MivacunaLA (MyshotLA): A Community-Partnered Mobile Phone Intervention to Improve COVID-19 Vaccination Behaviors among Low-Income, Spanish-Speaking, and Immigrant Latino Parents or Caregivers.

We developed and tested MivacunaLA/MyshotLA, a community-informed mobile phone intervention, to increase COVID-19 vaccination among Latino parents/caretakers of minors in under-resourced areas of Los Angeles by addressing misinformation and building trust. We recruited Latino parents/caregivers with at least one unvaccinated child in East and South Los Angeles in the summer of 2021 and evaluated MivacunaLA as a randomized controlled trial with a wait-list control group. A difference-in-difference analysis showed Latino parents/caregivers that participated in MivacunaLA (n = 246), in comparison to the control group, were 15 percentage points more likely (p = 0.04) to report vaccination of minors aged 12-17 years, and 12 percentage points more likely (p = 0.03) to report a positive intention to vaccinate minors aged 2-11 years (when COVID-19 vaccines became available). Mobile phone-delivered digital interventions using videos and culturally tailored educational material to promote COVID-19 vaccine confidence can be an effective way to combat misinformation and deliver timely information to marginalized communities. Community-based participatory research approaches are crucial to advance health equity among minority communities, especially immigrant Spanish-speaking underserved communities.

Understanding the implementation and sustainability needs of evidence-based programs for racial and ethnic minoritized older adults in under-resourced communities with limited aging services.

BACKGROUND: Evidence-based programs (EBPs) for older adults effectively improve health outcomes. However, there is a limited understanding of the unique needs of service providers as they consider adopting, implementing, and maintaining programs for older minority adults in low-income communities with limited aging services. METHODS: We conducted semi-structured interviews with key informants of community-based organizations (CBOs) to understand implementation and sustainability needs of CBOs within four racial and ethnically diverse Los Angeles County geographic areas. We performed thematic analysis of interview transcripts. RESULTS: Interviews were conducted with representatives from 25 senior-serving agencies providing aging-related EBPs. CBO representatives reported implementing EBPs in 8 domains: Falls Prevention (68%), Mental Health (64%), Caregiver Health (48%), Chronic Disease Management (48%), Diabetes Management (36%), Arthritis Management (28%), Physical Activity (24%), and Multiple Conditions Management (8%). Themes are presented using the six domains of the Bass and Judge framework for factors impacting successful and sustained EBP implementation. CBOs in low-income and diverse communities described unique challenges with tailoring interventions based on local community context (literacy, language), cultural context, and locally available resources (technology, safe community spaces, transportation) and faced resource-intensive administrative burdens through staff turnover, data collection, sustainable funding, and networking. CONCLUSIONS: Serving racial and ethnic communities has unique challenges that require tailored approaches and additional resources to ensure equitable access to EBPs for all communities. We describe suggestions for enhancing the effective adoption of EBPs among service agencies in under-resourced and diverse aging communities serving populations with aging-related health disparities.

A collaboration team to build social service partnerships within a safety-net health system.

BACKGROUND: To facilitate safety-net healthcare system partnerships with community social service providers, the Los Angeles County Department of Health Services (LAC DHS) created a new collaboration team to spur cross-agency social and medical referral networks and engage communities affected by health disparities as part of a Sect. 1115 Medicaid waiver in Los Angeles County entitled Whole Person Care-Los Angeles (WPC-LA). METHODS: This observational research reviews three years of collaboration team implementation (2018-2020) through Medicaid-reportable engagement reports, a collaboration team qualitative survey on challenges, facilitators, and recommendations for community engagement. Member reflections for survey findings were conducted with the collaboration team and LAC DHS WPC-LA leadership. RESULTS: Collaboration team Medicaid engagement reports (n = 144) reported > 2,700 events, reaching > 70,000 individuals through cross-agency and community-partnered meetings. The collaboration team survey (n = 9) and member reflection sessions portrayed engagement processes through outreach, service assessments, and facilitation of service partnerships. The collaboration team facilitated community engagement processes through countywide workgroups on justice-system diversion and African American infant and maternal health. Recommendations for future safety net health system engagement processes included assessing health system readiness for community engagement and identifying strategies to build mutually beneficial social service partnerships. CONCLUSIONS: A dedicated collaboration team allowed for bi-directional knowledge exchange between county services, populations with lived experience, and social services, identifying service gaps and recommendations. Engagement with communities affected by health disparities resulted in health system policy recommendations and changes.

