PATH, Seattle, Washington, United States of America.
Global Health Strategies, Rio de Janeiro, Rio de Janeiro, Brazil.
PLoS One. 2023 Oct 4;18(10):e0284659. doi: 10.1371/journal.pone.0284659. eCollection 2023.
The coronavirus disease (COVID-19) pandemic has led to an unprecedented public health crisis. Insufficient testing continues to limit the effectiveness of the global response to the COVID-19 pandemic. Molecular testing methods such as reverse transcriptase polymerase chain reaction (RT-PCR) continue to be highly centralized and are a sub-optimal option for population surveillance. Rapid antigen tests (Ag-RDTs) offer multiple benefits including low costs, high flexibility to conduct tests in a wide variety of settings, and faster return of results. Self-test Ag-RDTs (STs) have gained approval in several markets and offer the possibility to expand testing, reaching at-risk populations. While STs have the potential to assist the COVID-19 response, test result integrity, reporting, and appropriate linkage to care continue to hinder the widespread implementation of self-testing programs. This protocol presents a mixed-methods pragmatic trial (ISRCTN91602092) to better understand the feasibility of self-testing as part of a contact tracing strategy within the Brazilian public health system. Approximately 604 close contacts of 150 index cases testing positive for COVID-19 will be enrolled. Index cases will be randomized for their close contacts to participate in either serial (daily) self-testing over a 10-day follow-up period or a more traditional approach to contact tracing with a professional Ag-RDT at one time point post-exposure. Usability workshops and focus group discussions will also be conducted. This study protocol presents a comprehensive plan to assess the effectiveness, operational feasibility, and stakeholder preferences of a serial self-testing strategy for contact tracing within the Brazilian public health system. Our results will contribute to better understanding of the feasibility of a self-testing strategy within the public sector. Potential risks and limitations are discussed. Our findings will have important implications as governments continue working to mitigate the impact of COVID-19, particularly in the context of where to direct limited resources for testing and healthcare infrastructure. Registration: This trial is registered at ISCTRN (ISRCTN91602092).
新型冠状病毒病（COVID-19）大流行导致了前所未有的公共卫生危机。检测不足继续限制着全球对 COVID-19 大流行的应对效果。逆转录聚合酶链反应（RT-PCR）等分子检测方法仍然高度集中，是人群监测的次优选择。快速抗原检测（Ag-RDTs）具有多种优势，包括成本低、在各种环境中进行检测的高度灵活性，以及更快的结果回报。自我检测 Ag-RDT（ST）已在多个市场获得批准，并有可能扩大检测范围，接触到高危人群。虽然 ST 有可能协助 COVID-19 的应对，但测试结果的完整性、报告以及与护理的适当联系，继续阻碍着自我检测计划的广泛实施。本方案提出了一项混合方法实用临床试验（ISRCTN91602092），以更好地了解自我检测作为巴西公共卫生系统接触者追踪策略的一部分的可行性。大约 150 例 COVID-19 阳性指数病例的 604 名密切接触者将被纳入研究。指数病例将被随机分配，其密切接触者将在 10 天的随访期内进行连续（每日）自我检测，或在接触后进行一次更传统的专业 Ag-RDT 接触者追踪。还将进行可用性研讨会和焦点小组讨论。本研究方案提出了一项综合计划，以评估在巴西公共卫生系统中，连续自我检测策略对接触者追踪的有效性、操作可行性和利益相关者偏好。我们的研究结果将有助于更好地了解公共部门自我检测策略的可行性。讨论了潜在的风险和局限性。随着各国政府继续努力减轻 COVID-19 的影响，特别是在为检测和医疗保健基础设施分配有限资源的方向上，我们的发现将具有重要意义。注册：本试验在 ISCTRN 注册（ISRCTN91602092）。
