The role of funded partnerships in working towards decreasing COVID-19 vaccination disparities, United States, March 2021-December 2022.

During the COVID-19 vaccination rollout from March 2021- December 2022, the Centers for Disease Control and Prevention funded 110 primary and 1051 subrecipient partners at the national, state, local, and community-based level to improve COVID-19 vaccination access, confidence, demand, delivery, and equity in the United States. The partners implemented evidence-based strategies among racial and ethnic minority populations, rural populations, older adults, people with disabilities, people with chronic illness, people experiencing homelessness, and other groups disproportionately impacted by COVID-19. CDC also expanded existing partnerships with healthcare professional societies and other core public health partners, as well as developed innovative partnerships with organizations new to vaccination, including museums and libraries. Partners brought COVID-19 vaccine education into farm fields, local fairs, churches, community centers, barber and beauty shops, and, when possible, partnered with local healthcare providers to administer COVID-19 vaccines. Inclusive, hyper-localized outreach through partnerships with community-based organizations, faith-based organizations, vaccination providers, and local health departments was critical to increasing COVID-19 vaccine access and building a broad network of trusted messengers that promoted vaccine confidence. Data from monthly and quarterly REDCap reports and monthly partner calls showed that through these partnerships, more than 295,000 community-level spokespersons were trained as trusted messengers and more than 2.1 million COVID-19 vaccinations were administered at new or existing vaccination sites. More than 535,035 healthcare personnel were reached through outreach strategies. Quality improvement interventions were implemented in healthcare systems, long-term care settings, and community health centers resulting in changes to the clinical workflow to incorporate COVID-19 vaccine assessments, recommendations, and administration or referrals into routine office visits. Funded partners' activities improved COVID-19 vaccine access and addressed community concerns among racial and ethnic minority groups, as well as among people with barriers to vaccination due to chronic illness or disability, older age, lower income, or other factors.

Racial differences in two measures of trust in biomedical research.

OBJECTIVE: Lack of trust toward medical research is a major barrier to research participation, particularly among some population groups. Valid measures of trust are needed to develop appropriate interventions. The study purpose was to compare two previously validated scales that measure trust in biomedical research - one developed by Hall et al. (H-TBR; 2006) and the other by Mainous et al. (M-TBR; 2006) - in relation to socio-demographic variables and attitudes toward research. Differences between Black and White respondents were explored. METHODS: Two nearly identical surveys - one with H-TBR and the other with M-TBR - were systematically administered to a convenience sample. Internal consistency reliability of each scale was assessed. Associations were computed between scores on each scale with attitudes toward biomedical research and demographic variables (i.e., gender, age, race, and socioeconomic status). The difference between White and Black respondents on each TBR score while controlling for age, education, and race was also investigated. RESULTS: A total of 2020 participants completed the H-TBR survey; 1957 completed the M-TBR survey. Mean item scores for M-TBR were higher (F = 56.05, p < 0.001) among Whites than Blacks. Whites also had higher mean item scores than Blacks on H-TBR (F = 7.09, p < 0.001). Both scales showed a strong association with participants' perceived barriers to research (ps < 0.001) and significant, positive correlations with interest in research participation (ps < 0.001). Age and household income were positive predictors of TBR scores, but the effects of education differed. CONCLUSIONS: Both scales are internally consistent and show associations with attitudes toward research. Whites score higher than Blacks on both TBR scales, even while controlling for age and socioeconomic status.

A taxonomy of impacts on clinical and translational research from community stakeholder engagement.

BACKGROUND: Community engagement is increasingly recognized as a valuable tool in clinical and translational research; however, the impact of engagement is not fully understood. No standard nomenclature yet exists to clearly define how research changes when community stakeholders are engaged across the research spectrum. This severely limits our ability to assess the value of community engagement in research. To address this gap, we developed a taxonomy for characterizing and classifying changes in research due to community engagement. METHODS: Using an iterative process, we (a) identified areas of potential impact associated with community engagement from author experience, (b) categorized these in taxonomic bins based on research stages, (c) conducted semi-structured interviews with researchers and community stakeholders, (d) validated the codebook in a sample dataset and (e) refined the taxonomy based on the validation. Community stakeholders were involved in every step of the process including as members of the primary study team. RESULTS: The final taxonomy catalogues changes into eleven domains corresponding to research phases. Each domain includes 2-4 dimensions depicting concepts within the domain's scope and, within each dimension, 2-10 elements labelling activities through which community engagement could change research. CONCLUSIONS: Community engagement has great potential to enhance clinical and translational research. This taxonomy provides a common vocabulary and framework for understanding the impact of community engagement and suggests metrics for assessing the value of community engagement in research.

The Impact of an Educational Video on Clinical Trial Enrollment and Knowledge in Ethnic Minorities: A Randomized Control Trial.

Introduction: Innovative methods to increase awareness about clinical trials and address barriers associated with low participation among racial/ethnic minorities are desperately needed. African Americans comprise 5% of all clinical trial participants, and Hispanics make up 1%. Use of multimedia educational material has shown promise as an effective strategy to increase minority clinical trial enrollment. However, this approach has not been broadly implemented. We tested the effect of a video educational program on clinical trial knowledge and enrollment in a sample of oncology outpatients. Methods: A randomized controlled trial was conducted with 63 oncology patients without previous history of clinical trial participation. Participants were randomly assigned to the intervention, to watch a clinical trial educational video in the office, or to the control group which did not receive in-office education. The Clinical Trial Knowledge survey was administered before the intervention and 1 week after the intervention. Participation in clinical trials was assessed 1-year post study participation. Results for white participants and ethnic minorities were compared. Ethnicity was self-reported through the electronic health record and confirmed by self-reporting on questionnaire. Results: Sixty-three participants were recruited in this study. At 1-year follow-up, 3 participants enrolled in clinical trials in the study group which had received office-based video intervention and 2 participants enrolled in the control group (Z = 0.39, p = 0.69). These results were not statistically significant. Impact of the intervention by ethnicity could not be assessed due to low total clinical trial enrollment. The video intervention did not change knowledge, attitudes, or barriers as measured by the Clinical Trial Knowledge Survey. Minority participants did report significantly more negative beliefs and barriers to participation than white participants. Conclusions: Increasing awareness and knowledge about clinical trials in underrepresented communities is an important step to providing opportunities for participation. Future studies should focus on how to address the negative expectations of clinical trials and the greater information needs in minority populations. Tailored or personalized messaging may address negative perceptions of clinical trial participation.

A Community-Based Collaborative Care Model to Improve Functional Health in Underserved Community-Dwelling Older Adults.

OBJECTIVE: Examine the effects of a 6-month health multidimensional intervention on physical function, bone density, and mood in a diverse sample of community-dwelling older adults at risk for frailty and excess disability. METHOD: A quasi-experimental, pre- post-program design was implemented. Adults aged 55 years and older ( n = 337, 60% African American) participated in the intervention and received assessments at baseline, 6 months, and 12 months. RESULTS: Physical function was maintained during the intervention for both African American and White elders but declined at 12 months for both groups ( p < .0001). Symptoms of depression improved during the intervention ( M = 0.65 ± 0.07, M = 0.15 ± 0.04, M = 0.68 ± 0.07, p < .001, respectively) but worsened at 12 months ( M = 0.68 ± 0.07, p < .001). Bone density scores remained stable from baseline (distal: -1.62 ± 1.17, proximal: -2.73 ± 1.85) to 12 months (distal: -1.72 ± 1.21, proximal: -3.11 ± 1.85, ps > .05) for both groups. DISCUSSION: Program findings may serve as a basis for the development of a randomized, controlled study to provide empirical evidence of intervention efficacy. Such findings may help inform the development of community-based programs to identify vulnerable older adults and provide vital preventative care to decrease frailty and excess disability.

A Multilevel Approach to Stakeholder Engagement in the Formulation of a Clinical Data Research Network.

OBJECTIVES: To ensure meaningful engagement of stakeholders (patients, clinicians, and communities) in developing the Mid-South Clinical Data Research Network (MS-CDRN), we implemented a comprehensive, multilevel approach: (1) identify barriers to involving stakeholders in governance, network design, and implementation; (2) engage stakeholders in priority setting and research topic generation; (3) develop strategies to fully integrate stakeholders in CDRN governance and oversight; and (4) solicit guidance on patient-centered tools and strategies for recruiting research participants. METHODS: We engaged stakeholders: (1) as integral research team members; (2) on oversight and advisory committees; (3) as consultants (using Community Engagement Studios); and (4) through interviews and surveys. We recruited stakeholders from community health centers, churches, barbershops, health fairs, a volunteer registry, and a patient portal. We prioritized recruitment from populations often underrepresented in research. RESULTS: During the first 18 months, we engaged 5670 stakeholders in developing the MS-CDRN. These were research team members and on governance committees (N=10), consultants (N=58), survey respondents (N=5543), and interviewees (N=59). Stakeholders identified important barriers and facilitators to engagement, developed stakeholder-informed policies, provided feedback on priority topics and research questions, and developed an intake process for data requests and interventional studies that included reviewing for appropriate patient-centeredness, patient engagement, and dissemination. DISCUSSION: Multilevel stakeholder engagement is a novel systematic approach to developing a meaningful patient-centered and patient-engaged research program. This approach allows ongoing input from highly engaged stakeholders while leveraging focused input from larger, more diverse groups to enhance the patient-centeredness of research and increase relevance to broader audiences.

Quantitative proteomics with siRNA screening identifies novel mechanisms of trastuzumab resistance in HER2 amplified breast cancers.

HER2 is a receptor tyrosine kinase that is overexpressed in 20% to 30% of human breast cancers and which affects patient prognosis and survival. Treatment of HER2-positive breast cancer with the monoclonal antibody trastuzumab (Herceptin) has improved patient survival, but the development of trastuzumab resistance is a major medical problem. Many of the known mechanisms of trastuzumab resistance cause changes in protein phosphorylation patterns, and therefore quantitative proteomics was used to examine phosphotyrosine signaling networks in trastuzumab-resistant cells. The model system used in this study was two pairs of trastuzumab-sensitive and -resistant breast cancer cell lines. Using stable isotope labeling, phosphotyrosine immunoprecipitations, and online TiO(2) chromatography utilizing a dual trap configuration, ~1700 proteins were quantified. Comparing quantified proteins between the two cell line pairs showed only a small number of common protein ratio changes, demonstrating heterogeneity in phosphotyrosine signaling networks across different trastuzumab-resistant cancers. Proteins showing significant increases in resistant versus sensitive cells were subjected to a focused siRNA screen to evaluate their functional relevance to trastuzumab resistance. The screen revealed proteins related to the Src kinase pathway, such as CDCP1/Trask, embryonal Fyn substrate, and Paxillin. We also identify several novel proteins that increased trastuzumab sensitivity in resistant cells when targeted by siRNAs, including FAM83A and MAPK1. These proteins may present targets for the development of clinical diagnostics or therapeutic strategies to guide the treatment of HER2+ breast cancer patients who develop trastuzumab resistance.