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Clinical Trials/NCT01085799
NCT01085799
Completed
Not Applicable

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

McGill University Health Centre/Research Institute of the McGill University Health Centre1 site in 1 country1,101 target enrollmentStarted: April 2010Last updated:
ConditionsInfections

Overview

Phase
Not Applicable
Status
Completed
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Enrollment
1,101
Locations
1
Primary Endpoint
Soil-transmitted helminth re-infection (Ascaris, Trichuris, or Hookworm).

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Sex
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
  • 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.

Outcomes

Primary Outcomes

Soil-transmitted helminth re-infection (Ascaris, Trichuris, or Hookworm).

Time Frame: 4 months post-deworming

Secondary Outcomes

  • Absenteeism rate.(During the first 4 months following deworming)
  • Eggs per grams reduction rate.(4 months post-deworming)
  • Weight gain (kg)(4 months post-deworming)
  • Height gain (cm)(4 months post-deworming)

Investigators

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor Class
Other

Study Sites (1)

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