Hand-washing BehaviorNCT03280771
The Hope Soap Study: a Hand-washing Intervention Among Children in South Africa
A study testing Hope Soap in people with Hand-washing Behavior and Diarrhea, run by University of Cape Town.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Hand-washing Behavior, Diarrhea
- What is being tested?
- Hope Soap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2014to 15 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Enrollment in an ECD program
About this study
Official title: 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.
- Conditions
- Hand-washing Behavior, Diarrhea
- Being tested
- Hope Soap, Control group soap
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hope SoapCombination product
HOPE SOAP© is a colourful, translucent bar of soap with a toy embedded in its centre.
Control group soapCombination product
A colourful, translucent bar or soap with the toy alongside it
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Combination Product: Hope Soap |
| Control group | Active comparator | Children in control households received a colourful, translucent bar or soap with the toy alongside it. Receives: Combination Product: Control group soap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Direct observation of hand washing prior to eating a snack
Hands washed unprompted prior to eating a snack
Measured: 8 weeks
Secondary outcomes (4)
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
Measured: 8 weeks
Questionnaire data on hand washing prior to meals (scale of 1-10)
A score of 1-10 of hand washing prior to eating meals
Measured: 8 weeks
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
Measured: 8 weeks
Questionnaire data on experience of illness (13 items)
A score of 1-13 based on self-reported symptoms of illness
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Sep 2014
- Primary completion15 Dec 2014
- Study completion15 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand-washing BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- Abdul Latif Jameel Poverty Action Lab
- Responsible party
- Principal investigator, Brendan Maughan-Brown, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280771
- Sponsor's protocol ID
- 1952:BURNSFW
- Status last verified
- Sep 2017
- First submitted
- 8 Sep 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29879942
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hope Soap Study: a Randomized Controlled Trial of a Hand-washing Intervention Among Children in South Africa
- ClinicalTrials.gov ID
- NCT03280771
- Acronym / sponsor ID
- 1952:BURNSFW
- Conditions
- Hand-washing Behavior, Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- Abdul Latif Jameel Poverty Action Lab
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 15 Dec 2014 (actual)
- Study completion
- 15 Dec 2015 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hope Soap group | Experimental | Combination Product: Hope SoapChildren in treatment households received a bi-monthly delivery of HOPE SOAP©, a colourful, translucent bar of soap with a toy embedded in its centre |
| Control group | Active comparator | Combination Product: Control group soapChildren in control households received a colourful, translucent bar or soap with the toy alongside it. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- Enrollment in an ECD program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hope SoapHOPE SOAP© is a colourful, translucent bar of soap with a toy embedded in its centre. | Combination product | Hope Soap group |
| Control group soapA colourful, translucent bar or soap with the toy alongside it | Combination product | Control group |
Primary outcome
Direct observation of hand washing prior to eating a snack
Time frame: 8 weeks
Hands washed unprompted prior to eating a snack
4 secondary outcomes
Questionnaire data on hand washing after using the toilet (scale of 1-10)
Time frame: 8 weeks
Questionnaire data on hand washing prior to meals (scale of 1-10)
Time frame: 8 weeks
Questionnaire data on general soap usage when washing hands (scale of 1-10)
Time frame: 8 weeks
Questionnaire data on experience of illness (13 items)
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Derived from this study: PubMed 29879942Burns 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hope Soap in people with Hand-washing Behavior and Diarrhea, run by University of Cape Town.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Direct observation of hand washing prior to eating a snack (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03280771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2017.