JMIR Publications

ABSTRACT

Background:

As part of an Ebola outbreak preparedness initiative, a partnership between the University of Antwerp and the University of Kinshasa, through an Innovative Medicines Initiative-European Union (project ‘EBOVAC 3’), implemented a clinical trial on an Ebola vaccine regimen to be administered to health care provider participants (HCP-P) in Tshuapa Province (Democratic Republic of the Congo). The EBOVAC3 clinical trial used iris scan technology to identify all HCP-P participating in the vaccine trial so the right participant received the right vaccine at the right visit.

Objective:

To assess the acceptability, accuracy and feasibility of iris scan technology as an identification method within a population of HCP-P in a vaccine trial in a remote setting.

Methods:

A mixed-method study was utilized. The acceptability was assessed prior to the trial through 12 focus group discussions (FGDs) and assessed at enrolment. Feasibility and accuracy research was conducted using a longitudinal trial study design where iris scanning was compared to the unique study ID card to identify HCP-P at enrolment, and at their follow-up visits.

Results:

During the FGDs, main concerns raised by HCP-P about the iris scan technology were that it may cause physical problems to their eyes or expose them to spiritual problems through sorcery. Though, 99.1% (95%CI: 97.1;100.0) of HCP-P in the FGDs agreed to be identified by the iris scan. Also, at enrolment 99.0% (95%CI:98.3; 99.7) HCP-P accepted to be identified by iris scan. Iris scan technology correctly identified 93.1% (95%CI:91.2; 95.0) of the participants returning for scheduled follow-up visits. Iris scanning operation lasted no more than 2 minutes 30 seconds for 96.0% (95%CI: 99.0;100.0) and one attempt was enough to identify the majority of study volunteers [69.5% (95% CI:66.1;73.0)].

Conclusions:

Iris scan is highly acceptable as an identification tool in a clinical trial in HCP-Ps. 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 it requires a trained operator in order to reduce the duration and the number of attempts to identify a participant.