NCT04227834

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
432

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2019

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2020

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

2 days

First QC Date

January 4, 2020

Last Update Submit

January 10, 2020

Conditions

Keywords

Soil-transmitted helminthSchool-aged childrenHealth hygieneEducation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Prevalence of STHs among school-aged children prior to intervention

    STH prevalence at month 0

  • Knowledge of STHs prevention measures among school-aged children before and after intervention

    12 months

Study Arms (2)

Single education

ACTIVE COMPARATOR

Single health hygiene education

Behavioral: Health hygiene education

Repeated education

EXPERIMENTAL

Four-monthly health hygiene education

Behavioral: Health hygiene education

Interventions

A cartoon video explaining the etiology, risk factors, clinical symptoms, treatment and prevention of helminthiasis were given to the school-aged children

Repeated educationSingle education

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children who are negative for STHs infection on Kato Katz examination following 3 days treatment of albendazole

You may not qualify if:

  • Parents who refused to participate in the study
  • Severe malnutrition
  • Co-infected with other helminth infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singkuang sub-district, Mandailing Natal district

Panyabungan, North Sumatera, Indonesia

Location

MeSH Terms

Conditions

HelminthiasisAscariasisTrichuriasisHookworm Infections

Condition Hierarchy (Ancestors)

Parasitic DiseasesInfectionsAscaridida InfectionsSecernentea InfectionsNematode InfectionsEnoplida InfectionsAdenophorea InfectionsStrongylida Infections

Study Officials

  • Rizky KA Nasution, MD

    Universitas Sumatera Utara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Tropical Medicine Master Programme

Study Record Dates

First Submitted

January 4, 2020

First Posted

January 14, 2020

Study Start

March 4, 2019

Primary Completion

March 6, 2019

Study Completion

March 2, 2020

Last Updated

January 14, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations