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

Study 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.

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

Conditions
-----------------
Infections

Intervention / Treatment
-----------------
* Behavioral: Health Education Intervention


Participation Criteria
=================
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Education Intervention<br>Groups of schools receiving the health education intervention | Behavioral: Health Education Intervention<br>* 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.<br>|
| No Intervention: Control Schools - Regular curriculum<br>Groups of schools not receiving the health education intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soil-transmitted helminth re-infection (Ascaris, Trichuris, or Hookworm). |  | 4 months post-deworming | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Educational activities, Cluster-randomized controlled trial, Albendazole, Deworming, School-age children, Peru, Ascaris lumbricoides, Trichuris trichiura, Hookworm, STH infections, Intestinal helminth infections