Education Intervention to Reduce Helminth Infections and Absenteeism in Grade 5 School-children

March 15, 2011 updated by: McGill University Health Centre/Research Institute of the McGill University Health Centre

Effectiveness of a Post-deworming Education Intervention to Reduce Soil-transmitted Helminth Infections and Absenteeism in Grade 5 School-children in a Community of Extreme Poverty, Peruvian Amazon

To efficiently control soil-transmitted helminths (Ascaris, Trichuris, and hookworm), WHO, PAHO, and others recommend the inclusion of an education strategy in school-based deworming programs. However, the effectiveness of such a strategy on the rate of STH re-infection and on education indicators, such as absenteeism, remains to be fully understood. The proposed research aims to evaluate the effectiveness of a post-deworming education intervention targeted to Grade 5 school children enrolled in Belén's schools using a cluster-randomized trial design. Results will be used to inform school-based deworming programs in Peru and other similar endemic areas in Latin America and, indeed, around the world.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1101

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

  • Peru
    • Loreto
      • Iquitos, Loreto, Peru
        • Asociación Civil Selva Amazónica

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Girls and boys enrolled in Grade 5 in eligible schools located in the Belén district of Iquitos, Peru. Eligible schools have a minimum of 10 boys and 10 girls enrolled in grade 5.
  • Informed written consent obtained from the parents or legal guardian of the child.
  • Verbal assent from child.

Exclusion Criteria:

  • Parents (or guardians) refusing participation of their child.
  • Child who refuses to participate.

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Health Education Intervention
Groups of schools receiving the health education intervention
Behavioral: Health Education Intervention
This is a health hygiene education strategy which encourages the pro-active role of both teachers and students and changes in attitudes and practices with the aim of keeping the level of parasite infection low, through increased knowledge.
No Intervention: Control Schools - Regular curriculum
Groups of schools not receiving the health education intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Soil-transmitted helminth re-infection (Ascaris, Trichuris, or Hookworm).
Time Frame: 4 months post-deworming
4 months post-deworming

Secondary Outcome Measures

Outcome Measure
Time Frame
Absenteeism rate.
Time Frame: During the first 4 months following deworming
During the first 4 months following deworming
Eggs per grams reduction rate.
Time Frame: 4 months post-deworming
4 months post-deworming
Weight gain (kg)
Time Frame: 4 months post-deworming
4 months post-deworming
Height gain (cm)
Time Frame: 4 months post-deworming
4 months post-deworming

Collaborators and Investigators

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

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

  • Principal Investigator: Theresa W. Gyorkos, PhD, McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Study Director: Martín Casapía, MD, MPH, Asociación Civil Selva Amazónica

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

April 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

March 10, 2010

First Submitted That Met QC Criteria

March 11, 2010

First Posted (Estimate)

March 12, 2010

Study Record Updates

Last Update Posted (Estimate)

March 16, 2011

Last Update Submitted That Met QC Criteria

March 15, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEN-09-214
  • HOA-80064 (Other Grant/Funding Number: Canadian Institutes of Health Research)

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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