key: cord-260257-phmd0u6d authors: Siegler, Aaron J; Hall, Eric; Luisi, Nicole; Zlotorzynska, Maria; Wilde, Gretchen; Sanchez, Travis; Bradley, Heather; Sullivan, Patrick S title: Willingness to seek laboratory testing for SARS-CoV-2 with home, drive-through, and clinic-based specimen collection locations date: 2020-06-30 journal: Open Forum Infect Dis DOI: 10.1093/ofid/ofaa269 sha: doc_id: 260257 cord_uid: phmd0u6d BACKGROUND: SARS-CoV-2 virus testing for persons with COVID-19 symptoms, and contact tracing for those testing positive, will be critical to successful epidemic control. Willingness of persons experiencing symptoms to seek testing may determine the success of this strategy. METHODS: A cross-sectional, online survey in the United States measured willingness to seek testing if feeling ill under different specimen collection scenarios: home-based saliva, home-based swab, drive-through facility swab, and clinic-based swab. Instructions clarified that home-collected specimens would be mailed to a laboratory for testing. We presented similar willingness questions regarding testing during follow-up care. RESULTS: Of 1435 participants, comprising a broad range of sociodemographic groups, 92% were willing to test with a home saliva specimen, 88% with home swab, 71% with drive-through swab, and 60% with clinic collected swab. Moreover, 68% indicated they would be more likely to get tested if there was a home testing option. There were no significant differences in willingness items across sociodemographic variables or for those currently experiencing COVID-19 symptoms. Results were nearly identical for willingness to receive testing for follow-up COVID-19 care. CONCLUSIONS: We observed a hierarchy of willingness to test for SARS-CoV-2, ordered by the degree of contact required. Home specimen collection options could result in up to one-third more symptomatic persons seeking testing, facilitating contact tracing and optimal clinical care. Remote specimen collection options may ease supply chain challenges and decrease the likelihood of nosocomial transmission. As home specimen collection options receive regulatory approval, they should be scaled rapidly by health systems. A central component of COVID-19 disease containment strategies will be scaled-up testing and self-isolation/quarantine as applicable. 1,2 This strategy requires active identification of case patients, contact tracing, and testing of people within their networks. Successful implementation of this strategy will require widespread access to testing; substantial efforts are underway to increase SARS-CoV-2 virus testing capacity in the United States and globally. In addition to access (e.g. supply), success of testing strategies will be contingent on the extent to which they are acceptable to patients (e.g. demand). Case identification and contact tracing efforts depend greatly on willingness to test among patients experiencing COVID-19 disease-like symptoms. To inform patient isolation strategy, those who have tested positive should be tested again during follow-up care (US Centers for Disease Control and Prevention recommends two consecutive tests collected ≥24 hours apart) if supplies and laboratory capacity are sufficient,; alternatively, a symptom-based strategy is recommended. 3 Patient willingness to seek testing is especially critical because many persons infected with SARS-CoV-2 may experience only mild symptoms: in Italy, 30% of diagnosed cases have been classified as mildly symptomatic, 4 although such estimates may be an undercount due to the likely lower frequency of test seeking in this group. For other infectious diseases, self-collection procedures have long been practiced, 5,6 been identified as highly acceptable and preferred to in-clinic procedures, 7 and having diagnostic metrics comparable to healthcare worker specimen collection. 8, 9 Calls for home-based specimen collection or drive-through specimen collection models to address SARS-CoV-2 virus test scale-up have cogently argued that these approaches have the benefit of (1) avoiding burdening hospitals at a critical time, (2) avoiding potential nosocomial infections (the risk of acquiring disease from clinical or laboratory settings), (3) likely lowering costs, and (4) potentially achieving rapid scale-up due to laboratory centralization. 10, 11 One additional benefit of home specimen collection might be that supply chain issues, such as stockouts of swabs or personal protective equipment, could be alleviated if non-traditional specimens such as saliva or non-traditional locations such as home settings prove sufficient. Drive-through SARS-CoV-2 virus testing sites already exist, 12 and a number of laboratories are working to additionally validate home-based self-specimen collection for SARS-CoV-2 testing. Protocols for the self-collection of specimens at home for SARS-CoV-2 testing are currently being explored. 