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

Sponsor
Mekelle University (Other)
Overall Status
Completed
CT.gov ID
NCT01619254
Collaborator
University of Alcala (Other), Maastricht University (Other)
365
1
4
7.1
51.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Hand washing with soap and hand finger nail clipping
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
365 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
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 Start Date :
Jul 1, 2012
Actual Primary Completion Date :
Feb 1, 2013
Actual Study Completion Date :
Feb 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hand hygiene

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

Behavioral: Hand washing with soap and hand finger nail clipping
Assess the impact of hand washing with soap and nail clipping on child health
Other Names:
  • Hand washing and finger nails clipping
  • Experimental: Hand finger nail hygiene

    Hand finger nail clipping activities

    Behavioral: Hand washing with soap and hand finger nail clipping
    Assess the impact of hand washing with soap and nail clipping on child health
    Other Names:
  • Hand washing and finger nails clipping
  • Experimental: Hand and finger nails hygiene

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

    Behavioral: Hand washing with soap and hand finger nail clipping
    Assess the impact of hand washing with soap and nail clipping on child health
    Other Names:
  • Hand washing and finger nails clipping
  • Placebo Comparator: Customary practice

    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)

    Behavioral: Hand washing with soap and hand finger nail clipping
    Assess the impact of hand washing with soap and nail clipping on child health
    Other Names:
  • Hand washing and finger nails clipping
  • Outcome Measures

    Primary Outcome Measures

    1. - Proportion of intestinal parasitic re-infection rates among intervention and control groups [six months]

      Impact of hand hygiene activities (as intervention measures) on intestinal parasitic re-infection prevalence will be assessed.

    2. - Proportion of intestinal parasite load (mean eggs per gram) among intervention and control groups [six months]

      Impact of hand hygiene activities (as intervention measures) on intestinal parasitic infection intensity will be assessed.

    Secondary Outcome Measures

    1. Proportion of anaemia prevalence rates among intervention and control groups [six months]

      Impact of hand hygiene activities on the reduction of anaemia prevalence among the children will be assessed

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 College of Health Sciences, Mekelle University Mekelle Tigray Ethiopia

    Sponsors and Collaborators

    • Mekelle University
    • University of Alcala
    • Maastricht University

    Investigators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahmud Abdulkader, PhD fellow and Instructor, Mekelle University
    ClinicalTrials.gov Identifier:
    NCT01619254
    Other Study ID Numbers:
    • AECID
    First Posted:
    Jun 14, 2012
    Last Update Posted:
    Feb 3, 2015
    Last Verified:
    Jan 1, 2015
    Keywords provided by Mahmud Abdulkader, PhD fellow and Instructor, Mekelle University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 3, 2015