An interventional study of TOFTEE in Trachoma, sponsored by London School of Hygiene and Tropical Medicine. Terminated at 1 site in Tanzania. Open to participants aged 1 Year and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-22.
Sponsored by London School of Hygiene and Tropical Medicine · Not applicable, Interventional, and Other
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 develop a smartphone application and assess its acceptability and feasibility.
Fieldwork will take place during routine Tropical Data trainings and population-based prevalence surveys supported by Tropical Data.
Healthy adult volunteers in London will have photos of their conjunctivae taken to develop the app initially, with iterative improvements to the app based on image quality achieved. For fieldwork, images of the conjunctivae of children will be have photos of their conjunctivae taken with a digital single lens reflex (DSLR) camera and the newly developed smartphone app. Grading of the photos will be compared with field grading, to compare grading agreement, to assess utility for supervision, quality assurance and training purposes.
The investigators want to see whether it would be possible to take photos using Android smartphones, routinely used in trachoma surveys for collecting data, for quality assurance, supervision and training purposes. The investigators will develop an app in the United Kingdom (UK) by taking photos of the conjunctivae of healthy adult volunteers to iteratively improve the quality of images based on the image metadata and review by trachoma experts. The app will then be field tested, and trachoma grading based on the app photos, DSLR photos, and clinical grading, compared. Any management (treatment) will be based on routine clinical diagnosis only - the images are for research purposes only. The investigators will also ask participants for their views on acceptability of having photos of conjunctivae taken with the phone, and conduct a cost-consequences analysis of potential implementation of the app in routine trachoma surveys.
Objectives and approach:
2.1 To develop a mobile phone application to capture images of everted eyelids (conjunctivae) of children being examined as part of the Tropical Data field inter-grader agreement (IGA) test, or sampled as part of trachoma prevalence surveys.
2.2 To evaluate the quality of the mobile phone application images compared with field grading and DSLR images.
2.3 To assess the acceptability and feasibility of a mobile phone application for photographing everted eyelids (conjunctivae) from children being examined as part of the Tropical Data IGA test, or sampled as part of trachoma prevalence surveys.
2.4 To conduct a cost-consequences analysis of setting up an infrastructure for capturing and transmitting images in order to make the system economically viable.
39 studies on the registry are indexed under Trachoma; 3 are open to participants now.
This study's enrollment of 125 is below the median of 1,300 across 31 interventional studies indexed under Trachoma.
Browse Trachoma studies →London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Objectives 2.1 and 2.2:
Objective 2.3:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All children examined for clinical signs of trachoma will be invited to participate to have photos of conjunctivae taken with the TOFTEE smartphone app and a DSLR camera.
Other: TOFTEE
Smartphone app for taking quality images of conjunctivae
TOols For Trachoma Elimination Endgame (TOFTEE) app image quality
Photo quality will be assessed by trachoma grading experts. The technical parameters such as lighting, resolution, focus, etc. will be assessed using objective software or extracted from the photograph metadata.
Time frame: 30 minutes
Kappa score of TOFTEE image compared with field grading
Concordance in diagnosis of trachoma between field grading and app image
Time frame: 5 minutes
Kappa score of TOFTEE image compared with DSLR grading
Concordance in diagnosis of trachoma between app image and DSLR image
Time frame: 5 minutes
Kappa score of DSLR image compared with field grading
Concordance in diagnosis of trachoma between field grading and DSLR image
Time frame: 5 minutes
Association (reported as proportions, unadjusted and adjusted odds ratios) between child characteristics and TOFTEE image quality
Association (reported as proportions, unadjusted and adjusted odds ratios) between child characteristics acceptable photo quality
Time frame: 15 minutes
Acceptability and feasibility of TOFTEE app in communities
Common themes, as determined through thematic analysis of focus group discussion transcripts, relating to acceptability and feasibility of TOFTEE app in communities
Time frame: 45 minutes
Acceptability and feasibility of TOFTEE app in Tropical Data system
Common themes, as determined through thematic analysis of focus group discussion transcripts, relating to acceptability and feasibility of TOFTEE app as part of the Tropical Data system
Time frame: 45 minutes
Cost of TOFTEE app implementation
Cost (overall and broken down by category: personnel; supplies; transit; telecommunications) of TOFTEE app implementation into the Tropical Data system
Time frame: 5 days
Plan to share: Yes — Anonymised data will be shared with relevant study team members for the purposes of data analysis. Data Transfer Agreements will be completed, where appropriate.
Supporting information: 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.
No publications or documents are linked to this record.
This study is terminated, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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