TrachomaNCT04002726
App-based Versus Slide-based Inter-grader Agreement (IGA) Test for Trachoma Graders
A study testing Inter-grader agreement (IGA) app in people with Trachoma, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.
Trial summary
Trachomatous inflammation-follicular (TF) is diagnosed by looking for clinical signs of infection of everted eyelids (conjunctivae) of children. The overall objective of this project is to investigate the effectiveness, acceptability and feasibility of an app-based versus slide-based IGA for trachoma graders. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trachoma
- What is being tested?
- Inter-grader agreement (IGA) app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTanzania
- Study dates
- 8 Jul 2019to 12 Jul 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All trainers and trainee graders who attend selected Tropical Data training events will be eligible for inclusion in the study.
Who cannot join
- Individuals who do not provide consent are not eligible for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing and Evaluating Trachoma Diagnosis Training Tools in Preparation for the Trachoma Elimination Endgame: Investigating the Effectiveness, Acceptability and Feasibility of an App-based Versus Slide-based IGA Test for Trachoma Graders
Trachomatous inflammation-follicular (TF) is diagnosed by looking for clinical signs of infection of everted eyelids (conjunctivae) of children.
The overall objective of this project is to investigate the effectiveness, acceptability and feasibility of an app-based versus slide-based IGA for trachoma graders.
Fieldwork will take place during routine Tropical Data trainings. A non-inferiority randomised controlled trial design will be employed, with grader trainees randomised to app- or slide-based training, and then to app- or slide-based IGA testing. The training and IGA testing method will be compared with field IGA test score to determine which method best predicts passing the field IGA test.
Read the detailed description
Trachoma graders are currently trained using either slide- or app-based testing systems. The investigators want to formally assess whether the app-based training and testing system leads to better field-based diagnosis than the slide-based training and testing system. The investigators will also ask participants for their views on acceptability of the two systems and conduct a cost-consequences analysis of the two systems.
Objectives and approach:
1.1 To compare the two classroom IGA tests (app-based and slides-based) in terms of their ability to predict trainee success in the field IGA test.
1.2 To assess whether the kappa score threshold for the classroom IGA tests is appropriate.
1.3 To conduct a cost-consequences analysis of the training systems in order to effectively target the use of an app-based assessment and training system.
1.4 To investigate whether grader trainee characteristics have an impact on trainee performance in the IGA tests.
1.5 To obtain feedback on the app-based system's usability and acceptability. 1.6 To compare the two classroom IGA training methods (app-based and slides-based) in terms of classroom IGA test (app-based and slides-based) outcome and field IGA test outcome.
- Conditions
- Trachoma
- Being tested
- Inter-grader agreement (IGA) app
- Medical subject headings
- Trachoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inter-grader agreement (IGA) appOther
A smartphone-based app with images of conjunctivae for trachoma grading training purposes.
| Study group | Role | What they receive |
|---|---|---|
| Group Aa | Active comparator | Allocated to do the app-based training. Allocated to do the app-based classroom IGA test first, and the slide-based test second. Receives: Other: Inter-grader agreement (IGA) app |
| Group As | Active comparator | Allocated to do the app-based training. Allocated to do the slide-based classroom IGA test first, and the app-based test second. Receives: Other: Inter-grader agreement (IGA) app |
| Group Sa | Active comparator | Allocated to do the slide-based training. Allocated to do the app-based classroom IGA test first, and the slide-based test second. Receives: Other: Inter-grader agreement (IGA) app |
| Group Ss | Active comparator | Allocated to do the app-based training. Allocated to do the slide-based classroom IGA test first, and the app-based test second. Receives: Other: Inter-grader agreement (IGA) app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classroom IGA success
The proportion of participants successfully passing (kappa ≥0.7) the app-based IGA.
Measured: 1 day
Classroom IGA success
The proportion of participants successfully passing (kappa ≥0.7) the slide-based IGA.
Measured: 1 day
Field IGA success
The correlation between classroom IGA score and field IGA score
Measured: 3 days
Field IGA success
The proportion of participants who successfully pass the classroom IGA test (kappa ≥0.7) who also successfully pass the field-based IGA test (kappa ≥0.7)
Measured: 3 days
Secondary outcomes (6)
Trainee characteristics
Association (reported as proportions, unadjusted and adjusted odds ratios) between trainee characteristics and the probability of successfully passing classroom IGA test
Measured: 5 days
Trainee characteristics
Association (reported as proportions, unadjusted and adjusted odds ratios) between trainee characteristics and the probability of successfully passing the field IGA test
Measured: 5 days
Acceptability and feasibility (common themes from focus group discussions) of app versus slide-based training.
Common themes, as determined through thematic analysis of focus group discussion transcripts, relating to acceptability and feasibility of app versus slide-based training.
Measured: 45 minutes
Acceptability and feasibility (common themes from focus group discussions) of app versus slide-based IGA testing.
Common themes, as determined through thematic analysis of focus group discussion transcripts, relating to acceptability and feasibility of app versus slide-based IGA testing.
