BehaviorNCT04078633
Innovative Hand Washing Interventions for Internally Displaced Populations in Ethiopia
A study testing Hand hygiene interventions in people with Behavior, run by London School of Hygiene and Tropical Medicine at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Behavior
- What is being tested?
- Hand hygiene interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Sep 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Internally displaces persons living in humanitarian crises settings
Who cannot join
- Host community
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
London School of Hygiene and Tropical Medecine
London, WC1E7HT
About this study
Official title: Pilot Studies of Innovative Hand Washing Interventions for Internally Displaced Populations in Ethiopia
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.
Read the detailed 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:
- 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.
- 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.
- To conduct a pilot study of the effect of motivational stories on handwashing behaviour.
- 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.
- Conditions
- Behavior
- Being tested
- Hand hygiene interventions
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand hygiene interventionsBehavioural
Interventions are commonly used physical props for handwashing and commonly used hygiene promotion activities.
| Study group | Role | What they receive |
|---|---|---|
| Normal Liquid Soap (250mL) | Experimental | A normal hygiene kit will be distributed to the households. In addition, a liquid soap will be added to see the impact of having a liquid soap for hand washing on hygiene behaviors. Receives: Behavioral: Hand hygiene interventions |
| Bar soap (250gram) | Experimental | A normal hygiene kit will be distributed to the households. In addition, a nice bar soap will be added to see the impact of having a nicer bar soap for hand washing on hygiene behaviors. Receives: Behavioral: Hand hygiene interventions |
| Mirror (50x30cm) | Experimental | A normal hygiene kit will be distributed to the households. In addition, a mirror will be added to see the impact of having a mirror by the handwashing stand on handwashing behaviour. The mirror will have a plastic edge and be 30x 50cm in size. Receives: Behavioral: Hand hygiene interventions |
| Control | No intervention | A normal hygiene kit will be distributed to the households. No additional interventions will be given. |
| Nurture story for hygiene promotion | Experimental | Hygiene promoters will share a story of being a good parent through teaching their children to do hand washing with soap at critical times. A story about a good mother who every day reminds her child to wash her/his hands before eating or preparing food and after going to the toilet will be shared with participants. The story ends with the child growing up healthy, happy and with a good education. This story if belived to increae handwashing with soap in the household/ Receives: Behavioral: Hand hygiene interventions |
| Comfort story for hygiene promotion | Experimental | Hygiene promoters will deliver hygiene promotion through an activity that provoke the feeling of comfort by having clean hands. Hygiene promoters will deliver this intervention to up to 5 neighbor households at the time, sharing a story about a family that keeps good hygiene behaviors and therefore are clean, healthy and happy. This story is believed to encourage families to increase handwashing with soap in the household. Receives: Behavioral: Hand hygiene interventions |
| Education session for hygiene promotion | No intervention | Hygiene promoters will deliver regular hygiene promotion activities; an educational message about disease transmission and how handwashing with soap can help protect against disease. This would include teaching participants about the benefits of handwashing with soap, such as reducing diarrhea incidence and preventing cholera. |
| Hygiene Promotion Activity - Disgust | Experimental | The activity will be delivered to a group of maximum 5 neighbouring households at the time. Hygiene promoters will use 5 buckets of clean water and place them in front of households. They will then ask a member of one of the households to rinse their hands in the first bucket. Some dirt will come of their hands. Then the participant rinses their hands again in bucket number 2, then 3 and then 4. Before the 5th bucket the participant receives a bar of soap to use when they rinse their hand. When they do the water will have a dirty colour as the dirt comes of their hands. This activity is believed to encourage handwashing with soap. Receives: Behavioral: Hand hygiene interventions |
| Hygiene Promotion Activity - Comfort | Experimental | The activity will be delivered to a group of maximum 5 neighbouring households at the time. Hygiene promoters will bring some food oil and ask participants to cover their hands in food oil. They will then ask the participants to cover their hands in turmeric powder. The participants will then be asked to wash their hands with water only. This will have little effect on the cleanliness of their hands. Then participants will be given a bar of soap. The participants will then be asked to wash their hands again. This will leave their hands nice comfortable and clean. They will experience the comfort of clean hands and the activity hope to increase regular handwashing. Receives: Behavioral: Hand hygiene interventions |
| Education Hygiene Promotion Activity | No intervention | Hygiene promoters will deliver regular hygiene promotion activities; an educational message about disease transmission and how handwashing with soap can help protect against disease. This would include teaching participants about the benefits of handwashing with soap, such as reducing diarrhea incidence and preventing cholera. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks after implementation
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.
Measured: 4 weeks after implementation
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.
Measured: 1 hour per focus group discussion 6 weeks after implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start15 Sep 2019
- Primary completion30 Nov 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- N/A - the study does not involve drug or biologic products. The study looks at the impact of behavioural interventions
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Action Contre la Faim
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078633
- Sponsor's protocol ID
- 17604
- Status last verified
- Aug 2019
- First submitted
- 15 Aug 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Thorseth AH, Heath T, Sisay A, Hamo M, White S. An exploratory pilot study of the effect of modified hygiene kits on handwashing with soap among internally displaced persons in Ethiopia. Confl Health. 2021 May 4;15(1):35. doi: 10.1186/s13031-021-00368-3.
