More than Just a Number: Perspectives from Black Male Participants on Community-Based Interventions and Clinical Trials to Address Cardiovascular Health Disparities.

BACKGROUND: Black Americans remain significantly underrepresented and understudied in research. Community-based interventions have been increasingly recognized as an effective model for reckoning with clinical trial participation challenges amongst underrepresented groups, yet a paucity of studies implement this approach. The present study sought to gain insight into Black male participants' perception of clinical trials before and after participating in a community-based team lifestyle intervention in the United States. METHODS: Black Impact, a 24-week community-based lifestyle intervention, applied the American Heart Association's Life's Simple 7 (LS7) framework to assess changes in the cardiovascular health of seventy-four Black male participants partaking in weekly team-based physical activities and LS7-themed education and having their social needs addressed. A subset of twenty participants completed an exit survey via one of three semi-structured focus groups aimed at understanding the feasibility of interventions, including their perceptions of participating in clinical trials. Data were transcribed verbatim and analyzed using a content analysis, which involved systematically identifying, coding, categorizing, and interpreting the primary patterns of the data. RESULTS: The participants reported a positive change in their perceptions of clinical trials based on their experience with a community-based lifestyle intervention. Three prominent themes regarding their perceptions of clinical trials prior to the intervention were as follows: (1) History of medical abuse; (2) Lack of diversity amongst research teams and participants; and (3) A positive experience with racially concordant research teams. Three themes noted to influence changes in their perception of clinical trials based on their participation in Black Impact were as follows: (1) Building trust with the research team; (2) Increasing awareness about clinical trials; and (3) Motivating participation through community engagement efforts. CONCLUSIONS: Improved perceptions of participating in clinical trials were achieved after participation in a community-based intervention. This intervention may provide a framework by which to facilitate clinical trial participation among Black men, which must be made a priority so that Black men are "more than just a number" and no longer "receiving the short end of the stick".

Improving mental health in black men through a 24-week community-based lifestyle change intervention: the black impact program.

BACKGROUND: Poor mental health is a leading cause of morbidity and mortality among Black men in the United States. Efforts to improve mental health among Black men have been hampered by a lack of access and utilization of mental health services. Physical activity and social networks have been shown to improve mental health. Thus, we examined the effect of a community team-based physical activity, health education and social needs intervention among Black men on mental health over 24 weeks. METHODS: Black adult males (n = 74) from a large Midwestern city participated in Black Impact, a 24-week community-based lifestyle change program adapted from the Diabetes Prevention Program and American Heart Association's (AHA) Check, Change, Control Blood Pressure Self-Management Program, which incorporates AHA's Life's Simple 7 (LS7) framework. Measures of mental health including the Center for Epidemiological Studies Depression Scale (CES-D), Patient Health Questionnaire 2-question depression screener (PHQ-2), and Perceived Stress Scale-10 (PSS-10) were completed at baseline, 12 and 24 weeks. The change in mental health scores from baseline to 12 and 24 weeks were evaluated using linear mixed-effects models adjusting for age, education, and income. The change in cardiovascular health scores, defined as objective metrics of LS7 (LS5 [blood pressure, total cholesterol, fasting glucose, body mass index and smoking]), by baseline mental health were evaluated using linear mixed-effects models with an interaction term (time*baseline mental health variable) and a random intercept for each participant. RESULTS: Among 71 Black men (mean age 51, 85% employed) at 24 weeks, CES-D scores decreased from 10.54 to 7.90 (-2.64, 95%CI:-4.74, -0.55), PHQ-2 decreased from 1.04 to 0.63 (-0.41, 95%CI: -0.75, -0.07), and PSS-10 decreased from 14.62 to 12.91 (-1.71, 95%CI: -3.53, 0.12). A 1-unit higher CES-D at baseline was associated with less improvement in LS5 scores by -0.04 (95%CI: -0.076, -0.005) and - 0.032 (95%CI:-0.067, 0.003) units at week 12 and 24, respectively, with similar findings for PSS. CONCLUSIONS: The Black Impact community-based lifestyle program has the potential to reduce depressive symptoms and stress in Black men. There is a dire need for larger, randomized studies to test the impact of Black Impact on mental health in Black men to advance health equity. TRIAL REGISTRATION: Retrospectively Registered, ClinicalTrials.gov Identifier: NCT04787978.

Addressing non-medical health-related social needs through a community-based lifestyle intervention during the COVID-19 pandemic: The Black Impact program.

