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

January 31, 2015 updated by: Mahmud Abdulkader, Mekelle University

Hand Hygiene Promotion Activities: Effect on Intestinal Parasitic Infections and Anaemia Among School-aged Children in Eastern Tigray, Ethiopia: a Factorial Randomised Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

365

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 Locations

  • Ethiopia
    • Tigray
      • Mekelle, Tigray, Ethiopia
        • College of Health Sciences, Mekelle University

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

6 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- Proportion of intestinal parasitic re-infection rates among intervention and control groups
Time Frame: six months
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
Time Frame: six months
Impact of hand hygiene activities (as intervention measures) on intestinal parasitic infection intensity will be assessed.
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of anaemia prevalence rates among intervention and control groups
Time Frame: six months
Impact of hand hygiene activities on the reduction of anaemia prevalence among the children will be assessed
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mekelle University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

June 9, 2012

First Submitted That Met QC Criteria

June 13, 2012

First Posted (Estimate)

June 14, 2012

Study Record Updates

Last Update Posted (Estimate)

February 3, 2015

Last Update Submitted That Met QC Criteria

January 31, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AECID

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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