Back to resultsSoil-transmitted Helminth Reinfection Rates After Single and Repeated School Hygiene Education
Primary Purpose
Helminthiasis, Ascaris Infection, Trichuris Infection
Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Health hygiene education
Sponsored by
About this trial
This is an interventional prevention trial for Helminthiasis focused on measuring Soil-transmitted helminth, School-aged children, Health hygiene, Education
Eligibility Criteria
Inclusion Criteria:
- Children who are negative for STHs infection on Kato Katz examination following 3 days treatment of albendazole
Exclusion Criteria:
- Parents who refused to participate in the study
- Severe malnutrition
- Co-infected with other helminth infections
Sites / Locations
- Singkuang sub-district, Mandailing Natal district
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Single education
Repeated education
Arm Description
Single health hygiene education
Four-monthly health hygiene education
Outcomes
Primary Outcome Measures
The effectiveness of repeated health hygiene education on the reinfection rates of STHs among school-aged children
STH prevalence at 12 months
Secondary Outcome Measures
Prevalence of STHs among school-aged children prior to intervention
Ascaris lumbricoides, Trichuris trichiura, hookworm infections at month 0
Knowledge of STHs prevention measures among school-aged children before and after intervention
A questionnaire used to evaluate the knowledge about STHs prevention
Full Information
NCT ID
NCT04227834
First Posted
January 4, 2020
Last Updated
January 10, 2020
Sponsor
Universitas Sumatera Utara
1. Study Identification
Unique Protocol Identification Number
NCT04227834
Brief Title
Soil-transmitted Helminth Reinfection Rates After Single and Repeated School Hygiene Education
Official Title
Re-infection Rates of Soil-transmitted Helminth Infections Among School-aged Children Following a Single or a 4-monthly Health Hygiene Education: an Open Label Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
March 6, 2019 (Actual)
Study Completion Date
March 2, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Sumatera Utara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Soil-transmitted helminth (STH) infections caused by Ascaris lumbricoides, Trichuris trichiura, or hookworm, affect approximately 1.5 millions individuals primarily in tropical and subtropical regions. STHs infections have been associated with delay in growth and development in children. The prevalence in Indonesia varied from 45% to 65%, but in poor sanitation areas the prevalence can increased to 80%. World Health Organization currently recommends mass treatment with benzimidazoles and health hygiene education to control the disease. In this study we evaluated the effectiveness of single and four-monthly health hygiene education to STH reinfection rates among school-aged children in Mandailing Natal district, North Sumatera province, Indonesia.
Detailed Description
In this study we evaluate the prevalence of STH among school-aged children using Kato Katz examination prior to enrolment to the study. Two elementary schools in Mandailing Natal district, North Sumatera province, Indonesia have been selected and received either a single or repeated health hygiene education. Preliminary knowledge was also assessed using a questionnaire. Infected children received treatment of albendazole 400 mg for 3 days. Evaluation on reinfection status and STH knowledge is done at 4 month, 8 month and 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helminthiasis, Ascaris Infection, Trichuris Infection, Hookworm Infections, Children, Only
Keywords
Soil-transmitted helminth, School-aged children, Health hygiene, Education
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
432 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single education
Arm Type
Active Comparator
Arm Description
Single health hygiene education
Arm Title
Repeated education
Arm Type
Experimental
Arm Description
Four-monthly health hygiene education
Intervention Type
Behavioral
Intervention Name(s)
Health hygiene education
Intervention Description
A cartoon video explaining the etiology, risk factors, clinical symptoms, treatment and prevention of helminthiasis were given to the school-aged children
Primary Outcome Measure Information:
Title
The effectiveness of repeated health hygiene education on the reinfection rates of STHs among school-aged children
Description
STH prevalence at 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Prevalence of STHs among school-aged children prior to intervention
Description
Ascaris lumbricoides, Trichuris trichiura, hookworm infections at month 0
Time Frame
STH prevalence at month 0
Title
Knowledge of STHs prevention measures among school-aged children before and after intervention
Description
A questionnaire used to evaluate the knowledge about STHs prevention
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children who are negative for STHs infection on Kato Katz examination following 3 days treatment of albendazole
Exclusion Criteria:
Parents who refused to participate in the study
Severe malnutrition
Co-infected with other helminth infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rizky KA Nasution, MD
Organizational Affiliation
Universitas Sumatera Utara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singkuang sub-district, Mandailing Natal district
City
Panyabungan
State/Province
North Sumatera
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Soil-transmitted Helminth Reinfection Rates After Single and Repeated School Hygiene Education
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