An interventional study of Inter-grader agreement (IGA) app in Trachoma, sponsored by London School of Hygiene and Tropical Medicine. Terminated at 1 site in Tanzania. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-22.
Sponsored by London School of Hygiene and Tropical Medicine · Not applicable, Interventional, and Other
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.
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.
39 studies on the registry are indexed under Trachoma; 3 are open to participants now.
This study's enrollment of 32 is below the median of 1,300 across 31 interventional studies indexed under Trachoma.
Browse Trachoma studies →London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
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
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
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
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
A smartphone-based app with images of conjunctivae for trachoma grading training purposes.
Classroom IGA success
The proportion of participants successfully passing (kappa ≥0.7) the app-based IGA.
Time frame: 1 day
Classroom IGA success
The proportion of participants successfully passing (kappa ≥0.7) the slide-based IGA.
Time frame: 1 day
Field IGA success
The correlation between classroom IGA score and field IGA score
Time frame: 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)
Time frame: 3 days
Trainee characteristics
Association (reported as proportions, unadjusted and adjusted odds ratios) between trainee characteristics and the probability of successfully passing classroom IGA test
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 5 days
Plan to share: 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.
Supporting information: Study protocol
Time frame: Data will be shared with team members as they are collected.
Access criteria: Data access requests from outside the study team for the specified data analyses will be reviewed by the Principal Investigator. Requestors will be required to sign a Data Access Agreement.
No publications or documents are linked to this record.
This study is terminated, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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