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

NCT01085799 | Completed

• 2 other identifiers: GEN-09-214HOA-80064
• Study Type: interventional
• Target: 1,101
• Locations: 1 country
• Sites: 1

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.

Conditions

Infections

Keywords

Educational activities; Cluster-randomized controlled trial; Albendazole; Deworming; School-age children; Peru; Ascaris lumbricoides; Trichuris trichiura; Hookworm; STH infections; Intestinal helminth infections

Outcome Measures

Primary Outcomes (1)

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

  4 months post-deworming

Secondary Outcomes (4)

• 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

Study Arms (2)

Health Education Intervention

EXPERIMENTAL

Groups of schools receiving the health education intervention

Behavioral: Health Education Intervention

Control Schools - Regular curriculum

NO INTERVENTION

Groups of schools not receiving the health education intervention

Interventions

Health Education Intervention BEHAVIORAL

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.

Health Education Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Parents (or guardians) refusing participation of their child.
• Child who refuses to participate.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Asociación Civil Selva Amazónica

Iquitos, Loreto, Peru

Location

MeSH Terms

Conditions

Infections; Trichuriasis; Ancylostomiasis

Condition Hierarchy (Ancestors)

Enoplida Infections; Adenophorea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Hookworm Infections; Strongylida Infections; Secernentea Infections

Study Officials

• Theresa W. Gyorkos, PhD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

• Martín Casapía, MD, MPH

  Asociación Civil Selva Amazónica

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 12, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 16, 2011

Record last verified: 2011-03

Locations

PE (1)