BACKGROUND: Non-medical health-related social needs (social needs) are major contributors to worse health outcomes and may have an adverse impact on cardiovascular risk factors and cardiovascular disease. The present study evaluated the effect of a closed-loop community-based pathway in reducing social needs among Black men in a lifestyle change program. METHODS: Black men (n = 70) from a large Midwestern city participated in Black Impact, a 24-week community-based team lifestyle change single-arm pilot trial adapted from the Diabetes Prevention Program and American Heart Association's (AHA) Check, Change, Control Blood Pressure Self-Management Program, which incorporates AHA's Life's Simple 7 (LS7) framework. Participants were screened using the Centers for Medicare and Medicaid Services (CMS) Accountable Health Communities Health-Related Social Needs Screening Tool. Participants with affirmative responses were referred to a community hub pathway to address social needs. The primary outcome for this analysis is change in social needs based on the CMS social needs survey at 12 and 24 weeks using mixed effect logistic regressions with random intercepts for each participant. Change in a LS7 score (range 0-14) from baseline to 12 and 24 weeks was evaluated using a linear mixed-effects model stratified by baseline social needs. RESULTS: Among 70 participants, the mean age of participants was 52 ±10.5 years. The men were sociodemographically diverse, with annual income ranging from <$20,000 (6%) to ≥$75,000 (23%). Forty-three percent had a college degree or higher level of education, 73% had private insurance, and 84% were employed. At baseline 57% of participants had at least one social need. Over 12 and 24 weeks, this was reduced to 37% (OR 0.33, 95%CI: 0.13, 0.85) and 44% (OR 0.50, 95%CI: 0.21, 1.16), respectively. There was no association of baseline social needs status with baseline LS7 score, and LS7 score improved over 12 and 24 weeks among men with and without social needs, with no evidence of a differential effect. CONCLUSIONS: The Black Impact lifestyle change single-arm pilot program showed that a referral to a closed-loop community-based hub reduced social needs in Black men. We found no association of social needs with baseline or change in LS7 scores. Further evaluation of community-based strategies to advance the attainment of LS7 and address social needs among Black men in larger trials is warranted.

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.

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.

The Role of Social Support in Cardiovascular Clinical Trial Participation among Black Men: Black Impact.

BACKGROUND: Attainment of the American Heart Association's Life's Simple 7 (LS7) metrics reduces cardiovascular disease (CVD) risk; yet, Black Americans have the lowest LS7 attainment among all communities, the highest rate of CVD mortality, and low clinical trial participation. Social support is positively correlated with chronic disease self-management. Here, we describe the role of social support in a single-arm pilot clinical trial of a community-based lifestyle intervention among Black American men. METHODS: The 24-week intervention featured weekly team-based physical activity and LS7-themed education. Seventy-four Black men participated in the intervention; twenty agreed to participate in exit surveys via one of three semi-structured focus groups. Data were transcribed verbatim and analyzed using content analysis framed by House's social support framework. RESULTS: Participants reported support from both peers and health coaches. The sub-themes of social support among peers were: (1) acknowledgement, understanding, and validation, (2) inspiration, (3) sense of community, (4) fear of disappointing fellow participants, and (5) group synergy. The sub-themes of social support from the health coaches and study team staff included: (1) contemplation of current health status, (2) racial concordance of health coaches and study team staff, (3) investment of the research team, (4) incentives, (5) access to healthcare providers, and (6) the COVID-19 pandemic. Emotional support was the most frequently discussed theme. CONCLUSIONS: Social support, especially emotional support, from peers and health coaches was a driver of clinical trial participation among participants. The intervention created a positive social environment and decreased medical mistrust. This intervention may provide a framework by which to facilitate clinical trial participation among Black men.

Improving cardiovascular health in black men through a 24-week community-based team lifestyle change intervention: The black impact pilot study.

