An observational study in Helminthiasis and Intestinal Worms, sponsored by Jennifer Keiser. Completed at 2 sites in Uganda. Open to participants aged 5 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-20.
Sponsored by Jennifer Keiser · Observational
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:
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):
37 studies on the registry are indexed under Helminthiasis; 2 are open to participants now.
Browse Helminthiasis studies →Jennifer Keiser is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Single oral dose of Albendazole 400mg tablet
Also known as: Zentel
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
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)
Time frame: Documentation before, during and up to 12 weeks after the drug distribution
Acceptability and barriers & enablers to introduction of IVM-ALB co-administration (recipient perspective)
Qualitative data on acceptability of the intervention from a recipient perspective (parents) will be collected trough FGDs that will cover: * Current knowledge about STHs: transmission, health impact, prevention and treatment * Prior knowledge of MDA activities and related experiences * Potential enabling factors for willingness of parents to let their children participate in MDA * Potential barriers for acceptance of parents for their child's participation in MDA Quantitative data on acceptability of the intervention from a recipient perspective (schoolchildren) will be collected through structured interviews using Likert scale questions (5-point scale from strongly disagree to strongly agree) and cover aspects on: * Attitudes towards treatment * Convenience of taking the treatment * Self-reported willingness and understanding for need of treatment * Self-reported satisfaction with the treatment and procedures of the campaign
Time frame: 1-2 weeks after drug distribution
Potential incremental costs related to IVM-ALB co-administration
The following cost components related to the activities required to implement the interventions will be included in the analysis: * Medicine Procurement and Distribution: Costs associated with purchasing and distributing albendazole and ivermectin. * Stationary and Supplies: Costs related to necessary materials for documentation and record-keeping. * Transport: Costs involved in transporting medicines and supplies to the designated MDA locations. * Allowances: Allowances provided to personnel involved in the implementation. * Training Costs: Expenses associated with training personnel on the co-administration protocol. * Personnel Time: Costs of personnel time dedicated to delivering interventions.
Time frame: 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)
Qualitative data on acceptability of the intervention from a provider perspective (teachers and health workers) will be collected trough FGDs and KIIs and will cover: * Current knowledge about STHs: transmission, health impact, prevention and treatment * Prior involvement in any MDA activities and related experiences * Post-distribution training evaluation * Potential enabling factors for willingness and barriers for acceptance of parents to let their children participate in MDA Quantitative data on acceptability of the intervention from a provider perspective will be collected through structured interviews using Likert scale questions (5-point scale from strongly disagree to strongly agree) and cover: * Attitudes towards treatment * Convenience of distributing the treatment and satisfaction with training * Observed willingness and understanding for need of treatment * Observed satisfaction with the treatment and procedures of the campaign
Time frame: 1-2 weeks after drug distribution
Plan to share: No — There is a data sharing agreement between Swiss TPH, Uganda MoH and Makerere University in place. Data may be shared with other researchers upon request.
No publications or documents are linked to this record.
Ran from Jul 2024 to primary completion in Jul 2024, 0 months.
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Jennifer Keiser