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

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Brief Title

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

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.
    


Study Type

Interventional


Primary Outcome

Classroom IGA success

Secondary Outcome

 Trainee characteristics

Condition

Trachoma

Intervention

Inter-grader agreement (IGA) app

Study Arms / Comparison Groups

 Group Aa
Description:  Allocated to do the app-based training. Allocated to do the app-based classroom IGA test first, and the slide-based test second.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

32

Start Date

July 8, 2019

Completion Date

September 30, 2021

Primary Completion Date

July 12, 2019

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Emma Harding-Esch, , 

Location Countries

Tanzania

Location Countries

Tanzania

Administrative Informations


NCT ID

NCT04002726

Organization ID

2019-KEP-284 - 1


Responsible Party

Sponsor

Study Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

 National Institute for Medical Research, Tanzania

Study Sponsor

Emma Harding-Esch, Principal Investigator, LSHTM


Verification Date

September 2020