NCT03280771

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

4 months

First QC Date

September 8, 2017

Last Update Submit

September 12, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Direct observation of hand washing prior to eating a snack

    Hands washed unprompted prior to eating a snack

    8 weeks

Secondary Outcomes (4)

  • Questionnaire data on hand washing after using the toilet (scale of 1-10)

    8 weeks

  • Questionnaire data on hand washing prior to meals (scale of 1-10)

    8 weeks

  • Questionnaire data on general soap usage when washing hands (scale of 1-10)

    8 weeks

  • Questionnaire data on experience of illness (13 items)

    2 weeks

Study Arms (2)

Hope Soap group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Combination Product: Control group soap

Interventions

Hope SoapCOMBINATION_PRODUCT

HOPE SOAP© is a colourful, translucent bar of soap with a toy embedded in its centre.

Hope Soap group
Control group soapCOMBINATION_PRODUCT

A colourful, translucent bar or soap with the toy alongside it

Control group

Eligibility Criteria

Age3 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • Enrollment in an ECD program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Officer

Study Record Dates

First Submitted

September 8, 2017

First Posted

September 12, 2017

Study Start

September 1, 2014

Primary Completion

December 15, 2014

Study Completion

December 15, 2015

Last Updated

September 13, 2017

Record last verified: 2017-09