App-based Versus Slide-based Inter-grader Agreement (IGA) Test for Trachoma Graders
- Conditions
- Trachoma
- Interventions
- Other: Inter-grader agreement (IGA) app
- Registration Number
- NCT04002726
- Lead Sponsor
- London School of Hygiene and Tropical Medicine
- Brief 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.
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 32
- All trainers and trainee graders who attend selected Tropical Data training events will be eligible for inclusion in the study.
- Individuals who do not provide consent are not eligible for inclusion in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group Aa Inter-grader agreement (IGA) app Allocated to do the app-based training. Allocated to do the app-based classroom IGA test first, and the slide-based test second. Group Ss Inter-grader agreement (IGA) app Allocated to do the app-based training. Allocated to do the slide-based classroom IGA test first, and the app-based test second. Group Sa Inter-grader agreement (IGA) app Allocated to do the slide-based training. Allocated to do the app-based classroom IGA test first, and the slide-based test second. Group As Inter-grader agreement (IGA) app Allocated to do the app-based training. Allocated to do the slide-based classroom IGA test first, and the app-based test second.
- Primary Outcome Measures
Name Time Method Field IGA success 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)
Classroom IGA success 1 day The proportion of participants successfully passing (kappa ≥0.7) the slide-based IGA.
- Secondary Outcome Measures
Name Time Method Trainee characteristics 5 days Association (reported as proportions, unadjusted and adjusted odds ratios) between trainee characteristics and the probability of successfully passing the field IGA test
Acceptability and feasibility (common themes from focus group discussions) of app versus slide-based training. 45 minutes Common themes, as determined through thematic analysis of focus group discussion transcripts, relating to acceptability and feasibility of app versus slide-based training.
Acceptability and feasibility (common themes from focus group discussions) of app versus slide-based IGA testing. 45 minutes Common themes, as determined through thematic analysis of focus group discussion transcripts, relating to acceptability and feasibility of app versus slide-based IGA testing.
Cost of app versus slide-based training 5 days Cost (overall and broken down by category: personnel; supplies; transit; telecommunications) of app versus slide-based training
Cost of app versus slide-based IGA testing 5 days Cost (overall and broken down by category: personnel; supplies; transit; telecommunications) of app versus slide-based IGA testing
Trial Locations
- Locations (1)
Arusha region
🇹🇿Arusha, Tanzania