Use of COVIDTests.gov At-Home Test Kits Among Adults in a National Household Probability Sample - United States, 2022.

At-home rapid antigen COVID-19 tests were first authorized by the Food and Drug Administration in late 2020 (1-3). In January 2022, the White House launched COVIDTests.gov, which made all U.S. households eligible to receive free-to-the-user at-home test kits distributed by the U.S. Postal Service (2). By May 2022, more than 70 million test kit packages had been shipped to households across the United States (2); however, how these kits were used, and which groups were using them, has not been reported. Data from a national probability survey of U.S. households (COVIDVu), collected during April-May 2022, were used to evaluate awareness about and use of these test kits (4). Most respondent households (93.8%) were aware of the program, and more than one half (59.9%) had ordered kits. Among persons who received testing for COVID-19 during the preceding 6 months, 38.3% used a COVIDTests.gov kit. Among kit users, 95.5% rated the experience as acceptable, and 23.6% reported being unlikely to have tested without the COVIDTests.gov program. Use of COVIDTests.gov kits was similar among racial and ethnic groups (42.1% non-Hispanic Black or African American [Black]; 41.5% Hispanic or Latino [Hispanic]; 34.8% non-Hispanic White [White]; and 53.7% non-Hispanic other races [other races]). Use of other home COVID-19 tests differed by race and ethnicity (11.8% Black, 44.4% Hispanic, 45.8% White, 43.8% other races). Compared with White persons, Black persons were 72% less likely to use other home test kits (adjusted relative risk [aRR] = 0.28; 95% CI = 0.16-0.50). Provision of tests through this well-publicized program likely improved use of COVID-19 home testing and health equity in the United States, particularly among Black persons. National programs to address availability and accessibility of critical health services in a pandemic response have substantial health value.

A stakeholder-driven framework for measuring potential change in the health risks of people who inject drugs (PWID) during the COVID-19 pandemic.

BACKGROUND: People who inject drugs (PWID) have likely borne disproportionate health consequences of the COVID-19 pandemic. PWID experienced both interruptions and changes to drug supply and delivery modes of harm reduction, treatment, and other medical services, leading to potentially increased risks for HIV, hepatitis C virus (HCV), and overdose. Given surveillance and research disruptions, proximal, indirect indicators of infectious diseases and overdose should be developed for timely measurement of health effects of the pandemic on PWID. METHODS: We used group concept mapping and a systems thinking approach to produce an expert stakeholder-generated, multi-level framework for monitoring changes in PWID health outcomes potentially attributable to COVID-19 in the U.S. This socio-ecological measurement framework elucidates proximal and distal contributors to infectious disease and overdose outcomes, many of which can be measured using existing data sources. RESULTS: The framework includes multi-level components including policy considerations, drug supply/distribution systems, the service delivery landscape, network factors, and individual characteristics such as mental and general health status and service utilization. These components are generally mediated by substance use and sexual behavioral factors to cause changes in incidence of HIV, HCV, sexually transmitted infections, wound/skin infections, and overdose. CONCLUSION: This measurement framework is intended to increase the quality and timeliness of research on the impacts of COVID-19 in the context of the current pandemic and future crises. Next steps include a ranking process to narrow the drivers of change in health risks to a concise set of indicators that adequately represent framework components, can be written as measurable indicators, and are quantifiable using existing data sources, as well as a publicly available web-based platform for summary data contributions.

Association of Guideline Complexity With Individuals' Ability to Determine Eligibility for COVID-19 Vaccination.

This cross-sectional study examines the association between the complexity of consumer guidelines for COVID-19 vaccination and identification of eligibility.

Nationally representative social contact patterns among U.S. adults, August 2020-April 2021.

