School-based, Hand-washing, Program, MalawiNCT02968251
Designing and Evaluating a School-based Hand Washing Program in Malawi
A study testing Hand Washing Program (HWP) in people with School-based, Hand-washing, Program, Malawi, run by The Hong Kong Polytechnic University at 1 site in Malawi.
Trial summary
The aim of the study is to design and evaluate a school-based hand washing program for children in Malawi, Sub-Saharan Africa, using a cluster randomized controlled trial (CRCT), so as to improve proper hand washing, increase knowledge level and also reduce school absenteeism. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- School-based, Hand-washing, Program, Malawi
- What is being tested?
- Hand Washing Program (HWP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteMalawi
- Study dates
- Oct 2016to Jul 2017
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Schools that have piped tap water source situated in Mzuzu City,
- Private primary schools,
- Children in elementary one and six,
- Written parental consent allowing their child to participate in the study.
Who cannot join
- Schools without piped tap water source,
- Government primary schools,
- Children whose parents will not give consent.
Trial locations and contacts
1 site in 1 country.
Balwani M Chingatichifwe, MPH contact
Malawi1 site, 1 recruiting
- Recruiting
St John's College of Nursing and Midwifery
Mzuzu, Northern Region, 00000
Balwani M Chingatichifwe, MPH, (265) 888 159 286, balwani-mbakaya.chingatichifwe@connect.polyu.hk
Regina Lee, PhD, (852) 2766 6388, regina.Lee@polyu.edu.hk
About this study
The aim of the study is to design and evaluate a school-based hand washing program for children in Malawi, Sub-Saharan Africa, using a cluster randomized controlled trial (CRCT), so as to improve proper hand washing, increase knowledge level and also reduce school absenteeism.
Read the detailed description
A cluster randomized controlled trial (CRCT) design with pre-, mid- and post-interventions and follow-up measures will be randomized into intervention or control groups. A simplified 5-steps hand washing program will be implemented in the intervention group while the control group will continue with their usual practice where schoolchildren do not follow any standard recommended handwashing technique.
- Being tested
- Hand Washing Program (HWP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Washing Program (HWP)Behavioural
HWP consists of integrating hand washing practice in the school health policy, setting up proper hand washing facilities in the intervention schools, training to school teachers, delivering of health talk to schoolchildren and their parents, developing reminders and posters of a simplified 5-step hand washing technique, peer briefing session, take home package (5-steps hand washing, commitment letter, poster, leaflet). The program will be delivered once every week.
| Study group | Role | What they receive |
|---|---|---|
| Hand Washing Program (HWP) | Experimental | Clusters in this arm will be given a Hand Washing Program (HWP) which will consist of: integrating hand washing practice in the school health policy, setting up proper hand washing facilities in the intervention schools, training to school teachers, delivering of health talk to schoolchildren and their parents, developing reminders and posters of a simplified 5-step hand washing technique, peer briefing session, take home package (5-steps hand washing, commitment letter, poster, leaflet). The program will be delivered once every week. Receives: Behavioral: Hand Washing Program (HWP) |
| No Hand Washing Program (NHWP) | No intervention | Clusters in this arm will be allowed to continue with their usual practice regarding hand washing/hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proper hand washing
This will be achieved by giving a score to the amount of fluorescents stain on the hand.
Measured: 9 month
Secondary outcomes (1)
Knowledge gain
A quiz will be administered to assess knowledge of school children.
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for School-based, Hand-washing, Program, MalawiStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968251
- Sponsor's protocol ID
- HSEARS20160619001
- Status last verified
- Oct 2016
- First submitted
- 11 Oct 2016
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing and Evaluating a School-based Hand Washing Program in Malawi
- ClinicalTrials.gov ID
- NCT02968251
- Acronym / sponsor ID
- HSEARS20160619001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 18 Nov 2016 (estimated)
- 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 aim of the study is to design and evaluate a school-based hand washing program for children in Malawi, Sub-Saharan Africa, using a cluster randomized controlled trial (CRCT), so as to improve proper hand washing, increase knowledge level and also reduce school absenteeism.
Detailed description
A cluster randomized controlled trial (CRCT) design with pre-, mid- and post-interventions and follow-up measures will be randomized into intervention or control groups. A simplified 5-steps hand washing program will be implemented in the intervention group while the control group will continue with their usual practice where schoolchildren do not follow any standard recommended handwashing technique.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand Washing Program (HWP) | Experimental | Behavioral: Hand Washing Program (HWP)Clusters in this arm will be given a Hand Washing Program (HWP) which will consist of: integrating hand washing practice in the school health policy, setting up proper hand washing facilities in the intervention schools, training to school teachers, delivering of health talk to schoolchildren and their parents, developing reminders and posters of a simplified 5-step hand washing technique, peer briefing session, take home package (5-steps hand washing, commitment letter, poster, leaflet). The program will be delivered once every week. |
| No Hand Washing Program (NHWP) | No intervention | –Clusters in this arm will be allowed to continue with their usual practice regarding hand washing/hygiene |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Schools that have piped tap water source situated in Mzuzu City,
- Private primary schools,
- Children in elementary one and six,
- Written parental consent allowing their child to participate in the study.
Key exclusion criteria (3 listed)
- Schools without piped tap water source,
- Government primary schools,
- Children whose parents will not give consent.
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 |
|---|---|---|
| Hand Washing Program (HWP)HWP consists of integrating hand washing practice in the school health policy, setting up proper hand washing facilities in the intervention schools, training to school teachers, delivering of health talk to schoolchildren and their parents, developing reminders and posters of a simplified 5-step hand washing technique, peer briefing session, take home package (5-steps hand washing, commitment letter, poster, leaflet). The program will be delivered once every week. | Behavioural | Hand Washing Program (HWP) |
Primary outcome
Proper hand washing
Time frame: 9 month
This will be achieved by giving a score to the amount of fluorescents stain on the hand.
1 secondary outcome
Knowledge gain
Time frame: 9 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
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.
Balwani M Chingatichifwe, MPH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Washing Program (HWP) in people with School-based, Hand-washing, Program, Malawi, run by The Hong Kong Polytechnic University at 1 site in Malawi.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Balwani M Chingatichifwe, MPH (+265 888 159 286, balwani-mbakaya.chingatichifwe@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proper hand washing (time frame: 9 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2017.