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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04002726
Enrollment
32
Registered
2019-07-01
Start date
2019-07-08
Completion date
2019-07-12
Last updated
2022-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trachoma

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.

Interventions

OTHERInter-grader agreement (IGA) app

A smartphone-based app with images of conjunctivae for trachoma grading training purposes.

Sponsors

National Institute for Medical Research, Tanzania
CollaboratorOTHER_GOV
Federal Minstry of Health of Ethiopia
CollaboratorOTHER_GOV
Jos University Teaching Hospital
CollaboratorOTHER
University College London Hospitals
CollaboratorOTHER
RTI International
CollaboratorOTHER
Sightsavers
CollaboratorUNKNOWN
World Health Organization
CollaboratorOTHER
Pan American Health Organization
CollaboratorOTHER
London School of Hygiene and Tropical Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Classroom IGA success1 dayThe proportion of participants successfully passing (kappa ≥0.7) the app-based IGA.
Field IGA success3 daysThe correlation between classroom IGA score and field IGA score

Secondary

MeasureTime frameDescription
Trainee characteristics5 daysAssociation (reported as proportions, unadjusted and adjusted odds ratios) between trainee characteristics and the probability of successfully passing classroom IGA test
Acceptability and feasibility (common themes from focus group discussions) of app versus slide-based training.45 minutesCommon 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 minutesCommon 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 training5 daysCost (overall and broken down by category: personnel; supplies; transit; telecommunications) of app versus slide-based training
Cost of app versus slide-based IGA testing5 daysCost (overall and broken down by category: personnel; supplies; transit; telecommunications) of app versus slide-based IGA testing

Countries

Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026