The response to the COVID-19 pandemic in the U.S prompted abrupt and dramatic changes to social contact patterns. Monitoring changing social behavior is essential to provide reliable input data for mechanistic models of infectious disease, which have been increasingly used to support public health policy to mitigate the impacts of the pandemic. While some studies have reported on changing contact patterns throughout the pandemic, few have reported differences in contact patterns among key demographic groups and none have reported nationally representative estimates. We conducted a national probability survey of US households and collected information on social contact patterns during two time periods: August-December 2020 (before widespread vaccine availability) and March-April 2021 (during national vaccine rollout). Overall, contact rates in Spring 2021 were similar to those in Fall 2020, with most contacts reported at work. Persons identifying as non-White, non-Black, non-Asian, and non-Hispanic reported high numbers of contacts relative to other racial and ethnic groups. Contact rates were highest in those reporting occupations in retail, hospitality and food service, and transportation. Those testing positive for SARS-CoV-2 antibodies reported a higher number of daily contacts than those who were seronegative. Our findings provide evidence for differences in social behavior among demographic groups, highlighting the profound disparities that have become the hallmark of the COVID-19 pandemic.

Severe Acute Respiratory Syndrome Coronavirus 2 Cumulative Incidence, United States, August 2020-December 2020.

BACKGROUND: Reported coronavirus disease 2019 (COVID-19) cases underestimate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. We conducted a national probability survey of US households to estimate cumulative incidence adjusted for antibody waning. METHODS: From August-December 2020 a random sample of US addresses were mailed a survey and self-collected nasal swabs and dried blood spot cards. One adult household member completed the survey and mail specimens for viral detection and total (immunoglobulin [Ig] A, IgM, IgG) nucleocapsid antibody by a commercial, emergency use authorization-approved antigen capture assay. We estimated cumulative incidence of SARS-CoV-2 adjusted for waning antibodies and calculated reported fraction (RF) and infection fatality ratio (IFR). Differences in seropositivity among demographic, geographic, and clinical subgroups were explored. RESULTS: Among 39 500 sampled households, 4654 respondents provided responses. Cumulative incidence adjusted for waning was 11.9% (95% credible interval [CrI], 10.5%-13.5%) as of 30 October 2020. We estimated 30 332 842 (CrI, 26 703 753-34 335 338) total infections in the US adult population by 30 October 2020. RF was 22.3% and IFR was 0.85% among adults. Black non-Hispanics (Prevalence ratio (PR) 2.2) and Hispanics (PR, 3.1) were more likely than White non-Hispanics to be seropositive. CONCLUSIONS: One in 8 US adults had been infected with SARS-CoV-2 by October 2020; however, few had been accounted for in public health reporting. The COVID-19 pandemic is likely substantially underestimated by reported cases. Disparities in COVID-19 by race observed among reported cases cannot be attributed to differential diagnosis or reporting of infections in population subgroups.

Cumulative Incidence of SARS-CoV-2 Infections Among Adults in Georgia, United States, August to December 2020.

BACKGROUND: Reported coronavirus disease 2019 (COVID-19) cases underestimate true severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. Data on all infections, including asymptomatic infections, are needed. To minimize biases in estimates from reported cases and seroprevalence surveys, we conducted a household-based probability survey and estimated cumulative incidence of SARS-CoV-2 infections adjusted for antibody waning. METHODS: From August to December 2020, we mailed specimen collection kits (nasal swabs and blood spots) to a random sample of Georgia addresses. One household adult completed a survey and returned specimens for virus and antibody testing. We estimated cumulative incidence of SARS-CoV-2 infections adjusted for waning antibodies, reported fraction, and infection fatality ratio (IFR). Differences in seropositivity among demographic, geographic, and clinical subgroups were explored with weighted prevalence ratios (PR). RESULTS: Among 1370 participants, adjusted cumulative incidence of SARS-CoV-2 was 16.1% (95% credible interval [CrI], 13.5%-19.2%) as of 16 November 2020. The reported fraction was 26.6% and IFR was 0.78%. Non-Hispanic black (PR, 2.03; 95% confidence interval [CI], 1.0-4.1) and Hispanic adults (PR, 1.98; 95% CI, .74-5.31) were more likely than non-Hispanic white adults to be seropositive. CONCLUSIONS: As of mid-November 2020, 1 in 6 adults in Georgia had been infected with SARS-CoV-2. The COVID-19 epidemic in Georgia is likely substantially underestimated by reported cases.

SARS-CoV-2 Cumulative Incidence and Period Seroprevalence: Results From a Statewide Population-Based Serosurvey in California.