13 For instance, two saliva-based SARS-CoV-2 virus tests have recently received Emergency Use Authorization from the US Food and Drug Administration for home-based specimen collection. 14,15 These protocols involve persons being mailed specimen collection materials and instructions, self-collection of specimens at home, and return of specimens to a central laboratory using a supplied mailer. We conducted an online survey to assess patient willingness to use the following SARS-CoV-2 testing modalities for clinical care: home-based specimen collection, drive-through testing, and clinic-based testing. We hypothesized that persons would be more willing to use home-based and drive-through specimen collection modalities compared to clinic-based modalities. We recruited potential participants using online social media advertisements from March 27th to April 1st, 2020. To be eligible, respondents had to be 18 years of age or older. Given the disproportionate impact of COVID-19 on communities of color, on the final day of data M a n u s c r i p t collection eligibility criteria were adjusted to screen out non-Hispanic White respondents in an effort to increase minority representation in the sample. Participants completed a nonincentivized online survey after being recruited from social media sites with banner advertisements requesting participation in COVID-19 survey research. Survey measures included previously published demographic items, 16 COVID-19 disease knowledge, 17 COVID-19 disease stigma items, 17 and a list of COVID-19 disease symptoms based on several sources. [18] [19] [20] Regions were defined according to US Census Bureau classifications of states. To understand whether responses were differential by state COVID-19 burden, we created a binomial variable with high burden states defined as having >99 cases per 100,000 population (NY, NJ, MA, LA, CT) at the time of the survey; these states accounted for over half of all COVID-19 cases at that time. 21 We developed a series of questions about willingness to use different testing modalities, each rated with a five-point Likert scale (1-Strongly disagree to 5-Strongly agree). The questions were based on home test willingness questions we have previously used in HIV prevention research. 22 Definitions for each testing modality were: "A home saliva sample would involve you spitting in a tube and sending it to a certified laboratory," "A home throat swab would involve you using a throat swab and sending it into a certified laboratory," "A drive-through site for throat swab would involve your traveling to a drive-through facility in your car to have a healthcare worker collect the swab," and "A laboratory throat swab would involve your traveling to a laboratory facility in a clinic or private laboratory to have a healthcare worker collect the swab." Other questions assessed whether persons rated themselves as more likely to seek testing if the option to collect specimens at home for mail-in testing were available. 20 The full text of survey items can be seen in Supplement 1. All participants completed a written electronic consent procedure, and study procedures were approved by the Emory University IRB. From 4,593 persons initiating the survey screener, 1,260 were ineligible, 1,886 did not consent or provided only partial survey responses, and 1,435 completed all willingness items for the analysis dataset (Figure 1 ). The sample was 39% (n=560) aged 18-29, 27% (391) aged 30-49, 20% (289) aged 50-64, and 14% (194) aged 65 or older. Females comprised 57% (761), males 40% (536), and other gender identity 3% (36) . Overall 41% (587) were non-Hispanic White, 38% (548) were Hispanic, 11% (158) were non-Hispanic Black, 4% (52) were Asian/Pacific Islander, and 6% (90) were Native American/Alaska Native or identified as mixed race or other non-Hispanic. COVID-19 knowledge was high with 75% (997) answering at least 12 of 14 knowledge questions correctly, and COVID-19 stigma was moderate with 46% (631) answering at least one of four stigma questions in a stigmatizing direction. A majority of 72% (1,017) thought they were unlikely to have COVID-19, although 52% (747) reported 1 or more of a broad range of potential COVID-19 symptoms. M a n u s c r i p t Home specimen collection solutions were most preferred with 92% (1314/1435) of participants agreeing or strongly agreeing that they would provide a saliva specimen, and 88% (1258/1435) agreeing that they would provide a throat swab (Figure 2 ). There was attenuated willingness for drive through swab testing (71%, 1026/1435), and