Adapting the Evidence Academy model for virtual stakeholder engagement in a national setting during the COVID-19 pandemic.

The COVID-19 pandemic raised the importance of adaptive capacity and preparedness when engaging historically marginalized populations in research and practice. The Rapid Acceleration of Diagnostics in Underserved Populations' COVID-19 Equity Evidence Academy Series (RADx-UP EA) is a virtual, national, interactive conference model designed to support and engage community-academic partnerships in a collaborative effort to improve practices that overcome disparities in SARS-CoV-2 testing and testing technologies. The RADx-UP EA promotes information sharing, critical reflection and discussion, and creation of translatable strategies for health equity. Staff and faculty from the RADx-UP Coordination and Data Collection Center developed three EA events with diverse geographic, racial, and ethnic representation of attendees from RADx-UP community-academic project teams: February 2021 (n = 319); November 2021 (n = 242); and September 2022 (n = 254). Each EA event included a data profile; 2-day, virtual event; event summary report; community dissemination product; and an evaluation strategy. Operational and translational delivery processes were iteratively adapted for each EA across one or more of five adaptive capacity domains: assets, knowledge and learning, social organization, flexibility, and innovation. The RADx-UP EA model can be generalized beyond RADx-UP and tailored by community and academic input to respond to local or national health emergencies.

Listening to Community Partners: Successes and Challenges in Fostering Authentic, Effective, and Trusting Partnerships in the RADx-UP Program

Engaging community partners helps public health researchers to (1) identify meaningful questions based on their authentic knowledge and lived experience, (2) develop protocols responsive to community needs, (3) ensure that interventions are culturally and contextually relevant, and (4) disseminate findings accessible for communities.1-3 The Rapid Acceleration of DiagnosticsUnderserved Populations (RADx-UP) program, created by the National Institutes of Health, is a consortium of more than 125 research projects aiming to understand and reduce COVID-19 disparities in morbidity and mortality through community-engaged research partnerships. The CEC also is critical to meeting communities' social needs in the midst of the pandemic, including building social networks, promoting trust in academic partners, and fostering mutual respect. LISTENING SESSION Attendees consisted of an executive director of a health coalition in Garden City, Kansas (CP1);a founder and director of a Christian faith community-based organization in Shubuta, Mississippi (CP2);a community partner working with a RADx-UP study aiming to understand the effects of COVID-19 and violence within African American communities in Chicago, Illinois (CP3);and a chief executive officer of a minority health institute in Jackson, Mississippi (CP4). Whereas we were sending people to community health center health care providers, we now have self-tests, and organizations are also making it more convenient for the community to have access to testing.

Integrating special and underserved populations in translational research: Environmental scan of adaptive capacity and preparedness of Clinical and Translational Science Award (CTSA) program hubs.

The COVID-19 pandemic has exacerbated health disparities and rendered them acutely more visible. Special and underrepresented populations need to be fully integrated into the translational research process from the very beginning and all the way through. This article presents findings and rapid analysis mini-case studies from the Environmental Scan (E-Scan) of adaptive capacity and preparedness of Clinical and Translational Science Award hubs, specific to the goal of integrating special and vulnerable populations in different institutional research settings. In our discussion of the findings and case studies, we flexibly apply local adaptive capacity framework concepts and characteristics, and, whenever possible, we present ideas on how to enhance capacity in those areas, based on the challenges and practices identified through the E-Scan. Although the past year has recorded incredible achievements in vaccine development, clinical trials, diagnostics, and overall biomedical research, these successes continue to be hampered by our inability to turn them into achievements equally available and accessible to all populations.

Advancing Health Equity Through Equity-Centered Leadership Development with Interprofessional Healthcare Teams.

INTRODUCTION: Events of spring 2020-the COVID19 pandemic and re-birth of a social justice movement-have thrown disparities in disease risk, morbidity, and mortality in sharp relief. In response, healthcare organizations have shifted attentions and resources towards equity, diversity, and inclusion (EDI) issues and initiatives like never before. Focused, proven equity-centered skill and mindset development is needed for healthcare professionals to operationalize these pledges and stated aims. AIM: This article highlights program evaluation results for this Clinical Scholars National Leadership Institute (CSNLI) specific to EDI. We will show that CSNLI imparts the valuable and essential skills to health professionals that are needed to realize health equity through organizational and system change. SETTING: Initial cohort of 29 participants in CSNLI, engaging in the program over 3 years through in-person and distance-based learning offerings and activities. PROGRAM DESCRIPTION: The CSNLI is a 3-year, intensive leadership program that centers EDI skill development across personal, interpersonal, organizational, and systems domains through its design, competencies, and curriculum. PROGRAM EVALUATION: A robust evaluation following the Kirkpatrick Model offers analysis of four data collecting activities related to program participants' EDI learning, behavioral change, and results. DISCUSSION: Over the course of the program, participants made significant gains in competencies related to equity, diversity, and inclusion. Furthermore, participants demonstrated growth in behavior change and leadership activities in the areas of organizational and system change. Results demonstrate the need to center both leader and leadership development on equity, diversity, and inclusion curriculum to make real change in the US Healthcare System.

Learning about Adaptive Capacity and Preparedness of CTSA Hubs

IMPACT: This work will inform the ongoing development of adaptive capacity and preparedness of the CTSA Program and other clinical and translational research organizations in their quest of improving processes that drive outcomes and impacts, shaping effective programs and services, and strengthening their emergency readiness and sustainability. OBJECTIVES/GOALS: -Share the progress and preliminary findings of an ‘Adaptive Capacity and Preparedness of CTSA Hubs’ CTSA Working Group;-Improve our awareness and understanding of the efficient and effective changes helping CTSA hubs build robust capacity to address METHODS/STUDY POPULATION: A multi-case study including: - Triangulating multiple sources of information and mixed methods (survey/interviews of research administrators, researchers, evaluators, and other key stakeholders), literature review, document and M&E system information analysis, and expert review;- Describing CTSA hubs’ experiences as related to research implementation, translation, and support during the time of emergency;- Administering a comprehensive survey of the CTSAs addressing their challenges, lessons learned, and practices that work in various program components/areas. Data collection includes aggregate and cross-sectional data, with representation based on CTSA size, maturity, and population density. RESULTS/ANTICIPATED RESULTS: The described approach shows sound promise to investigate and share strategies and best practices for building adaptive capacity and preparedness of CTSAs -- across various scientific sectors, translational research spectrum, and the goals outlined by NCATS for the CTSA program. The anticipated results of this research will include the identified/shared innovative solutions and lessons learned for this rapidly emerging, high-priority clinical and translational science issue. ‘High-quality lessons learned’ are those that represent principles extrapolated from multiple sources and triangulated to increase transferability to new contexts and situations. DISCUSSION/SIGNIFICANCE OF FINDINGS: The project provides useful knowledge and tools to research organizations and stakeholders across multiple disciplines -- for mitigating the impact of the COVID-19 disaster via effective adjusting programs, practices, and processes, and building capacity for future successful, ‘emergency ready and responsive’ research and training.

At-home testing to mitigate community transmission of SARS-CoV-2: protocol for a public health intervention with a nested prospective cohort study.

BACKGROUND: The COVID-19 pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to evolve as a global health crisis. Although highly effective vaccines have been developed, non-pharmaceutical interventions remain critical to controlling disease transmission. One such intervention-rapid, at-home antigen self-testing-can ease the burden associated with facility-based testing programs and improve testing access in high-risk communities. However, its impact on SARS-CoV-2 community transmission has yet to be definitively evaluated, and the socio-behavioral aspects of testing in underserved populations remain unknown. METHODS: As part of the Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) program funded by the National Institutes of Health, we are implementing a public health intervention titled "Say Yes! COVID Test" (SYCT) involving at-home self-testing using a SARS-CoV-2 rapid antigen assay in North Carolina (Greenville, Pitt County) and Tennessee (Chattanooga City, Hamilton County). The intervention is supported by a multifaceted communication and community engagement strategy to ensure widespread awareness and uptake, particularly in marginalized communities. Participants receive test kits either through online orders or via local community distribution partners. To assess the impact of this intervention on SARS-CoV-2 transmission, we will conduct a non-randomized, ecological study using community-level outcomes. Specifically, we will evaluate trends in SARS-CoV-2 cases and hospitalizations, SARS-CoV-2 viral load in wastewater, and population mobility in each community before, during, and after the SYCT intervention. Individuals who choose to participate in SYCT will also have the option to enroll in an embedded prospective cohort substudy gathering participant-level data to evaluate behavioral determinants of at-home self-testing and socio-behavioral mechanisms of SARS-CoV-2 community transmission. DISCUSSION: This is the first large-scale, public health intervention implementing rapid, at-home SARS-CoV-2 self-testing in the United States. The program consists of a novel combination of an at-home testing program, a broad communications and community engagement strategy, an ecological study to assess impact, and a research substudy of the behavioral aspects of testing. The findings from the SYCT project will provide insights into innovative methods to mitigate viral transmission, advance the science of public health communications and community engagement, and evaluate emerging, novel assessments of community transmission of disease.

ReGARDD (Regulatory Guidance for Academic Research of Drugs and Devices): The evolution of a collaborative regional CTSA-funded forum and website for regulatory support.

Availability of trained professionals to assist researchers navigating regulatory pathways for new drug and device development is limited within academic institutions. We created ReGARDD (Regulatory Guidance for Academic Research of Drugs and Devices), a regional forum initially involving regulatory professionals from four Clinical and Translational Science Award (CTSA)-funded institutions, to build and capitalize on local expertise and to develop a regulatory guidance website geared toward academic researchers. Since 2015, members organized 15 forums covering topics such as FDA premarket submissions, gene therapy, and intellectual property for devices and therapeutics. Through user feedback, targeted surveys, and ongoing iterative processes, we refined and maintained a shared regulatory website, which reached 6000+ users in 2019. Website updates improved navigation to drug versus device topic areas, provided new educational content and videos to address commonly asked questions, and created a portal for posting upcoming training opportunities. Survey respondents rated the website favorably and endorsed expanding ReGARDD as a centralized resource. ReGARDD strengthened the regional regulatory workforce, increased regulatory efficiency, and promulgated best organizational and operational practices. Broad-scale deployment of the ReGARDD model across the CTSA consortium may facilitate the creation of a network of regional forums and reduce gaps in access to regulatory support.

Training "Pivots" from the Pandemic: Lessons Learned Transitioning from In-Person to Virtual Synchronous Training in the Clinical Scholars Leadership Program.

INTRODUCTION: Since the inception of distance-based teaching modalities, a debate has ensued over the quality of online versus in-person instruction. Due to the COVID-19 pandemic, a number of teaching environments-including leadership development trainings for post-graduate learners-have been thrust into exploring the virtual learning environment more thoroughly. One three-year leadership development program for interdisciplinary healthcare professionals transitioned three simultaneous leadership intensives from in-person to online in the spring of 2020. METHODS: Documented changes in overall training length, session length, and session format are described. Further, evaluative data were collected from participants at both retreats via post-session surveys. Ninety-three participants attended the 2019 retreat, and 92 participants attended the 2020 virtual retreat. Quantitative data of three rating questions per session are reported: 1) overall session satisfaction, 2) participants' reported knowledge gain, and 3) participants' reported ability gain. Qualitative data were obtained via two open-ended feedback questions per session. RESULTS: In comparing pre/post scores for knowledge and ability, participants had meaningful (and in some cases higher) self-reported gains in knowledge and ability measures in the online environment, as compared to the in-person environment. Participants reported statistically significant gains in all sessions for both knowledge and ability. Qualitative data of participant feedback identified a number of positive themes similar across the in-person and virtual settings. Negative or constructive feedback of the virtual setting included time constraint issues (eg too much content in one session, a desire for more sessions overall), technical difficulties, and the loss of social connection and networking with fellow participants as compared to in-person trainings. DISCUSSION: While meaningful shifts in knowledge and ability ratings indicate that the transition to successful online learning is possible, several disadvantages remain. The preparation time for both faculty and participants was considerable, there is a need to reduce overall content in each session due to time restraints, and participants indicated feeling the loss of one-on-one connections with their peers in the training. Lessons learned of transitioning leadership training from in-person to an online experience are highlighted.

Centering Equity and Community in the Recovery of the COVID-19 Pandemic.

The COVID-19 pandemic has exposed socioeconomic, geographic, and medical vulnerabilities in our country. In North Carolina, inequalities resulting from centuries of structural racism exacerbate disparate impacts of infection and death. We propose three opportunities that leaders in our state can embrace to move toward equity as we weather, and emerge from, this pandemic.

High affinity interaction of Solanum tuberosum and Brassica juncea residue smoke water compounds with proteins involved in coronavirus infection.

The world is in an immediate need of treatment for coronavirus disease (COVID-19). Chronic exposure of hydroxychloroquine in the treatment of COVID-19 may have multiple adverse effects on human physiology, such as cardiac arrhythmias. Natural compounds need to be evaluated as treatment and preventive agents in coronavirus infection. A total of 30 compounds of Solanum tuberosum and Brassica juncea residue smoke water were selected for the virtual screening against SARS-CoV-1, SARS-CoV-2 and cellular proteins involved in the mechanism of infection. Docking analysis identified lead molecules with favorable binding energy, number of poses and hydrogen bond interactions, which indicates the effective modulation of ACE2 and TMPRSS2 receptors. Results indicated (a) curcumenol, (b) N-desmethylselegiline, (c) phentermine and (d) sphingolipid derivatives as a selective and potent candidates in comparison to hydroxychloroquine for COVID-19 treatment. Our in silico findings, therefore, warrant further in vitro validations of the selected compounds for the discovery of novel preventive and therapeutic drug against SARS-CoV-2 infection.