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

Sponsor

London School of Hygiene and Tropical Medicine (Other)

Overall Status

Terminated

CT.gov ID

NCT04002726

Collaborator

National Institute for Medical Research, Tanzania (Other), Federal Minstry of Health of Ethiopia (Other), Jos University Teaching Hospital (Other), University College London Hospitals (Other), RTI International (Other), Sightsavers (Other), World Health Organization (Other), Pan American Health Organization (Other)

Enrollment

Location

Arms

Actual Duration (Days)

243.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Trachoma	Other: Inter-grader agreement (IGA) app	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

32 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 :

Jul 8, 2019

Actual Primary Completion Date :

Jul 12, 2019

Actual Study Completion Date :

Jul 12, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Classroom IGA success [1 day]
The proportion of participants successfully passing (kappa ≥0.7) the app-based IGA.
Classroom IGA success [1 day]
The proportion of participants successfully passing (kappa ≥0.7) the slide-based IGA.
Field IGA success [3 days]
The correlation between classroom IGA score and field IGA score
Field IGA success [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

Trainee characteristics [5 days]
Association (reported as proportions, unadjusted and adjusted odds ratios) between trainee characteristics and the probability of successfully passing classroom IGA test
Trainee characteristics [5 days]
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. [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.
Acceptability and feasibility (common themes from focus group discussions) of app versus slide-based IGA testing. [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.
Cost of app versus slide-based training [5 days]
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 [5 days]
Cost (overall and broken down by category: personnel; supplies; transit; telecommunications) of app versus slide-based IGA testing

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arusha region	Arusha		Tanzania

Investigators

Principal Investigator: Emma Harding-Esch, LSHTM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

London School of Hygiene and Tropical Medicine

ClinicalTrials.gov Identifier:

NCT04002726

Other Study ID Numbers:

2019-KEP-284 - 1

First Posted:

Jul 1, 2019

Last Update Posted:

Aug 22, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Trachoma

Study Results

No Results Posted as of Aug 22, 2022