Smartphone App for Taking Images of Conjunctivae

Developing and Evaluating Trachoma Diagnosis Training Tools in Preparation for the Trachoma Elimination Endgame: Development of a Smartphone Application to Capture Quality Images of Everted Eye Lids and Assessment of Its Acceptability and Feasibility

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.

Study Overview

• Status: Terminated
• Conditions: Trachoma
• Intervention / Treatment: Other: TOFTEE

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tanzania
  • Arusha, Tanzania
    • Arusha region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Objectives 2.1 and 2.2:

• For the London-based app development, any eligible healthy adult who provides written informed consent will be eligible.
• For the field-based app development, any child aged 1-9 years being examined as part of the Tropical Data IGA test, or sampled as part of trachoma prevalence surveys, and for whom written informed consent has been provided by a guardian, will be eligible.

Objective 2.3:

• All Tropical Data trainers and trainees attending the Tropical Data (initial and refresher) training events and who provide written informed consent, will be eligible.
• Community leaders and children's guardians who provide written informed consent will be eligible.

Exclusion Criteria:

• For each of the objectives, if the inclusion criteria are not fulfilled, the participant will not be eligible to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Children examined; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 minutes
Kappa score of TOFTEE image compared with field grading	Concordance in diagnosis of trachoma between field grading and app image	5 minutes
Kappa score of TOFTEE image compared with DSLR grading	Concordance in diagnosis of trachoma between app image and DSLR image	5 minutes
Kappa score of DSLR image compared with field grading	Concordance in diagnosis of trachoma between field grading and DSLR image	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	5 days

Collaborators and Investigators

• Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: University College London Hospitals; World Health Organization; RTI International; National Institute for Medical Research, Tanzania; Federal Minstry of Health of Ethiopia; Pan American Health Organization; Jos University Teaching Hospital; Sightsavers

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 8, 2019
• Primary Completion (ACTUAL): July 12, 2019
• Study Completion (ACTUAL): July 12, 2019

Study Registration Dates

• First Submitted: June 19, 2019
• First Submitted That Met QC Criteria: June 21, 2019
• First Posted (ACTUAL): June 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Eye Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Conjunctivitis; Conjunctival Diseases; Corneal Diseases; Chlamydiaceae Infections; Eye Infections, Bacterial; Eye Infections; Chlamydia Infections; Conjunctivitis, Bacterial; Trachoma
• Other Study ID Numbers: 2019-KEP-284 - 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised data will be shared with relevant study team members for the purposes of data analysis. Data Transfer Agreements will be completed, where appropriate.
• IPD Sharing Time Frame: Data will be shared with team members as they are collected.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No