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

Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085799
• Other study ID #: GEN-09-214
• Secondary ID: HOA-80064
• Status: Completed
• Phase: N/A
• First received: March 10, 2010
• Last updated: March 15, 2011
• Start date: April 2010
• Est. completion date: October 2010

Study information

• Verified date: March 2011
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteePeru: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1101
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Helminthiasis
• Infection
• Infections

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.

Locations

Country	Name	City	State
Peru	Asociación Civil Selva Amazónica	Iquitos	Loreto

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soil-transmitted helminth re-infection (Ascaris, Trichuris, or Hookworm).		4 months post-deworming	No
Secondary	Absenteeism rate.		During the first 4 months following deworming	No
Secondary	Eggs per grams reduction rate.		4 months post-deworming	No
Secondary	Weight gain (kg)		4 months post-deworming	No
Secondary	Height gain (cm)		4 months post-deworming	No