App-based Versus Slide-based Inter-grader Agreement (IGA) Test for Trachoma Graders

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Trachoma

Intervention / Treatment
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* Other: Inter-grader agreement (IGA) app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All trainers and trainee graders who attend selected Tropical Data training events will be eligible for inclusion in the study. Exclusion Criteria: Individuals who do not provide consent are not eligible for inclusion in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group Aa<br>Allocated to do the app-based training. Allocated to do the app-based classroom IGA test first, and the slide-based test second. | Other: Inter-grader agreement (IGA) app<br>* A smartphone-based app with images of conjunctivae for trachoma grading training purposes.<br>|
| Active Comparator: Group As<br>Allocated to do the app-based training. Allocated to do the slide-based classroom IGA test first, and the app-based test second. | Other: Inter-grader agreement (IGA) app<br>* A smartphone-based app with images of conjunctivae for trachoma grading training purposes.<br>|
| Active Comparator: Group Sa<br>Allocated to do the slide-based training. Allocated to do the app-based classroom IGA test first, and the slide-based test second. | Other: Inter-grader agreement (IGA) app<br>* A smartphone-based app with images of conjunctivae for trachoma grading training purposes.<br>|
| Active Comparator: Group Ss<br>Allocated to do the app-based training. Allocated to do the slide-based classroom IGA test first, and the app-based test second. | Other: Inter-grader agreement (IGA) app<br>* A smartphone-based app with images of conjunctivae for trachoma grading training purposes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Classroom IGA success | The proportion of participants successfully passing (kappa ≥0.7) the app-based IGA. | 1 day | 
| Classroom IGA success | The proportion of participants successfully passing (kappa ≥0.7) the slide-based IGA. | 1 day | 
| Field IGA success | The correlation between classroom IGA score and field IGA score | 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) | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trainee characteristics | Association (reported as proportions, unadjusted and adjusted odds ratios) between trainee characteristics and the probability of successfully passing classroom IGA test | 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 | 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. | 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. | 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 | 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 | 5 days |