Impact of Hand Hygiene Activities on the Prevention of Intestinal Parasitic Infections and Anaemia Among School Children
Hand Hygiene Promotion Activities: Effect on Intestinal Parasitic Infections and Anaemia Among School-aged Children in Eastern Tigray, Ethiopia: a Factorial Randomised Controlled Trial
1 other identifier
interventional
365
1 country
1
Brief Summary
Impact exerted by intestinal parasitic infections is much higher in developing countries. School-aged children are at higher risk from the burden of disease, because they specially have many parasitic infections. The poor health results in deficits in physical and cognitive development and educational achievements. Nowadays, there is huge commitment among the global community to control intestinal parasitic infections and to improve nutritional status of young children in developing countries. Large-scale anthelminthic drug administration through vertical control programmes is still required for the foreseeable future and is, therefore, recommended by the World Health Organization (WHO). However, due to the inevitability of re-infection in endemic areas, children need to be treated regularly, and once morbidity control is consolidated, the strategy must shift to transmission control emphasising access to clean water and adequate sanitation. To lower dependency on 'drug only' approach and to enhance sustainability, from the onset of control activities, complementary measures should be implemented, that depend on available resources. Therefore, the investigators are proposing to undertake a randomised controlled trial to assess the impact of simple and easy-to-do hand hygiene intervention packages (hand washing with soap and hand finger nail clipping) on intestinal parasitic infection prevalence, intensity and re-infection rates and on haemoglobin concentration and anaemia prevalence rates among 6-15 years old schoolchildren. Our results will provide solid evidence on if and how hand hygiene practice affects infection prevalence and re-infection rates, as well as, anaemia prevalence among the highly vulnerable age group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2012
CompletedFirst Posted
Study publicly available on registry
June 14, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedFebruary 3, 2015
January 1, 2015
7 months
June 9, 2012
January 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
- Proportion of intestinal parasitic re-infection rates among intervention and control groups
Impact of hand hygiene activities (as intervention measures) on intestinal parasitic re-infection prevalence will be assessed.
six months
- Proportion of intestinal parasite load (mean eggs per gram) among intervention and control groups
Impact of hand hygiene activities (as intervention measures) on intestinal parasitic infection intensity will be assessed.
six months
Secondary Outcomes (1)
Proportion of anaemia prevalence rates among intervention and control groups
six months
Study Arms (4)
Hand hygiene
EXPERIMENTALHand washing with soap measures will be carried out as an intervention activity
Hand finger nail hygiene
EXPERIMENTALHand finger nail clipping activities
Hand and finger nails hygiene
EXPERIMENTALBoth hand washing with soap and hand finger nail clipping activities will be implemented
Customary practice
PLACEBO COMPARATORNo hand washing with soap and nail clipping activities. House holds and children assigned to the control group will not have the interventions (hand washing with soap and nail clipping activities)
Interventions
Assess the impact of hand washing with soap and nail clipping on child health
Eligibility Criteria
You may qualify if:
- households and children who will give a written consent to participate in the study
- households and children who are going to stay in the area throughout the study period
- children aged 6 to 15
You may not qualify if:
- households and children who able to produce a written consent
- children who are under treatment
- children with age less than 6 and greater than 15 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mekelle Universitylead
- University of Alcalacollaborator
- Maastricht Universitycollaborator
Study Sites (1)
College of Health Sciences, Mekelle University
Mek'ele, Tigray, Ethiopia
Related Publications (1)
Mahmud MA, Spigt M, Bezabih AM, Dinant GJ, Velasco RB. Associations between intestinal parasitic infections, anaemia, and diarrhoea among school aged children, and the impact of hand-washing and nail clipping. BMC Res Notes. 2020 Jan 2;13(1):1. doi: 10.1186/s13104-019-4871-2.
PMID: 31898526DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mahmud Ab Mahmud, PhD fellow
College of Health Scieneces, Mekelle University
- STUDY DIRECTOR
Roman B Velasco, MD, PhD
Alcala University, Madrid, Spain
- STUDY CHAIR
Mark Spigt, MSC, PhD
Maastricht University, The Netherlands
- STUDY CHAIR
Afework M Bezabeh, MSC, PhD
College of Health Sciences, Mekelle University
- STUDY CHAIR
Geert J Dinant, Professor
Maastricht University, The Netherlands
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD fellow and Instructor
Study Record Dates
First Submitted
June 9, 2012
First Posted
June 14, 2012
Study Start
July 1, 2012
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
February 3, 2015
Record last verified: 2015-01