The Impact of the COVID-19 Pandemic on Sexual Behavior and HIV Prevention and Treatment Services Among U.S. Men Who Have Sex With Men in the Post-Lockdown Era.

Early in the COVID-19 pandemic, disruptions to sexual health services and changes to sexual behavior due to the first COVID-19 lockdowns were common among U.S. gay, bisexual, and other men who have sex with men (GBMSM). Less is known about the persistence of these changes after this initial lockdown period. These changes have long-term implications for HIV prevention for current and future pandemic periods. This study collected information on COVID-related impacts on sexual behavior and HIV-related health service disruptions from a cohort of U.S. GBMSM at three time points during the COVID-19 pandemic. We observed that COVID-related disruptions to sexual behavior continued from early lockdown periods through December 2020. Although early interruptions to pre-exposure prophylaxis (PrEP) access resolved in later 2020 and interruptions to antiretroviral therapy (ART) adherence were minimal, extended disruptions were observed in HIV testing, sexually transmitted infection (STI) testing, HIV care clinical visits, and HIV viral load testing. Although sexual behavior did not return to prepandemic levels in late 2020, the reduced access to HIV prevention, testing, and treatment services during this period could result in an overall increased HIV transmission rate, with long-term impacts to the trajectory of the U.S. HIV epidemic. Additional resources and programs are needed to address challenges created by the COVID-19 pandemic, as well as prepare for future potential pandemics and other disruptive events.

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.

Impacts of COVID-19 on sexual behaviors, HIV prevention and care among men who have sex with men: A comparison of New York City and Metropolitan Atlanta.

The COVID-19 pandemic has disrupted HIV prevention, care, and transmission opportunities. This likely varies by geography, given differences in COVID-19 burden and mandates over time, and by age, given different likelihoods of severe COVID-19 consequences. We consider changes in sexual behavior, HIV testing, pre-exposure prophylaxis (PrEP) use and antiretroviral therapy (ART) use among men who have sex with men (MSM) over the first year of the COVID-19 epidemic, comparing the Atlanta metropolitan area and New York City (NYC). We use two continuous time-series datasets and one panel dataset, assessing changes over time within city and comparing across cities, and disaggregate major findings by age. For clinical results, ART use showed by far the smallest reductions, and testing the largest. Disruptions occurred concurrently between cities, despite the major wave of COVID-19, and government mandates, occurring later in Atlanta. Test positivity increased in NYC only. In both cities, younger MSM saw the greatest reductions in testing and PrEP use, but the smallest in sexual behavior. Reduced clinical service usage would be unconcerning if stemming solely from reductions in exposure; however, the patterns for young MSM suggest that the COVID-19 epidemic likely generated new conditions for increased HIV transmission, especially in this cohort.

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.

Physical Violence and Psychological Distress Among Asian and Pacific Islander Sexual Minority Men in the United States Before and During the COVID-19 Pandemic.

Purpose: This study examined differences in self-reported physical violence and psychological distress among Asian American and Pacific Islander (AAPI) sexual minority men (SMM) before and during the 2019 novel coronavirus (COVID-19) pandemic (2019 vs. 2020). Methods: We used data from 1127 AAPI SMM who completed the 2019 (August 2019-December 2019) and 2020 (August 2020-January 2021) cycles of the American Men's Internet Survey (AMIS). We assessed differences in experiencing physical violence and serious psychological distress by year of survey completion. We used Poisson regression with robust variance estimation to examine whether physical violence was associated with serious psychological distress before and during COVID-19. Multivariate analyses adjusted for sociodemographic characteristics and the interaction between year and violence. Results: A greater percentage of AAPI SMM had serious psychological distress in 2020 during the pandemic relative to 2019 before the pandemic (56.6% vs. 35.64%, p < 0.001). AAPI SMM who experienced physical violence in the last 6 months were more likely to experience serious psychological distress than those who never experienced physical violence. The association between violence and psychological distress among AAPI SMM was not significantly different before and during the COVID-19 pandemic. Conclusions: Violence against AAPI SMM in the United States is widespread. Although we did not find significant differences in exposure to physical violence among AAPI SMM before and during the COVID-19 pandemic, the increase in serious psychological distress during the pandemic among AAPI SMM may indicate heightened need of mental health services.

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.

