Virtual Community Engagement for Retention of Black Men in Clinical Research.

Black American men have worse cardiovascular health compared with their White counterparts, yet are highly underrepresented in clinical trials. In 2020, Black men were recruited to participate in Black Impact, a community-based lifestyle intervention to increase cardiovascular health. Due to the research pause during the Coronavirus Disease (COVID-19) pandemic, a virtual community engagement (VCE) process was co-designed with community stakeholders and evaluated for its effect on retention for the clinical trial. VCE via weekly virtual video conference sessions occurred for 9 weeks as a run-in phase prior to in-person research activities. Data collected during sessions included attendance, anecdotes on acceptability, and topical requests for subsequent weeks. Content analysis was performed on scribe notes from sessions to ascertain themes describing the implementation and participant perceptions of the VCE. Descriptive statistics were used to analyze quantitative data. The VCE provided opportunities to co-create a safe atmosphere in small groups, discuss mental health, foster trust, capitalize on the power of spirituality, and establish a brotherhood. Following the VCE run-in phase, 74 of 100 participants remained engaged for participation in the Black Impact study. The VCE described provides a framework that can be used to retain Black men during study delays or disruptions through fostering engagement and building community among participants and researchers.

Community engagement and clinical trial diversity: Navigating barriers and co-designing solutions-A report from the "Health Equity through Diversity" seminar series.

INTRODUCTION: In recent years, there has been increasing awareness of the lack of diversity among clinical trial participants. Equitable representation is key when testing novel therapeutic and non-therapeutic interventions to ensure safety and efficacy across populations. Unfortunately, in the United States (US), racial and ethnic minority populations continue to be underrepresented in clinical trials compared to their White counterparts. METHODS: Two webinars in a four-part series, titled "Health Equity through Diversity," were held to discuss solutions for advancing health equity through diversifying clinical trials and addressing medical mistrust in communities. Each webinar was 1.5 hours long, beginning with panelist discussions followed by breakout rooms where moderators led discussions related to health equity and scribes recorded each room's conversations. The diverse groups of panelists included community members, civic representatives, clinician-scientists, and biopharmaceutical representatives. Scribe notes from discussions were collected and thematically analyzed to uncover the central themes. RESULTS: The first two webinars were attended by 242 and 205 individuals, respectively. The attendees represented 25 US states, four countries outside the US, and shared various backgrounds including community members, clinician/researchers, government organizations, biotechnology/biopharmaceutical professionals, and others. Barriers to clinical trial participation are broadly grouped into the themes of access, awareness, discrimination and racism, and workforce diversity. Participants noted that innovative, community-engaged, co-designed solutions are essential. CONCLUSIONS: Despite racial and ethnic minority groups making up nearly half of the US population, underrepresentation in clinical trials remains a critical challenge. The community engaged co-developed solutions detailed in this report to address access, awareness, discrimination and racism, and workforce diversity are critical to advancing clinical trial diversity.

Rationale and design of the linking education, produce provision, and community referrals to improve diabetes care (LINK) study.

BACKGROUND: Individuals with type 2 diabetes (T2D) experiencing food insecurity may have other non-medical, health-related social needs (e.g., transportation, housing instability) that decrease their ability to attain T2D control and impact other health outcomes. METHODS: A pragmatic randomized controlled trial (pRCT) to test the effect of produce provision, diabetes and culinary skills training and education, and social needs screening, navigation, and resolution, on hemoglobin A1c (A1c) levels in individuals with T2D (A1c ≥7.5%) experiencing food insecurity; a cost-effectiveness evaluation of the interventions that comprise the pRCT; and a process evaluation to understand the contextual factors that impact the uptake, effectiveness, and sustainability of the interventions. SETTING: Ambulatory care clinics (e.g., family medicine, general internal medicine, endocrinology) affiliated with an academic medical center in an urban environment in the Midwest. DESIGN: 2 × 2 factorial design. INTERVENTIONS: Cooking Matters for Diabetes is a 6-week diabetes and culinary education intervention. The Health Impact Ohio Central Ohio Pathways Hub intervention is a community health worker model designed to evaluate and address participants' social needs. All participants will receive referral to the Mid-Ohio Farmacy to provide weekly access to fresh produce. OUTCOMES: Primary outcome of the pRCT is change in A1c at 3 months; secondary outcomes include A1c at 6 months, and diabetes self-efficacy, food insecurity, and diet quality at 3 and 6 months. DISCUSSION: Food insecurity, unmet social needs, diabetes education and self-efficacy are critical issues that must be addressed to improve T2D treatment, care, and health equity. CLINICALTRIALS: gov: NCT05472441.