Division of Infectious Diseases, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, USA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, USA.
Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, USA.
Contemp Clin Trials. 2021 Nov;110:106585. doi: 10.1016/j.cct.2021.106585. Epub 2021 Oct 2.
Background Widely available population testing is critical to public health efforts to control the ongoing COVID-19 pandemic. However, COVID-19 testing has been low in underserved communities disproportionately affected by COVID-19. One approach to increase testing rates is through the secondary distribution of self-collection kits, where an individual distributes test kits to contacts in their social network and encourages them to self-collect test specimens. We outline a randomized clinical trial, COVID-19 Self-testing Through Rapid Network Distribution (C-STRAND), and a cohort study of individuals with COVID-19, to determine the impact of a secondary distribution strategy on COVID-19 testing among medically underserved populations. Methods The clinical trial will seek to enroll 1048 adult index participants from federally health qualified centers in Philadelphia, PA seeking COVID-19 testing. Eligible participants will be randomized 1:1 to receive multiple self-collection test kits or multiple referrals for standard clinic-based tests to distribute to contacts within their social network. The primary outcome will be testing among at least two network contacts at 8 weeks. Index participants and network contacts who test positive for COVID-19 from C-STRAND will be eligible to join the COVID-19 Close Contact Self-testing Study (CloseST), assessing the secondary distribution of self-collection test kits among individuals with COVID-19. The primary outcome of this cohort will be the number of close contacts who test positive at 8 weeks. Conclusion Novel strategies to promote COVID-19 testing are necessary, particularly among underserved populations most affected by COVID-19. We will determine the efficacy of a self-testing secondary distribution strategy. The results may inform efforts to increase testing rates during the current pandemic.
背景 广泛的人群检测对于公共卫生部门控制当前 COVID-19 大流行的努力至关重要。然而,在服务不足的社区,COVID-19 检测率较低,这些社区受到 COVID-19 的不成比例影响。提高检测率的一种方法是通过二次分发自我采集试剂盒,即个人将试剂盒分发给社交网络中的联系人,并鼓励他们自行采集检测样本。我们概述了一项随机临床试验 COVID-19 通过快速网络分布进行自我检测(C-STRAND),以及一项针对 COVID-19 患者的队列研究,以确定二次分发策略对医疗服务不足人群 COVID-19 检测的影响。
方法 该临床试验将尝试从宾夕法尼亚州费城的联邦健康合格中心招募 1048 名成年指数参与者进行 COVID-19 检测。符合条件的参与者将按 1:1 随机分配接受多个自我采集测试包或多个标准诊所测试的转介,以分发给社交网络中的联系人。主要结果是在 8 周内至少有两个网络联系人进行检测。从 C-STRAND 中检测出 COVID-19 呈阳性的指数参与者和网络联系人将有资格参加 COVID-19 密切接触者自我检测研究(CloseST),评估 COVID-19 患者自我采集测试包的二次分发情况。该队列的主要结果是在 8 周时检测呈阳性的密切接触者人数。
结论 有必要采取新的策略来促进 COVID-19 检测,特别是在受 COVID-19 影响最大的服务不足人群中。我们将确定自我检测二次分发策略的效果。研究结果可能为当前大流行期间提高检测率的努力提供信息。