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Clinical Trials/NCT06497075
NCT06497075
Completed
Not Applicable

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

Jennifer Keiser2 sites in 1 country8,767 target enrollmentJuly 1, 2024

Overview

Phase
Not Applicable
Intervention
Albendazole 400mg
Conditions
Helminthiasis
Sponsor
Jennifer Keiser
Enrollment
8767
Locations
2
Primary Endpoint
Feasibility of IVM + ALB introduction
Status
Completed
Last Updated
last year

Overview

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 10,000 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 (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.
Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
October 19, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Jennifer Keiser
Responsible Party
Sponsor Investigator
Principal Investigator

Jennifer Keiser

Prof. Dr.

Swiss Tropical & Public Health Institute

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Albendazole only

Schoolchildren aged 5-14 years of 10 schools randomized to receive the standard deworming treatment of a single dose of albendazole 400mg.

Intervention: Albendazole 400mg

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.

Intervention: Albendazole 400mg

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.

Intervention: Ivermectin 3 MG

Outcomes

Primary Outcomes

Feasibility of IVM + ALB introduction

Time Frame: Documentation before, during and up to 12 weeks after the drug distribution

Feasibility will be assessed using quantitative and qualitative data sources for the following performance and process indicators: * Reported therapeutic coverage (proportion) * Programme reach (proportion) * Compliance rate (children that ingested drugs divided by the total number of children who got offered the drugs) * Reasons for not offering the drugs (non-eligibility) * Reasons for not swallowing the drugs (refusal) * Reported safety: Number, type and severity of adverse events recorded * Incremental time needs for IVM-ALB co-administration * Additional training needs * Incremental staff needs * Drug logistics (tablet balance) Short and structured training evaluation questionnaires will be administered to teachers and health workers directly after training and cover aspects on (i) drug dosing including dose-pole utilization, (ii) identification of non-eligible populations, (iii) documentation processes and (iv) drug information (including safety)

Secondary Outcomes

  • Acceptability and barriers & enablers to introduction of IVM-ALB co-administration (recipient perspective)(1-2 weeks after drug distribution)
  • Potential incremental costs related to IVM-ALB co-administration(Documentation before, during and up to 12 weeks after the drug distribution)
  • Acceptability and barriers & enablers to introduction of IVM-ALB co-administration (provider perspective)(1-2 weeks after drug distribution)

Study Sites (2)

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