Increasing Access to HIV Testing Through Direct-to-Consumer HIV Self-Test Distribution - United States, March 31, 2020-March 30, 2021.

During 2019, approximately 34,800 new HIV infections occurred in the United States (1), and it is estimated that approximately 80% of HIV transmission occurs from persons who either do not know they have HIV infection or are not receiving regular care (2). Since 2006, CDC has recommended that persons who are disproportionately affected by HIV (including men who have sex with men [MSM]) should test for HIV at least annually (3,4). However, data from multiple sources indicate that these recommendations are not being fully implemented (5,6). TakeMeHome, a novel public-private partnership to deliver HIV self-testing kits to persons seeking HIV testing in the United States, was launched during March 2020 as home care options for testing became increasingly important during the COVID-19 pandemic. The initiation of the program coincided with the national COVID-19 Public Health Emergency declaration, issuance of stay-at-home orders, and other restrictions that led to disruption of traditional HIV testing services. During March 31, 2020-March 30, 2021, 17 state and local health departments participating in the program allowed residents of their jurisdictions to order test kits. Marketing for TakeMeHome focused on reaching gay, bisexual, and MSM through messages and embedded links in gay dating applications. Most participants in the program reported that they had either never tested for HIV (36%) or that they had last tested >1 year before receiving their self-test kit (56%). After receiving the self-test kit, >10% of respondents reported accessing additional prevention services. Health departments can increase options for HIV testing by distributing publicly funded self-test kits to persons without proximate access to clinic-based testing or who prefer to test at home. Increased and regular HIV testing among MSM will help meet annual testing goals.

Scaling Up CareKit: Lessons Learned from Expansion of a Centralized Home HIV and Sexually Transmitted Infection Testing Program.

BACKGROUND: Despite advances in implementing human immunodeficiency virus (HIV)/sexually transmitted infection (STI) services for men who have sex with men (MSM), many remain underserved because of barriers like stigma, low facility coverage, and provider competency. This article describes the implementation of centralized nationwide mailed HIV/STI home testing (CareKit). METHODS: The Emory Center for AIDS Research developed CareKit for research study participants to request HIV self-test kits, STI specimen collection kits, and condom/lubricant packs to be shipped to any mailing address in the United States. Sexually transmitted infection kits were customized according to study needs and could include materials to collect whole blood, dried blood spots, urine sample, and rectal and pharyngeal swab samples for syphilis, gonorrhea, and chlamydia testing. Specimens were mailed back to a central Clinical Laboratory Improvement Amendments-approved laboratory for testing, and results were returned to participants. RESULTS: CareKit was used by 12 MSM studies and mailed 1132 STI kits to 775 participants between January 2018 and March 2020. Participants returned 507 (45%) STI kits, which included 1594 individual specimens. Eighty-one kits (16%) had at least one positive STI test result: pharyngeal chlamydia (n = 7), pharyngeal gonorrhea (n = 11), rectal chlamydia (n = 15), rectal gonorrhea (n = 12), genital chlamydia (n = 6), genital gonorrhea (n = 1), and syphilis (n = 54). In this same 2-year period, 741 HIV self-test kits were mailed to 643 MSM. CONCLUSIONS: CareKit successfully met studies' needs for home HIV/STI testing and diagnosed many STIs. These processes continue to be adapted for research and programs. The ability to mail home test kits has become increasingly important to reach those who may have limited access to health care services, particularly during the COVID-19 pandemic.

Projected HIV and Bacterial Sexually Transmitted Infection Incidence Following COVID-19-Related Sexual Distancing and Clinical Service Interruption.

BACKGROUND: The global COVID-19 pandemic has the potential to indirectly impact transmission dynamics and prevention of HIV and other sexually transmitted infections (STI). It is unknown what combined impact reductions in sexual activity and interruptions in HIV/STI services will have on HIV/STI epidemic trajectories. METHODS: We adapted a model of HIV, gonorrhea, and chlamydia for a population of approximately 103 000 men who have sex with men (MSM) in the Atlanta area. Model scenarios varied the timing, overlap, and relative extent of COVID-19-related sexual distancing and service interruption within 4 service categories (HIV screening, preexposure prophylaxis, antiretroviral therapy, and STI treatment). RESULTS: A 50% relative decrease in sexual partnerships and interruption of all clinical services, both lasting 18 months, would generally offset each other for HIV (total 5-year population impact for Atlanta MSM, -227 cases), but have net protective effect for STIs (-23 800 cases). If distancing lasted only 3 months but service interruption lasted 18 months, the total 5-year population impact would be an additional 890 HIV cases and 57 500 STI cases. CONCLUSIONS: Immediate action to limit the impact of service interruptions is needed to address the indirect effects of the global COVID-19 pandemic on the HIV/STI epidemic.

