Clinical trial NCT06497075: Co-administration of IVM and ALB in School-based Deworming in Uganda
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helminthiasis
Intestinal Worms
Keywords: soil-transmitted helminths
ivermectin
deworming
albendazole
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health, Uganda
name: Makerere University
First posted: 2024-07-11
Enrollment: 8767
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Study population receiving intervention: All eligible school-aged children (5-14 years) from 20 pre-selected schools present in the school at the day of the treatment campaign, will be treated with the respective single or combination treatment regimen depending on the treatment arm under which the schools fall.
* Study population of post-distribution social science study: Subsamples of treated schoolchildren, parents of school-aged children of the respective study schools, teachers involved in distribution, health workers involved in distribution.

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.


Eligibility criteria: * School-aged children (5-14 years) of the selected schools
* 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)

Primary outcomes:
measure: Feasibility of IVM + ALB introduction
timeFrame: Documentation before, during and up to 12 weeks after the drug distribution
Secondary outcomes:
measure: Acceptability and barriers & enablers to introduction of IVM-ALB co-administration (recipient perspective)
timeFrame: 1-2 weeks after drug distribution
measure: Potential incremental costs related to IVM-ALB co-administration
timeFrame: Documentation before, during and up to 12 weeks after the drug distribution
measure: Acceptability and barriers & enablers to introduction of IVM-ALB co-administration (provider perspective)
timeFrame: 1-2 weeks after drug distribution
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Makerere University, College of Humanities and Social Sciences
city: Kampala
country: Uganda
facility: Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health
Study officials:
affiliation: Swiss Tropical & Public Health Institute
name: Jennifer Keiser, Prof.
role: PRINCIPAL_INVESTIGATOR
References: