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NCT Number: NCT01619254

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

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.

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Key information

Conditions

Intestinal Parasitic Infections Anaemia Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Health Sciences, Mekelle University

Mek'ele, Tigray, Ethiopia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hand washing with soap and hand finger nail clipping

Behavioral

Assess the impact of hand washing with soap and nail clipping on child health

Other names: Hand washing and finger nails clipping

Primary outcomes

  1. - 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.

  2. - 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Mekelle University

Other

Collaborators

  • Maastricht University
  • University of Alcala

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 14, 2012
Registry last updated
Feb 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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