Associations Between the Superwoman Schema, Stress, and Cardiovascular Health Among African-American Women.

BACKGROUND: African-American (AA) women are less likely to achieve ideal cardiovascular (CV) health compared with women of other racial/ethnic subgroups, primarily due to structural and psychosocial barriers. A potential psychosocial construct relevant to ideal CV health is the superwoman schema (SWS). PURPOSE: We explored whether the SWS was associated with perceived stress, CV risk factors, and overall CV health among AA women. METHODS: This cross-sectional analysis of the FAITH! Heart Health+ Study was conducted among AA women with high cardiometabolic risk. Pearson correlation evaluated associations between SWS and CV risk factors (e.g., stress, hypertension, diabetes, etc.). The 35-item SWS questionnaire includes five domains. Stress was measured by the 8-item Global Perceived Stress Scale (GPSS). CV health was assessed using the American Heart Association Life's Simple 7 (LS7) rubric of health behaviors/biometrics. Data acquisition spanned from February to August 2022. RESULTS: The 38 women included in the analysis (mean age 54.3 [SD 11.5] years) had a high CV risk factor burden (71.1% hypertension, 76.3% overweight/obesity, 28.9% diabetes, 39.5% hyperlipidemia). Mean GPSS level was 7.7 (SD 5.2), CV health score 6.7 (SD 1.8), and SWS score 60.3 (SD 18.0). Feeling an "obligation to help others" and "obligation to present an image of strength" had strongest correlations with GPSS score among all SWS domains (r = 0.51; p = .002 and r = 0.39; p = .02, respectively). Correlation among the SWS domains and traditional CV risk factors was not statistically significant. CONCLUSION: Our findings suggest that an obligation to help others and to project an image of strength could be contributing to stress among AA women.

Compared with women of other racial groups, African-American (AA) women in the USA have a higher cardiovascular (CV) disease burden and are at higher risk of maternal mortality from preventable CV health outcomes. The Giscombe Superwoman Schema (SWS) is a framework designed to characterize various aspects of the superwoman role that AA women may adopt to preserve themselves, their families, and their communities amidst the myriad of inequities that can compromise their ability to achieve ideal CV health. In this Brief Report, our team explored whether the SWS was associated with perceived stress, CV risk factors, and overall CV health among AA women. The study participants were AA women with high cardiometabolic risk residing in the Rochester and Minneapolis, St. Paul, Minnesota areas, recruited from the FAITH! Heart Health+ Study. We observed a positive association between the SWS and perceived stress levels, suggesting that the obligation to help others and to project an image of strength could be contributing to overall stress levels among AA women.

Community-Based, Cluster-Randomized Pilot Trial of a Cardiovascular Mobile Health Intervention: Preliminary Findings of the FAITH! Trial.

