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

This study has been completed.
Sponsor:
Collaborators:
University of Alcala
Maastricht University
Information provided by (Responsible Party):
Mahmud Abdulkader, Mekelle University
ClinicalTrials.gov Identifier:
NCT01619254
First received: June 9, 2012
Last updated: April 23, 2013
Last verified: June 2012
  Purpose

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 Intervention
Intestinal Parasitic Infections
Anaemia
Behavioral: Hand washing with soap and hand finger nail clipping

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Mekelle University:

Primary Outcome Measures:
  • - Proportion of intestinal parasitic infection prevalence among intervention and control groups [ Time Frame: six months ] [ Designated as safety issue: No ]
    Impact of hand hygiene activities (as intervention measures) on intestinal parasitic infection prevalence will be assessed.

  • - Proportion of intestinal parasite load (mean eggs per gram) among intervention and control groups [ Time Frame: six months ] [ Designated as safety issue: No ]
    Impact of hand hygiene activities (as intervention measures) on intestinal parasitic infection intensity will be assessed.


Secondary Outcome Measures:
  • Mean (± standard deviation) of haemoglobin concentration rates among intervention and control groups [ Time Frame: six months ] [ Designated as safety issue: No ]
  • Proportion of re-infection rates among the intervention and control group [ Time Frame: six months ] [ Designated as safety issue: No ]
    Impact of hand hygiene activities on the prevention of intestinal parasite re-infection will be assessed

  • Proportion of anaemia prevalence rates among intervention and control groups [ Time Frame: six months ] [ Designated as safety issue: No ]
    Impact of hand hygiene activities on the reduction of anaemia prevalence among the children will be assessed


Enrollment: 365
Study Start Date: July 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Hand washing and finger nails clipping

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.

  Eligibility

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619254

Locations
Ethiopia
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
  More Information

No publications provided

Responsible Party: Mahmud Abdulkader, PhD fellow and Instructor, Mekelle University
ClinicalTrials.gov Identifier: NCT01619254     History of Changes
Other Study ID Numbers: AECID
Study First Received: June 9, 2012
Last Updated: April 23, 2013
Health Authority: Ethiopia: Ethical Review Committee

Keywords provided by Mekelle University:
Intestinal parasitic infections
Anaemia
School-aged children
Hand washing and nail clipping

Additional relevant MeSH terms:
Anemia
Intestinal Diseases, Parasitic
Parasitic Diseases
Hematologic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 15, 2014