NCT04078633

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

September 15, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

April 28, 2021

Status Verified

August 1, 2019

Enrollment Period

3 months

First QC Date

August 15, 2019

Last Update Submit

April 27, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (10)

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.

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.

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.

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/

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.

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.

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.

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.

Interventions

Interventions are commonly used physical props for handwashing and commonly used hygiene promotion activities.

Bar soap (250gram)Comfort story for hygiene promotionHygiene Promotion Activity - ComfortHygiene Promotion Activity - DisgustMirror (50x30cm)Normal Liquid Soap (250mL)Nurture story for hygiene promotion

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Internally displaces persons living in humanitarian crises settings

You may not qualify if:

  • Host community

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London School of Hygiene and Tropical Medecine

London, WC1E7HT, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: N/A - the study does not involve drug or biologic products. The study looks at the impact of behavioural interventions
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2019

First Posted

September 6, 2019

Study Start

September 15, 2019

Primary Completion

November 30, 2019

Study Completion

March 31, 2020

Last Updated

April 28, 2021

Record last verified: 2019-08

Locations