At the intersection of trust and mistrust: A qualitative analysis of motivators and barriers to research participation at a safety-net hospital.

INTRODUCTION: The underrepresentation of Black, Indigenous, and People of Color (BIPOC) individuals in healthcare research limits generalizability and contributes to healthcare inequities. Existing barriers and attitudes toward research participation must be addressed to increase the representation of safety net and other underserved populations. METHODS: We conducted semi-structured qualitative interviews with patients at an urban safety net hospital, focusing on facilitators, barriers, motivators, and preferences for research participation. We conducted direct content analysis guided by an implementation framework and used rapid analysis methods to generate final themes. RESULTS: We completed 38 interviews and identified six major themes related to preferences for engagement in research participation: (1) wide variation in research recruitment preferences; (2) logistical complexity negatively impacts willingness to participate; (3) risk contributes to hesitation toward research participation; (4) personal/community benefit, interest in study topic, and compensation serve as motivators for research participation; (5) continued participation despite reported shortcomings of informed consent process; and (6) mistrust could be overcome by relationship or credibility of information sources. CONCLUSION: Despite barriers to participation in research studies among safety-net populations, there are also facilitators that can be implemented to increase knowledge and comprehension, ease of participation, and willingness to join research studies. Study teams should vary recruitment and participation methods to ensure equal access to research opportunities. PATIENT/PUBLIC CONTRIBUTION: Our analysis methods and study progress were presented to individuals within the Boston Medical Center healthcare system. Through this process community engagement specialists, clinical experts, research directors, and others with significant experience working with safety-net populations supported data interpretation and provided recommendations for action following the dissemination of data.

"Community members have more impact on their neighbors than celebrities": leveraging community partnerships to build COVID-19 vaccine confidence.

BACKGROUND: Vaccines are a strong public health tool to protect against severe disease, hospitalization, and death from COVID-19. Still, inequities in COVID-19 vaccination rates and health outcomes continue to exist among Black and Latino populations. Boston Medical Center (BMC) has played a significant role in vaccinating medically underserved populations, and organized a series of community-engaged conversations to better understand community concerns regarding the COVID-19 vaccine. This paper describes the themes which resulted from these community-engaged conversations and proposes next steps for healthcare leaders. METHODS: We accessed nine publicly available recordings of the community-engaged conversations which were held between March 2021 and September 2021 and ranged from 8 to 122 attendees. Six conversations prioritized specific groups: the Haitian-Creole community, the Cape Verdean community, the Latino community, the Black Christian Faith community, guardians who care for children living with disabilities, and individuals affected by systemic lupus erythematosus. Remaining conversations targeted the general public of the Greater Boston Area. We employed a Consolidated Framework for Implementation Research-driven codebook to code our data. Our analysis utilized a modified version of qualitative rapid analysis methods. RESULTS: Five main themes emerged from these community-engaged conversations: (1) Structural factors are important barriers to COVID-19 vaccination; (2) Mistrust exists due to the negative impact of systemic oppression and perceived motivation of the government; (3) There is a desire to learn more about biological and clinical characteristics of the COVID-19 vaccine as well as the practical implications of being vaccinated; (4) Community leaders emphasize community engagement for delivering COVID-19 information and education and; (5) Community leaders believe that the COVID-19 vaccine is a solution to address the pandemic. CONCLUSION: This study illustrates a need for community-engaged COVID-19 vaccine messaging which reflects the nuances of the COVID-19 vaccine and pandemic without oversimplifying information. In highlighting common concerns of the Greater Boston Area which contribute to a lack of confidence in the COVID-19 vaccine, we underscore important considerations for public health and healthcare leadership in the development of initiatives which work to advance health equity.

Keep It Up! 3.0: Study protocol for a type III hybrid implementation-effectiveness cluster-randomized trial.

BACKGROUND: Despite evidence that eHealth approaches can be effective in reducing HIV risk, their implementation requirements for public health scale up are not well established, and effective strategies to bring these programs into practice are still unknown. Keep It Up! (KIU!) is an online program proven to reduce HIV risk among young men who have sex with men (YMSM) and ideal candidate to develop and evaluate novel strategies for implementing eHealth HIV prevention programs. KIU! 3.0 is a Type III Hybrid Effectiveness-Implementation cluster randomized trial designed to 1) compare two strategies for implementing KIU!: community-based organizations (CBO) versus centralized direct-to-consumer (DTC) recruitment; 2) examine the effect of strategies and determinants on variability in implementation success; and 3) develop materials for sustainment of KIU! after the trial concludes. In this article, we describe the approaches used to achieve these aims. METHODS: Using county-level population estimates of YMSM, 66 counties were selected and randomized 2:1 to the CBO and DTC approaches. The RE-AIM model was used to drive outcome measurements, which were collected from CBO staff, YMSM, and technology providers. Mixed-methods research mapped onto the domains of the Consolidated Framework for Implementation Research will examine determinants and their relationship with implementation outcomes. DISCUSSION: In comparing our implementation recruitment models, we are examining two strategies which have shown effectiveness in delivering health technology interventions in the past, yet little is known about their comparative advantages and disadvantages in implementation. The results of the trial will further the understanding of eHealth prevention intervention implementation.

Laboratory test trends within 72 hours of hospital admission associated with death among COVID-19 patients.

Early identification of patients at risk for severe coronavirus disease 2019 (COVID-19) is crucial for appropriate triage and determination of need for closer monitoring. Few studies have examined laboratory trends in COVID-19 infection and sought to quantify the degree to which laboratory values affect mortality. We conducted a retrospective cohort (n = 407) study of hospitalized patients with COVID-19 early in the course of the pandemic, from March 16th to April 8th, 2020 and compared baseline to repeat laboratory testing 72 hours into admission. The primary outcome was death. We found that rises of 25 mg/L C-reactive protein, 50 units/L lactate dehydrogenase, and 100 ng/mL ferritin were associated with 23%, 28%, and 1% increased odds of death, respectively. In contrast, changes in fibrinogen, D-dimer, white blood cell count, and creatinine in the first few days of hospital admission were not associated with mortality. These quantitative findings may assist clinicians in determining the risk of potential clinical decline in patients with COVID-19 and influence early management.

Projected Long-Term Impact of the Coronavirus Disease 2019 (COVID-19) Pandemic on Hepatitis C Outcomes in the United States: A Modeling Study.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic disrupted access to and uptake of hepatitis C virus (HCV) care services in the United States. It is unknown how substantially the pandemic will impact long-term HCV-related outcomes. METHODS: We used a microsimulation to estimate the 10-year impact of COVID-19 disruptions in healthcare delivery on HCV outcomes including identified infections, linkage to care, treatment initiation and completion, cirrhosis, and liver-related death. We modeled hypothetical scenarios consisting of an 18-month pandemic-related disruption in HCV care starting in March 2020 followed by varying returns to pre-pandemic rates of screening, linkage, and treatment through March 2030 and compared them to a counterfactual scenario in which there was no COVID-19 pandemic or disruptions in care. We also performed alternate scenario analyses in which the pandemic disruption lasted for 12 and 24 months. RESULTS: Compared to the "no pandemic" scenario, in the scenario in which there is no return to pre-pandemic levels of HCV care delivery, we estimate 1060 fewer identified cases, 21 additional cases of cirrhosis, and 16 additional liver-related deaths per 100 000 people. Only 3% of identified cases initiate treatment and <1% achieve sustained virologic response (SVR). Compared to "no pandemic," the best-case scenario in which an 18-month care disruption is followed by a return to pre-pandemic levels, we estimated a smaller proportion of infections identified and achieving SVR. CONCLUSIONS: A recommitment to the HCV epidemic in the United States that involves additional resources coupled with aggressive efforts to screen, link, and treat people with HCV is needed to overcome the COVID-19-related disruptions.

Addressing Inequities in SARS-CoV-2 Vaccine Uptake: The Boston Medical Center Health System Experience.

Academic medical centers could play an important role in increasing access to and uptake of SARS-CoV-2 vaccines, especially in Black and Latino communities that have been disproportionately affected by the pandemic. This article describes the vaccination program developed by the Boston Medical Center (BMC) health system (New England's largest safety-net health system), its affiliated community health centers (CHCs), and community partners. The program was based on a conceptual framework for community interventions and aimed to increase equitable access to vaccination in the hardest-hit communities through community-based sites in churches and community centers, mobile vaccination events, and vaccination on the BMC campus. Key strategies included a communication campaign featuring trusted messengers, a focus on health equity, established partnerships with community leaders and CHCs, and strong collaboration with local health departments and the Commonwealth of Massachusetts to ensure equitable allocation of the vaccine supply. Process factors involved the use of robust analytics relying on the Centers for Disease Control and Prevention's Social Vulnerability Index (SVI). The vaccination program administered 109 938 first doses, with 94 703 (86%) given at community sites and 2466 (2%) given at mobile sites. Mobile vaccination events were key in reaching younger people living in locations with the highest SVIs. Challenges included the need for a robust operational infrastructure and mistrust of the health system given the long history of economic disinvestment in the surrounding community. The BMC model could serve as a blueprint for other medical centers interested in implementing programs aimed at increasing vaccine uptake during a pandemic and in developing an infrastructure to address other health-related disparities.

Projecting COVID-19 Mortality as States Relax Nonpharmacologic Interventions.

Importance: A key question for policy makers and the public is what to expect from the COVID-19 pandemic going forward as states lift nonpharmacologic interventions (NPIs), such as indoor mask mandates, to prevent COVID-19 transmission. Objective: To project COVID-19 deaths between March 1, 2022, and December 31, 2022, in each of the 50 US states, District of Columbia, and Puerto Rico assuming different dates of lifting of mask mandates and NPIs. Design Setting and Participants: This simulation modeling study used the COVID-19 Policy Simulator compartmental model to project COVID-19 deaths from March 1, 2022, to December 31, 2022, using simulated populations in the 50 US states, District of Columbia, and Puerto Rico. Projected current epidemiologic trends for each state until December 31, 2022, assuming the current pace of vaccination is maintained into the future and modeling different dates of lifting NPIs. Exposures: Date of lifting statewide NPI mandates as March 1, April 1, May 1, June 1, or July 1, 2022. Main Outcomes and Measures: Projected COVID-19 incident deaths from March to December 2022. Results: With the high transmissibility of current circulating SARS-CoV-2 variants, the simulated lifting of NPIs in March 2022 was associated with resurgences of COVID-19 deaths in nearly every state. In comparison, delaying by even 1 month to lift NPIs in April 2022 was estimated to mitigate the amplitude of the surge. For most states, however, no amount of delay was estimated to be sufficient to prevent a surge in deaths completely. The primary factor associated with recurrent epidemics in the simulation was the assumed high effective reproduction number of unmitigated viral transmission. With a lower level of transmissibility similar to those of the ancestral strains, the model estimated that most states could remove NPIs in March 2022 and likely not see recurrent surges. Conclusions and Relevance: This simulation study estimated that the SARS-CoV-2 virus would likely continue to take a major toll in the US, even as cases continued to decrease. Because of the high transmissibility of the recent Delta and Omicron variants, premature lifting of NPIs could pose a substantial threat of rebounding surges in morbidity and mortality. At the same time, continued delay in lifting NPIs may not prevent future surges.

Resources Required for Implementation of SARS-CoV-2 Screening in Massachusetts K-12 Public Schools in Winter/Spring 2021.

BACKGROUND: The financial costs and human resource requirements at the school and district level to implement a SARS-CoV-2 screening program are not well known. METHODS: A consortium of Massachusetts public K-12 schools was formed to implement and evaluate a range of SARS-CoV-2 screening approaches. Participating districts were surveyed weekly about their programs, including: type of assay used, individual vs. pooled screening, approaches to return of results and deconvolution of positive pools, number and type of personnel, and hours spent implementing the screening program, and hours spent on program implementation. RESULTS: In 21 participating districts, over 21 weeks from January to June 2021, the positivity rate was 0.0% to 0.21% among students and 0.0% to 0.13% among educators/staff. The average weekly cost to implement a screening program, including assay and personnel costs, was $17.00 per person tested; this was $46.68 for individual screenings and $15.61 for pooled screenings. The total weekly costs by district ranged from $1,644 to $93,486, and districts screened between 58 and 3675 people per week. CONCLUSIONS: Where screening is recommended for the 2021 to 2022 school year due to high COVID-19 incidence, understanding the human resources and finances required to implement screening will assist district policymakers in planning.

Association of Limited In-Person Attendance in US National Football League and National Collegiate Athletic Association Games With County-Level COVID-19 Cases.

Importance: In 2020 and early 2021, the National Football League (NFL) and National Collegiate Athletic Association (NCAA) opted to host football games in stadiums across the country. The in-person attendance of games varied with time and from county to county. There is currently no evidence on whether limited in-person attendance of games is associated with COVID-19 case numbers on a county-level. Objective: To assess whether NFL and NCAA football games with limited in-person attendance were associated with increased COVID-19 cases in the counties they were held compared with a matched set of counties. Design, Setting, and Participants: In this time-series cross-sectional study, every county hosting NFL or NCAA games with in-person attendance (treated group) in 2020 and 2021 was matched with a county that that did not host a game on the corresponding day but had an identical game history for up to 14 days prior (control group). A standard matching method was used to further refine this matched set so that the treated and matched control counties had similar population size, nonpharmaceutical interventions in place, and COVID-19 trends. The association of hosting games with in-person attendance with COVID-19 cases was assessed using a difference-in-difference estimator. Data were analyzed from August 29 to December 28, 2020. Exposures: Hosting NFL or NCAA games. Main Outcomes and Measures: The main outcome was estimation of new COVID-19 cases per 100 000 residents at the county level reported up to 14 days after a game among counties with NFL and NCAA games with in-person attendance. Results: A total of 528 games with in-person attendance (101 NFL games [19.1%]; 427 NCAA games [80.9%]) were included. The matching algorithm returned 361 matching sets of counties. The median (interquartile range [IQR]) number of attendance for NFL games was 9949 (6000 to 13 797) people. The median number of attendance for NCAA games was not available, and attendance was recorded as a binary variable. The median (IQR) daily new COVID-19 cases in treatment group counties hosting games was 26.14 (10.77-50.25) cases per 100 000 residents on game day. The median (IQR) daily new COVID-19 cases in control group counties where no games were played was 24.11 (9.64-48.55) cases per 100 000 residents on game day. The treatment effect size ranged from -5.17 to 4.72, with a mean (SD) of 1.21 (2.67) cases per 100 000 residents, within the 14-day period in all counties hosting the games, and the daily treatment effect trend remained relatively steady during this period. Conclusions and Relevance: This cross-sectional study did not find a consistent increase in the daily COVID-19 cases per 100 000 residents in counties where NFL and NCAA games were held with limited in-person attendance. These findings suggest that NFL and NCAA football games hosted with limited in-person attendance were not associated with substantial risk for increased local COVID-19 cases.

Time to SARS-CoV-2 PCR Clearance in Immunocompromising Conditions: Is Test-Based Removal From Isolation Necessary in Severely Immunocompromised Individuals?

To determine the association between immunosuppression and time to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction (PCR) clearance, we studied 3758 adults retested following initial SARS-CoV-2 infection. Cox proportional hazards models demonstrated delayed PCR clearance with older age, multiple comorbidities, and solid organ transplant but not by degree of immunocompromise. These findings challenge current retesting practices.

Combination Therapy With Tocilizumab and Dexamethasone Cost-Effectively Reduces Coronavirus Disease 2019 Mortality.

Recent randomized trials suggest that interleukin-6 inhibitors reduce mortality due to severe coronavirus disease 2019. Using a decision tree model, we found that tocilizumab is cost-effective with an estimated incremental cost-effectiveness ratio of $16 520 per quality-adjusted life year gained (95% credible interval, 10 760-51 530).

A clash of epidemics: Impact of the COVID-19 pandemic response on opioid overdose.

Coronavirus disease 2019 (COVID-19) will have a lasting impact on public health. In addition to the direct effects of COVID-19 infection, physical distancing and quarantine interventions have indirect effects on health. While necessary, physical distancing interventions to control the spread of COVID-19 could have multiple impacts on people living with opioid use disorder, including impacts on mental health that lead to greater substance use, the availability of drug supply, the ways that people use drugs, treatment-seeking behaviors, and retention in care. The degree to which COVID-19 will impact the opioid epidemic and through which of the possible mechanisms that we discuss is important to monitor. We employed simulation modeling to demonstrate the potential impact of physical distancing on overdose mortality.

Early administration of interleukin-6 inhibitors for patients with severe COVID-19 disease is associated with decreased intubation, reduced mortality, and increased discharge.

OBJECTIVE: The aim of this observational study was to determine the optimal timing of interleukin-6 receptor inhibitor (IL6ri) administration for coronavirus disease 2019 (COVID-19). METHODS: Patients with COVID-19 were given an IL6ri (sarilumab or tocilizumab) based on iteratively reviewed guidelines. IL6ri were initially reserved for critically ill patients, but after review, treatment was liberalized to patients with lower oxygen requirements. Patients were divided into two groups: those requiring ≤45% fraction of inspired oxygen (FiO2) (termed stage IIB) and those requiring >45% FiO2 (termed stage III) at the time of IL6ri administration. The main outcomes were all-cause mortality, discharge alive from hospital, and extubation. RESULTS: A total of 255 COVID-19 patients were treated with IL6ri (149 stage IIB and 106 stage III). Patients treated in stage IIB had lower mortality than those treated in stage III (adjusted hazard ratio (aHR) 0.24, 95% confidence interval (CI) 0.08-0.74). Overall, 218 (85.5%) patients were discharged alive. Patients treated in stage IIB were more likely to be discharged (aHR 1.43, 95% CI 1.06-1.93) and were less likely to be intubated (aHR 0.43, 95% CI 0.24-0.79). CONCLUSIONS: IL6ri administration prior to >45% FiO2 requirement was associated with improved COVID-19 outcomes. This can guide clinical management pending results from randomized controlled trials.