Data For: Optimising Instructional Materials for COVID-19 Rapid Tests for Self-Sampling and Testing: Mapping the Optimization Process of Manufacturer’s Instructions for Use for Self-Testing RDTs Intended for Low Literacy Contexts

Project Overview This is an observational, cross-sectional study of the feasibility and acceptability of self-sampling and self-testing using SARS-CoV-2 antigen tests in adults in the general population and health care workers. COVID-19 has caused significant mortality and morbidity since it was first reported. Testing, isolation and contact tracing remain key to managing the spread of infection. Nucleic acid amplification tests (NAAT) are required for diagnosis. However, many resource setting face shortages of testing supplies, skilled laboratory personnel, high costs and logistical challenges. SARS COV-2 Rapid antigen diagnostic tests provide a quick and instrument-free alternative to nucleic acid amplification tests (NAAT) and data is emerging that more simple-to-collect alternative sampling methods, such as nasal swabs or saliva specimens, will be accurate alternatives. While it may be too preliminary to use self-tests among the general public, particularly in settings of lower literacy, health workers at primary level facilities (including lay health workers) have a wealth of experience using point-of-care (POC) rapid diagnostic tests (RDTs) for COVID-19 and other diseases, and may be good candidates for self-testing for SARS-CoV-2. Self-sampling and self-testing could reduce the demand on health facilities while addressing many of the usual barriers to uptake of services, leading to timely testing of larger volumes. Objectives 1. Develop culturally relevant instructional information (pictorial and written materials) to support self-sampling from the anterior nares using nasal swabs for up to four antigen tests 2. Develop culturally relevant instructional information (pictorial and written materials) to support self-testing of self-collected AN samples, for two COVID-19 antigen tests 3. Elucidate preferences that influence willingness to test for SARS-CoV-2 and link to prevention and care if using self-sampling/-testing versus professional sampling/testing using qualitative methods
Data and Data Collection Overview The cognitive interviews were conducted at two sites within Blantyre, Malawi, namely: Queen Elizabeth Central Hospital (QECH) and Lirangwe in Blantyre, urban and rural respectively. A total of 120 participants were recruited during the cognitive interviews; out of these 50 were health care workers, while 70 were the community members. The total number of health care workers that were recruited at QECH was 11, while at Lirangwe was 39. The total number of male participants who participated in the cognitive interviews was 52 and 68 for the females. All the participants were recruited based on factors such as age, literacy level and their willingness to participant in the study among others. Once recruited, cognitive interviews with study participants began with the original instructions for use for two Covid-19 rapid diagnostics tests (RDTs) kits namely: Standard Q and PanBio. Data collected from the cognitive interviews were captured using digital audio recorders and observation form. Using an iterative process, between 1 to 6th iterations of the instruction for use were made for the two RDTs. After recruiting a total of 4 participants per the initial instructions-for-use (IFU) version, a meeting was convened aimed at discussing the outcomes of the cognitive interview and agreeing on the iterations to be made to the IFU before the actual change were made. Using participants’ suggestions contained in summaries of observation forms, the study team made appropriate adaptations and changes to the IFUs before proceeding with a subsequent iteration. During the process of the cognitive interviews, 6 iterations were made for the IFU for each kit during the entire process of cognitive interviews. At total of 120 participants were recruited in the study: 58 Standard Q and 62 PanBio.
Selection and Organization of Shared Data The data files shared in this first version of the deposit consist of 58 PANBIO and 62 STDQ interview transcripts. The interviewer questions are typically in English, while the respondents’ answers are given in Chichewa. The study involved sites in Zimbabwe as well. The data from those are not currently being shared. The documentation files consist of a file defining acronyms used, 4 PANBIO and 5 STDQ observation summaries of participants performing standardized instructions for rapid diagnostic COVID-19 tests, a consent form in English and Chichewa, the questionnaire used for the initial iteration of interviews, summary of participant characteristics, this data narrative, and an administrative README file.

项目概述：本项研究是一项对普通人群及医护人员进行自我采样和自我检测SARS-CoV-2抗原检测可行性和接受度的观察性横断面研究。自COVID-19首次报告以来，该病毒已导致大量死亡和疾病。检测、隔离和接触者追踪仍然是管理感染传播的关键措施。核酸检测扩增试验（NAAT）是诊断所必需的。然而，许多资源匮乏的地区面临着检测供应不足、缺乏熟练的实验室人员、高昂的成本和物流挑战。SARS COV-2快速抗原诊断检测为核酸检测扩增试验（NAAT）提供了一种快速且无需仪器的替代方案，且有数据表明，更易于收集的替代采样方法，如鼻拭子或唾液样本，将成为准确的替代品。尽管在普通人群中采用自我检测可能还处于初步阶段，尤其是在低文化素养的环境中，但初级医疗机构（包括非专业医护人员）的卫生工作者在COVID-19及其他疾病的即时诊断测试（RDTs）方面拥有丰富的经验，因此可能是SARS-CoV-2自我检测的良好候选者。自我采样和自我检测可以减少对医疗机构的依赖，同时克服许多服务普及的常规障碍，从而实现大量样本的及时检测。

目标：1. 开发与当地文化相关的指导信息（图像和文字材料），以支持使用鼻拭子从前鼻孔进行自我采样，进行最多四次抗原检测；2. 开发与当地文化相关的指导信息（图像和文字材料），以支持自我检测自行采集的鼻拭子样本，进行两次COVID-19抗原检测；3. 阐明影响进行SARS-CoV-2检测意愿的偏好，并使用定性方法将自我采样/检测与专业采样/检测联系起来。

数据和数据收集概述：认知访谈在马拉维布兰太尔的两个地点进行，分别是：伊丽莎白女王中央医院（QECH）和布兰太尔的利兰韦，分别代表城市和农村。在认知访谈中，共招募了120名参与者；其中50名为医护人员，70名为社区成员。在QECH招募的医护人员总数为11人，在利兰韦为39人。参与认知访谈的男性参与者总数为52人，女性为68人。所有参与者均根据年龄、文化程度以及参与研究的意愿等因素进行招募。一旦招募，认知访谈便以两种COVID-19快速诊断测试（RDTs）套件的原版使用说明为起点。认知访谈收集的数据使用数字录音机和观察表进行记录。通过迭代过程，对两种RDTs的使用说明进行了1至6次迭代。根据初始使用说明版本招募每位参与者后，召开了一次会议，旨在讨论认知访谈的结果，并就实际修改前需要进行的迭代达成一致。研究团队根据观察表总结中的参与者建议，对使用说明进行了适当的调整和修改，然后进行后续迭代。在整个认知访谈过程中，对每个套件的IFU进行了6次迭代。研究中共招募了120名参与者：58名使用标准Q，62名使用PanBio。

共享数据和数据的组织：本存档的第一版中共享的数据文件包括58份PANBIO和62份STDQ访谈记录。访谈者的问题通常用英语提出，而受访者的回答用奇切瓦语给出。该研究还涉及津巴布韦的地点。那些数据目前尚未共享。文档文件包括一个定义缩略语的文件、4份PANBIO和5份STDQ观察总结，其中记录了参与者执行标准化快速诊断COVID-19测试的情况、英文和奇切瓦语的知情同意书、用于初始迭代访谈的问卷、参与者特征总结、本数据叙述和行政README文件。