Prevalence of SARS-CoV-2 antibodies in pediatric healthcare workers.

OBJECTIVES: To determine SARS-CoV-2-antibody prevalence in pediatric healthcare workers (pHCWs). DESIGN: Baseline prevalence of anti-SARS-CoV-2-IgG was assessed in a prospective cohort study from a large pediatric healthcare facility. Prior SARS-CoV-2 testing history, potential risk factors and anxiety level about COVID-19 were determined. Prevalence difference between emergency department (ED)-based and non-ED-pHCWs was modeled controlling for those covariates. Chi-square test-for-trend was used to examine prevalence by month of enrollment. RESULTS: Most of 642 pHCWs enrolled were 31-40years, female and had no comorbidities. Half had children in their home, 49% had traveled, 42% reported an illness since January, 31% had a known COVID-19 exposure, and 8% had SARS-CoV-2 PCR testing. High COVID-19 pandemic anxiety was reported by 71%. Anti-SARS-CoV-2-IgG prevalence was 4.1%; 8.4% among ED versus 2.0% among non-ED pHCWs (p < 0.001). ED-work location and known COVID-19 exposure were independent risk factors. 31% of antibody-positive pHCWs reported no symptoms. Prevalence significantly (p < 0.001) increased from 3.0% in April-June to 12.7% in July-August. CONCLUSIONS: Anti-SARS-CoV-2-IgG prevalence was low in pHCWs but increased rapidly over time. Both working in the ED and exposure to a COVID-19-positive contact were associated with antibody-seropositivity. Ongoing universal PPE utilization is essential. These data may guide vaccination policies to protect front-line workers.

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.

Projected HIV and Bacterial STI Incidence Following COVID-Related Sexual Distancing and Clinical Service Interruption.

BACKGROUND: The global COVID-19 pandemic has the potential to indirectly impact the transmission dynamics and prevention of HIV and other sexually transmitted infections (STI). Studies have already documented reductions in sexual activity ("sexual distancing") and interruptions in HIV/STI services, but it is unknown what combined impact these two forces will have on HIV/STI epidemic trajectories. METHODS: We adapted a network-based model of co-circulating HIV, gonorrhea, and chlamydia for a population of approximately 103,000 men who have sex with men (MSM) in the Atlanta area. Model scenarios varied the timing, overlap, and relative extent of COVID-related sexual distancing in casual and one-time partnership networks and service interruption within four service categories (HIV screening, HIV PrEP, HIV ART, and STI treatment). RESULTS: A 50% relative decrease in sexual partnerships and interruption of all clinical services, both lasting 18 months, would generally offset each other for HIV (total 5-year population impact for Atlanta MSM: -227 cases), but have net protective effect for STIs (-23,800 cases). Greater relative reductions and longer durations of service interruption would increase HIV and STI incidence, while greater relative reductions and longer durations of sexual distancing would decrease incidence of both. If distancing lasted only 3 months but service interruption lasted 18 months, the total 5-year population impact would be an additional 890 HIV cases and 57,500 STI cases. CONCLUSIONS: The counterbalancing impact of sexual distancing and clinical service interruption depends on the infection and the extent and durability of these COVID-related changes. If sexual behavior rebounds while service interruption persists, we project an excess of hundreds of HIV cases and thousands of STI cases just among Atlanta MSM over the next 5 years. Immediate action to limit the impact of service interruptions is needed to address the indirect effects of the global COVID pandemic on the HIV/STI epidemic.

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.

At-home self-collection of saliva, oropharyngeal swabs and dried blood spots for SARS-CoV-2 diagnosis and serology: Post-collection acceptability of specimen collection process and patient confidence in specimens.

