基于风险的新冠病毒自我检测以保护我们免受新冠病毒感染（STOP COVID-19）检测方案的依从性设计与初步结果：前瞻性数字研究

Design and Preliminary Findings of Adherence to the Self-Testing for Our Protection From COVID-19 (STOP COVID-19) Risk-Based Testing Protocol: Prospective Digital Study.

作者信息

Herbert Carly, Kheterpal Vik, Suvarna Thejas, Broach John, Marquez Juan Luis, Gerber Ben, Schrader Summer, Nowak Christopher, Harman Emma, Heetderks William, Fahey Nisha, Orvek Elizabeth, Lazar Peter, Ferranto Julia, Noorishirazi Kamran, Valpady Shivakumar, Shi Qiming, Lin Honghuang, Marvel Kathryn, Gibson Laura, Barton Bruce, Lemon Stephenie, Hafer Nathaniel, McManus David, Soni Apurv

机构信息

Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, United States.

CareEvolution, Inc, Ann Arbor, MI, United States.

出版信息

JMIR Form Res. 2022 Jun 16;6(6):e38113. doi: 10.2196/38113.

DOI:10.2196/38113

PMID:35649180

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9205422/

Abstract

BACKGROUND

Serial testing for SARS-CoV-2 is recommended to reduce spread of the virus; however, little is known about adherence to recommended testing schedules and reporting practices to health departments.

OBJECTIVE

The Self-Testing for Our Protection from COVID-19 (STOP COVID-19) study aims to examine adherence to a risk-based COVID-19 testing strategy using rapid antigen tests and reporting of test results to health departments.

METHODS

STOP COVID-19 is a 12-week digital study, facilitated using a smartphone app for testing assistance and reporting. We are recruiting 20,000 participants throughout the United States. Participants are stratified into high- and low-risk groups based on history of COVID-19 infection and vaccination status. High-risk participants are instructed to perform twice-weekly testing for COVID-19 using rapid antigen tests, while low-risk participants test only in the case of symptoms or exposure to COVID-19. All participants complete COVID-19 surveillance surveys, and rapid antigen results are recorded within the smartphone app. Primary outcomes include participant adherence to a risk-based serial testing protocol and percentage of rapid tests reported to health departments.

RESULTS

As of February 2022, 3496 participants have enrolled, including 1083 high-risk participants. Out of 13,730 tests completed, participants have reported 13,480 (98.18%, 95% CI 97.9%-98.4%) results to state public health departments with full personal identifying information or anonymously. Among 622 high-risk participants who finished the study period, 35.9% showed high adherence to the study testing protocol. Participants with high adherence reported a higher percentage of test results to the state health department with full identifying information than those in the moderate- or low-adherence groups (high: 71.7%, 95% CI 70.3%-73.1%; moderate: 68.3%, 95% CI 66.0%-70.5%; low: 63.1%, 59.5%-66.6%).

CONCLUSIONS

Preliminary results from the STOP COVID-19 study provide important insights into rapid antigen test reporting and usage, and can thus inform the use of rapid testing interventions for COVID-19 surveillance.

摘要

背景

建议对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）进行系列检测以减少病毒传播；然而，对于遵守推荐的检测时间表以及向卫生部门报告检测结果的情况知之甚少。

目的

“自我检测以预防新冠病毒（STOP COVID-19）”研究旨在调查使用快速抗原检测对基于风险的新冠病毒检测策略的遵守情况以及向卫生部门报告检测结果的情况。

方法

“STOP COVID-19”是一项为期12周的数字研究，通过一款智能手机应用程序协助检测和报告。我们正在美国招募20000名参与者。参与者根据新冠病毒感染史和疫苗接种状况分为高风险组和低风险组。高风险参与者被要求使用快速抗原检测每周进行两次新冠病毒检测，而低风险参与者仅在出现症状或接触新冠病毒时进行检测。所有参与者都要完成新冠病毒监测调查，快速抗原检测结果记录在智能手机应用程序中。主要结果包括参与者对基于风险的系列检测方案的遵守情况以及向卫生部门报告的快速检测的百分比。

结果

截至2022年2月，已有3496名参与者登记，其中包括1083名高风险参与者。在完成的13730次检测中，参与者已向州公共卫生部门报告了13480次（98.18%，95%置信区间97.9%-98.4%）结果，提供了完整的个人身份信息或匿名报告。在完成研究期的622名高风险参与者中，35.9%对研究检测方案表现出高度遵守。与中度或低度遵守组相比，高度遵守的参与者向州卫生部门报告的带有完整身份信息的检测结果百分比更高（高度：71.7%，95%置信区间70.3%-73.1%；中度：68.3%，95%置信区间66.0%-70.5%；低度：63.1%，59.5%-66.6%）。