BACKGROUND: African Americans continue to have suboptimal cardiovascular health (CVH) based on the American Heart Association Life's Simple 7 (LS7), 7 health-promoting behaviors and biological risk factors (eg, physical activity, blood pressure). Innovative, community-level interventions in partnership with trusted institutions such as African American churches are potential means to improve CVH in this population. METHODS: Using a community-based participatory research approach, the FAITH! Trial (Fostering African American Improvement in Total Health) rigorously assessed the feasibility and preliminary efficacy of a refined, community-informed, mobile health intervention (FAITH! App) for promoting CVH among African Americans in faith communities using a cluster randomized controlled trial. Participants from 16 churches in Rochester and Minneapolis-St Paul, MN, were randomized to receive the FAITH! App (immediate intervention) or were assigned to a delayed intervention comparator group. The 10-week intervention core features included culturally relevant and LS7-focused education modules, diet/physical activity self-monitoring, and a group sharing board. Data were collected via electronic surveys and health assessments. Primary outcomes were average change in mean LS7 score (continuous measure of CVH ranging from poor to ideal [0-14 points]) from baseline to 6 months post-intervention (using generalized estimating equations) and app engagement/usability (by the Health Information Technology Usability Evaluation Scale; range, 0-5). RESULTS: Of 85 enrolled participants (randomized to immediate [N=41] and delayed [control] intervention [N=44] groups), 76 and 68 completed surveys/health assessments at baseline and 6 months post-intervention, respectively (80% retention rate with assessments at both baseline and 6-month time points); immediate intervention [N=30] and control [N=38] groups). At baseline, the majority of participants (mean age [SD], 54.2 [12.3] years, 71% female) had <4-year college education level (39/66, 59%) and poor CVH (44% in poor category; mean LS7 score [SD], 6.8 [1.9]). The mean LS7 score of the intervention group increased by 1.9 (SD 1.9) points compared with 0.7 (SD 1.7) point in the control group (both P<0.0001) at 6 months. The estimated difference of this increase between the groups was 1.1 (95% CI, 0.6-1.7; P<0.0001). App engagement/usability was overall high (100% connection to app; >75% completed weekly diet/physical activity tracking; Health Information Technology Usability Evaluation Scale, mean [SD], 4.2 [0.7]). CONCLUSIONS: On the basis of preliminary findings, the refined FAITH! App appears to be an efficacious mobile health tool to promote ideal CVH among African Americans. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03777709.

Sharing Perspectives in African American Communities to Reduce Stroke Risk Through Community Listening Circles.

PURPOSE: To build trust and explore community perception on stroke disparities as well as barriers and strengths to stroke prevention. DESIGN: Mixed methods study. METHODS: A convenience sample (n = 54) of African Americans responded to questionnaires and participated in focus groups. FINDINGS: Although a majority of participants had some knowledge of stroke warning signs and risk factors, there were misconceptions identified through the Community Listening Circles (CLCs). Misconceptions about stroke were identified. Six key themes emerged. CONCLUSIONS: Focus groups provided a better understanding of stroke perception. CLINICAL EVIDENCE: Community health nurses may be able to use this information to provide care appropriately.

Community-based, cluster-randomized pilot trial of a cardiovascular mHealth intervention: Rationale, design, and baseline findings of the FAITH! Trial.

BACKGROUND: Compared to whites, African-Americans have lower prevalence of ideal cardiovascular health (CVH) based on the American Heart Association Life's Simple 7 (LS7). These CVH inequities have worsened during the COVID-19 pandemic. Ideal LS7 health-promoting behaviors and biological risk factors (eg, diet, blood pressure) are associated with improved CVH outcomes. The FAITH! (Fostering African-American Improvement in Total Health) App, a community-informed, mobile health (mHealth) intervention, previously demonstrated significant improvements in LS7 components among African-Americans, suggesting that mHealth interventions may be effective in improving CVH. This paper presents the FAITH! Trial design, baseline findings, and pandemic-related lessons learned. METHODS: Utilizing a community-based participatory research approach, this study assessed the feasibility/preliminary efficacy of a refined FAITH! App for promoting LS7 among African-Americans in faith communities using a cluster, randomized controlled trial. Participants received the FAITH! App (immediate intervention) or were assigned to a delayed intervention comparator group. Baseline data were collected via electronic surveys and health assessments. Primary outcomes are change in LS7 score from baseline to 6-months post-intervention and app engagement/usability. RESULTS: Of 85 enrolled individuals, 76 completed baseline surveys/health assessments, for a participation rate of 89% (N = 34 randomized to the immediate intervention, N = 42 to delayed intervention). At baseline, participants were predominantly female (54/76, 71%), employed (56/76, 78%) and of high cardiometabolic risk (72/76, 95% with hypertension and/or overweight/obesity) with mean LS7 scores in the poor range (6.8, SD = 1.9). CONCLUSIONS: The FAITH! Trial recruitment was feasible, and its results may inform the use of mHealth tools to increase ideal CVH among African-Americans.

Factors Facilitating Academic-Community Research Partnerships With African American Churches: Recruitment Process for a Community-Based, Cluster Randomized Controlled Trial During the COVID-19 Pandemic.

