Soil-transmitted Helminth Reinfection Rates After Single and Repeated School Hygiene Education

Children, Only Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04227834
• Other study ID #: STH032019
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 4, 2019
• Est. completion date: March 2, 2020

Study information

• Verified date: January 2020
• Source: Universitas Sumatera Utara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 432
• Est. completion date: March 2, 2020
• Est. primary completion date: March 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Ascariasis
• Ascaris Infection
• Children, Only
• Communicable Diseases
• Helminthiasis
• Hookworm Infections
• Infection
• Trichuriasis
• Trichuris Infection

Intervention

Behavioral:
• Health hygiene education
A cartoon video explaining the etiology, risk factors, clinical symptoms, treatment and prevention of helminthiasis were given to the school-aged children

Locations

Country	Name	City	State
Indonesia	Singkuang sub-district, Mandailing Natal district	Panyabungan	North Sumatera

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Sumatera Utara

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effectiveness of repeated health hygiene education on the reinfection rates of STHs among school-aged children	STH prevalence at 12 months	12 months
Secondary	Prevalence of STHs among school-aged children prior to intervention	Ascaris lumbricoides, Trichuris trichiura, hookworm infections at month 0	STH prevalence at month 0
Secondary	Knowledge of STHs prevention measures among school-aged children before and after intervention	A questionnaire used to evaluate the knowledge about STHs prevention	12 months