BACKGROUND: California has reported the largest number of coronavirus disease 2019 (COVID-19) cases of any US state, with more than 3.5 million confirmed as of March 2021. However, the full breadth of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission in California is unknown as reported cases only represent a fraction of all infections. METHODS: We conducted a population-based serosurvey, utilizing mailed, home-based SARS-CoV-2 antibody testing along with a demographic and behavioral survey. We weighted data from a random sample to represent the adult California population and estimated period seroprevalence overall and by participant characteristics. Seroprevalence estimates were adjusted for waning antibodies to produce statewide estimates of cumulative incidence, the infection fatality ratio (IFR), and the reported fraction. RESULTS: California's SARS-CoV-2 weighted seroprevalence during August-December 2020 was 4.6% (95% CI, 2.8%-7.4%). Estimated cumulative incidence as of November 2, 2020, was 8.7% (95% CrI, 6.4%-11.5%), indicating that 2 660 441 adults (95% CrI, 1 959 218-3 532 380) had been infected. The estimated IFR was 0.8% (95% CrI, 0.6%-1.0%), and the estimated percentage of infections reported to the California Department of Public Health was 31%. Disparately high risk for infection was observed among persons of Hispanic/Latinx ethnicity and people with no health insurance and who reported working outside the home. CONCLUSIONS: We present the first statewide SARS-CoV-2 cumulative incidence estimate among adults in California. As of November 2020, ~1 in 3 SARS-CoV-2 infections in California adults had been identified by public health surveillance. When accounting for unreported SARS-CoV-2 infections, disparities by race/ethnicity seen in case-based surveillance persist.

Willingness to Seek Diagnostic Testing for SARS-CoV-2 With Home, Drive-through, and Clinic-Based Specimen Collection Locations.

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.

Willingness to Use Home Collection Methods to Provide Specimens for SARS-CoV-2/COVID-19 Research: Survey Study.

BACKGROUND: Innovative laboratory testing approaches for SARS-CoV-2 infection and immune response are needed to conduct research to establish estimates of prevalence and incidence. Self-specimen collection methods have been successfully used in HIV and sexually transmitted infection research and can provide a feasible opportunity to scale up SARS-CoV-2 testing for research purposes. OBJECTIVE: The aim of this study was to assess the willingness of adults to use different specimen collection modalities for themselves and children as part of a COVID-19 research study. METHODS: Between March 27 and April 1, 2020, we recruited 1435 adults aged 18 years or older though social media advertisements. Participants completed a survey that included 5-point Likert scale items stating how willing they were to use the following specimen collection testing modalities as part of a research study: home collection of a saliva sample, home collection of a throat swab, home finger-prick blood collection, drive-through site throat swab, clinic throat swab, and clinic blood collection. Additionally, participants indicated how the availability of home-based collection methods would impact their willingness to participate compared to drive-through and clinic-based specimen collection. We used Kruskal-Wallis tests and Spearman rank correlations to assess if willingness to use each testing modality differed by demographic variables and characteristics of interest. We compared the overall willingness to use each testing modality and estimated effect sizes with Cohen d. RESULTS: We analyzed responses from 1435 participants with a median age of 40.0 (SD=18.2) years and over half of which were female (761/1435, 53.0%). Most participants agreed or strongly agreed that they would be willing to use specimens self-collected at home to participate in research, including willingness to collect a saliva sample (1259/1435, 87.7%) or a throat swab (1191/1435, 83.1%). Willingness to collect a throat swab sample was lower in both a drive-through setting (64%) and clinic setting (53%). Overall, 69.0% (990/1435) of participants said they would be more likely to participate in a research study if they could provide a saliva sample or throat swab at home compared to going to a drive-through site; only 4.4% (63/1435) of participants said they would be less likely to participate using self-collected samples. For each specimen collection modality, willingness to collect specimens from children for research was lower than willingness to use on oneself, but the ranked order of modalities was similar. CONCLUSIONS: Most participants were willing to participate in a COVID-19 research study that involves laboratory testing; however, there was a strong preference for home specimen collection procedures over drive-through or clinic-based testing. To increase participation and minimize bias, epidemiologic research studies of SARS-CoV-2 infection and immune response should consider home specimen collection methods.

Similarities and Differences in COVID-19 Awareness, Concern, and Symptoms by Race and Ethnicity in the United States: Cross-Sectional Survey.

