Not provided
Not provided
Not provided
Not provided
Not provided
Lack of funding
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute for Medical Research, Tanzania | OTHER_GOV |
| Federal Minstry of Health of Ethiopia | OTHER_GOV |
| Jos University Teaching Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Aa | Active Comparator | Allocated 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 Comparator | Allocated 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 Comparator | Allocated 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 Comparator | Allocated to do the app-based training. Allocated to do the slide-based classroom IGA test first, and the app-based test second. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inter-grader agreement (IGA) app | Other | A smartphone-based app with images of conjunctivae for trachoma grading training purposes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Trainee characteristics | Association (reported as proportions, unadjusted and adjusted odds ratios) between trainee characteristics and the probability of successfully passing classroom IGA test | 5 days |
| Trainee characteristics |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emma Harding-Esch | London School of Hygiene and Tropical Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arusha region | Arusha | Tanzania |
Anonymised data will be shared with relevant study team members for the purposes of data analysis. Data Transfer Agreements will be completed, where appropriate.
Data will be shared with team members as they are collected.
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.
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 5, 2024 | |
| Reset | Jun 28, 2024 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 5, 2024 | Jun 28, 2024 |
| ID | Term |
|---|---|
| D014141 | Trachoma |
| ID | Term |
|---|---|
| D003234 | Conjunctivitis, Bacterial |
| D015818 | Eye Infections, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
| ID | Term |
|---|---|
| D007070 | Immunoglobulin A |
| D000682 | Amyloid |
| ID | Term |
|---|---|
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
Not provided
Not provided
| University College London Hospitals |
| OTHER |
| RTI International | OTHER |
| Sightsavers | UNKNOWN |
| World Health Organization | OTHER |
| Pan American Health Organization | OTHER |
Not provided
Not provided
Not provided
Not provided
Association (reported as proportions, unadjusted and adjusted odds ratios) between trainee characteristics and the probability of successfully passing the field IGA test
| 5 days |
| 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. | 45 minutes |
| 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. | 45 minutes |
| Cost of app versus slide-based training | Cost (overall and broken down by category: personnel; supplies; transit; telecommunications) of app versus slide-based training | 5 days |
| 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 | 5 days |
| D007239 | Infections |
| D002690 | Chlamydia Infections |
| D002694 | Chlamydiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D015817 | Eye Infections |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D003316 | Corneal Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D046912 | Multiprotein Complexes |
| D046911 | Macromolecular Substances |