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Background: This is the first study, to our knowledge, to assess uptake of oral antiviral treatment (OAV) for COVID-19 in the US and assess whether it is reaching recommended groups., Objective: The study evaluated uptake among persons of all ages, with emphasis on utilization among individuals ages 65 + who comprise 75% of all COVID-19 deaths. To maximize public health outreach and benefit, we sought to understand reasons for use and non-use of OAV among individuals 65 + with at least mild COVID-19 symptoms., Design: Data were collected from phase 3.5 of the US Census Household Pulse Survey, during three 2022 time periods: June 1-13, June 29-July 11, and July 27-August 8., Participants: Respondents (n = 12,299) were ages 18 + with active or resolved COVID-19 within the last 4 weeks of their survey participation., Main Measure(s): Comparisons of demographic variables were made for OAV uptake using the chi-square test of independence. A logistic regression was conducted to identify characteristics of participants independently associated with receipt of an OAV. Comparisons were made with chi-square testing, between those ages 65 + with at least mild symptoms who endorsed one of a number of specific reasons for not using OAV., Key Results: Utilization was low-17.9% of all respondents, 20.5% of respondents ages 50-64, and 33.9% of respondents 65 years and older received guideline-concordant treatment for their infection. Receipt did not differ by income or sex. The average response across the three phases was 5.4%. Most common reasons for not receiving treatment included having minimal symptoms, not thinking that they needed treatment, and not receiving a recommendation from their healthcare provider., Conclusions: A minority of increased-risk US residents have accessed early therapy for COVID-19 despite being made available without cost. Responses suggest that efforts to improve patient and provider knowledge could improve utilization to mitigate future COVID-19 hospitalizations., (© 2023. The Author(s), under exclusive licence to Society of General Internal Medicine.)

Background: In the EPIC-HR (Evaluation of Protease Inhibition for Covid-19 in High-Risk Patients) trial, nirmatrelvir plus ritonavir led to an 89% reduction in hospitalization or death among unvaccinated outpatients with early COVID-19. The clinical impact of nirmatrelvir plus ritonavir among vaccinated populations is uncertain., Objective: To assess whether nirmatrelvir plus ritonavir reduces risk for hospitalization or death among outpatients with early COVID-19 in the setting of prevalent SARS-CoV-2 immunity and immune-evasive SARS-CoV-2 lineages., Design: Population-based cohort study analyzed to emulate a clinical trial using inverse probability-weighted models to account for anticipated bias in treatment., Setting: A large health care system providing care for 1.5 million patients in Massachusetts and New Hampshire during the Omicron wave (1 January to 17 July 2022)., Patients: 44 551 nonhospitalized adults (90.3% with ≥3 vaccine doses) aged 50 years or older with COVID-19 and no contraindications for nirmatrelvir plus ritonavir., Measurements: The primary outcome was a composite of hospitalization within 14 days or death within 28 days of a COVID-19 diagnosis., Results: During the study period, 12 541 (28.1%) patients were prescribed nirmatrelvir plus ritonavir, and 32 010 (71.9%) were not. Patients prescribed nirmatrelvir plus ritonavir were more likely to be older, have more comorbidities, and be vaccinated. The composite outcome of hospitalization or death occurred in 69 (0.55%) patients who were prescribed nirmatrelvir plus ritonavir and 310 (0.97%) who were not (adjusted risk ratio, 0.56 [95% CI, 0.42 to 0.75]). Recipients of nirmatrelvir plus ritonavir had lower risk for hospitalization (adjusted risk ratio, 0.60 [CI, 0.44 to 0.81]) and death (adjusted risk ratio, 0.29 [CI, 0.12 to 0.71])., Limitation: Potential residual confounding due to differential access to COVID-19 vaccines, diagnostic tests, and treatment., Conclusion: The overall risk for hospitalization or death was already low (1%) after an outpatient diagnosis of COVID-19, but nirmatrelvir plus ritonavir reduced this risk further., Primary Funding Source: National Institutes of Health.

Longitudinal clinical studies traditionally require in-person study visits which are well documented to pose barriers to participation and contribute challenges to enrolling representative samples. Remote trial models may reduce barriers to research engagement, improve retention, and reach a more representative cohort. As remote trials become more common following the COVID-19 pandemic, a critical evaluation of this approach is imperative to optimize this paradigm shift in research. The TestBoston study was launched to understand prevalence and risk factors for COVID-19 infection in the greater Boston area through a fully remote home-testing model. Participants (adults, within 45 miles of Boston, MA) were recruited remotely from patient registries at Brigham and Women's Hospital and the general public. Participants were provided with monthly and "on-demand" at-home SARS-CoV-2 RT-PCR and antibody testing using nasal swab and dried blood spot self-collection kits and electronic surveys to assess symptoms and risk factors for COVID-19 via an online dashboard. Between October 2020 and January 2021, we enrolled 10,289 participants reflective of Massachusetts census data. Mean age was 47 years (range 18-93), 5855 (56.9%) were assigned female sex at birth, 7181(69.8%) reported being White non-Hispanic, 952 (9.3%) Hispanic/Latinx, 925 (9.0%) Black, 889 (8.6%) Asian, and 342 (3.3%) other and/or more than one race. Lower initial enrollment among Black and Hispanic/Latinx individuals required an adaptive approach to recruitment, leveraging connections to the medical system, coupled with community partnerships to ensure a representative cohort. Longitudinal retention was higher among participants who were White non-Hispanic, older, working remotely, and with lower socioeconomic vulnerability. Implementation highlighted key differences in remote trial models as participants independently navigate study milestones, requiring a dedicated participant support team and robust technology platforms, to reduce barriers to enrollment, promote retention, and ensure scientific rigor and data quality. Remote clinical trial models offer tremendous potential to engage representative cohorts, scale biomedical research, and promote accessibility by reducing barriers common in traditional trial design. Barriers and burdens within remote trials may be experienced disproportionately across demographic groups. To maximize engagement and retention, researchers should prioritize intensive participant support, investment in technologic infrastructure and an adaptive approach to maximize engagement and retention., Competing Interests: The authors have declared that no competing interests exist.

This cohort study examines the alignment of vaccination and SARS-CoV-2 risk in Massachusetts by creating and applying a vaccination-to-infection risk ratio., Competing Interests: Conflict of Interest Disclosures: Dr Dryden-Peterson reported grants from the National Institutes of Health during the conduct of the study. Dr Velásquez reported grants from the National Institute of Allergy and Infectious Diseases during the conduct of the study and grants from the Unitaid endTB-Q trial outside the submitted work. Dr Gandhi reported personal fees from Merck and Gilead for serving on scientific advisory boards outside the submitted work. No other disclosures were reported., (Copyright 2021 Dryden-Peterson S et al. JAMA Health Forum.)

