HelminthiasisNCT04227834
Soil-transmitted Helminth Reinfection Rates After Single and Repeated School Hygiene Education
A study testing Health hygiene education in people with Helminthiasis and Ascaris Infection, run by Universitas Sumatera Utara at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Helminthiasis, Ascaris Infection, Trichuris Infection
- What is being tested?
- Health hygiene education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteIndonesia
- Study dates
- 4 Mar 2019to 2 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children who are negative for STHs infection on Kato Katz examination following 3 days treatment of albendazole
Who cannot join
- Parents who refused to participate in the study
- Severe malnutrition
- Co-infected with other helminth infections
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Singkuang sub-district, Mandailing Natal district
Panyabungan, North Sumatera
About this study
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
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.
- Conditions
- Helminthiasis, Ascaris Infection, Trichuris Infection, Hookworm Infections, Children, Only
- Being tested
- Health hygiene education
- Keywords
- Soil-transmitted helminth, School-aged children, Health hygiene, Education
- Medical subject headings
- Helminthiasis, Ascariasis, Trichuriasis, Hookworm Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health hygiene educationBehavioural
A cartoon video explaining the etiology, risk factors, clinical symptoms, treatment and prevention of helminthiasis were given to the school-aged children
| Study group | Role | What they receive |
|---|---|---|
| Single education | Active comparator | Single health hygiene education Receives: Behavioral: Health hygiene education |
| Repeated education | Experimental | Four-monthly health hygiene education Receives: Behavioral: Health hygiene education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of repeated health hygiene education on the reinfection rates of STHs among school-aged children
STH prevalence at 12 months
Measured: 12 months
Secondary outcomes (2)
Prevalence of STHs among school-aged children prior to intervention
Ascaris lumbricoides, Trichuris trichiura, hookworm infections at month 0
Measured: STH prevalence 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start4 Mar 2019
- Primary completion6 Mar 2019
- Study completion2 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HelminthiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Sumatera Utara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inke Nadia Diniyanti Lubis, Universitas Sumatera Utara
- Investigators
- Rizky KA Nasution, MD, Principal investigator, Universitas Sumatera Utara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227834
- Sponsor's protocol ID
- STH032019
- Status last verified
- Jan 2020
- First submitted
- 4 Jan 2020
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04227834
- Acronym / sponsor ID
- STH032019
- Conditions
- Helminthiasis, Ascaris Infection, Trichuris Infection, Hookworm Infections, Children, Only
- Keywords
- Soil-transmitted helminth, School-aged children, Health hygiene, Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- Universitas Sumatera UtaraUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 2 Mar 2020 (estimated)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single education | Active comparator | Behavioral: Health hygiene educationSingle health hygiene education |
| Repeated education | Experimental | Behavioral: Health hygiene educationFour-monthly health hygiene education |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children who are negative for STHs infection on Kato Katz examination following 3 days treatment of albendazole
Key exclusion criteria (3 listed)
- Parents who refused to participate in the study
- Severe malnutrition
- Co-infected with other helminth infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health hygiene educationA cartoon video explaining the etiology, risk factors, clinical symptoms, treatment and prevention of helminthiasis were given to the school-aged children | Behavioural | Repeated education, Single education |
Primary outcome
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
2 secondary outcomes
Prevalence of STHs among school-aged children prior to intervention
Time frame: STH prevalence at month 0
Knowledge of STHs prevention measures among school-aged children before and after intervention
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rizky KA Nasution, MD principal investigator
Universitas Sumatera Utara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health hygiene education in people with Helminthiasis and Ascaris Infection, run by Universitas Sumatera Utara at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effectiveness of repeated health hygiene education on the reinfection rates of STHs among school-aged children (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.