Use of Iris Scanning for Biometric Recognition of Healthy Adults Participating in an Ebola Vaccine Trial in the Democratic Republic of the Congo: Mixed Methods Study.

Trésor Zola Matuvanga,Emmanuel Esanga Longomo,Bruno Lapika,Vivi Maketa,Ginger Johnson,Jessie De Bie,Hypolite Muhindo Mavoko,Junior Matangila,Jean-Pierre Van Geertruyden,Ynke Larivière,Patrick Mitashi,Pierre Van Damme,Paula Mc Kenna

doi:10.2196/28573

Trésor Zola Matuvanga, Emmanuel Esanga Longomo + Show 11 more

Open Access

https://doi.org/10.2196/28573

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Abstract

BackgroundA partnership between the University of Antwerp and the University of Kinshasa implemented the EBOVAC3 clinical trial with an Ebola vaccine regimen administered to health care provider participants in Tshuapa Province, Democratic Republic of the Congo. This randomized controlled trial was part of an Ebola outbreak preparedness initiative financed through Innovative Medicines Initiative-European Union. The EBOVAC3 clinical trial used iris scan technology to identify all health care provider participants enrolled in the vaccine trial, to ensure that the right participant received the right vaccine at the right visit.ObjectiveWe aimed to assess the acceptability, accuracy, and feasibility of iris scan technology as an identification method within a population of health care provider participants in a vaccine trial in a remote setting.MethodsWe used a mixed methods study. The acceptability was assessed prior to the trial through 12 focus group discussions (FGDs) and was assessed at enrollment. Feasibility and accuracy research was conducted using a longitudinal trial study design, where iris scanning was compared with the unique study ID card to identify health care provider participants at enrollment and at their follow-up visits.ResultsDuring the FGDs, health care provider participants were mainly concerned about the iris scan technology causing physical problems to their eyes or exposing them to spiritual problems through sorcery. However, 99% (85/86; 95% CI 97.1-100.0) of health care provider participants in the FGDs agreed to be identified by the iris scan. Also, at enrollment, 99.0% (692/699; 95% CI 98.2-99.7) of health care provider participants accepted to be identified by iris scan. Iris scan technology correctly identified 93.1% (636/683; 95% CI 91.2-95.0) of the participants returning for scheduled follow-up visits. The iris scanning operation lasted 2 minutes or less for 96.0% (656/683; 95% CI 94.6-97.5), and 1 attempt was enough to identify the majority of study participants (475/683, 69.5%; 95% CI 66.1-73.0).ConclusionsIris scans are highly acceptable as an identification tool in a clinical trial for health care provider participants in a remote setting. Its operationalization during the trial demonstrated a high level of accuracy that can reliably identify individuals. Iris scanning is found to be feasible in clinical trials but requires a trained operator to reduce the duration and the number of attempts to identify a participant.Trial RegistrationClinicalTrials.gov NCT04186000; https://clinicaltrials.gov/ct2/show/NCT04186000

Highlights

Identification and recognition of study participants in a clinical trial—during the process of recruitment and during follow-up visits—is a growing issue [1]
During the focus group discussions (FGDs), health care provider participants were mainly concerned about the iris scan technology causing physical problems to their eyes or exposing them to spiritual problems through sorcery
99% (85/86; 95% CI 97.1-100.0) of health care provider participants in the FGDs agreed to be identified by the iris scan

Summary

Introduction

Identification and recognition of study participants in a clinical trial—during the process of recruitment and during follow-up visits—is a growing issue [1]. Conventional methods for the recognition of participants in health facilities may include patient name, date of birth, government identity card with photo, and phone number [2,3,4,5] These methods are not always reliable or accurate [5]. A partnership between the University of Antwerp and the University of Kinshasa implemented the EBOVAC3 clinical trial with an Ebola vaccine regimen administered to health care provider participants in Tshuapa Province, Democratic Republic of the Congo. This randomized controlled trial was part of an Ebola outbreak preparedness initiative financed through Innovative Medicines Initiative-European Union. The EBOVAC3 clinical trial used iris scan technology to identify all health care provider participants enrolled in the vaccine trial, to ensure that the right participant received the right vaccine at the right visit

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Conclusion