PubMed 33947443
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Studies of Innovative Hand Washing Interventions for Internally Displaced Populations in Ethiopia
- ClinicalTrials.gov ID
- NCT04078633
- Acronym / sponsor ID
- 17604
- Conditions
- Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Action Contre la Faim
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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.
- 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.
- To conduct a pilot study of the effect of motivational stories on handwashing behaviour.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 10
- Model description
- N/A - the study does not involve drug or biologic products. The study looks at the impact of behavioural interventions
| Arm | Type | Receives |
|---|---|---|
| Normal Liquid Soap (250mL) | Experimental | Behavioral: Hand hygiene interventionsA normal hygiene kit will be distributed to the households. In addition, a liquid soap will be added to see the impact of having a liquid soap for hand washing on hygiene behaviors. |
| Bar soap (250gram) | Experimental | Behavioral: Hand hygiene interventionsA normal hygiene kit will be distributed to the households. In addition, a nice bar soap will be added to see the impact of having a nicer bar soap for hand washing on hygiene behaviors. |
| Mirror (50x30cm) | Experimental | Behavioral: Hand hygiene interventionsA normal hygiene kit will be distributed to the households. In addition, a mirror will be added to see the impact of having a mirror by the handwashing stand on handwashing behaviour. The mirror will have a plastic edge and be 30x 50cm in size. |
| Control | No intervention | –A normal hygiene kit will be distributed to the households. No additional interventions will be given. |
| Nurture story for hygiene promotion | Experimental | Behavioral: Hand hygiene interventionsHygiene promoters will share a story of being a good parent through teaching their children to do hand washing with soap at critical times. A story about a good mother who every day reminds her child to wash her/his hands before eating or preparing food and after going to the toilet will be shared with participants. The story ends with the child growing up healthy, happy and with a good education. This story if belived to increae handwashing with soap in the household/ |
| Comfort story for hygiene promotion | Experimental | Behavioral: Hand hygiene interventionsHygiene promoters will deliver hygiene promotion through an activity that provoke the feeling of comfort by having clean hands. Hygiene promoters will deliver this intervention to up to 5 neighbor households at the time, sharing a story about a family that keeps good hygiene behaviors and therefore are clean, healthy and happy. This story is believed to encourage families to increase handwashing with soap in the household. |
| Education session for hygiene promotion | No intervention | –Hygiene promoters will deliver regular hygiene promotion activities; an educational message about disease transmission and how handwashing with soap can help protect against disease. This would include teaching participants about the benefits of handwashing with soap, such as reducing diarrhea incidence and preventing cholera. |
| Hygiene Promotion Activity - Disgust | Experimental | Behavioral: Hand hygiene interventionsThe activity will be delivered to a group of maximum 5 neighbouring households at the time. Hygiene promoters will use 5 buckets of clean water and place them in front of households. They will then ask a member of one of the households to rinse their hands in the first bucket. Some dirt will come of their hands. Then the participant rinses their hands again in bucket number 2, then 3 and then 4. Before the 5th bucket the participant receives a bar of soap to use when they rinse their hand. When they do the water will have a dirty colour as the dirt comes of their hands. This activity is believed to encourage handwashing with soap. |
| Hygiene Promotion Activity - Comfort | Experimental | Behavioral: Hand hygiene interventionsThe activity will be delivered to a group of maximum 5 neighbouring households at the time. Hygiene promoters will bring some food oil and ask participants to cover their hands in food oil. They will then ask the participants to cover their hands in turmeric powder. The participants will then be asked to wash their hands with water only. This will have little effect on the cleanliness of their hands. Then participants will be given a bar of soap. The participants will then be asked to wash their hands again. This will leave their hands nice comfortable and clean. They will experience the comfort of clean hands and the activity hope to increase regular handwashing. |
| Education Hygiene Promotion Activity | No intervention | –Hygiene promoters will deliver regular hygiene promotion activities; an educational message about disease transmission and how handwashing with soap can help protect against disease. This would include teaching participants about the benefits of handwashing with soap, such as reducing diarrhea incidence and preventing cholera. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Internally displaces persons living in humanitarian crises settings
Key exclusion criteria (1 listed)
- Host community
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand hygiene interventionsInterventions are commonly used physical props for handwashing and commonly used hygiene promotion activities. | Behavioural | Bar soap (250gram), Comfort story for hygiene promotion, Hygiene Promotion Activity - Comfort, Hygiene Promotion Activity - Disgust, Mirror (50x30cm), Normal Liquid Soap (250mL), Nurture story for hygiene promotion |
Primary outcome
Structured observation to measure frequency of handwashing, who is washing their hands and whether soap was used.
Time frame: 4 weeks after implementation
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
Survey on socio-demographics and hand hygiene behaviours
Time frame: 4 weeks after implementation
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.
Focus group discussions on drivers and barriers to handwashing in the IDP settlement
Time frame: 1 hour per focus group discussion 6 weeks after implementation
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 33947443Thorseth AH, Heath T, Sisay A, Hamo M, White S. An exploratory pilot study of the effect of modified hygiene kits on handwashing with soap among internally displaced persons in Ethiopia. Confl Health. 2021 May 4;15(1):35. doi: 10.1186/s13031-021-00368-3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand hygiene interventions in people with Behavior, run by London School of Hygiene and Tropical Medicine at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structured observation to measure frequency of handwashing, who is washing their hands and whether soap was used. (time frame: 4 weeks after implementation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04078633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.