BACKGROUND: Higher cardiovascular health scores, using American Heart Association's (AHA) Life's Simple 7 (LS7), have been associated with lower risk of cardiovascular disease, type 2 diabetes, cancer, and mortality among all racial/ethnic groups. Nationally, Black men have the lowest levels of LS7. Thus, a study was conducted to evaluate the impact of a community-based team lifestyle change program on LS7 among Black men. METHODS: Black adult males (n = 74) from a large Midwestern city participated in Black Impact, a 24-week community-based team lifestyle change program adapted from the Diabetes Prevention Program and AHA's Check, Change, Control Blood Pressure Self-Management Program, which incorporates AHA's LS7 framework. The change in a LS7 score (range 0-14) from baseline to 12 and 24 weeks was evaluated using a linear mixed-effects model adjusted for age, education, and income. RESULTS: The mean age of participants was 52 ± 10 years. The men were sociodemographically diverse, with annual income ranging from <$20,000 (7%) to ≥$75,000 (25%). Twenty-five percent were college graduates, 73% had private insurance, and 84% were employed. In fully adjusted models, LS7 score at baseline was 7.12 and increased 0.67 (95%CI: 0.14, 1.20, p = 0.013) and 0.93 (95%CI: 0.40, 1.46, p<0.001) points at 12 and 24 weeks, respectively, compared to baseline. Sensitivity analysis evaluating 5 components (excluding diet and physical activity) and 6 components (excluding diet) also showed significant increases at 12 and 24 weeks (all p<0.01). CONCLUSIONS: The Black Impact lifestyle change single-arm pilot program showed that a community-based lifestyle intervention has the potential to improve LS7 in Black men. Further randomized studies are urgently needed to improve cardiovascular health and advance cardiovascular health equity in Black men.

Psychosocial determinants of colorectal Cancer screening uptake among African-American men: understanding the role of masculine role norms, medical mistrust, and normative support.

OBJECTIVES: Despite having the highest colorectal cancer (CRC) incidence and mortality across all major racial/ethnic groups, African-American men consistently have poor CRC screening rates. Gendered and racialized beliefs and norms have been associated with African-American men's lower medical assistance-seeking rates, but how these notions influence African-American men's CRC screening practices merits further investigation. The purpose of this study was to examine the influence of psychosocial determinants of men's health on CRC screening uptake among African-American men in three states. DESIGN: Participants were recruited via CuttingCRC.com and through culturally-tailored flyers, newspaper ads, and snowball sampling, among other methods. From April 2019-August 2019, 11 focus groups were conducted with English-speaking Black/African-American men who (a) were between ages 45-75, (b) were born in the United States, (c) had a working telephone, and (d) lived in Minnesota, Ohio, or Utah. Multiple-cycle coding, Hatch's 9-step approach, and constant comparative data analysis was employed for de-identified transcript data. RESULTS: Eighty-four African-American men met inclusion criteria and participated. Their mean age was 59.34 ± 7.43. In regards to CRC screening status, Ohio had the most previously screened participants (85%), followed by Minnesota (84%) and Utah (76%). Two major CRC screening barriers (masculine role norms and medical mistrust) - both encompassed 3-5 subthemes, and one major facilitator (normative support from family members or social networks) emerged. CONCLUSIONS: Despite CRC screening's life-saving potential, African-American men have had the lowest 5-year relative survival for more than 40 years. When developing interventions and health promotion programs aiming to eliminate the racial disparity in CRC outcomes, addressing both masculine role norms and medical mistrust barriers to CRC screening completion among African-American men is warranted.

Barriers to and Facilitators of Recruitment of Adult African American Men for Colorectal Cancer Research: An Instrumental Exploratory Case Study.

PURPOSE: Racial and ethnic minorities remain underrepresented in research and clinical trials. Better understanding of the components of effective minority recruitment into research studies is critical to understanding and reducing health disparities. Research on recruitment strategies for cancer-specific research-including colorectal cancer (CRC)-among African American men is particularly limited. We present an instrumental exploratory case study examining successful and unsuccessful strategies for recruiting African American men into focus groups centered on identifying barriers to and facilitators of CRC screening completion. METHODS: The parent qualitative study was designed to explore the social determinants of CRC screening uptake among African American men 45-75 years of age. Recruitment procedures made use of community-based participatory research strategies combined with built community relationships, including the use of trusted community members, culturally tailored marketing materials, and incentives. RESULTS: Community involvement and culturally tailored marketing materials facilitated recruitment. Barriers to recruitment included limited access to public spaces, transportation difficulties, and medical mistrust leading to reluctance to participate. CONCLUSION: The use of strategies such as prioritizing community relationship building, partnering with community leaders and gatekeepers, and using culturally tailored marketing materials can successfully overcome barriers to the recruitment of African American men into medical research studies. To improve participation and recruitment rates among racial and ethnic minorities in cancer-focused research studies, future researchers and clinical trial investigators should aim to broaden recruitment, strengthen community ties, offer incentives, and use multifaceted approaches to address specific deterrents such as medical mistrust and economic barriers.