substantially attenuated willingness for clinic or laboratory throat swab (60%, 854/1435). Differences in mean willingness scores across testing modalities were all significant (p<.001), with very small effect size for home saliva testing compared to home throat swab testing (d=0.12), medium effect size for home saliva testing compared to drive-through testing (d=0.55), and large effect size for home saliva testing compared to clinic-based testing (d=0.81). We found highly similar willingness to seek testing for COVID-19 follow-up care (Figure 2) , and identical significance and effect size findings (Supplement 2). Willingness to seek testing for diagnosis and care within each testing modality was remarkably consistent across all covariates in the analysis, with no differences across age groups, race/ethnicities, COVID-19 stigma scores, COVID-19 knowledge scores, COVID-19 symptomology, region, or state-level COVID burden (Table 1) . To directly assess potential behavioral change associated with different home care testing modalities, we asked participants whether they would be more likely, no different, or less likely to seek testing for COVID-19 disease if at-home specimen collection options were available. Relative to availability of a drive-through modality, 65% (933) noted they would be more likely to test if at-home specimen collection were available, 32% (459) noted no difference, and 3% (43) noted lower likelihood. Relative to availability of a clinic-or lab-based modality, 68% (970) noted they would be more likely to test if at-home specimen collection were available, 29% (418) noted no difference, and 3% (47) noted lower likelihood (results not reported in table). Across a diverse sample of 1,435 participants, one-third more persons reported that they would be willing to collect specimens at home for SARS-CoV-2 testing if they experienced illness, compared to clinic-based testing. There was a hierarchy of willingness to test for SARS-CoV-2 that was decreased as the required degree of contact with healthcare systems increased: home testing was most preferred, followed by drive-through testing, and then by laboratory or clinicbased testing. If differences in reported willingness approximate those in actual willingness, the magnitude of the findings has considerable public health and clinical care implications. One indicator that the hypothetical may approach actual behavior is that participant preferences were consistent across COVID-19 symptomology levels: persons currently experiencing COVID-19 related symptoms reported similarly lower willingness to seek drive-through and clinic-based SARS-CoV-2 testing as persons not currently experiencing symptoms. Preference differences were also constant across a wide variety of sociodemographic variables, which is important to note, considering the differential impact of SARS-CoV-2 on elderly persons 24 and on African-Americans, as reported in media and confirmed by coroner's offices in Louisiana, Chicago, and Michigan. 25 There are currently vast differences in how countries and jurisdictions are handling testing due to supply limitations. In Iceland, testing has been widely provided as a strategy to combat epidemic spread, and not surprisingly this appears to be substantially contributing to their control of epidemic spread. 26 With a combined approach for testing that included targeted recruitment of symptomatic persons or those in contact with symptomatic persons, an open invitation M a n u s c r i p t recruitment, and a random sample recruitment, Iceland tested over 22,000 persons using an inperson testing strategy. 26 At-home self-collection of specimens is one of several options worthy of exploration to achieve similar gains in other settings. Home-based and drive-through testing strategies are promising in part because they may allow for rapid scale-up of newly validated approaches that may relieve supply chain problems. It is clear that, if sufficient laboratory capacity and supplies are available, increased testing using at-home specimen collection is critical for public health response for three reasons. First, it would facilitate increased initiation of contact tracing, a tool known to limit epidemic spread, by identifying people with mild symptoms and allowing public health authorities to test close contacts. Second, it would reduce the risk of disease transmission from clinical settings. Third, it would facilitate improved selfmanagement, because mild and moderate COVID-19 symptoms are non-specific. Persons receiving a formal SARS-CoV-2 diagnosis are likely to perform self-isolation activities with substantially more rigor than persons whose actions are informed only by their mild symptoms. Conversely, those determined