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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01085799
Recruitment Status : Completed
First Posted : March 12, 2010
Last Update Posted : March 16, 2011
Information provided by:
McGill University Health Center

Brief Summary:
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 or disease Intervention/treatment Phase
Infections Behavioral: Health Education Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Soil-transmitted helminth re-infection (Ascaris, Trichuris, or Hookworm). [ Time Frame: 4 months post-deworming ]

Secondary Outcome Measures :
  1. Absenteeism rate. [ Time Frame: During the first 4 months following deworming ]
  2. Eggs per grams reduction rate. [ Time Frame: 4 months post-deworming ]
  3. Weight gain (kg) [ Time Frame: 4 months post-deworming ]
  4. Height gain (cm) [ Time Frame: 4 months post-deworming ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01085799

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

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Responsible Party: Theresa W. Gyorkos, PhD, McGill University Identifier: NCT01085799     History of Changes
Other Study ID Numbers: GEN-09-214
HOA-80064 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
First Posted: March 12, 2010    Key Record Dates
Last Update Posted: March 16, 2011
Last Verified: March 2011

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

Additional relevant MeSH terms:
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Communicable Diseases
Parasitic Diseases