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The Hope Soap Study: a Hand-washing Intervention Among Children in South Africa

Primary Purpose

Hand-washing Behavior, Diarrhea

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hope Soap
Control group soap
Sponsored by
University of Cape Town
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hand-washing Behavior

Eligibility Criteria

3 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Enrolled in the Family-in-Focus program
  • Caregiver provided informed consent
  • the age-eligible children were not involved in any other sort of ECD program (e.g. crèche or other day-care)

Exclusion Criteria:

  • Enrollment in an ECD program

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Hope Soap group

    Control group

    Arm Description

    Children in treatment households received a bi-monthly delivery of HOPE SOAP©, a colourful, translucent bar of soap with a toy embedded in its centre

    Children in control households received a colourful, translucent bar or soap with the toy alongside it.

    Outcomes

    Primary Outcome Measures

    Direct observation of hand washing prior to eating a snack
    Hands washed unprompted prior to eating a snack

    Secondary Outcome Measures

    Questionnaire data on hand washing after using the toilet (scale of 1-10)
    A score of 1-10 of hand washing after using the toilet
    Questionnaire data on hand washing prior to meals (scale of 1-10)
    A score of 1-10 of hand washing prior to eating meals
    Questionnaire data on general soap usage when washing hands (scale of 1-10)
    A score of 1-10 of soap usage when hands are washed
    Questionnaire data on experience of illness (13 items)
    A score of 1-13 based on self-reported symptoms of illness

    Full Information

    First Posted
    September 8, 2017
    Last Updated
    September 12, 2017
    Sponsor
    University of Cape Town
    Collaborators
    Abdul Latif Jameel Poverty Action Lab
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03280771
    Brief Title
    The Hope Soap Study: a Hand-washing Intervention Among Children in South Africa
    Official Title
    The Hope Soap Study: a Randomized Controlled Trial of a Hand-washing Intervention Among Children in South Africa
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2014 (Actual)
    Primary Completion Date
    December 15, 2014 (Actual)
    Study Completion Date
    December 15, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Cape Town
    Collaborators
    Abdul Latif Jameel Poverty Action Lab

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The Hope Soap Study is a randomised-control pilot study of a hand-washing intervention in which children in treatment households received a bi-monthly delivery of HOPE SOAP©, a colourful, translucent bar of soap with a toy embedded in its centre.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hand-washing Behavior, Diarrhea

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    288 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hope Soap group
    Arm Type
    Experimental
    Arm Description
    Children in treatment households received a bi-monthly delivery of HOPE SOAP©, a colourful, translucent bar of soap with a toy embedded in its centre
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Children in control households received a colourful, translucent bar or soap with the toy alongside it.
    Intervention Type
    Combination Product
    Intervention Name(s)
    Hope Soap
    Intervention Description
    HOPE SOAP© is a colourful, translucent bar of soap with a toy embedded in its centre.
    Intervention Type
    Combination Product
    Intervention Name(s)
    Control group soap
    Intervention Description
    A colourful, translucent bar or soap with the toy alongside it
    Primary Outcome Measure Information:
    Title
    Direct observation of hand washing prior to eating a snack
    Description
    Hands washed unprompted prior to eating a snack
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Questionnaire data on hand washing after using the toilet (scale of 1-10)
    Description
    A score of 1-10 of hand washing after using the toilet
    Time Frame
    8 weeks
    Title
    Questionnaire data on hand washing prior to meals (scale of 1-10)
    Description
    A score of 1-10 of hand washing prior to eating meals
    Time Frame
    8 weeks
    Title
    Questionnaire data on general soap usage when washing hands (scale of 1-10)
    Description
    A score of 1-10 of soap usage when hands are washed
    Time Frame
    8 weeks
    Title
    Questionnaire data on experience of illness (13 items)
    Description
    A score of 1-13 based on self-reported symptoms of illness
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Enrolled in the Family-in-Focus program Caregiver provided informed consent the age-eligible children were not involved in any other sort of ECD program (e.g. crèche or other day-care) Exclusion Criteria: Enrollment in an ECD program

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29879942
    Citation
    Burns J, Maughan-Brown B, Mouzinho A. Washing with hope: evidence of improved handwashing among children in South Africa from a pilot study of a novel soap technology. BMC Public Health. 2018 Jun 7;18(1):709. doi: 10.1186/s12889-018-5573-8.
    Results Reference
    derived

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    The Hope Soap Study: a Hand-washing Intervention Among Children in South Africa

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