- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04002726
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Arusha, Tanzania
- Arusha region
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group Aa
Allocated to do the app-based training.
Allocated to do the app-based classroom IGA test first, and the slide-based test second.
|
A smartphone-based app with images of conjunctivae for trachoma grading training purposes.
|
Active Comparator: Group As
Allocated to do the app-based training.
Allocated to do the slide-based classroom IGA test first, and the app-based test second.
|
A smartphone-based app with images of conjunctivae for trachoma grading training purposes.
|
Active Comparator: Group Sa
Allocated to do the slide-based training.
Allocated to do the app-based classroom IGA test first, and the slide-based test second.
|
A smartphone-based app with images of conjunctivae for trachoma grading training purposes.
|
Active Comparator: Group Ss
Allocated to do the app-based training.
Allocated to do the slide-based classroom IGA test first, and the app-based test second.
|
A smartphone-based app with images of conjunctivae for trachoma grading training purposes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Classroom IGA success
Time Frame: 1 day
|
The proportion of participants successfully passing (kappa ≥0.7) the app-based IGA.
|
1 day
|
Classroom IGA success
Time Frame: 1 day
|
The proportion of participants successfully passing (kappa ≥0.7) the slide-based IGA.
|
1 day
|
Field IGA success
Time Frame: 3 days
|
The correlation between classroom IGA score and field IGA score
|
3 days
|
Field IGA success
Time Frame: 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)
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trainee characteristics
Time Frame: 5 days
|
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
Time Frame: 5 days
|
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.
Time Frame: 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.
|
45 minutes
|
Acceptability and feasibility (common themes from focus group discussions) of app versus slide-based IGA testing.
Time Frame: 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.
|
45 minutes
|
Cost of app versus slide-based training
Time Frame: 5 days
|
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
Time Frame: 5 days
|
Cost (overall and broken down by category: personnel; supplies; transit; telecommunications) of app versus slide-based IGA testing
|
5 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-KEP-284 - 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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