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| Name | Class |
|---|---|
| Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health, Uganda | UNKNOWN |
| Makerere University | OTHER |
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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):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albendazole only | Schoolchildren aged 5-14 years of 10 schools randomized to receive the standard deworming treatment of a single dose of 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albendazole 400mg | Drug | Single oral dose of Albendazole 400mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of IVM + ALB introduction | Feasibility will be assessed using quantitative and qualitative data sources for the following performance and process indicators:
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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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:
|
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Keiser, Prof. | Swiss Tropical & Public Health Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Makerere University, College of Humanities and Social Sciences | Kampala | Uganda | ||||
| Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health |
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.
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| ID | Term |
|---|---|
| D006373 | Helminthiasis |
| ID | Term |
|---|---|
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D015766 | Albendazole |
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| 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) |
|
|
| 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:
| 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:
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:
| 1-2 weeks after drug distribution |
| Kampala |
| Uganda |
| D001562 |
| Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |