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.

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.

"The System Doesn't Let Us in"-A Call for Inclusive COVID-19 Vaccine Outreach Rooted in Los Angeles Latinos' Experience of Pandemic Hardships and Inequities.

OBJECTIVE: Latino adults in Los Angeles have experienced disproportionate cases, deaths, and socioeconomic impacts from the COVID-19 pandemic. This qualitative study aimed to explore community perspectives on readiness for COVID-19 vaccination and to identify culturally tailored vaccine outreach strategies. METHODS: We conducted virtual focus groups with Los Angeles County Latino/a residents via Zoom between December 2020 to January 2021, as the first COVID-19 vaccines were receiving Emergency Use Authorization (EUA). Focus groups were facilitated in Spanish and English by bilingual members of the research team. Discussions were analyzed via Atlas.ti software using reflexive thematic analysis. RESULTS: Three focus groups (n = 15; four to six people each; two Spanish focus groups; one English) were conducted. Thematic findings centered on Latino COVID-19 vaccine equity: (1) Disproportionate infection risk due to essential worker status and socioeconomic burdens, misinformation, and familial or cultural tensions (2) Concerns for inequitable vaccine access due to immigration fears and limited healthcare access, and (3) A need for community-centered COVID-19 vaccine outreach and access. CONCLUSIONS: Our study on early Latino adult reactions to vaccine roll-out suggests the need for outreach strategies centering on validating community hardships, combating dis-/misinformation through trusted sources, and addressing socio-economic needs impacted by the pandemic.

COVID-19 Vaccine Decision-making Factors in Racial and Ethnic Minority Communities in Los Angeles, California.

Importance: The COVID-19 pandemic has had disproportionate effects on racial and ethnic minority communities, where preexisting clinical and social conditions amplify health and social disparities. Many of these communities report lower vaccine confidence and lower receipt of the COVID-19 vaccine. Understanding factors that influence the multifaceted decision-making process for vaccine uptake is critical for narrowing COVID-19-related disparities. Objective: To examine factors that members of multiethnic communities at high risk for COVID-19 infection and morbidity report as contributing to vaccine decision-making. Design, Setting, and Participants: This qualitative study used community-engaged methods to conduct virtual focus groups from November 16, 2020, to January 28, 2021, with Los Angeles County residents. Potential participants were recruited through email, video, and telephone outreach to community partner networks. Focus groups were stratified by self-identified race and ethnicity as well as age. Transcripts were analyzed using reflexive thematic analysis. Main Outcomes and Measures: Themes were categorized by contextual, individual, and vaccine-specific influences using the World Health Organization's Vaccine Hesitancy Matrix categories. Results: A total of 13 focus groups were conducted with 70 participants (50 [71.4%] female) who self-identified as American Indian (n = 17 [24.3%]), Black/African American (n = 17 [24.3%]), Filipino/Filipina (n = 11 [15.7%]), Latino/Latina (n = 15 [21.4%]), or Pacific Islander (n = 10 [14.3%]). A total of 39 participants (55.7%) were residents from high-poverty zip codes, and 34 (48.6%) were essential workers. The resulting themes included policy implications for equitable vaccine distribution: contextual influences (unclear and unreliable information, concern for inequitable access or differential treatment, references to mistrust from unethical research studies, accessibility and accommodation barriers, eligibility uncertainty, and fears of politicization or pharmaceutical industry influence); social and group influences (inadequate exposure to trusted messengers or information, altruistic motivations, medical mistrust, and desire for autonomy); and vaccination-specific influences (need for vaccine evidence by subpopulation, misconceptions on vaccine development, allocation ambiguity, vaccination safety preferences, the importance of perceiving vaccine equity, burden of vaccine scheduling, cost uncertainty, and desire for practitioner recommendation). Conclusions and Relevance: In this qualitative study, participants reported a number of factors that affected their vaccine decision-making, including concern for inequitable vaccine access. Participants endorsed policy recommendations and strategies to promote vaccine confidence. These results suggest that support of informed deliberation and attainment of vaccine equity will require multifaceted, multilevel policy approaches that improve COVID-19 vaccine knowledge, enhance trust, and address the complex interplay of sociocultural and structural barriers to vaccination.