BACKGROUND: Options to increase the ease of testing for SARS-CoV-2 infection and immune response are needed. Self-collection of diagnostic specimens at home offers an avenue to allow people to test for SARS-CoV-2 infection or immune response without traveling to a clinic or laboratory. Before this study, survey respondents indicated willingness to self-collect specimens for COVID-related tests, but hypothetical willingness can differ from post-collection acceptability after participants collect specimens. METHODS: 153 US adults were enrolled in a study of the willingness and feasibility of patients to self-collect three diagnostic specimens (saliva, oropharyngeal swab (OPS) and dried blood spot (DBS) card) while observed by a clinician through a telehealth session. After the specimens were collected, 148 participants participated in a survey about the acceptability of the collection, packing and shipping process, and their confidence in the samples collected for COVID-related laboratory testing. RESULTS: A large majority of participants (>84%) reported that collecting, packing and shipping of saliva, OPS, and DBS specimens were acceptable. Nearly nine in 10 (87%) reported being confident or very confident that the specimens they collected were sufficient for laboratory analysis.There were no differences in acceptability for any specimen type, packing and shipping, or confidence in samples, by gender, age, race/ethnicity, or educational level. CONCLUSIONS: Self-collection of specimens for SARS-CoV-2 testing, and preparing and shipping specimens for analysis, were acceptable in a diverse group of US adults. Further refinement of materials and instructions to support self-collection of saliva, OPS and DBS specimens for COVID-related testing is needed.

Protocol for a national probability survey using home specimen collection methods to assess prevalence and incidence of SARS-CoV-2 infection and antibody response.

PURPOSE: The U.S. response to the SARS-CoV-2 epidemic has been hampered by early and ongoing delays in testing for infection; without data on where infections were occurring and the magnitude of the epidemic, early public health responses were not data-driven. Understanding the prevalence of SARS-CoV-2 infections and immune response is critical to developing and implementing effective public health responses. Most serological surveys have been limited to localities that opted to conduct them and/or were based on convenience samples. Moreover, results of antibody testing might be subject to high false positive rates in the setting of low prevalence of immune response and imperfect test specificity. METHODS: We will conduct a national serosurvey for SARS-CoV-2 PCR positivity and immune experience. A probability sample of U.S. addresses will be mailed invitations and kits for the self-collection of anterior nares swab and finger prick dried blood spot specimens. Within each sampled household, one adult 18 years or older will be randomly selected and asked to complete a questionnaire and to collect and return biological specimens to a central laboratory. Nasal swab specimens will be tested for SARS-CoV-2 RNA by RNA PCR; dried blood spot specimens will be tested for antibodies to SARS-CoV-2 (i.e., immune experience) by enzyme-linked immunoassays. Positive screening tests for antibodies will be confirmed by a second antibody test with different antigenic basis to improve predictive value of positive (PPV) antibody test results. All persons returning specimens in the baseline phase will be enrolled into a follow-up cohort and mailed additional specimen collection kits 3 months after baseline. A subset of 10% of selected households will be invited to participate in full household testing, with tests offered for all household members aged ≥3 years. The main study outcomes will be period prevalence of infection with SARS-CoV-2 and immune experience, and incidence of SARS-CoV-2 infection and antibody responses. RESULTS: Power calculations indicate that a national sample of 4000 households will facilitate estimation of national SARS-CoV-2 infection and antibody prevalence with acceptably narrow 95% confidence intervals across several possible scenarios of prevalence levels. Oversampling in up to seven populous states will allow for prevalence estimation among subpopulations. Our 2-stage algorithm for antibody testing produces acceptable PPV at prevalence levels ≥1.0%. Including oversamples in states, we expect to receive data from as many as 9156 participants in 7495 U.S. households. CONCLUSIONS: In addition to providing robust estimates of prevalence of SARS-CoV-2 infection and immune experience, we anticipate this study will establish a replicable methodology for home-based SARS-CoV-2 testing surveys, address concerns about selection bias, and improve positive predictive value of serology results. Prevalence estimates of SARS-CoV-2 infection and immune experience produced by this study will greatly improve our understanding of the spectrum of COVID-19 disease, its current penetration in various demographic, geographic, and occupational groups, and inform the range of symptoms associated with infection. These data will inform resource needs for control of the ongoing epidemic and facilitate data-driven decisions for epidemic mitigation strategies.