BACKGROUND: Existing health disparities based on race and ethnicity in the United States are contributing to disparities in morbidity and mortality during the coronavirus disease (COVID-19) pandemic. We conducted an online survey of American adults to assess similarities and differences by race and ethnicity with respect to COVID-19 symptoms, estimates of the extent of the pandemic, knowledge of control measures, and stigma. OBJECTIVE: The aim of this study was to describe similarities and differences in COVID-19 symptoms, knowledge, and beliefs by race and ethnicity among adults in the United States. METHODS: We conducted a cross-sectional survey from March 27, 2020 through April 1, 2020. Participants were recruited on social media platforms and completed the survey on a secure web-based survey platform. We used chi-square tests to compare characteristics related to COVID-19 by race and ethnicity. Statistical tests were corrected using the Holm Bonferroni correction to account for multiple comparisons. RESULTS: A total of 1435 participants completed the survey; 52 (3.6%) were Asian, 158 (11.0%) were non-Hispanic Black, 548 (38.2%) were Hispanic, 587 (40.9%) were non-Hispanic White, and 90 (6.3%) identified as other or multiple races. Only one symptom (sore throat) was found to be different based on race and ethnicity (P=.003); this symptom was less frequently reported by Asian (3/52, 5.8%), non-Hispanic Black (9/158, 5.7%), and other/multiple race (8/90, 8.9%) participants compared to those who were Hispanic (99/548, 18.1%) or non-Hispanic White (95/587, 16.2%). Non-Hispanic White and Asian participants were more likely to estimate that the number of current cases was at least 100,000 (P=.004) and were more likely to answer all 14 COVID-19 knowledge scale questions correctly (Asian participants, 13/52, 25.0%; non-Hispanic White participants, 180/587, 30.7%) compared to Hispanic (108/548, 19.7%) and non-Hispanic Black (25/158, 15.8%) participants. CONCLUSIONS: We observed differences with respect to knowledge of appropriate methods to prevent infection by the novel coronavirus that causes COVID-19. Deficits in knowledge of proper control methods may further exacerbate existing race/ethnicity disparities. Additional research is needed to identify trusted sources of information in Hispanic and non-Hispanic Black communities and create effective messaging to disseminate correct COVID-19 prevention and treatment information.

Suitability and Sufficiency of Telehealth Clinician-Observed, Participant-Collected Samples for SARS-CoV-2 Testing: The iCollect Cohort Pilot Study.

BACKGROUND: The severe acute respiratory coronavirus 2 (SARS-CoV-2) pandemic calls for expanded opportunities for testing, including novel testing strategies such as home-collected specimens. OBJECTIVE: We aimed to understand whether oropharyngeal swab (OPS), saliva, and dried blood spot (DBS) specimens collected by participants at home and mailed to a laboratory were sufficient for use in diagnostic and serology tests of SARS-CoV-2. METHODS: Eligible participants consented online and were mailed a participant-collection kit to support collection of three specimens for SARS-CoV-2 testing: saliva, OPS, and DBS. Participants performed the specimen collection procedures during a telehealth video appointment while clinical observers watched and documented the suitability of the collection. The biological sufficiency of the specimens for detection of SARS-CoV-2 by reverse transcriptase-polymerase chain reaction and serology testing was assessed by laboratorians using visual inspection and quantification of the nucleic acid contents of the samples by ribonuclease P (RNase P) measurements. RESULTS: Of the enrolled participants,153/159 (96.2%) returned their kits, which were included in this analysis. All these participants attended their video appointments. Clinical observers assessed that of the samples collected, 147/153 (96.1%) of the saliva samples, 146/151 (96.7%) of the oropharyngeal samples, and 135/145 (93.1%) of the DBS samples were of sufficient quality for submission for laboratory testing; 100% of the OPS samples and 98% of the saliva samples had cycle threshold values for RNase P <30, indicating that the samples contained sufficient nucleic acid for RNA-PCR testing for SARS-CoV-2. CONCLUSIONS: These pilot data indicate that most participant-collected OPS, saliva, and DBS specimens are suitable and sufficient for testing for SARS-CoV-2 RNA and serology. Clinical observers rated the collection of specimens as suitable for testing, and visual and quantitative laboratory assessment indicated that the specimens were biologically sufficient. These data support the utility of participant-collected and mailed-in specimens for SARS-CoV-2 testing. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/19054.