HelminthiasisFACE-ITpilotNCT06497075
Co-administration of IVM and ALB in School-based Deworming in Uganda
An observational study of Helminthiasis and Intestinal Worms, run by Jennifer Keiser at 2 sites in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Helminthiasis, Intestinal Worms
- What is being tested?
- Albendazole 400mg and Ivermectin 3 MG
- Type of treatment
- Pill or oral medicine
- How many people
- 8,767 participants
- Where
- 2 sitesUganda
- Study dates
- 1 Jul 2024to 19 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
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)
Trial locations and contacts
2 sites in 1 country.
Uganda2 sites
Makerere University, College of Humanities and Social Sciences
Kampala
Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health
Kampala
About this study
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
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:
Read more
- 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
- Being tested
- Albendazole 400mg, Ivermectin 3 MG
- Keywords
- soil-transmitted helminths, ivermectin, deworming, albendazole
- Medical subject headings
- Helminthiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albendazole 400mgDrug
Also called Zentel
Single oral dose of Albendazole 400mg tablet
Ivermectin 3 MGDrug
Also called Mectizan, Stromectol
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)
| Study group | Role | What they receive |
|---|---|---|
| Albendazole only | Schoolchildren aged 5-14 years of 10 schools randomized to receive the standard deworming treatment of a single dose of albendazole 400mg. Receives: 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. Receives: Drug: Albendazole 400mg; Drug: Ivermectin 3 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
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
Measured: 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.
Measured: 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
Measured: 1-2 weeks after drug distribution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Jul 2024
- Primary completion16 Jul 2024
- Study completion19 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HelminthiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 8,767 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Keiser
- Sponsor type
- University, hospital or other
- Collaborators
- Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health, Uganda, Makerere University
- Responsible party
- Sponsor-investigator, Jennifer Keiser, Swiss Tropical & Public Health Institute
- Investigators
- Jennifer Keiser, Prof., Principal investigator, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497075
- Sponsor's protocol ID
- 2283p
- Acronym
- FACE-ITpilot
- Status last verified
- Dec 2024
- First submitted
- 26 Jun 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06497075
- Acronym / sponsor ID
- FACE-ITpilot / 2283p
- Conditions
- Helminthiasis, Intestinal Worms
- Keywords
- soil-transmitted helminths, ivermectin, deworming, albendazole
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,767 participants (actual)
- Lead sponsor
- Jennifer KeiserUniversity, hospital or other
- Collaborators
- Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health, Uganda, Makerere University
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- 19 Oct 2024 (actual)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albendazole only | – | Drug: Albendazole 400mgSchoolchildren aged 5-14 years of 10 schools randomized to receive the standard deworming treatment of a single dose of albendazole 400mg. |
| Ivermectin and albendazole | – | Drug: Albendazole 400mg, Drug: Ivermectin 3 MGSchoolchildren 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. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albendazole 400mgAlso: ZentelSingle oral dose of Albendazole 400mg tablet | Drug | Albendazole only, Ivermectin and albendazole |
| Ivermectin 3 MGAlso: Mectizan, StromectolGeneric 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) | Drug | Ivermectin and albendazole |
Primary outcome
Feasibility of IVM + ALB introduction
Time frame: Documentation before, during and up to 12 weeks after the drug distribution
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)
3 secondary outcomes
Acceptability and barriers & enablers to introduction of IVM-ALB co-administration (recipient perspective)
Time frame: 1-2 weeks after drug distribution
Potential incremental costs related to IVM-ALB co-administration
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)
Time frame: 1-2 weeks after drug distribution
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Keiser, Prof. principal investigator
Swiss Tropical & Public Health Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helminthiasis and Intestinal Worms, run by Jennifer Keiser at 2 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of IVM + ALB introduction (time frame: Documentation before, during and up to 12 weeks after the drug distribution). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.