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.: PACTR201703002084166 Date of Approval: 09/03/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluating the Effect of Integration of Hygiene of Weaning Foods with Water and Sanitation on Diarrhoeal Disease in Under Fives (Malawi)
Official scientific title Measure the relative impact of WASH and food hygiene interventions on diarrhoeal disease in children under 5 in Chikwawa District, Southern Malawi
Brief summary describing the background and objectives of the trial The study will develop, implement and evaluate a household-targeted intervention that seeks to improve WASH behaviours alone or in combination with food hygiene behaviours The impact of the interventions will be measured in terms of the incidence of diarrhoea in children under 5, comprehensive microbiological sampling will be used to identify the key organisms and contamination pathways that were affected by the interventions, and observed changes in household practices. Through formative research we will identify the key behavioural, cultural, socio-economic and environmental risk factors, which will then be used to inform the community-based interventions. Objectives: ¿ Identify potential sources and causes of diarrhoeal disease in the sample population of children under 5. (1) Identify specifically, how many and what type of pathogens are present in weaning foods, water source, stored water, mothers hands, food preparation surfaces, and latrine surfaces before and after the intervention so that the impact of the two interventions can be quantified. (2) Identify the key intervention points and target behaviours that can be targeted by either a WASH or a WASH+food hygiene community-based intervention, (3) Develop an intervention based on the quantitative and qualitative formative and baseline results. (4) Test the absolute and relative impact of the 2 different interventions (relative to the control group, and relative to each other) on the incidence of diarrhoea in children under 5. (5) Test the absolute and relative impact of the 2 different interventions (relative to the control group, and relative to each other) on targeted behaviours pertaining to WASH and food hygiene.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Diarrhoea,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/02/2017
Actual trial start date 01/03/2017
Anticipated date of last follow up 31/12/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 1000
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
P.04/16/1935 University of Malawi - College of Medicine Ethics 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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Combined WASH and Hygiene of Weaning Foods Behaviour change intervention 12 months Households will be targeted with specific behaviour change activities targeting critical points identified in formative research 400
Experimental Group Water and Sanitation OR Hygiene of weaning foods only Behaviour change intervention 12 months Treatment arm will receive behaviour change intervention focussed on either WASH or hygiene of weaning foods only as determined by formative research 400
Control Group None None 12 months The control group will receive no intervention but will be followed to record related health incidents over study period 200 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Eligible households will have a child between 3 months to 21 months at enrolment to ensure that children are not neonates and that all children are likely not be eating weaning foods throughout the study period. All eligible households will have a functional latrine (toilet) All eligible households will reside within a 500m of a functioning borehole (protected water source). Household does not have a functional latrine (toilet) Household is over 500m from the nearest functional borehole (protected water source) Household does not have a child aged between 3 and 21 months. 3 Month(s) 21 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 30/06/2016 College of Medicine Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Mahatma Ghandi Road Blantyre 3 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of diarrhoea disease End point of intervention (December 2018)
Secondary Outcome Reduced concentration of pathogens in weaning foods End point (December 2018)
Secondary Outcome Reduced concentration of pathogens on caregiver hands End point (December 2018)
Secondary Outcome Reduced concentration of pathogens on food contact surfaces End point (December 2018)
Secondary Outcome Reduced concentration of pathogens on target child hands End point (December 2018)
Secondary Outcome Reduced incidence of trachoma End point (December 2018)
Secondary Outcome Reduce incidence of acute respiratory infections End point (December 2018)
Secondary Outcome Reduction in soil transmitted helminths in target children End point (STH)
Secondary Outcome Observed change in hygiene related behaviours End point (December 2018)
Secondary Outcome Reduction of E coli in drinking water at household level End point (December 2018)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Malawi - Polytechnic Chipembere Highway Blantyre 3 Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
Sanitation and Hygiene Applied Research for Equity Keppel Street London WC1E 7HT United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor SHARE - London School of Hygiene and Tropical Medicine Keppel Street London WC1E 7HT United Kingdom University
Secondary Sponsor Malawi Epidemiology and Intervention Research Unit Community Health Sciences Unit, PO box 148 Lilongwe Malawi University
Secondary Sponsor University of Malawi - The Polytechnic Chipembere Highway Blantyre 3 Malawi University
Secondary Sponsor University of Strathclyde 75 Montrose Street Glasgow G1 1XJ United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
University of Malawi - College of Medicine Mahatma Ghandi Road Blantyre Malawi
Ministry of Health - Preentive Health Services Capital Hill Lilongwe Malawi
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tracy Morse tracy.thomson@strath.ac.uk +265 999945 779 PO Box 30376, Chichiri
City Postal code Country Position/Affiliation
Blantyre 3 Malawi Research Fellow
Role Name Email Phone Street address
Public Enquiries Temwa Msiska washtedshare@gmail.com +265 1870411 Malawi Polytechnic, Chipembere Highway
City Postal code Country Position/Affiliation
Blantyre 3 Malawi Research Manager
Role Name Email Phone Street address
Scientific Enquiries Sandy Cairncross Sandy.Cairncross@lshtm.ac.uk +44 (0) 207 927 2211 Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Research Director for SHARE
REPORTING
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