Strengths and challenges among Black and Latinx people living with HIV during COVID-19: A mixed-methods investigation of the translation of self-management across syndemic health crises.

Black and Latinx people are disproportionately impacted by HIV, COVID-19, and other syndemic health crises with similar underlying social determinants of health. Lessons learned from the HIV pandemic and COVID-19 response have been invoked to improve health equity at the systemic level in the face of other emergent health crises. However, few have examined the potential translation of strategies between syndemics at the individual level. The current mixed-methods study examined strategies used to manage HIV during the COVID-19 pandemic and the extent to which they were helpful in managing COVID-19 vulnerability among Black and Latinx people living with HIV. Participants (n = 30) were interviewed by telephone and completed demographic, mental health, alcohol and substance use, health literacy, and clinical measures in October and November 2020 in Los Angeles County. Rapid qualitative analysis, descriptive statistics, and mixed-methods merging were used to analyze the data. Qualitative results demonstrated that participants found HIV self-management strategies translated to aspects of the COVID-19 pandemic including hygiene and social distancing and coping with a health-related stressor. Although telemedicine provided continuity of HIV care for most participants, technology access and literacy posed a potential barrier, particularly to those facing other sociodemographic marginalization (i.e., low education, disability). Findings suggest providers can encourage leveraging individual HIV self-management strategies in response to other public health crises. However, these interventions must be culturally responsive and address intersecting social determinants of health. Future research should examine mechanisms that predict individual translation of HIV management strategies to other health concerns. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Disparities in Huntington Disease Severity: Analysis Using the ENROLL-HD Dataset.

Background and Objectives: Social and structural determinants of health (SDOH) have been associated with disability in neurologic diseases. However, the association between these factors and disability in Huntington disease (HD) has not been studied. This study aimed to evaluate the association of racial and sociodemographic factors with disease severity in patients with HD in North America. Methods: We conducted a cross-sectional study of genetically confirmed participants with HD (36+ CAG repeats) in the North American region using the ENROLL-HD 2020 periodic dataset. In this analysis, our exposure variable was the participant's race/ethnicity. The main outcome measure was disease severity, as measured by the Total Functional Capacity Score (TFC), which measures the level of disability of patients with HD. We used multivariate regression models to adjust for sociodemographic factors that may mediate or moderate a causal effect between race/ethnicity and disease severity. Results: Among 4,717 gene-positive participants in the North American region, 89.5% identified as White, 3.4% as Hispanic or Latino, and 2.3% as African American/Black. The average TFC score was 10.22 (SD 3.22); 48% of participants completed either secondary education (including college) or a professional degree, and 55% lived in a city and not in a town, village, or rural location. In multivariate regression models, we found that Black participants and those with less than a high school degree entered the ENROLL-HD study with lower TFC scores than White participants. We also found that compared with those with at least a high school degree, those who completed some form of higher education or professional degree had higher TFC scores (p < 0.001). This multivariate analysis did not find an association between geographic location and TFC score. Discussion: Our study found that Black participants in North America presented to ENROLL-HD with more advanced disease than White patients. We also found that higher education was associated with less advanced disease when entering the ENROLL-HD study. The role of race/ethnicity and education in HD symptom severity warrants further investigation. These findings underscore the importance of further studying the role of social and structural determinants of health in patients with HD, particularly those from historically marginalized communities.

Proceedings of a Workshop to Promote Community Health Worker Interventions in Nephrology.

ABSTRACT: Latinx populations face a higher burden of kidney failure and associated negative outcomes compared with non-Latinx White populations, despite sharing a similar prevalence of CKD. Community health worker (CHW) interventions have been shown to improve outcomes for Latinx individuals, but they are largely underutilized in kidney disease. We convened a workshop of four ongoing kidney disease CHW programs to identify successes, challenges, potential solutions, and needed research to promote CHW programs for Latinx individuals with kidney disease. Key points from the workshop and recommendations for intervention and research are highlighted. Facilitators of program success included prioritizing trust-building with participants, enabling participants to determine what aspects of the intervention were needed, providing participants with tools to help themselves and others after the intervention, and taking a trauma-informed approach to relationships. Challenges included persistent systemic barriers despite successful care navigation and low recruitment and retention. Research is needed to capture the effect of CHW interventions on outcomes and to determine how to implement CHW interventions for people with kidney disease nationwide.

Community-based organization perspectives on participating in state-wide community canvassing program aimed to reduce COVID-19 vaccine disparities in California.

BACKGROUND: Inequities in COVID-19 vaccine accessibility and reliable COVID-related information disproportionately affected marginalized racial and ethnic communities in the U.S. The Get Out the Vaccine (GOTVax) program, an innovative statewide government-funded COVID-19 vaccine canvassing program in California, aimed to reduce structural barriers to COVID-19 vaccination in high-risk communities with low vaccination rates. GOTVax consisted of a community-academic-government partnership with 34 local trusted community-based organizations' (CBOs) to conduct COVID-19 vaccine outreach, education, and vaccine registration. The purpose of this qualitative evaluation study was to explore the barriers and facilitators of using local CBOs to deploy a geographically, racially, and ethnically diverse state-wide COVID-19 vaccine outreach program. METHODS: Semi-structured online interviews were conducted with participating GOTVax CBO leaders from November 2021 to January 2022. Transcripts were analyzed using reflexive thematic analysis. RESULTS: Thirty-one of 34 CBOs participated (91% response rate). Identified themes encompassed both facilitators and barriers to program participation. Key facilitators included leveraging trust through recognized entities; promoting empathetic, tailored outreach; and flexibility of milestone-based CBO funding contracts for rapid program implementation. Barriers included navigating community sociopolitical, geographic, and cultural factors; managing canvassers' safety; desiring metrics for self-evaluation of outreach success; mitigating canvassing technology challenges; and concerns of program infrastructure initially limiting outreach. CBOs problem-solved barriers with academic and government partners. CONCLUSIONS: Between May and December 2021, the GOTVax program reached over 2 million California residents and registered over 60,000 residents for COVID-19 vaccination. Public health campaigns may improve benefits from leveraging the expertise of community-trusted CBOs and universities by providing flexible infrastructure and funding, allowing CBOs to seamlessly tailor outreach most applicable to local minoritized communities.

Evaluation of COVID-19 vaccine implementation in a large safety net health system.

Objectives: To evaluate rapid COVID-19 vaccine clinic implementation from January-April 2021 in the Los Angeles County Department of Health Services (LACDHS), the second-largest US safety net health system. During initial vaccine clinic implementation, LACDHS vaccinated 59,898 outpatients, 69% of whom were Latinx (exceeding the LA County Latinx population of 46%). LACDHS is a unique safety net setting to evaluate rapid vaccine implementation due to system size, geographic breadth, language/racial/ethnic diversity, limited health staffing resources, and socioeconomic complexity of patients. Methods: Implementation factors were assessed through semi-structured interviews of staff from all twelve LACDHS vaccine clinics from August-November 2021 using the Consolidated Framework for Implementation Research (CFIR) and themes analyzed using rapid qualitative analysis. Results: Of 40 potential participants, 25 health professionals completed an interview (27% clinical providers/medical directors, 23% pharmacist, 15% nursing staff, and 35% other). Qualitative analysis of participant interviews yielded ten narrative themes. Implementation facilitators included bidirectional communication between system leadership and clinics, multidisciplinary leadership and operations teams, expanded use of standing orders, teamwork culture, use of active and passive communication structures, and development of patient-centered engagement strategies. Barriers to implementation included vaccine scarcity, underestimation of resources needed for patient outreach, and numerous process challenges encountered. Conclusion: Previous studies focused on robust advance planning as a facilitator and understaffing and high staff turnover as barriers to implementation in safety net health systems. This study found facilitators that can mitigate lack of advance planning and staffing challenges present during public health emergencies such as the COVID-19 pandemic. The ten identified themes may inform future implementations in safety net health systems.

Geospatial analysis of access to dermatology care in Los Angeles County: a cross sectional study.

Geographic maldistribution of dermatologists contributes to disparities in access to dermatologic care. We aimed to investigate the geographic distribution of, and differences in wait times for medical dermatology services in Los Angeles County (LAC). We placed phone calls to 251 dermatology practices in LAC to ask for a new patient appointment for a changing mole. We found West LAC (Service Planning Area [SPA] 5) had the highest number of dermatologists and South LAC (SPA 6) had the lowest (26.1 versus 0 per 100,000 residents, P=0.01). Service Planning Area 6 has a higher non-White, uninsured, and impoverished population than SPA 5. Dermatology appointment wait times and Medicaid acceptance varied between SPAs but was not statistically significant (P=0.37 and P=0.20, respectively). Medicaid-accepting practices had a significantly longer mean wait time for an appointment than practices that did not accept Medicaid (26.1 versus 15.1 days, P=0.003). Regions with predominantly non-White, Spanish-speaking, and medically underinsured residents were found to be disproportionately lacking in dermatologists across LAC, which may contribute to impaired access to dermatology services in LAC.

Inclusion of Race and Ethnicity With Neighborhood Socioeconomic Deprivation When Assessing COVID-19 Hospitalization Risk Among California Veterans Health Administration Users.

Importance: Despite complexities of racial and ethnic residential segregation (hereinafter referred to as segregation) and neighborhood socioeconomic deprivation, public health studies, including those on COVID-19 racial and ethnic disparities, often rely on composite neighborhood indices that do not account for residential segregation. Objective: To examine the associations by race and ethnicity among California's Healthy Places Index (HPI), Black and Hispanic segregation, Social Vulnerability Index (SVI), and COVID-19-related hospitalization. Design, Setting, and Participants: This cohort study included veterans with positive test results for COVID-19 living in California who used Veterans Health Administration services between March 1, 2020, and October 31, 2021. Main Outcomes and Measures: Rates of COVID-19-related hospitalization among veterans with COVID-19. Results: The sample available for analysis included 19 495 veterans with COVID-19 (mean [SD] age, 57.21 [17.68] years), of whom 91.0% were men, 27.7% were Hispanic, 16.1% were non-Hispanic Black, and 45.0% were non-Hispanic White. For Black veterans, living in lower-HPI (ie, less healthy) neighborhoods was associated with higher rates of hospitalization (odds ratio [OR], 1.07 [95% CI, 1.03-1.12]), even after accounting for Black segregation (OR, 1.06 [95% CI, 1.02-1.11]). Among Hispanic veterans, living in lower-HPI neighborhoods was not associated with hospitalization with (OR, 1.04 [95% CI, 0.99-1.09]) and without (OR, 1.03 [95% CI, 1.00-1.08]) Hispanic segregation adjustment. For non-Hispanic White veterans, lower HPI was associated with more frequent hospitalization (OR, 1.03 [95% CI, 1.00-1.06]). The HPI was no longer associated with hospitalization after accounting for Black (OR, 1.02 [95% CI, 0.99-1.05]) or Hispanic (OR, 0.98 [95% CI, 0.95-1.02]) segregation. Hospitalization was higher for White (OR, 4.42 [95% CI, 1.62-12.08]) and Hispanic (OR, 2.90 [95% CI, 1.02-8.23]) veterans living in neighborhoods with greater Black segregation and for White veterans in more Hispanic-segregated neighborhoods (OR, 2.81 [95% CI, 1.96-4.03]), adjusting for HPI. Living in higher SVI (ie, more vulnerable) neighborhoods was associated with greater hospitalization for Black (OR, 1.06 [95% CI, 1.02-1.10]) and non-Hispanic White (OR, 1.04 [95% CI, 1.01-1.06]) veterans. Conclusions and Relevance: In this cohort study of US veterans with COVID-19, HPI captured neighborhood-level risk for COVID-19-related hospitalization for Black, Hispanic, and White veterans comparably with SVI. These findings have implications for the use of HPI and other composite neighborhood deprivation indices that do not explicitly account for segregation. Understanding associations between place and health requires ensuring composite measures accurately account for multiple aspects of neighborhood deprivation and, importantly, variation by race and ethnicity.

A community-partnered approach for diversity in COVID-19 vaccine clinical trials.

Introduction: Communities of color have faced disproportionate morbidity and mortality from COVID-19, coupled with historical underrepresentation in US clinical trials, creating challenges for equitable participation in developing and testing a safe and effective COVID-19 vaccine. Methods: To increase diversity, including racial and ethnic representation, in local Los Angeles County NIH-sponsored Phase 3 SARS-CoV-2 vaccine clinical trials, we used deliberative community engagement approaches to form a Community Consultant Panel (CCP) that partnered with trial research teams. Thirteen members were recruited, including expertise from essential workers, community-based and faith-based organizations, or leaders from racial and ethnic minority communities. Results: Working closely with local investigators for the vaccine studies, the CCP provided critical insight on best practices for community trust building, clinical trial participation, and reliable information dissemination regarding COVID-19 vaccines. Modifying recruitment, outreach, and trial protocols led to majority-minority participants (55%-78%) in each of the three vaccine clinical trials. CCP's input led to cultural tailoring of recruitment materials, changes in recruitment messaging, and supportive services to improve trial accessibility and acceptability (transportation, protocols for cultural competency, and support linkages to care in case of an adverse event). Barriers to clinical trial participation unable to be resolved included childcare, requests for after-hours appointment availability, and mobile locations for trial visits. Conclusion: Using deliberative community engagement can provide critical and timely insight into the community-centered barriers to COVID-19 vaccine trial participation, including addressing social determinants of health, trust, clinical trial literacy, structural barriers, and identifying trusted messenger and reliable sources of information.

Addressing racial/ethnic inequities in vaccine hesitancy and uptake: lessons learned from the California alliance against COVID-19.

Lack of trust in biomedical research, government, and health care systems, especially among racial/ethnic minorities and under-resourced communities, is a longstanding issue rooted in social injustice. The COVID-19 pandemic has further highlighted existing health and socioeconomic inequities and increased the urgency for solutions to provide access to timely, culturally, and linguistically appropriate evidence-based information about COVID-19; and ultimately to promote vaccine uptake. California's statewide alliance STOP COVID-19 CA (comprising eleven sites), leverages long standing community partnerships to better understand concerns, misinformation, and address racial/ethnic inequities in vaccine hesitancy and uptake. Using data from the California CEAL Communication Working Group, we demonstrate the wide range of strategies, communication methods, languages, and trusted messengers that have been effective in reaching diverse communities across the state. We also showcase challenges and lessons learned, such as the importance of including trusted community partners to share information or provide vaccines. These approaches, rooted in community engagement, are crucial for addressing inequities and responding to future public health emergencies.

The Role of Anti-Racist Community-Partnered Praxis in Implementing Restorative Circles Within Marginalized Communities in Southern California During the COVID-19 Pandemic.

The COVID-19 pandemic has exacerbated the adverse influence of structural racism and discrimination experienced by historically marginalized communities (e.g., Black, Latino/a/x, Indigenous, and transgender people). Structural racism contributes to trauma-induced health behaviors, increasing exposure to COVID-19 and restricting access to testing and vaccination. This intersection of multiple disadvantages has a negative impact on the mental health of these communities, and interventions addressing collective healing are needed in general and in the context of the COVID-19 pandemic. The Share, Trust, Organize, and Partner COVID-19 California Alliance (STOP COVID-19 CA), a statewide collaborative of 11 universities and 75 community partners, includes several workgroups to address gaps in COVID-19 information, vaccine trial participation, and access. One of these workgroups, the Vaccine Hesitancy Workgroup, adopted an anti-racist community-partnered praxis to implement restorative circles in historically marginalized communities to facilitate collective healing due to structural racism and the COVID-19 pandemic. The project resulted in the development of a multilevel pre-intervention restorative process to build or strengthen community-institutional partnerships when procurement of funds has been sought prior to community partnership. This article discusses this workgroup's role in advancing health justice by providing a community-based mental health intervention to marginalized communities in Southern California while using an antiracist praxis tool to develop a successful community-institutional partnership and to live up to the vision of community-based participatory research.

Sleep Health as a Determinant of Disparities in Stroke Risk and Health Outcome.

Sleep is essential to human survival and overall vascular health. Sleep health encompasses the objective and subjective qualities associated with one's daily pattern of sleep and wakefulness and has become a growing clinical and public health concern. Impaired sleep duration and quality can increase stroke risk and mediate the relationship between the physical aspects of an individual's environment and disparities in stroke incidence. Here, we review observational studies evaluating the association between sleep health and cerebrovascular disease. We assess the influence on sleep of the physical environment, including the ambient environment with noise levels and the built environment. We also describe the influences on sleep health and stroke risk of social determinants of health, including the chronic stressor of racial discrimination. Finally, we discuss how changes in historical neighborhood characteristics or societal policies can influence the social factors affecting sleep health and stroke risk among socioeconomically disadvantaged groups or ethnic and racial minorities. Given the regional and racial or ethnic differences in stroke risk across the United States, an understanding of novel vascular risk factors, such as the multifaceted role of sleep health, will be critical to develop effective public policies to improve population health.

Community and Healthcare Perspectives on Implementing Hypertension Interventions for a Multiethnic Safety-Net Population.

Objective: To synthesize community and healthcare informants' perspectives on contextual considerations and tailoring recommendations for high-quality, sustainable implementation of evidence-based practices (EBPs) for managing hypertension (HTN) in a multiethnic safety-net population. Design: Structured focus-group discussions and semistructured qualitative interviews. Background: High-quality, sustainable implementation of HTN-related EBPs can promote equitable care. Implementation challenges extend beyond individual patients to span multiple levels of context. Few studies have systematically engaged community and healthcare perspectives to inform the design of HTN intervention trials. Setting: A large safety-net healthcare system. Participants/Methods: We conducted four structured discussions with each of five race- or ethnicity-specific community action boards (CABs) to understand community members' HTN-related norms, assets, needs, and experiences across local healthcare systems. We interviewed 41 personnel with diverse roles in our partnered healthcare system to understand the system's HTN-related strengths and needs. We solicited EBP tailoring recommendations from both groups. We summarized the findings using rapid content analysis. Results: Participants identified contextual considerations spanning seven themes: social determinants, healthcare engagement, clinical interaction, system operations, standardization, patient education, and partnerships and funding. They offered tailoring recommendations spanning nine themes: addressing complex contexts, addressing social needs, system operations, healthcare system training and resources, linguistic and cultural tailoring, behavioral engagement, relational engagement, illness-course engagement, and community partnerships. Conclusions: Engaging community and healthcare informants can ground implementation in the policy, community, healthcare system, clinical, and interpersonal contexts surrounding diverse patients at risk for disparities. Such grounding can reframe inequitable implementation as a multilevel social problem facing communities and healthcare systems, rather than individuals.

Exploring Perspectives on Establishing COVID-19 Vaccine Confidence in Black Communities.

Objective: To explore factors influencing COVID-19 vaccine decision-making among Black adults at high-risk for COVID-19 infection. Despite effective treatment and vaccination availability, Black Americans continue to be disproportionately impacted by COVID-19. Design Setting and Participants: Using community-engaged qualitative methods, we conducted virtual, semi-structured focus groups with Black residents in Los Angeles County before widespread vaccine rollout. Recruitment occurred through local community partners. Main Outcome Measures: Themes and subthemes on factors for vaccine confidence and accessibility. Methods: As part of a larger study exploring COVID-19 vaccine decision-making factors among multiethnic groups, two-hour virtual focus groups were conducted between December 15, 2020 and January 27, 2021. Transcripts were analyzed using reflexive thematic analysis. Results: Three focus groups were conducted with 17 Black participants, who were primarily female (n=15), residents of high-poverty zip codes (n=11) and employed full-time (n=6). Black-specific considerations for vaccine confidence and accessibility include: 1) reduced confidence in COVID-19 vaccines due to historical government inaction and racism (existing health inequities and disparities are rooted in racism; historical unethical research practices); 2) misunderstanding of Black communities' vaccine concerns ("vaccine hesitancy" as an inaccurate label to describe vaccine skepticism; ignorance to root causes of vaccine skepticism); and 3) recognizing and building on resources (community agency to address COVID-19 vaccine needs adequately). Conclusions: Vaccination campaigns should improve understanding of underlying vaccination concerns to improve vaccine outreach effectiveness and should partner with, provide resources to, and invest in local, trusted Black community entities to improve COVID-19 vaccination disparities.

Earlier treatment in adults with high lifetime risk of cardiovascular diseases: What prevention trials are feasible and could change clinical practice? Report of a National Heart, Lung, and Blood Institute (NHLBI) Workshop.

More than half of U.S. young adults have low ten-year but high lifetime risk of cardiovascular disease (CVD). Improving primary prevention in young adulthood may help reduce persistent CVD disparities and overall CVD morbidity and mortality. The National Heart, Lung, and Blood Institute (NHLBI) convened a workshop in 2021 to identify potential trial opportunities in CVD prevention in young adults. The workshop identified promising interventions that could be tested, including interventions that focus on a single cardiovascular risk factor (e.g., lipids or inflammation) to multiple risk factor interventions (e.g., multicomponent lifestyle interventions or fixed-low dose combination of medications). Given the sample size and duration for a trial with hard endpoints, more research is needed on the utility of intermediate endpoints identified noninvasively such as subclinical coronary atherosclerosis as a surrogate endpoint. For now, clinical outcomes trials with hard endpoints will more likely change clinical practice. Trial efficiency depends on accurate identification of high-risk young adults, which can potentially be done using traditional risk equations, coronary artery calcium screening, computerized tomography coronary angiography, and polygenic risk scores. Trials in young adults should include enhanced recruitment strategies with intense community engagement to enroll a trial population that is racially, ethnically, geographically, and socially diverse. Despite the challenges in conducting large prevention trials in young adults, recent advances including innovation in clinical trial conduct, new therapies and successful interventions in older populations, and an increasing recognition of a lifespan approach to risk assessment have made such trials more feasible than ever. Disclosures: The views expressed in this manuscript are those of the authors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute; the National Institutes of Health; or the U.S. Department of Health and Human Services.

A qualitative study of COVID-19 vaccine decision making among urban Native Americans.

Background: Significant disparities in COVID-19 morbidity and mortality exist for Native American (NA) people, the majority of whom live in urban areas. COVID-19 vaccination is a key strategy for mitigating these disparities; however, vaccination disparities affect NA communities. The current study investigated COVID-19 vaccine decision-making before widespread vaccine rollout occurred, among urban NA communities. We aimed to understand vaccine decision-making factors to develop recommendations about COVID-19 vaccine outreach. Methods: We conducted three in-depth virtual focus groups with 17 NA adults living in an urban community (Los Angeles County) between December 2020 and January 2021. Participants were recruited through NA community-based organizations and community stakeholders. Reflexive thematic analysis was conducted using Atlas.ti. Findings: Participants in this study identified two overarching themes with implications for health vaccination campaigns. First, participants described a need for tailored information and outreach, including NA vaccine outreach that addresses misconceptions about vaccine development to calm fears of experimentation and support communication of vaccine evidence specific to NA people. Second, participants suggested strategies to improve public health resources in the urban NA community, such as the need for unified, proactive communication across trusted NA entities, navigation support to improve vaccine accessibility, and adequately resourcing health partnerships with and among trusted NA community agencies for improved reach. Conclusion: In this qualitative study, we found that urban NA participants reported several factors that affected their vaccine decision-making, including a lack of tailored information for their communities. Our findings also underscore the need to work with tribes, tribal leadership, and urban NA serving organizations to coordinate vaccine communication and distribution to urban communities where the majority of NAs now reside. Further, these findings have implications for COVID-19 vaccine outreach among urban NA communities and demonstrate the need for clear and tailored engagement about the COVID-19 vaccine.

Inclusionary Trials: A Review of Lessons Not Learned.

The COVID-19 pandemic revealed weaknesses in the public health infrastructure of the United States, including persistent barriers to engaging marginalized communities toward inclusion in clinical research, including trials. Inclusive participation in clinical trials is crucial for promoting vaccine confidence, public trust, and addressing disparate health outcomes. A long-standing body of literature describes the value of community-based participatory research in increasing marginalized community participation in research. Community-based participatory research emphasizes shared leadership with community members in all phases of the research process, including in the planning and implementation, interpretation, and dissemination. Shared leadership between academic and industry with marginalized communities can assist with inclusive participation in vaccine trials and increase public trust in the development of the vaccines and other therapies used during public emergencies. Nevertheless, epidemiologic and clinical research do not yet have a strong culture of community partnership in the scientific process, which takes time to build and therefore may be difficult to develop and rapidly scale to respond to the pandemic. We outline practices that contribute to a lack of inclusive participation and suggest steps that trialists and other researchers can take to increase marginalized communities' participation in research. Practices include planning for community engagement during the planning and recruitment phases, having regular dialogues with communities about their priorities, supporting them throughout a study, and navigating complex structural determinants of health. Additionally, we discuss how research institutions can support inclusive practices by reexamining their policies to increase participation in clinical trials and instilling institutional trustworthiness.