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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04078633
Other study ID # 17604
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2019
Est. completion date March 31, 2020

Study information

Verified date August 2019
Source London School of Hygiene and Tropical Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Understanding how different types of visual prompts and props could impact handwashing practices in humanitarian emergency settings could allow organisations managing camps to deliver hygiene interventions tailored to populations in humanitarian crises. The study aims to test how liquid soap, bar soap and the use of a mirror could impact handwashing behaviours. As such, this research could lead to participants increased handwashing, which should lead to decreased disease transmission of important infectious diseases. With the compliance of NGOs, and the working relationship that will be formed, the results of the research will be shared directly with them. It is likely they will immediately act on any findings.


Description:

According to UNICEF, respiratory and diarrheal diseases are the first and second leading causes of deaths among children under-five years of age worldwide. Handwashing has the potential to reduce diarrhoeal disease by almost half and respiratory infections by a quarter. Internally Displaced Persons (IDPs) are especially vulnerable to diarrheal and respiratory diseases, mainly due to overcrowding of settlements and camps and lack of access to WASH facilities. Hygiene programmes delivered in humanitarian crises primarily involve distributing hygiene kits and teaching people about disease transmission. These things are important but are commonly insufficient to lead to behaviour change. Research in non-emergency settings has shown that the presence of a convenient and desirable handwashing facility may be the factor most likely to determine whether or not people wash their hands. This is particularly relevant to handwashing promotion in IDP camps where it is typically the responsibility of governments or organisations to provide water, sanitation and hygiene (WASH) facilities. Research in non-emergency settings has also shown that using stories and emotional motivators can be a powerful way of changing behaviour, but to date such approaches have not been tried in emergency settings, where they could potentially have a more substantial impact on disease transmission. Study Aim: To develop and test innovative behaviour change approaches to improve handwashing behaviour among IDPs in Ethiopia. Study objectives: 1. To conduct a cluster randomised pilot study to assess whether the provision of liquid soap makes handwashing more desirable and more likely to be practiced. 2. To conduct a cluster randomised pilot study to assess whether installing mirrors above the handwashing facility makes handwashing more desirable and more likely to be practiced. 3. To conduct a pilot study of the effect of motivational stories on handwashing behaviour. 4. To conduct a pilot study of the effect of educational activities on handwashing behaviour. Methodology: The study will be conducted in IDP settlements in Oromia Region. Zones of the camp will be randomised to either receive one of the interventions or to act as a control. If the intervention is successful, the control arm will receive the intervention also. Households will be informed about the research and provide voluntary consent if they wish to participate. Handwashing behaviour will be assessed through structured observation and socio-demographic information will be collected through a survey. Focus groups will be conducted to understand people's perceptions about the interventions.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date March 31, 2020
Est. primary completion date November 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Internally displaces persons living in humanitarian crises settings Exclusion Criteria: - Host community

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Hand hygiene interventions
Interventions are commonly used physical props for handwashing and commonly used hygiene promotion activities.

Locations

Country Name City State
United Kingdom London School of Hygiene and Tropical Medecine London

Sponsors (2)

Lead Sponsor Collaborator
London School of Hygiene and Tropical Medicine Action Contre la Faim

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Structured observation to measure frequency of handwashing, who is washing their hands and whether soap was used. The primary outcome measure for this study will be observed handwashing at five key critical times (after using the toilet, before preparing food, before eating, before feeding a child and after cleaning a child's faeces). It will also be monitored whether hands are washed with soap or with water only. This will be measured via 3-hour structured observations which is considered to be the gold standard within the sector 4 weeks after implementation
Primary Survey on socio-demographics and hand hygiene behaviours After completing the structured observation, a short survey will be conducted with each household. This will cover family demographics, and information about water, sanitation and hygiene practices. The survey will be administered to the female head of the household. It is estimated that this will take 30 minutes to complete. 4 weeks after implementation
Primary Focus group discussions on drivers and barriers to handwashing in the IDP settlement Focus group discussions will be conducted with recipients in the intervention arms. These will be designed to explore reactions to the interventions and generate reflections on what was liked or disliked about them. The focus group discussions aim to explore what is driving handwashing behaviour, or preventing it in the camps. Two focus group discussions, one with women and one with men, will be conducted in each of the intervention arms. It is estimated that about seven people will participate in each group discussion. Participants will be selected to represent a diverse mix of demographics within the camp and will be individuals that are believed yo contribute most to our learning about hygiene in the local context. The focus group discussions will involve participatory activities using visual prompts or tasks like ranking and scaling. Focus group discussions will be audio recorded. 1 hour per focus group discussion 6 weeks after implementation
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