Co-administration of IVM and ALB in School-based Deworming in Uganda
NCT ID: NCT06497075
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
8767 participants
OBSERVATIONAL
2024-07-01
2024-10-19
Brief Summary
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The main questions it aims to answer are:
* How feasible is the introduction of co-administered IVM plus ALB in the routine school-based deworming campaign in terms of training, material and processes?
* How well do beneficiary communities (pupils, parents) and implementers (teachers, health workers) accept the new treatment scheme and what are potential barriers and enablers for uptake?
* What are common implementation-related costs that can inform the methodology to estimate monetary and non-monetary costs as well as performance of the two treatment arms for the future cost-effectiveness analysis?
The study employs a cross-sectional mixed-method design (we will collect qualitative and quantitative data) to evaluate the feasibility and acceptability of co-administering IVM and ALB versus ALB alone in routine school-based mass drug administration. Assessments will take place during and after the drug distribution to document the implementation process and evaluate experiences made by the different stakeholders (e.g. children, parents, teachers, health workers):
* The implementation activities start with a training of all implementers at district level who will also undergo a pre- and post-training knowledge assessment.
* Schoolchildren aged 5-14 years will receive a single dose of ALB alone or co-administered ALb (400mg) and IVM (200µg/kg; as determined by height category on a dose pole) by health workers at school. 1-2 weeks post-distribution a subsample of 19 children per school will be invited to answer to questionnaires administered by social science researchers.
* Implementers will administer the treatments and document all distribution-related aspects during the campaign under supervision of the routine staff. Researchers will conduct additional monitoring and evaluation in order to assure data quality and provide support in performance assessment and cost evaluation.
* Beneficiaries (parents) and implementers will be asked to take part in focus group discussions and questionnaire interviews one week after the drug distribution.
Detailed Description
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Conditions
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Keywords
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
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Albendazole only
Schoolchildren aged 5-14 years of 10 schools randomized to receive the standard deworming treatment of a single dose of albendazole 400mg.
Albendazole 400mg
Single oral dose of Albendazole 400mg tablet
Ivermectin and albendazole
Schoolchildren aged 5-14 years of 10 schools randomized to receive the combination treatment of a single dose of ivermectin 200ug/kg (according to height category using a dose-pole) plus albendazole 400mg.
Albendazole 400mg
Single oral dose of Albendazole 400mg tablet
Ivermectin 3 MG
Generic ivermectin 3mg tablets given as a single oral dose of 200ug/kg using a dose-pole (height categories: 90-119 cm: 1 tablet , 120-140 cm: 2 tablets, 141-158 cm: 3 tablets or \> 158 cm: 4 tablets)
Interventions
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Albendazole 400mg
Single oral dose of Albendazole 400mg tablet
Ivermectin 3 MG
Generic ivermectin 3mg tablets given as a single oral dose of 200ug/kg using a dose-pole (height categories: 90-119 cm: 1 tablet , 120-140 cm: 2 tablets, 141-158 cm: 3 tablets or \> 158 cm: 4 tablets)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent from the participant's parents/caretakers and assent (for children aged 8 years and older) from the participant him/herself or written informed consent from the school teacher (for children attending schools receiving routine albendazole deworming)
* No signs of major acute or chronic illness
* No known allergy to study medication (i.e. benzimidazoles or ivermectin)
5 Years
14 Years
ALL
Yes
Sponsors
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Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health, Uganda
UNKNOWN
Makerere University
OTHER
Jennifer Keiser
OTHER
Responsible Party
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Jennifer Keiser
Prof. Dr.
Principal Investigators
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Jennifer Keiser, Prof.
Role: PRINCIPAL_INVESTIGATOR
Swiss Tropical & Public Health Institute
Locations
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Makerere University, College of Humanities and Social Sciences
Kampala, , Uganda
Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health
Kampala, , Uganda
Countries
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Other Identifiers
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2283p
Identifier Type: -
Identifier Source: org_study_id