to be uninfected would be anticipated to have reduced anxiety, and be able to continue with their lives without an unnecessary isolation period. Given our finding that people were more willing to test with home specimen strategies, making such an option available might allow for earlier informed discussions with a clinician via an office visit or telemedicine regarding the optimal next steps in their care. This is especially relevant given media reports, confirmed by local health authorities, of the substantial increases of persons found dead in their homes in some cities in the United States compared to historic averages. In Detroit, there were more than 150 persons founds dead in their homes first 10 days of April compared to around 40 during that same period in the three years prior. 27 In New York City in early April 2020, a spokesperson for the Department of Health confirmed that around 200 deaths per day have been observed in homes, compared to 20-25 deaths per day in 2019. 28 It is likely that many of the deceased did not have an opportunity to receive clinical care, a problem that could potentially be mitigated through more wide-spread and easily accessible testing. Other authors have previously called for SARS-CoV-2 home testing, but mainly for its social distancing and reduced healthcare system burdens. 12, 29 Such calls can and have equally supported drive-through facilities. 12 But our findings indicate home collection was substantially preferred to drive-through methods, with over 20% more persons indicating willingness to complete a home test compared to a drive-through test. Drive-through testing venues may achieve benefits of viral transmission control, but have lower benefits for increasing the demand for testing. These results are aligned with previous work that has found home specimen collection a highly preferred method of seeking clinical care, 22, 30, 31 and can be understood as part of an already ongoing move towards remote care facilitated by at-home specimen collection. [32] [33] [34] [35] An additional benefit is that home testing has the potential to reach persons with limited access to transportation, or living far from available testing sites. This national online survey study has a number of limitations. Participants volunteered to take an online survey regarding COVID-19, potentially skewing willingness values higher than among the general population. Moreover, reported willingness has been observed to overestimate uptake for other interventions, 36 and our findings are likely subject to similar bias. We do not think, however, that this would produce bias in the relative levels of support for the testing options presented. Cost of different SARS-CoV-2 testing strategies will likely vary, and if the healthcare M a n u s c r i p t system does not cover the cost of some test options, this would likely influence willingness to use that modality. In unpublished work, the sensitivity performance of saliva-based tests has been found to be higher than nasopharyngeal swabs in clinical settings, 37 yet a separate study identified poor sensitivity performance of saliva specimens in a community-based setting. 38 Further studies for saliva as a specimen type in community settings are needed. The high overall preference for home testing, including for pharyngeal specimen collection, indicates that other home-based specimens such as anterior nares swab may likewise be highly acceptable. The convenience sample used in the present study may not represent the broader population in other ways, although the consistent and strong differences in preference across categories and item types indicates this would likely have little influence on study results. We found strong preferences for home testing options. Providing a home testing option is consistent with social distancing strategies and also patient-centered care strategies demonstrated to improve patient adherence to clinician-recommendations. Home specimen collection and central laboratory testing can ease supply chain problems, and be quickly scaled up for contact tracing use by public health authorities. Such home testing methods should be validated as soon as possible, and brought to scale by clinicians and health systems. All authors have no conflicts of interest to declare. M a n u s c r i p t Willingness to seek laboratory testing for SARS-CoV-2 under different specimen collection scenarios *For home specimens, instructions clarified that specimens would be collected at-home and mailed to a central laboratory for testing COVID-19: towards controlling of a pandemic COVID-19 epidemic in Switzerland: on the importance of testing, contact tracing and isolation Discontinuation of Isolation for Persons with COVID-19 