Measured: 45 minutes
Cost of app versus slide-based training
Cost (overall and broken down by category: personnel; supplies; transit; telecommunications) of app versus slide-based training
Measured: 5 days
Cost of app versus slide-based IGA testing
Cost (overall and broken down by category: personnel; supplies; transit; telecommunications) of app versus slide-based IGA testing
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start8 Jul 2019
- Primary completion12 Jul 2019
- Study completion12 Jul 2019
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrachomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania, Federal Minstry of Health of Ethiopia, Jos University Teaching Hospital, University College London Hospitals, RTI International, Sightsavers, World Health Organization, Pan American Health Organization
- Responsible party
- Sponsor
- Investigators
- Emma Harding-Esch, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002726
- Sponsor's protocol ID
- 2019-KEP-284 - 1
- Status last verified
- May 2022
- First submitted
- 19 Jun 2019
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be shared with relevant study team members for the purposes of data analysis. Data Transfer Agreements will be completed, where appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Evaluating Trachoma Diagnosis Training Tools in Preparation for the Trachoma Elimination Endgame: Investigating the Effectiveness, Acceptability and Feasibility of an App-based Versus Slide-based IGA Test for Trachoma Graders
- ClinicalTrials.gov ID
- NCT04002726
- Acronym / sponsor ID
- 2019-KEP-284 - 1
- Conditions
- Trachoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 32 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania, Federal Minstry of Health of Ethiopia, Jos University Teaching Hospital, University College London Hospitals, RTI International, Sightsavers, World Health Organization, Pan American Health Organization
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 1 Jul 2019 (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.
Trachomatous inflammation-follicular (TF) is diagnosed by looking for clinical signs of infection of everted eyelids (conjunctivae) of children.
The overall objective of this project is to investigate the effectiveness, acceptability and feasibility of an app-based versus slide-based IGA for trachoma graders.
Fieldwork will take place during routine Tropical Data trainings. A non-inferiority randomised controlled trial design will be employed, with grader trainees randomised to app- or slide-based training, and then to app- or slide-based IGA testing. The training and IGA testing method will be compared with field IGA test score to determine which method best predicts passing the field IGA test.
Detailed description
Trachoma graders are currently trained using either slide- or app-based testing systems. The investigators want to formally assess whether the app-based training and testing system leads to better field-based diagnosis than the slide-based training and testing system. The investigators will also ask participants for their views on acceptability of the two systems and conduct a cost-consequences analysis of the two systems.
Objectives and approach:
1.1 To compare the two classroom IGA tests (app-based and slides-based) in terms of their ability to predict trainee success in the field IGA test.
1.2 To assess whether the kappa score threshold for the classroom IGA tests is appropriate.
1.3 To conduct a cost-consequences analysis of the training systems in order to effectively target the use of an app-based assessment and training system.
1.4 To investigate whether grader trainee characteristics have an impact on trainee performance in the IGA tests.
1.5 To obtain feedback on the app-based system's usability and acceptability. 1.6 To compare the two classroom IGA training methods (app-based and slides-based) in terms of classroom IGA test (app-based and slides-based) outcome and field IGA test outcome.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group Aa | Active comparator | Other: Inter-grader agreement (IGA) appAllocated to do the app-based training. Allocated to do the app-based classroom IGA test first, and the slide-based test second. |
| Group As | Active comparator | Other: Inter-grader agreement (IGA) appAllocated to do the app-based training. Allocated to do the slide-based classroom IGA test first, and the app-based test second. |
| Group Sa | Active comparator | Other: Inter-grader agreement (IGA) appAllocated to do the slide-based training. Allocated to do the app-based classroom IGA test first, and the slide-based test second. |
| Group Ss | Active comparator | Other: Inter-grader agreement (IGA) appAllocated to do the app-based training. Allocated to do the slide-based classroom IGA test first, and the app-based test second. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All trainers and trainee graders who attend selected Tropical Data training events will be eligible for inclusion in the study.
Key exclusion criteria (1 listed)
- Individuals who do not provide consent are not eligible for inclusion in the study.
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 |
|---|---|---|
| Inter-grader agreement (IGA) appA smartphone-based app with images of conjunctivae for trachoma grading training purposes. | Other | Group Aa, Group As, Group Sa, Group Ss |
Primary outcome
Classroom IGA success
Time frame: 1 day
The proportion of participants successfully passing (kappa ≥0.7) the app-based IGA.
Classroom IGA success
Time frame: 1 day
The proportion of participants successfully passing (kappa ≥0.7) the slide-based IGA.
Field IGA success
Time frame: 3 days
The correlation between classroom IGA score and field IGA score
Field IGA success
Time frame: 3 days
The proportion of participants who successfully pass the classroom IGA test (kappa ≥0.7) who also successfully pass the field-based IGA test (kappa ≥0.7)
6 secondary outcomes
Trainee characteristics
Time frame: 5 days
Trainee characteristics
Time frame: 5 days
Acceptability and feasibility (common themes from focus group discussions) of app versus slide-based training.
Time frame: 45 minutes
Acceptability and feasibility (common themes from focus group discussions) of app versus slide-based IGA testing.
Time frame: 45 minutes
Cost of app versus slide-based training
Time frame: 5 days
Cost of app versus slide-based IGA testing
Time frame: 5 days
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Individual participant dataSharing planned: Yes. Anonymised data will be shared with relevant study team members for the purposes of data analysis. Data Transfer Agreements will be completed, where appropriate.
Related trials for Trachoma
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The Effects of Hand and Face Washing With Soap on Active Trachoma Among Children 1-9 Years Old.
Active Trachoma
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Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma
Survival of Flies Developing in Faecal Samples
Recruiting
RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Trachoma, Eye Diseases
Active, not recruitingPhase 4
Kebele Elimination of Trachoma for Ocular Health
Trachoma
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.
Emma Harding-Esch principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inter-grader agreement (IGA) app in people with Trachoma, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: stopped early, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. 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 was stopped early (reason given: Lack of funding). Results are not available in the source record.
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?
Classroom IGA success (time frame: 1 day). The study lists 4 primary outcomes in all. 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 22 Aug 2022.