Smartphone App for Taking Images of Conjunctivae

NCT03997487 | Terminated

• 1 other identifier: 2019-KEP-284 - 2
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 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 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.

Conditions

Trachoma

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Association (reported as proportions, unadjusted and adjusted odds ratios) between child characteristics and TOFTEE image quality

  15 minutes

• Acceptability and feasibility of TOFTEE app in communities

  45 minutes

• Acceptability and feasibility of TOFTEE app in Tropical Data system

  45 minutes

• Cost of TOFTEE app implementation

  5 days

Study Arms (1)

Children examined

EXPERIMENTAL

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

Interventions

TOFTEE OTHER

Smartphone app for taking quality images of conjunctivae

Children examined

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Arusha region

Arusha, Tanzania

Location

MeSH Terms

Conditions

Trachoma

Condition Hierarchy (Ancestors)

Conjunctivitis, Bacterial; Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Chlamydia Infections; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Corneal Diseases

Study Officials

• Emma Harding-Esch

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 25, 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.

Locations

TA (1)