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

NCT ID: NCT04002726

Last Updated: 2022-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-08

Study Completion Date

2019-07-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trachoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Inter-grader agreement (IGA) app

Intervention Type OTHER

A smartphone-based app with images of conjunctivae for trachoma grading training purposes.

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.

Group Type ACTIVE_COMPARATOR

Inter-grader agreement (IGA) app

Intervention Type OTHER

A smartphone-based app with images of conjunctivae for trachoma grading training purposes.

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.

Group Type ACTIVE_COMPARATOR

Inter-grader agreement (IGA) app

Intervention Type OTHER

A smartphone-based app with images of conjunctivae for trachoma grading training purposes.

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.

Group Type ACTIVE_COMPARATOR

Inter-grader agreement (IGA) app

Intervention Type OTHER

A smartphone-based app with images of conjunctivae for trachoma grading training purposes.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Inter-grader agreement (IGA) app

A smartphone-based app with images of conjunctivae for trachoma grading training purposes.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute for Medical Research, Tanzania

OTHER_GOV

Sponsor Role collaborator

Federal Minstry of Health of Ethiopia

OTHER_GOV

Sponsor Role collaborator

Jos University Teaching Hospital

OTHER

Sponsor Role collaborator

University College London Hospitals

OTHER

Sponsor Role collaborator

RTI International

OTHER

Sponsor Role collaborator

Sightsavers

UNKNOWN

Sponsor Role collaborator

World Health Organization

OTHER

Sponsor Role collaborator

Pan American Health Organization

OTHER

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Emma Harding-Esch

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arusha region

Arusha, , Tanzania

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Tanzania

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-KEP-284 - 1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Photoscreening for Retinoblastoma
NCT04344652 WITHDRAWN NA
Educational Eczema Video Intervention
NCT03664271 NOT_YET_RECRUITING NA