InfectionsNCT01085799
Education Intervention to Reduce Helminth Infections and Absenteeism in Grade 5 School-children
A study testing Health Education Intervention in people with Infections, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Peru.
Trial summary
To efficiently control soil-transmitted helminths (Ascaris, Trichuris, and hookworm), WHO, PAHO, and others recommend the inclusion of an education strategy in school-based deworming programs. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infections
- What is being tested?
- Health Education Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,101 participants
- Where
- 1 sitePeru
- Study dates
- Apr 2010to Oct 2010
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Girls and boys enrolled in Grade 5 in eligible schools located in the Belén district of Iquitos, Peru. Eligible schools have a minimum of 10 boys and 10 girls enrolled in grade 5.
- Informed written consent obtained from the parents or legal guardian of the child.
- Verbal assent from child.
Who cannot join
- Parents (or guardians) refusing participation of their child.
- Child who refuses to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Post-deworming Education Intervention to Reduce Soil-transmitted Helminth Infections and Absenteeism in Grade 5 School-children in a Community of Extreme Poverty, Peruvian Amazon
To efficiently control soil-transmitted helminths (Ascaris, Trichuris, and hookworm), WHO, PAHO, and others recommend the inclusion of an education strategy in school-based deworming programs. However, the effectiveness of such a strategy on the rate of STH re-infection and on education indicators, such as absenteeism, remains to be fully understood. The proposed research aims to evaluate the effectiveness of a post-deworming education intervention targeted to Grade 5 school children enrolled in Belén's schools using a cluster-randomized trial design. Results will be used to inform school-based deworming programs in Peru and other similar endemic areas in Latin America and, indeed, around the world.
- Conditions
- Infections
- Being tested
- Health Education Intervention
- Keywords
- Educational activities, Cluster-randomized controlled trial, Albendazole, Deworming, School-age children, Peru, Ascaris lumbricoides, Trichuris trichiura, Hookworm, STH infections, Intestinal helminth infections
- Medical subject headings
- Infections, Trichuriasis, Ancylostomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Education InterventionBehavioural
This is a health hygiene education strategy which encourages the pro-active role of both teachers and students and changes in attitudes and practices with the aim of keeping the level of parasite infection low, through increased knowledge.
| Study group | Role | What they receive |
|---|---|---|
| Health Education Intervention | Experimental | Groups of schools receiving the health education intervention Receives: Behavioral: Health Education Intervention |
| Control Schools - Regular curriculum | No intervention | Groups of schools not receiving the health education intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soil-transmitted helminth re-infection (Ascaris, Trichuris, or Hookworm).
Measured: 4 months post-deworming
Secondary outcomes (4)
Absenteeism rate.
Measured: During the first 4 months following deworming
Eggs per grams reduction rate.
Measured: 4 months post-deworming
Weight gain (kg)
Measured: 4 months post-deworming
Height gain (cm)
Measured: 4 months post-deworming
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Investigators
- Theresa W. Gyorkos, PhD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreMartín Casapía, MD, MPH, Study director, Asociación Civil Selva Amazónica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085799
- Sponsor's protocol ID
- GEN-09-214
- Other IDs
- HOA-80064
- Status last verified
- Mar 2011
- First submitted
- 10 Mar 2010
- Last updated
- 16 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Post-deworming Education Intervention to Reduce Soil-transmitted Helminth Infections and Absenteeism in Grade 5 School-children in a Community of Extreme Poverty, Peruvian Amazon
- ClinicalTrials.gov ID
- NCT01085799
- Acronym / sponsor ID
- GEN-09-214
- Conditions
- Infections
- Keywords
- Educational activities, Cluster-randomized controlled trial, Albendazole, Deworming, School-age children, Peru, Ascaris lumbricoides, Trichuris trichiura
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,101 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 12 Mar 2010 (estimated)
- 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.
To efficiently control soil-transmitted helminths (Ascaris, Trichuris, and hookworm), WHO, PAHO, and others recommend the inclusion of an education strategy in school-based deworming programs. However, the effectiveness of such a strategy on the rate of STH re-infection and on education indicators, such as absenteeism, remains to be fully understood. The proposed research aims to evaluate the effectiveness of a post-deworming education intervention targeted to Grade 5 school children enrolled in Belén's schools using a cluster-randomized trial design. Results will be used to inform school-based deworming programs in Peru and other similar endemic areas in Latin America and, indeed, around the world.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Education Intervention | Experimental | Behavioral: Health Education InterventionGroups of schools receiving the health education intervention |
| Control Schools - Regular curriculum | No intervention | –Groups of schools not receiving the health education intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Girls and boys enrolled in Grade 5 in eligible schools located in the Belén district of Iquitos, Peru. Eligible schools have a minimum of 10 boys and 10 girls enrolled in grade 5.
- Informed written consent obtained from the parents or legal guardian of the child.
- Verbal assent from child.
Key exclusion criteria (2 listed)
- Parents (or guardians) refusing participation of their child.
- Child who refuses to participate.
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 Education InterventionThis is a health hygiene education strategy which encourages the pro-active role of both teachers and students and changes in attitudes and practices with the aim of keeping the level of parasite infection low, through increased knowledge. | Behavioural | Health Education Intervention |
Primary outcome
Soil-transmitted helminth re-infection (Ascaris, Trichuris, or Hookworm).
Time frame: 4 months post-deworming
4 secondary outcomes
Absenteeism rate.
Time frame: During the first 4 months following deworming
Eggs per grams reduction rate.
Time frame: 4 months post-deworming
Weight gain (kg)
Time frame: 4 months post-deworming
Height gain (cm)
Time frame: 4 months post-deworming
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2011.
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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.
Theresa W. Gyorkos, PhD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Martín Casapía, MD, MPH study director
Asociación Civil Selva Amazónica
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 Education Intervention in people with Infections, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Peru.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 16 Mar 2011. 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 Peru. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Soil-transmitted helminth re-infection (Ascaris, Trichuris, or Hookworm). (time frame: 4 months post-deworming). 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 16 Mar 2011.