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

NCT ID: NCT01619254

Last Updated: 2015-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

365 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-02-28

Brief Summary

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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

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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.

Conditions

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Intestinal Parasitic Infections Anaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Hand hygiene

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

Group Type EXPERIMENTAL

Hand washing with soap and hand finger nail clipping

Intervention Type BEHAVIORAL

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

Hand finger nail hygiene

Hand finger nail clipping activities

Group Type EXPERIMENTAL

Hand washing with soap and hand finger nail clipping

Intervention Type BEHAVIORAL

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

Hand and finger nails hygiene

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

Group Type EXPERIMENTAL

Hand washing with soap and hand finger nail clipping

Intervention Type BEHAVIORAL

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

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)

Group Type PLACEBO_COMPARATOR

Hand washing with soap and hand finger nail clipping

Intervention Type BEHAVIORAL

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

Interventions

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Hand washing with soap and hand finger nail clipping

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Hand washing and finger nails clipping

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alcala

OTHER

Sponsor Role collaborator

Maastricht University

OTHER

Sponsor Role collaborator

Mekelle University

OTHER

Sponsor Role lead

Responsible Party

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Mahmud Abdulkader

PhD fellow and Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmud Ab Mahmud, PhD fellow

Role: PRINCIPAL_INVESTIGATOR

College of Health Scieneces, Mekelle University

Roman B Velasco, MD, PhD

Role: STUDY_DIRECTOR

Alcala University, Madrid, Spain

Mark Spigt, MSC, PhD

Role: STUDY_CHAIR

Maastricht University, The Netherlands

Afework M Bezabeh, MSC, PhD

Role: STUDY_CHAIR

College of Health Sciences, Mekelle University

Geert J Dinant, Professor

Role: STUDY_CHAIR

Maastricht University, The Netherlands

Locations

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College of Health Sciences, Mekelle University

Mek'ele, Tigray, Ethiopia

Site Status

Countries

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Ethiopia

References

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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.

Reference Type DERIVED
PMID: 31898526 (View on PubMed)

Other Identifiers

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AECID

Identifier Type: -

Identifier Source: org_study_id

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