Background: Widespread lockdowns imposed during the coronavirus disease 2019 crisis may impact birth outcomes., Objective: This study aimed to evaluate the association between the COVID-19 lockdown and the risk of adverse birth outcomes in Botswana., Study Design: In response to the coronavirus disease 2019 crisis, Botswana enforced a lockdown that restricted movement within the country. We used data from an ongoing nationwide birth outcomes surveillance study to evaluate adverse outcomes (stillbirth, preterm birth, small-for-gestational-age fetuses, and neonatal death) and severe adverse outcomes (stillbirth, very preterm birth, very-small-for-gestational-age fetuses, and neonatal death) recorded prelockdown (January 1, 2020-April 2, 2020), during lockdown (April 3, 2020-May 7, 2020), and postlockdown (May 8, 2020-July 20, 2020). Using difference-in-differences analyses, we compared the net change in each outcome from the prelockdown to lockdown periods in 2020 relative to the same 2 periods in 2017-2019 with the net change in each outcome from the prelockdown to postlockdown periods in 2020 relative to the same 2 periods in 2017-2019., Results: In this study, 68,448 women delivered a singleton infant in 2017-2020 between January 1 and July 20 and were included in our analysis (mean [interquartile range] age of mothers, 26 [22-32] years). Across the included calendar years and periods, the risk of any adverse outcome ranged from 27.92% to 31.70%, and the risk of any severe adverse outcome ranged from 8.40% to 11.38%. The lockdown period was associated with a 0.81 percentage point reduction (95% confidence interval, -2.95% to 1.30%) in the risk of any adverse outcome (3% relative reduction) and a 0.02 percentage point reduction (95% confidence interval, -0.79% to 0.75%) in the risk of any severe adverse outcome (0% relative reduction). The postlockdown period was associated with a 1.72 percentage point reduction (95% confidence, -3.42% to 0.02%) in the risk of any adverse outcome (5% relative reduction) and a 1.62 percentage point reduction (95% confidence interval, -2.69% to -0.55%) in the risk of any severe adverse outcome (14% relative reduction). Reductions in adverse outcomes were largest among women with human immunodeficiency virus and among women delivering at urban delivery sites, driven primarily by reductions in preterm birth and small-for-gestational-age fetuses., Conclusion: Adverse birth outcomes decreased from the prelockdown to postlockdown periods in 2020, relative to the change during the same periods in 2017-2019. Our findings may provide insights into associations between mobility and birth outcomes in Botswana and other low- and middle-income countries., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: This is the first study, to our knowledge, to assess uptake of oral antiviral treatment (OAV) for COVID-19 in the US and assess whether it is reaching recommended groups. Objective: The study evaluated uptake among persons of all ages, with emphasis on utilization among individuals ages 65 + who comprise 75% of all COVID-19 deaths. To maximize public health outreach and benefit, we sought to understand reasons for use and non-use of OAV among individuals 65 + with at least mild COVID-19 symptoms. Design: Data were collected from phase 3.5 of the US Census Household Pulse Survey, during three 2022 time periods: June 1–13, June 29–July 11, and July 27–August 8. Participants: Respondents (n = 12,299) were ages 18 + with active or resolved COVID-19 within the last 4 weeks of their survey participation. Main Measure(s): Comparisons of demographic variables were made for OAV uptake using the chi-square test of independence. A logistic regression was conducted to identify characteristics of participants independently associated with receipt of an OAV. Comparisons were made with chi-square testing, between those ages 65 + with at least mild symptoms who endorsed one of a number of specific reasons for not using OAV. Key Results: Utilization was low—17.9% of all respondents, 20.5% of respondents ages 50–64, and 33.9% of respondents 65 years and older received guideline-concordant treatment for their infection. Receipt did not differ by income or sex. The average response across the three phases was 5.4%. Most common reasons for not receiving treatment included having minimal symptoms, not thinking that they needed treatment, and not receiving a recommendation from their healthcare provider. Conclusions: A minority of increased-risk US residents have accessed early therapy for COVID-19 despite being made available without cost. Responses suggest that efforts to improve patient and provider knowledge could improve utilization to mitigate future COVID-19 hospitalizations. [ABSTRACT FROM AUTHOR]

There are limited data for the clinical efficacy of bebtelovimab in preventing severe coronavirus disease 2019. Among outpatients unable to take nirmatrelvir-ritonavir at a large health system, 10 of 377 (2.7%) patients who received bebtelovimab and 17 of 377 (4.5%) matched untreated patients were hospitalized or died. The 43% observed risk reduction with bebtelovimab was not statistically significant (P = 0.14). [ABSTRACT FROM AUTHOR]

Background Unbiased assessment of the risks associated with acquisition of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is critical to informing mitigation efforts during pandemics. The objective of our study was to understand the risk factors for acquiring coronavirus disease 2019 (COVID-19) in a large prospective cohort of adult residents in a large US metropolitan area. Methods We designed a fully remote longitudinal cohort study involving monthly at-home SARS-CoV-2 polymerase chain reaction (PCR) and serology self-testing and monthly surveys. Results Between October 2020 and January 2021, we enrolled 10 289 adults reflective of the Boston metropolitan area census data. At study entry, 567 (5.5%) participants had evidence of current or prior SARS-CoV-2 infection. This increased to 13.4% by June 15, 2021. Compared with Whites, Black non-Hispanic participants had a 2.2-fold greater risk of acquiring COVID-19 (hazard ratio [HR], 2.19; 95% CI, 1.91–2.50; P <.001), and Hispanics had a 1.5-fold greater risk (HR, 1.52; 95% CI, 1.32–1.71; P <.016). Individuals aged 18–29, those who worked outside the home, and those living with other adults and children were at an increased risk. Individuals in the second and third lowest disadvantaged neighborhood communities were associated with an increased risk of acquiring COVID-19. Individuals with medical risk factors for severe disease were at a decreased risk of SARS-CoV-2 acquisition. Conclusions These results demonstrate that race/ethnicity and socioeconomic status are the biggest determinants of acquisition of infection. This disparity is significantly underestimated if based on PCR data alone, as noted by the discrepancy in serology vs PCR detection for non-White participants, and points to persistent disparity in access to testing. Medical conditions and advanced age, which increase the risk for severity of SARS-CoV-2 disease, were associated with a lower risk of COVID-19 acquisition, suggesting the importance of behavior modifications. These findings highlight the need for mitigation programs that overcome challenges of structural racism in current and future pandemics. [ABSTRACT FROM AUTHOR]