Co-administration of IVM and ALB in School-based Deworming in Uganda

NCT06497075 | Completed

• 1 other identifier: 2283p
• Study Type: observational
• Target: 8,767
• Locations: 1 country
• Sites: 2

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.

Conditions

Helminthiasis; Intestinal Worms

Keywords

soil-transmitted helminths; ivermectin; deworming; albendazole

Outcome Measures

Primary Outcomes (1)

• Feasibility of IVM + ALB introduction

  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)

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

Secondary Outcomes (3)

• 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 Arms (2)

Albendazole only

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

Drug: 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.

Drug: Albendazole 400mg; Drug: Ivermectin 3 MG

Interventions

Albendazole 400mg DRUG

Single oral dose of Albendazole 400mg tablet

Also known as: Zentel

Albendazole only; Ivermectin and albendazole

Ivermectin 3 MG DRUG

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)

Also known as: Mectizan, Stromectol

Ivermectin and albendazole

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

* 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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jennifer Keiser: lead
• Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health, Uganda: collaborator
• Makerere University: collaborator

Study Sites (2)

Makerere University, College of Humanities and Social Sciences

Kampala, Uganda

Location

Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health

Kampala, Uganda

Location

MeSH Terms

Conditions

Helminthiasis

Interventions

Albendazole; Ivermectin

Condition Hierarchy (Ancestors)

Parasitic Diseases; Infections

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Macrolides; Polyketides; Lactones

Study Officials

• Jennifer Keiser, Prof.

  Swiss Tropical & Public Health Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 11, 2024
• Study Start: July 1, 2024
• Primary Completion: July 16, 2024
• Study Completion: October 19, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

UG (2)