安特卫普大学和金沙萨大学之间的合作伙伴关系实施了EBOVAC3临床试验,并向Tshuapa省的医疗保健提供者参与者提供了埃博拉疫苗方案,刚果民主共和国。这项随机对照试验是由欧盟创新药物倡议资助的埃博拉疫情准备计划的一部分。EBOVAC3临床试验使用虹膜扫描技术来识别所有参加疫苗试验的医疗保健提供者参与者,确保正确的参与者在正确的就诊时接种了正确的疫苗。
我们旨在评估可接受性,准确度,以及虹膜扫描技术作为在远程环境中疫苗试验的卫生保健提供者参与者人群中的识别方法的可行性。
我们使用了混合方法研究。在试验之前通过12个焦点小组讨论(FGD)评估可接受性,并在登记时进行评估。可行性和准确性研究采用纵向试验研究设计,将虹膜扫描与唯一的研究身份证进行比较,以确定纳入时和随访时的卫生保健提供者参与者.
在FGD期间,卫生保健提供者的参与者主要关注虹膜扫描技术给他们的眼睛带来身体问题或通过巫术使他们面临精神问题。然而,FGD中99%(85/86;95%CI97.1-100.0)的卫生保健提供者参与者同意通过虹膜扫描进行识别。此外,在入学时,99.0%(692/699;95%CI98.2-99.7)的医疗保健提供者参与者接受通过虹膜扫描识别。虹膜扫描技术正确识别了93.1%(636/683;95%CI91.2-95.0)的参与者返回定期随访。虹膜扫描手术持续2分钟或更短的96.0%(656/683;95%CI94.6-97.5),1次尝试足以确定大多数研究参与者(475/683,69.5%;95%CI66.1-73.0).
虹膜扫描作为远程环境中医疗保健提供者参与者的临床试验中的识别工具是高度可接受的。它在试验期间的操作证明了高度的准确性,可以可靠地识别个人。虹膜扫描在临床试验中被发现是可行的,但是需要经过训练的操作者减少持续时间和尝试识别参与者的次数。
ClinicalTrials.govNCT04186000;https://clinicaltrials.gov/ct2/show/NCT04186000。
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.
We 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.
We 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.
During 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).
Iris 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.
ClinicalTrials.gov NCT04186000; https://clinicaltrials.gov/ct2/show/NCT04186000.