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Status unknownNCT04227834Updated Jan 14, 2020

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

An interventional study of Health hygiene education in Helminthiasis, Ascaris Infection and Trichuris Infection, sponsored by Universitas Sumatera Utara. Status unknown at 1 site in Indonesia. Open to participants aged 6 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-14.

Sponsored by Universitas Sumatera Utara · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Mar 2019, registered Jan 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
432
Allocation
Non-randomized
Ages
6 Years to 15 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Helminthiasis
  • Ascaris Infection
  • Trichuris Infection
  • Hookworm Infections
  • Children, Only

Keywords

  • Soil-transmitted helminth
  • School-aged children
  • Health hygiene
  • Education
03

In context

Helminthiasis

37 studies on the registry are indexed under Helminthiasis; 2 are open to participants now.

This study's planned enrollment of 432 is above the median of 326 across 29 interventional studies indexed under Helminthiasis.

Browse Helminthiasis studies →

Lead sponsor

Universitas Sumatera Utara is the lead sponsor of 24 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Parents who refused to participate in the study
  • Severe malnutrition
  • Co-infected with other helminth infections
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
432 participants (estimated)

Study arms

  • Active comparator
    Single education

    Single health hygiene education

    Behavioral: Health hygiene education

  • Experimental
    Repeated education

    Four-monthly health hygiene education

    Behavioral: Health hygiene education

Interventions

  • BehavioralHealth hygiene education

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

06

What researchers measure

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

    Time frame: 12 months

Secondary outcomes

  1. Prevalence of STHs among school-aged children prior to intervention

    Ascaris lumbricoides, Trichuris trichiura, hookworm infections at month 0

    Time frame: STH prevalence at month 0

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

    A questionnaire used to evaluate the knowledge about STHs prevention

    Time frame: 12 months

07

Study locations

1 site
  • Singkuang sub-district, Mandailing Natal district
    Panyabungan, North Sumatera, Indonesia
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2019 to primary completion in Mar 2019, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 4, 2020
First posted
Jan 14, 2020
StartActual
Mar 4, 2019
Primary completionActual
Mar 6, 2019
CompletionEst.
Mar 2, 2020
Last update
Jan 14, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04227834
Lead sponsor
Universitas Sumatera Utara
Responsible party
Inke Nadia Diniyanti Lubis (Head of Tropical Medicine Master Programme, Universitas Sumatera Utara) — Principal investigator
First posted
Jan 14, 2020
Start date
Mar 4, 2019
Primary completion
Mar 6, 2019
Completion
Mar 2, 2020 (estimated)
Last update
Jan 14, 2020

Study contacts

Rizky KA Nasution, MD
principal investigator · Universitas Sumatera Utara

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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