Clinical trial NCT04002726: App-based Versus Slide-based Inter-grader Agreement (IGA) Test for Trachoma Graders
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Trachoma
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: National Institute for Medical Research, Tanzania
name: Federal Minstry of Health of Ethiopia
name: Jos University Teaching Hospital
name: University College London Hospitals
name: RTI International
name: Sightsavers
name: World Health Organization
name: Pan American Health Organization
First posted: 2019-07-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Classroom IGA success
timeFrame: 1 day
measure: Classroom IGA success
timeFrame: 1 day
measure: Field IGA success
timeFrame: 3 days
measure: Field IGA success
timeFrame: 3 days
Secondary outcomes:
measure: Trainee characteristics
timeFrame: 5 days
measure: Trainee characteristics
timeFrame: 5 days
measure: Acceptability and feasibility (common themes from focus group discussions) of app versus slide-based training.
timeFrame: 45 minutes
measure: Acceptability and feasibility (common themes from focus group discussions) of app versus slide-based IGA testing.
timeFrame: 45 minutes
measure: Cost of app versus slide-based training
timeFrame: 5 days
measure: Cost of app versus slide-based IGA testing
timeFrame: 5 days
Other outcomes:
Locations:
city: Arusha
country: Tanzania
facility: Arusha region
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Emma Harding-Esch
role: PRINCIPAL_INVESTIGATOR
References: