single and combined intervention of point-of-use water treatment and handwashing on diarrhea among under-five children in rural Dire Dawa from 17 September 2018 to 7 February 2019. Specific Objectives:  To determine prevalence and determinants of diarrhea among children under the age of five years  To identify the effect of household chlorination in reducing incidence of diarrhea among children under the age of five years  To identify the effect of household handwashing in reducing incidence of diarrhea among children under the age of five years  To compare the effect of combined interventions of household chlorination and handwashing with each single intervention in reducing incidence of diarrhea among children under the age of five years
Type of trial RCT
Acronym (If the trial has an acronym then please provide) AAU EIWR
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Acute Diarrhea
Purpose of the trial Prevention
Anticipated trial start date 17/09/2018
Actual trial start date 11/10/2018
Anticipated date of last follow up 07/02/2019
Actual Last follow-up date 07/02/2019
Anticipated target sample size (number of participants) 1180
Actual target sample size (number of participants) 816
Recruitment status Not yet recruiting
Publication URL Not yet determined
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 from a statistics book 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 A cluster randomized controlled trial No dose at all Four months Those participants assigned to water treatment arm receive one bottle of waterguard once every two month for four months. Intervention providers explain and demonstrate how to treat water using waterGuard. Those participants assigned to handwashing arm receive two bars of soap once every two weeks for four months. Intervention providers will demonstrate proper hand hygiene i.e. wet with water; lather completely with soap, scrub the hands for at least 20 seconds; rinse with water; and dry with clean cloth. Intervention providers assigned to the combined water treatment and handwashing arm will provide WaterGuard and two bars of plain soaps with all the explanations and demonstrations as the above two arms. Those data collectors who are assigned to control arm will provide neither hand hygiene promotion nor water treatment products that can likely to affect diarrhea of under-fives. 612
Control Group A cluster randomized controlled trial No dose at all Four months These are study participants provided with no household water treating product and bars of soaps. Rather they will be left to continue with their customary practice. 204 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Households having one child aged between 6 and 59 months age [Since, infants less than six months of age are on exclusive breast feeding, their defecation might be more than three per day which is not actually diarrhea, but seems diarrhea as per WHO definition. That is why they are excluded]  Households having under-five child who is not suffering from chronic disease  Householders who are voluntary to participate and who will give informed written consent  Householders who allow the data collectors and intervention providers to do regular follow up  Model households who implemented the full health extension packages  Households whose family members are allergic for soap  Under-five child with persistent diarrhea  Either caretaker or household head who are severely ill and unable to respond to the questionnaire Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 6 Month(s) 59 Month(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 14/03/2018 National Research Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Ministry of Science and Technology Addis Ababa 2490 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Study participants randomized to water treatment arm will be given two bottles of waterguard for a total four months (one for each two months) to treat their drinking water continuously for four months and the occurrence and non-occurrence of the health outcome of interest i.e diarrhea will be checked once every two weeks by interviewing the mother or care giver or guardian of the under-five child. Diarrhea is defined as the passage of three or more loose or liquid stool by the child in 24 hours or the passage of single bloody loose stool during the 24 hour period. Study participants randomized to handwashing arm will be given two bars of soap once every two weeks for four months and they will be instructed to wash their hands regularly at five critical times; these are handwashing with soap and water before preparing food, before eating, before feeding a child, after defecation and after contact with child feces. Then the occurrence and non-occurrence of the health outcome of interest i.e diarrhea will be checked once every two weeks by interviewing the mother or care giver or guardian of the under-five child. Diarrhea is defined as the passage of three or more loose or liquid stool by the child in 24 hours or the passage of single bloody loose stool during the 24 hour period. Similarly, study participants randomized to water treatment arm will be given two bottles of waterguard for a total four months (one for each two months) to treat their drinking water continuously for four months. Similarly, those randomized to handwashing arm will be given two bars of soap once every two weeks for four months and they will be instructed to wash their hands regularly at five critical times; these are handwashing with soap and water before preparing food, before eating, before feeding a child, after defecation and after contact with child feces. Then the occurrence and non-occurrence of the health outcome of interest i.e diarrhea will be checked once every two weeks by intervi two weeks
Secondary Outcome Behavioral change of handwashing habit and treatment habit of drinking water using WaterGaurd four months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Rural areas of Dire Dawa city Administration Biyo Awale Kebele, Wahil Kebele, Hula Hulul Kebele, and Bishan Behe Kebeles. Dire Dawa 1377 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Ethiopian Institute of Water Resources Addis Ababa University Akaki Campus Akaki Kality Sub City Addis Ababa 150461 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ethiopian Institute of Water Resources Addis Ababa University Akakai Campus Akaki Kality Sub city Addis Ababa 150461 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ephrem Tefera ephtesol@gmail.com +251913039082 Akaki Campus Akakai Kality sub City
City Postal code Country Position/Affiliation
Addis Ababa 150461 Ethiopia PhD Student
Role Name Email Phone Street address
Scientific Enquiries Bezatu Mengistie bezatum@gmail.com +251911068832 Arategna
City Postal code Country Position/Affiliation
Harar 1570 Ethiopia Major Advisor
Role Name Email Phone Street address
Public Enquiries Sirak Robele sirakr@gmail.com +251947380225 Nifas silk Lafto sub city
City Postal code Country Position/Affiliation
Addis Ababa 150461 Ethiopia Co Advisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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