Ignite Creation Date:
2024-07-17 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497075
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-26
Brief Title:
Co-administration of IVM and ALB in School-based Deworming in Uganda
Sponsor:
Jennifer Keiser
Organization:
Swiss Tropical Public Health Institute
Study Overview
Official Title:
The Feasibility and Acceptability of the Co-administration of Ivermectin and Albendazole Vs Albendazole Alone in the Frame of Mass Drug Administration to School-aged Children in Uganda a Small-scale Implementation Pilot Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FACE-ITpilot
Brief Summary:
The goal of this small-scale implementation research pilot study is to assess the feasibility and acceptability of the co-administration of ivermectin IVM and albendazole ALB compared to albendazole alone during school-based mass drug administration in Uganda The study will target up to 10000 school-aged children from 20 schools in Kabale and Kisoro districts in South-Western Uganda
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 eg 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 200µgkg 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
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 eg 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 200µgkg 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None