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Impact of Hand Hygiene Activities on the Prevention of Intestinal Parasitic Infections and Anaemia Among School Children

Primary Purpose

Intestinal Parasitic Infections, Anaemia

Status
Completed
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
Hand washing with soap and hand finger nail clipping
Sponsored by
Mekelle University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intestinal Parasitic Infections focused on measuring Intestinal parasitic infections, Anaemia, School-aged children, Hand washing and nail clipping

Eligibility Criteria

6 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • College of Health Sciences, Mekelle University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Hand hygiene

Hand finger nail hygiene

Hand and finger nails hygiene

Customary practice

Arm Description

Hand washing with soap measures will be carried out as an intervention activity

Hand finger nail clipping activities

Both hand washing with soap and hand finger nail clipping activities will be implemented

No 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)

Outcomes

Primary Outcome Measures

- 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.
- 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.

Secondary Outcome Measures

Proportion of anaemia prevalence rates among intervention and control groups
Impact of hand hygiene activities on the reduction of anaemia prevalence among the children will be assessed

Full Information

First Posted
June 9, 2012
Last Updated
January 31, 2015
Sponsor
Mekelle University
Collaborators
University of Alcala, Maastricht University
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1. Study Identification

Unique Protocol Identification Number
NCT01619254
Brief Title
Impact of Hand Hygiene Activities on the Prevention of Intestinal Parasitic Infections and Anaemia Among School Children
Official Title
Hand Hygiene Promotion Activities: Effect on Intestinal Parasitic Infections and Anaemia Among School-aged Children in Eastern Tigray, Ethiopia: a Factorial Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mekelle University
Collaborators
University of Alcala, Maastricht University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The controlled prospective cohort study will be carried out in Kilte awlaelo wereda, north Ethiopia. A total of 216 households with at least one school-aged child (aged 6-15) will be randomly selected by systematic random sampling method. Different intervention packages will be randomised among households. Intervention activities will be implemented at household level, using the selected child within the household as study unit. If there are more than one child per randomised household all children will receive the intervention, but only two children, selected by simple random selection method, will be included in the trial. Selected children will be screened for intestinal parasitosis, following acquisition of signed informed consent, and will be recruited for the study after treatment. Parasite negative children in the respective households will be randomly allocated into intervention and control groups. Sequence allocation will be done in a central office by an individual who do not know and have no contact with the study sites and households. Each intervention and control group will have a fixed number of participants, and will be subjected to only one of the study interventions. Children and households in each group will be followed-up for 6 months by trained fieldworkers and the investigators according to a developed protocol throughout the study period. Parasitological, haemoglobin and anthropometric data will be collected at entry and after six months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Parasitic Infections, Anaemia
Keywords
Intestinal parasitic infections, Anaemia, School-aged children, Hand washing and nail clipping

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
365 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hand hygiene
Arm Type
Experimental
Arm Description
Hand washing with soap measures will be carried out as an intervention activity
Arm Title
Hand finger nail hygiene
Arm Type
Experimental
Arm Description
Hand finger nail clipping activities
Arm Title
Hand and finger nails hygiene
Arm Type
Experimental
Arm Description
Both hand washing with soap and hand finger nail clipping activities will be implemented
Arm Title
Customary practice
Arm Type
Placebo Comparator
Arm Description
No 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)
Intervention Type
Behavioral
Intervention Name(s)
Hand washing with soap and hand finger nail clipping
Other Intervention Name(s)
Hand washing and finger nails clipping
Intervention Description
Assess the impact of hand washing with soap and nail clipping on child health
Primary Outcome Measure Information:
Title
- Proportion of intestinal parasitic re-infection rates among intervention and control groups
Description
Impact of hand hygiene activities (as intervention measures) on intestinal parasitic re-infection prevalence will be assessed.
Time Frame
six months
Title
- Proportion of intestinal parasite load (mean eggs per gram) among intervention and control groups
Description
Impact of hand hygiene activities (as intervention measures) on intestinal parasitic infection intensity will be assessed.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Proportion of anaemia prevalence rates among intervention and control groups
Description
Impact of hand hygiene activities on the reduction of anaemia prevalence among the children will be assessed
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmud Ab Mahmud, PhD fellow
Organizational Affiliation
College of Health Scieneces, Mekelle University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roman B Velasco, MD, PhD
Organizational Affiliation
Alcala University, Madrid, Spain
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mark Spigt, MSC, PhD
Organizational Affiliation
Maastricht University, The Netherlands
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Afework M Bezabeh, MSC, PhD
Organizational Affiliation
College of Health Sciences, Mekelle University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Geert J Dinant, Professor
Organizational Affiliation
Maastricht University, The Netherlands
Official's Role
Study Chair
Facility Information:
Facility Name
College of Health Sciences, Mekelle University
City
Mekelle
State/Province
Tigray
Country
Ethiopia

12. IPD Sharing Statement

Citations:
PubMed Identifier
31898526
Citation
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.
Results Reference
derived

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Impact of Hand Hygiene Activities on the Prevention of Intestinal Parasitic Infections and Anaemia Among School Children

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