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

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

Interventions

DRUG

Albendazole 400mg

Single oral dose of Albendazole 400mg tablet

DRUG

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)

Sponsors & Collaborators

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

  collaborator UNKNOWN

• Makerere University

  collaborator OTHER

• Jennifer Keiser

  lead OTHER

Principal Investigators

• Jennifer Keiser, Prof. · Swiss Tropical & Public Health Institute

Eligibility

Min Age

5 Years

Max Age

14 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-07-01

Primary Completion

2024-07-16

Completion

2024-10-19

Countries

• Uganda

Study Locations