Education Intervention to Reduce Helminth Infections and Absenteeism in Grade 5 School-children
This study has been completed.
Sponsor:
McGill University Health Center
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01085799
First received: March 10, 2010
Last updated: March 15, 2011
Last verified: March 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 10, 2010 | ||||||||
| Last Updated Date | March 15, 2011 | ||||||||
| Start Date ICMJE | April 2010 | ||||||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Soil-transmitted helminth re-infection (Ascaris, Trichuris, or Hookworm). [ Time Frame: 4 months post-deworming ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01085799 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Education Intervention to Reduce Helminth Infections and Absenteeism in Grade 5 School-children | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Infections | ||||||||
| Intervention ICMJE | 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. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 1101 | ||||||||
| Completion Date | October 2010 | ||||||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Peru | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01085799 | ||||||||
| Other Study ID Numbers ICMJE | GEN-09-214, HOA-80064 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Theresa W. Gyorkos, PhD, McGill University | ||||||||
| Study Sponsor ICMJE | McGill University Health Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | McGill University Health Center | ||||||||
| Verification Date | March 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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