- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02968251
Designing and Evaluating a School-based Hand Washing Program in Malawi
May 8, 2017 updated by: The Hong Kong Polytechnic University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
360
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Balwani M Chingatichifwe, MPH
- Phone Number: +265 888 159 286
- Email: balwani-mbakaya.chingatichifwe@connect.polyu.hk
Study Contact Backup
- Name: Regina Lee, PhD
- Phone Number: (852) 2766 6388
- Email: regina.Lee@polyu.edu.hk
Study Locations
-
-
Northern
-
Mzuzu, Northern, Malawi, 00000
- Recruiting
- St John's College of Nursing and Midwifery
-
Contact:
- Regina Lee, PhD
- Phone Number: (852) 2766 6388
- Email: regina.Lee@polyu.edu.hk
-
Contact:
- Balwani M Chingatichifwe, MPH
- Phone Number: (265) 888 159 286
- Email: balwani-mbakaya.chingatichifwe@connect.polyu.hk
-
-
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
5 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Schools without piped tap water source,
- Government primary schools,
- Children whose parents will not give consent.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
No Intervention: No Hand Washing Program (NHWP)
Clusters in this arm will be allowed to continue with their usual practice regarding hand washing/hygiene
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proper hand washing
Time Frame: 9 month
|
This will be achieved by giving a score to the amount of fluorescents stain on the hand.
|
9 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge gain
Time Frame: 9 month
|
A quiz will be administered to assess knowledge of school children.
|
9 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
October 1, 2016
Primary Completion (Anticipated)
July 1, 2017
Study Completion (Anticipated)
July 1, 2017
Study Registration Dates
First Submitted
October 11, 2016
First Submitted That Met QC Criteria
November 17, 2016
First Posted (Estimate)
November 18, 2016
Study Record Updates
Last Update Posted (Actual)
May 9, 2017
Last Update Submitted That Met QC Criteria
May 8, 2017
Last Verified
October 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- HSEARS20160619001
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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