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

This study has been completed.
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01085799
First received: March 10, 2010
Last updated: March 15, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention
Infections
 Behavioral: Health Education Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Soil-transmitted helminth re-infection (Ascaris, Trichuris, or Hookworm). [ Time Frame: 4 months post-deworming ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absenteeism rate. [ Time Frame: During the first 4 months following deworming ] [ Designated as safety issue: No ]
  • Eggs per grams reduction rate. [ Time Frame: 4 months post-deworming ] [ Designated as safety issue: No ]
  • Weight gain (kg) [ Time Frame: 4 months post-deworming ] [ Designated as safety issue: No ]
  • Height gain (cm) [ Time Frame: 4 months post-deworming ] [ Designated as safety issue: No ]

Estimated Enrollment: 1101
Study Start Date: April 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085799

Locations
Peru
Asociación Civil Selva Amazónica
Iquitos, Loreto, Peru
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Theresa W. Gyorkos, PhD McGill University Health Center
Study Director: Martín Casapía, MD, MPH Asociación Civil Selva Amazónica
  More Information

No publications provided

Responsible Party: Theresa W. Gyorkos, PhD, McGill University
ClinicalTrials.gov Identifier: NCT01085799     History of Changes
Other Study ID Numbers: GEN-09-214, HOA-80064
Study First Received: March 10, 2010
Last Updated: March 15, 2011
Health Authority: Canada: Ethics Review Committee
Peru: Ethics Committee

Keywords provided by McGill University Health Center:
Educational activities
Cluster-randomized controlled trial
Albendazole
Deworming
School-age children
Peru
 Ascaris lumbricoides
Trichuris trichiura
Hookworm
STH infections
Intestinal helminth infections

Additional relevant MeSH terms:
Helminthiasis
Parasitic Diseases

ClinicalTrials.gov processed this record on May 23, 2013