Back to resultsEducation Intervention to Reduce Helminth Infections and Absenteeism in Grade 5 School-children
Primary Purpose
Infections
Status
Completed
Phase
Not Applicable
Locations
Peru
Study Type
Interventional
Intervention
Health Education Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Infections focused on measuring Educational activities, Cluster-randomized controlled trial, Albendazole, Deworming, School-age children, Peru, Ascaris lumbricoides, Trichuris trichiura, Hookworm, STH infections, Intestinal helminth infections
Eligibility 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.
Sites / Locations
- Asociación Civil Selva Amazónica
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Health Education Intervention
Control Schools - Regular curriculum
Arm Description
Groups of schools receiving the health education intervention
Groups of schools not receiving the health education intervention
Outcomes
Primary Outcome Measures
Soil-transmitted helminth re-infection (Ascaris, Trichuris, or Hookworm).
Secondary Outcome Measures
Absenteeism rate.
Eggs per grams reduction rate.
Weight gain (kg)
Height gain (cm)
Full Information
NCT ID
NCT01085799
First Posted
March 10, 2010
Last Updated
March 15, 2011
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
1. Study Identification
Unique Protocol Identification Number
NCT01085799
Brief Title
Education Intervention to Reduce Helminth Infections and Absenteeism in Grade 5 School-children
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 Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections
Keywords
Educational activities, Cluster-randomized controlled trial, Albendazole, Deworming, School-age children, Peru, Ascaris lumbricoides, Trichuris trichiura, Hookworm, STH infections, Intestinal helminth infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1101 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Health Education Intervention
Arm Type
Experimental
Arm Description
Groups of schools receiving the health education intervention
Arm Title
Control Schools - Regular curriculum
Arm Type
No Intervention
Arm Description
Groups of schools not receiving the health education intervention
Intervention Type
Behavioral
Intervention Name(s)
Health Education Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Soil-transmitted helminth re-infection (Ascaris, Trichuris, or Hookworm).
Time Frame
4 months post-deworming
Secondary Outcome Measure Information:
Title
Absenteeism rate.
Time Frame
During the first 4 months following deworming
Title
Eggs per grams reduction rate.
Time Frame
4 months post-deworming
Title
Weight gain (kg)
Time Frame
4 months post-deworming
Title
Height gain (cm)
Time Frame
4 months post-deworming
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa W. Gyorkos, PhD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martín Casapía, MD, MPH
Organizational Affiliation
Asociación Civil Selva Amazónica
Official's Role
Study Director
Facility Information:
Facility Name
Asociación Civil Selva Amazónica
City
Iquitos
State/Province
Loreto
Country
Peru
12. IPD Sharing Statement
Learn more about this trial
Education Intervention to Reduce Helminth Infections and Absenteeism in Grade 5 School-children
We'll reach out to this number within 24 hrs