DOI: 10.5064/f6h1qlnl
title: 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

description: &lt;h3&gt;Project Overview&lt;/h3&gt; 
 &lt;p&gt;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.&lt;/p&gt; 
 &lt;p&gt;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.&lt;/p&gt;

&lt;p&gt;&lt;i&gt;Objectives&lt;/i&gt;&lt;/p&gt; 
&lt;ol.&gt;&lt;li&gt;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 
&lt;li&gt;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 
&lt;li&gt;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&lt;/ol&gt;
description: &lt;h3&gt;Data and Data Collection Overview&lt;/h3&gt;
 &lt;p&gt;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.&lt;/p&gt;
 &lt;p&gt;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.&lt;/p&gt;
description: &lt;h3&gt;Selection and Organization of Shared Data&lt;/h3&gt;
 &lt;p&gt;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.&lt;/p&gt; 
&lt;p&gt;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.&lt;/p&gt;