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.: PACTR201501000892239 Date of Approval: 24/09/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Design and Evaluation of an Intervention to Promote ¿Safe¿ Handwashing in Abidjan, Cote d'Ivoire: a cluster randomized controlled trial
Official scientific title Design and Evaluation of an Intervention to Promote ¿Safe¿ Handwashing in Abidjan, Cote d'Ivoire: a cluster randomized controlled trial
Brief summary describing the background and objectives of the trial Background: Diarrhoeal diseases account for 11% of all death in children younger than 5 years old, and are the second leading cause of death in children under the age of 5, of all infectious diseases. Handwashing with soap (HWWS) is considered as among the most cost-effective methods of preventing diarrhoeal diseases, by interrupting the transmission of pathogens responsible for diarrhoea. A systematic review of the effect of HWWS on diarrhoea suggests that, if practiced, HWWS could reduce the risk of any diarrhoea by 47%. However, HWWS rates around the globe are staggeringly low. In Cote d¿Ivoire, diarrhoeal diseases is the third (infectious disease) leading cause of infant mortality death, and HWWS prevalence is potentially lower than 4%. Traditional interventions built around educating populations on the link between HWWS and disease prevention to increase handwashing practices have been rather ineffective. This could be partly explained by the fact health has been shown not to be a primary motivator of handwashing behaviour. By contrast, social norms around HWWS (e.g. whether individuals in one¿s social environment wash their hands with soap), and the absence of environmental barriers (e.g. the presence of handwashing facilities) have been posited as among the key influencers of handwashing behaviours. Nevertheless, the actual effect of these factors on modifying handwashing practices still remains relatively unknown. Additionally, although an increasing number of developing countries have urban populations exceeding their rural populations, there is a rural bias pertaining to testing in HWWS interventions in urban settings. Aims: This research has, as its primary aims, to design an intervention using social norms theories and evaluate its effectiveness at increasing handwashing with soap (HWWS) after visiting the latrine, and evaluate the effect of handwashing stations alone on HWWS after visiting the latrine.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Diarrheal disease,Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 09/08/2014
Actual trial start date 02/08/2014
Anticipated date of last follow up 30/07/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 randomisation was computed using STATA 13. Due to the nature of the interventions, the allocation sequence was not concealed. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Handwashing promotion and supply of handwashing stations 34 implementations 34 weeks Non-health related handwashing promotion short video clips, posters, Glow germ demonstration, and provision of handwashing stations. 25 Uncontrolled
Experimental Group Handwashing stations only 1 implementation 1 week Handwashing stations supply 25
Control Group No intervetnions n/a n/a no intervention 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Compounds between 9 to 10 households; - with only shared water and sanitation facilities, - and at least four children under the age of 5. - Compounds with structures that do not support structured observations (e.g. L-shaped compounds; very large compounds; compounds with households with individual water and sanitation facilities). - Compounds with predominantly single males as occupiers will also be excluded. 0 Year(s) 99 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 04/12/2013 Comite Consultatif National de Bioethique de Cote d'Ivoire
Ethics Committee Address
Street address City Postal code Country
Abidjan 22 BP 1323 Abidjan Cote Divoire
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 16/12/2013 LSHTM
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E 7HT United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome percentage increase in the proportion of observed handwashing with soap after visiting the toilets - 1 month - 4 months
Secondary Outcome Change in the percentage of handwashing related norms (descriptive, injunctive behavior) Publicness 1 month to 4 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Koumassi commune Koumassi commune Abidjan Cote Divoire
FUNDING SOURCES
Name of source Street address City Postal code Country
Private funds Abidjan Cote Divoire
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor LSHTM, Patricia Henley Keppel Street London London WC1E 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Pr. Simon Cousens Keppel Street London WC1E 7HT United Kingdom
Dr Jim McCambridge Keppel Street London WC1E 7HT United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maud Amon maud.amon@lshtm.ac.uk 00 225 0130 6565 Cocody
City Postal code Country Position/Affiliation
Abidjan 01BP1609 Cote Divoire PHD Student
Role Name Email Phone Street address
Public Enquiries Maud Amon maud.amon@lshtm.ac.uk 00 225 0130 6565 Cocody
City Postal code Country Position/Affiliation
Abidjan Cote Divoire PHD Student
Role Name Email Phone Street address
Scientific Enquiries Maud Amon maud.amon@lshtm.ac.uk 00 225 0130 6565 Cocody
City Postal code Country Position/Affiliation
Abidjan Cote Divoire PHD Student
REPORTING
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