Innovative Hand Washing Interventions for Internally Displaced Populations in Ethiopia

April 27, 2021 updated by: London School of Hygiene and Tropical Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1E7HT
        • London School of Hygiene and Tropical Medecine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Internally displaces persons living in humanitarian crises settings

Exclusion Criteria:

  • Host community

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Normal Liquid Soap (250mL)
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.
Behavioral: Hand hygiene interventions
Interventions are commonly used physical props for handwashing and commonly used hygiene promotion activities.
Experimental: Bar soap (250gram)
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.
Behavioral: Hand hygiene interventions
Interventions are commonly used physical props for handwashing and commonly used hygiene promotion activities.
Experimental: Mirror (50x30cm)
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.
Behavioral: Hand hygiene interventions
Interventions are commonly used physical props for handwashing and commonly used hygiene promotion activities.
No Intervention: Control
A normal hygiene kit will be distributed to the households. No additional interventions will be given.
Experimental: Nurture story for hygiene promotion
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/
Behavioral: Hand hygiene interventions
Interventions are commonly used physical props for handwashing and commonly used hygiene promotion activities.
Experimental: Comfort story for hygiene promotion
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.
Behavioral: Hand hygiene interventions
Interventions are commonly used physical props for handwashing and commonly used hygiene promotion activities.
No Intervention: Education session for hygiene promotion
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.
Experimental: Hygiene Promotion Activity - Disgust
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.
Behavioral: Hand hygiene interventions
Interventions are commonly used physical props for handwashing and commonly used hygiene promotion activities.
Experimental: Hygiene Promotion Activity - Comfort
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.
Behavioral: Hand hygiene interventions
Interventions are commonly used physical props for handwashing and commonly used hygiene promotion activities.
No Intervention: Education Hygiene Promotion Activity
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
4 weeks after implementation
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.
4 weeks after implementation
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.
1 hour per focus group discussion 6 weeks after implementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
London School of Hygiene and Tropical Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Action Contre la Faim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17604

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Behavior

Clinical Trials on Hand hygiene interventions

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings