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

Terminated

Conditions

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

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Arusha, Tanzania
        • Arusha region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2019

Primary Completion (Actual)

July 12, 2019

Study Completion (Actual)

July 12, 2019

Study Registration Dates

First Submitted

June 19, 2019

First Submitted That Met QC Criteria

June 28, 2019

First Posted (Actual)

July 1, 2019

Study Record Updates

Last Update Posted (Actual)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Anonymised data will be shared with relevant study team members for the purposes of data analysis. Data Transfer Agreements will be completed, where appropriate.

IPD Sharing Time Frame

Data will be shared with team members as they are collected.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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