Study Stopped
Lack of funding
App-based Versus Slide-based Inter-grader Agreement (IGA) Test for Trachoma Graders
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
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2019
CompletedFirst Posted
Study publicly available on registry
July 1, 2019
CompletedStudy Start
First participant enrolled
July 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2019
CompletedAugust 22, 2022
May 1, 2022
4 days
June 19, 2019
August 18, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Classroom IGA success
The proportion of participants successfully passing (kappa ≥0.7) the app-based IGA.
1 day
Classroom IGA success
The proportion of participants successfully passing (kappa ≥0.7) the slide-based IGA.
1 day
Field IGA success
The correlation between classroom IGA score and field IGA score
3 days
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)
3 days
Secondary Outcomes (6)
Trainee characteristics
5 days
Trainee characteristics
5 days
Acceptability and feasibility (common themes from focus group discussions) of app versus slide-based training.
45 minutes
Acceptability and feasibility (common themes from focus group discussions) of app versus slide-based IGA testing.
45 minutes
Cost of app versus slide-based training
5 days
- +1 more secondary outcomes
Study Arms (4)
Group Aa
ACTIVE COMPARATORAllocated to do the app-based training. Allocated to do the app-based classroom IGA test first, and the slide-based test second.
Group As
ACTIVE COMPARATORAllocated to do the app-based training. Allocated to do the slide-based classroom IGA test first, and the app-based test second.
Group Sa
ACTIVE COMPARATORAllocated to do the slide-based training. Allocated to do the app-based classroom IGA test first, and the slide-based test second.
Group Ss
ACTIVE COMPARATORAllocated to do the app-based training. Allocated to do the slide-based classroom IGA test first, and the app-based test second.
Interventions
A smartphone-based app with images of conjunctivae for trachoma grading training purposes.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- London School of Hygiene and Tropical Medicinelead
- National Institute for Medical Research, Tanzaniacollaborator
- Federal Minstry of Health of Ethiopiacollaborator
- Jos University Teaching Hospitalcollaborator
- University College London Hospitalscollaborator
- RTI Internationalcollaborator
- Sightsaverscollaborator
- World Health Organizationcollaborator
- Pan American Health Organizationcollaborator
Study Sites (1)
Arusha region
Arusha, Tanzania
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emma Harding-Esch
London School of Hygiene and Tropical Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2019
First Posted
July 1, 2019
Study Start
July 8, 2019
Primary Completion
July 12, 2019
Study Completion
July 12, 2019
Last Updated
August 22, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- 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.
Anonymised data will be shared with relevant study team members for the purposes of data analysis. Data Transfer Agreements will be completed, where appropriate.