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

Primary Purpose

Trachoma

Status
Terminated
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Inter-grader agreement (IGA) app
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Trachoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Arusha region

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group Aa

Group As

Group Sa

Group Ss

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Classroom IGA success
The proportion of participants successfully passing (kappa ≥0.7) the app-based IGA.
Classroom IGA success
The proportion of participants successfully passing (kappa ≥0.7) the slide-based IGA.
Field IGA success
The correlation between classroom IGA score and field IGA score
Field IGA success
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

Trainee characteristics
Association (reported as proportions, unadjusted and adjusted odds ratios) between trainee characteristics and the probability of successfully passing classroom IGA test
Trainee characteristics
Association (reported as proportions, unadjusted and adjusted odds ratios) between trainee characteristics and the probability of successfully passing the field IGA test
Acceptability and feasibility (common themes from focus group discussions) of app versus slide-based training.
Common themes, as determined through thematic analysis of focus group discussion transcripts, relating to acceptability and feasibility of app versus slide-based training.
Acceptability and feasibility (common themes from focus group discussions) of app versus slide-based IGA testing.
Common themes, as determined through thematic analysis of focus group discussion transcripts, relating to acceptability and feasibility of app versus slide-based IGA testing.
Cost of app versus slide-based training
Cost (overall and broken down by category: personnel; supplies; transit; telecommunications) of app versus slide-based training
Cost of app versus slide-based IGA testing
Cost (overall and broken down by category: personnel; supplies; transit; telecommunications) of app versus slide-based IGA testing

Full Information

First Posted
June 19, 2019
Last Updated
August 18, 2022
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
National Institute for Medical Research, Tanzania, Federal Minstry of Health of Ethiopia, Jos University Teaching Hospital, University College London Hospitals, RTI International, Sightsavers, World Health Organization, Pan American Health Organization
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1. Study Identification

Unique Protocol Identification Number
NCT04002726
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
July 12, 2019 (Actual)
Study Completion Date
July 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
National Institute for Medical Research, Tanzania, Federal Minstry of Health of Ethiopia, Jos University Teaching Hospital, University College London Hospitals, RTI International, Sightsavers, World Health Organization, Pan American Health Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trachoma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Aa
Arm Type
Active Comparator
Arm Description
Allocated to do the app-based training. Allocated to do the app-based classroom IGA test first, and the slide-based test second.
Arm Title
Group As
Arm Type
Active Comparator
Arm Description
Allocated to do the app-based training. Allocated to do the slide-based classroom IGA test first, and the app-based test second.
Arm Title
Group Sa
Arm Type
Active Comparator
Arm Description
Allocated to do the slide-based training. Allocated to do the app-based classroom IGA test first, and the slide-based test second.
Arm Title
Group Ss
Arm Type
Active Comparator
Arm Description
Allocated to do the app-based training. Allocated to do the slide-based classroom IGA test first, and the app-based test second.
Intervention Type
Other
Intervention Name(s)
Inter-grader agreement (IGA) app
Intervention Description
A smartphone-based app with images of conjunctivae for trachoma grading training purposes.
Primary Outcome Measure Information:
Title
Classroom IGA success
Description
The proportion of participants successfully passing (kappa ≥0.7) the app-based IGA.
Time Frame
1 day
Title
Classroom IGA success
Description
The proportion of participants successfully passing (kappa ≥0.7) the slide-based IGA.
Time Frame
1 day
Title
Field IGA success
Description
The correlation between classroom IGA score and field IGA score
Time Frame
3 days
Title
Field IGA success
Description
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)
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Trainee characteristics
Description
Association (reported as proportions, unadjusted and adjusted odds ratios) between trainee characteristics and the probability of successfully passing classroom IGA test
Time Frame
5 days
Title
Trainee characteristics
Description
Association (reported as proportions, unadjusted and adjusted odds ratios) between trainee characteristics and the probability of successfully passing the field IGA test
Time Frame
5 days
Title
Acceptability and feasibility (common themes from focus group discussions) of app versus slide-based training.
Description
Common themes, as determined through thematic analysis of focus group discussion transcripts, relating to acceptability and feasibility of app versus slide-based training.
Time Frame
45 minutes
Title
Acceptability and feasibility (common themes from focus group discussions) of app versus slide-based IGA testing.
Description
Common themes, as determined through thematic analysis of focus group discussion transcripts, relating to acceptability and feasibility of app versus slide-based IGA testing.
Time Frame
45 minutes
Title
Cost of app versus slide-based training
Description
Cost (overall and broken down by category: personnel; supplies; transit; telecommunications) of app versus slide-based training
Time Frame
5 days
Title
Cost of app versus slide-based IGA testing
Description
Cost (overall and broken down by category: personnel; supplies; transit; telecommunications) of app versus slide-based IGA testing
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Harding-Esch
Organizational Affiliation
LSHTM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arusha region
City
Arusha
Country
Tanzania

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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