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

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ClinicalTrials.gov Identifier: NCT04002726
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : July 16, 2019
Sponsor:
Collaborators:
National Institute for Medical Research, Tanzania
Federal Minstry of Health of Ethiopia
Jos University Teaching Hospital
University College London, UK.
RTI International
Sightsavers
World Health Organization
Pan American Health Organization
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

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.


Condition or disease Intervention/treatment Phase
Trachoma Other: Inter-grader agreement (IGA) app Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : July 8, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


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.
Other: Inter-grader agreement (IGA) app
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.
Other: Inter-grader agreement (IGA) app
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.
Other: Inter-grader agreement (IGA) app
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.
Other: Inter-grader agreement (IGA) app
A smartphone-based app with images of conjunctivae for trachoma grading training purposes.




Primary Outcome Measures :
  1. Classroom IGA success [ Time Frame: 1 day ]
    The proportion of participants successfully passing (kappa ≥0.7) the app-based IGA.

  2. Classroom IGA success [ Time Frame: 1 day ]
    The proportion of participants successfully passing (kappa ≥0.7) the slide-based IGA.

  3. Field IGA success [ Time Frame: 3 days ]
    The correlation between classroom IGA score and field IGA score

  4. 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)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002726


Contacts
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Contact: Emma Harding-Esch, PhD +442076127982 emma.harding-esch@lshtm.ac.uk

Locations
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Tanzania
Arusha region Recruiting
Arusha, Tanzania
Contact: Upenda Mwingira         
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
National Institute for Medical Research, Tanzania
Federal Minstry of Health of Ethiopia
Jos University Teaching Hospital
University College London, UK.
RTI International
Sightsavers
World Health Organization
Pan American Health Organization
Investigators
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Principal Investigator: Emma Harding-Esch LSHTM
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT04002726    
Other Study ID Numbers: 2019-KEP-284 - 1
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Time Frame: Data will be shared with team members as they are collected.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Trachoma
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Infection
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Corneal Diseases