NCT01619254

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
365

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2012

Completed
17 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

February 3, 2015

Status Verified

January 1, 2015

Enrollment Period

7 months

First QC Date

June 9, 2012

Last Update Submit

January 31, 2015

Conditions

Keywords

Intestinal parasitic infectionsAnaemiaSchool-aged childrenHand washing and nail clipping

Outcome Measures

Primary Outcomes (2)

  • - Proportion of intestinal parasitic re-infection rates among intervention and control groups

    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

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

    six months

Secondary Outcomes (1)

  • Proportion of anaemia prevalence rates among intervention and control groups

    six months

Study Arms (4)

Hand hygiene

EXPERIMENTAL

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

Behavioral: Hand washing with soap and hand finger nail clipping

Hand finger nail hygiene

EXPERIMENTAL

Hand finger nail clipping activities

Behavioral: Hand washing with soap and hand finger nail clipping

Hand and finger nails hygiene

EXPERIMENTAL

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

Behavioral: Hand washing with soap and hand finger nail clipping

Customary practice

PLACEBO COMPARATOR

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

Interventions

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

Also known as: Hand washing and finger nails clipping
Customary practiceHand and finger nails hygieneHand finger nail hygieneHand hygiene

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Health Sciences, Mekelle University

Mek'ele, Tigray, Ethiopia

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Anemia

Interventions

Hand DisinfectionSoaps

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Hand HygieneHygienePublic HealthEnvironment and Public HealthDetergentsSurface-Active AgentsSpecialty Uses of ChemicalsChemical Actions and UsesHousehold ProductsTechnology, Industry, and Agriculture

Study Officials

  • Mahmud Ab Mahmud, PhD fellow

    College of Health Scieneces, Mekelle University

    PRINCIPAL INVESTIGATOR
  • Roman B Velasco, MD, PhD

    Alcala University, Madrid, Spain

    STUDY DIRECTOR
  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD fellow and Instructor

Study Record Dates

First Submitted

June 9, 2012

First Posted

June 14, 2012

Study Start

July 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

February 3, 2015

Record last verified: 2015-01

Locations