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

January 10, 2020 updated by: Inke Nadia Diniyanti Lubis, Universitas Sumatera Utara

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

432

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • North Sumatera
      • Panyabungan, North Sumatera, Indonesia
        • Singkuang sub-district, Mandailing Natal district

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Single education
Single health hygiene education
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
Experimental: Repeated education
Four-monthly health hygiene education
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effectiveness of repeated health hygiene education on the reinfection rates of STHs among school-aged children
Time Frame: 12 months
STH prevalence at 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of STHs among school-aged children prior to intervention
Time Frame: STH prevalence at month 0
Ascaris lumbricoides, Trichuris trichiura, hookworm infections at month 0
STH prevalence at month 0
Knowledge of STHs prevention measures among school-aged children before and after intervention
Time Frame: 12 months
A questionnaire used to evaluate the knowledge about STHs prevention
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Sumatera Utara

Investigators

  • Principal Investigator: Rizky KA Nasution, MD, Universitas Sumatera Utara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2019

Primary Completion (Actual)

March 6, 2019

Study Completion (Anticipated)

March 2, 2020

Study Registration Dates

First Submitted

January 4, 2020

First Submitted That Met QC Criteria

January 10, 2020

First Posted (Actual)

January 14, 2020

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 10, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STH032019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Helminthiasis

Clinical Trials on Health hygiene education

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe