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

September 12, 2017 updated by: Brendan Maughan-Brown, University of Cape Town

The Hope Soap Study: a Randomized Controlled Trial of a Hand-washing Intervention Among Children in South Africa

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

288

Phase

  • Not Applicable

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

Ages Eligible for Study

3 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hope Soap group
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
Combination product: Hope Soap
HOPE SOAP© is a colourful, translucent bar of soap with a toy embedded in its centre.
Active Comparator: Control group
Children in control households received a colourful, translucent bar or soap with the toy alongside it.
Combination product: Control group soap
A colourful, translucent bar or soap with the toy alongside it

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Direct observation of hand washing prior to eating a snack
Time Frame: 8 weeks
Hands washed unprompted prior to eating a snack
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire data on hand washing after using the toilet (scale of 1-10)
Time Frame: 8 weeks
A score of 1-10 of hand washing after using the toilet
8 weeks
Questionnaire data on hand washing prior to meals (scale of 1-10)
Time Frame: 8 weeks
A score of 1-10 of hand washing prior to eating meals
8 weeks
Questionnaire data on general soap usage when washing hands (scale of 1-10)
Time Frame: 8 weeks
A score of 1-10 of soap usage when hands are washed
8 weeks
Questionnaire data on experience of illness (13 items)
Time Frame: 2 weeks
A score of 1-13 based on self-reported symptoms of illness
2 weeks

Collaborators and Investigators

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

Sponsor

University of Cape Town

Collaborators

Abdul Latif Jameel Poverty Action Lab

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)

September 1, 2014

Primary Completion (Actual)

December 15, 2014

Study Completion (Actual)

December 15, 2015

Study Registration Dates

First Submitted

September 8, 2017

First Submitted That Met QC Criteria

September 8, 2017

First Posted (Actual)

September 12, 2017

Study Record Updates

Last Update Posted (Actual)

September 13, 2017

Last Update Submitted That Met QC Criteria

September 12, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1952:BURNSFW

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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