Not in Healthcare Settings On the front lines of coronavirus: the Italian response to covid-19 Self-testing for HIV: a new option for HIV prevention? The Lancet infectious diseases Selfcollection of vaginal swabs for the detection of Chlamydia, gonorrhea, and trichomoniasis: opportunity to encourage sexually transmitted disease testing among adolescents. Sexually transmitted diseases Developing and Assessing the Feasibility of a Home-based Preexposure Prophylaxis Monitoring and Support Program Reliability of HIV rapid diagnostic tests for self-testing compared with testing by health-care workers: a systematic review and meta-analysis. The lancet HIV Self-Collected versus Clinician-Collected Sampling for Chlamydia and Gonorrhea Screening: A Systemic Review and Meta-Analysis Self-Service Diagnosis of COVID-19-Ready for Prime Time? Proposed protocol to keep COVID-19 out of hospitals Self-Service Diagnosis of COVID-19-Ready for Prime Time? Paper presented at: JAMA Health Forum2020 Detection of SARS-CoV-2 RNA and Antibodies in Diverse Samples: Protocol to Validate the Sufficiency of Provider-Observed, Home-Collected Blood, Saliva, and Oropharyngeal Samples Food and Drug Administration. Phosphorus COVID-19 RT-qPCR Test EUA Food and Drug Administration. Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay EUA The Annual American Men's Internet Survey of Behaviors of Men Who Have Sex With Men in the United States: Protocol and Key Indicators Report Knowledge and Perceptions of COVID-19 Among the General Public in the United States and the United Kingdom: A Cross-sectional Online Survey. Annals of internal medicine A novel coronavirus outbreak of global health concern Coronavirus outbreaks: prevention and management recommendations Loss of smell and taste in combination with other symptoms is a strong predictor of COVID-19 infection. medRxiv. 2020. 21. USA Facts. Coronavirus Locations: COVID-19 Map by County and State Clinical infectious diseases : an official publication of the Infectious Diseases Society of America The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. The Lancet Clinical Features of 85 Fatal Cases of COVID-19 from Wuhan: A Retrospective Observational Study Spread of SARS-CoV-2 in the Icelandic Population. The New England journal of medicine There's Been a Spike in People Dying at Home in Several Cities. That Suggests Coronavirus Deaths Are Higher Than Reported Staggering Surge Of NYers Dying In Their Homes Suggests City Is Undercounting Coronavirus Fatalities. Gothamist Web site Virtually perfect? Telemedicine for covid-19 Bringing HIV Self-Testing to Scale in the United States: a Review of Challenges, Potential Solutions, and Future Opportunities Attitudes and acceptability on HIV selftesting among key populations: a literature review An Electronic Pre-Exposure Prophylaxis Initiation and Maintenance Home Care System for Nonurban Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial Usability and Acceptability of a Mobile Comprehensive HIV Prevention App for Men Who Have Sex With Men: A Pilot Study Acceptability of self-collecting oropharyngeal swabs for sexually transmissible infection testing among men and women The Respiratory Specimen Collection Trial (ReSpeCT): A Randomized Controlled Trial to Compare Quality and Timeliness of Respiratory Sample Collection in the Home by Parents and Healthcare Workers From Children Aged< 2 Years Distinguishing hypothetical willingness from behavioral intentions to initiate HIV pre-exposure prophylaxis (PrEP): Findings from a large cohort of gay and bisexual men in the U Saliva is more sensitive for SARS-CoV-2 detection in COVID-19 patients than nasopharyngeal swabs Saliva is less sensitive than nasopharyngeal swabs for COVID-19 detection in the community setting We appreciate and acknowledge the contributions of our study participants. All authors had full access to study data, and AJS had final responsibility for the decision to submit for publication. This work was supported by the National Institute of Allergy and Infectious Diseases (3R01AI143875-02S1). The study was facilitated by the Center for AIDS Research at Emory University (P30AI050409). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. A c c e p t e d M a n u s c r i p t A c c e p t e d M a n u s c r i p t A c c e p t e d M a n u s c r i p t 2. There were no significant differences in testing scenario scores by any variable considered (e.g. home saliva specimen score differences across gender, age, etc), after Bonferroni-Holms correction for multiple hypothesis testing.3. High burden states as of the time of the survey (April 1 2020), defined as >99 cases / 100,000 population.A c c e p t e d M a n u s c r i p t A c c e p t e d M a n u s c r i p t Figure 2