African American (AA) churches are valuable partners in implementing health promotion programming (HPP) to combat health disparities. The study purpose was to evaluate AA church characteristics associated with enrollment into the FAITH! (Fostering African American Improvement in Total Health) Trial, a community-based, cluster randomized controlled trial (RCT) of a mobile health intervention for cardiovascular health promotion among AA churches. Churches located in Minneapolis-St. Paul and Rochester, Minnesota were invited to complete an electronic screening survey and follow-up telephone interview including the PREACH (Predicting Readiness to Engage African American Churches in Health) tool to assess church characteristics and infrastructure for HPP. The primary outcome was church enrollment in the FAITH! Trial. Key predictors included overall PREACH scores and its subscales (Personnel, Physical Structure, Faith-based Approach, Funding), congregation size, and mean congregation member age. Of the 26 churches screened, 16 (61.5%) enrolled in the trial. The enrolled churches had higher overall mean PREACH scores (36.1 vs. 30.2) and subscales for Personnel (8.8 vs. 5.6), Faith-based Approach (11.0 vs. 9.6), and Funding (7.3 vs. 4.8) compared with non-enrolled churches; all differences were not statistically significant due to small sample size. Twelve (75.0%) of the enrolled churches had >75 members versus six (60.0%) of the non-enrolled churches. Twelve (80.0%) of the enrolled churches had an average congregation member age ≤54 years versus six (67.0%) of the non-enrolled churches. AA churches enrolling into a community-based RCT reported greater infrastructure for HPP, larger congregations, and members of younger age. These characteristics may be helpful to consider among researchers partnering with AA churches for HPP studies.

Establishing a SARS-CoV-2 (COVID-19) Drive-Through Collection Site: A Community-Based Participatory Research Partnership With a Federally Qualified Health Center.

The COVID-19 pandemic has disproportionately affected underserved and minority populations in the United States. This is partially attributable to limited access to diagnostic testing from deeply rooted structural inequities precipitating higher infection and mortality rates. We describe the process of establishing a drive-through collection site by leveraging an academic-community partnership between a medical institution and a federally qualified health center in Minnesota. Over 10 weeks, 2006 COVID-19 tests were provided to a socioeconomically disadvantaged population of racial/ethnic minorities and low-income essential workers.

Low-dose aspirin for primary prevention of cardiovascular disease: Trends in use patterns among African American adults in Minnesota, 2015-2019.

Cardiovascular disease (CVD) disproportionately affects African Americans. Aspirin has long been recommended to reduce cardiovascular events. However, national guideline changes in 2016 limited the aspirin recommended population and several clinical trials questioning the utility of primary prevention aspirin were published in 2018. In light of the recent guidelines and study findings, we investigated primary prevention aspirin use among urban African American adults. Using three cross-sectional surveys, we collected data from self-identified African Americans with no CVD in 2015, 2017 and 2019, querying information on CVD risk factors, health behaviors and beliefs, and aspirin use. Poisson regression modeling was used to estimate age- and risk-factor adjusted aspirin prevalence, trends and associations. A total of 1491 African Americans adults, ages 45-79, were included in this analysis; 61% were women. There was no change in age- and risk factor-adjusted aspirin use over the 3 surveys for women (37%, 34% and 35% respectively) or men (27%, 25%, 30% respectively). However, fewer participants believed aspirin was helpful in 2019 compared to 2015-75% versus 84% (p < 0.001). Aspirin discussions with a health care practitioner were highly associated with aspirin use (adjusted RR 2.97, 95% CI 2.49-3.54) and aspirin use was 2.56 times higher (adjusted RR 95% CI 2.17-3.03) in respondents who agreed that people close to them thought they should take aspirin compared with those who disagreed or did not know. Despite major changes in national guidelines, overall primary prevention aspirin use did not significantly change in these African American samples from 2015 to 2019.

Aspirin Use and Awareness for Cardiovascular Disease Prevention Among Hispanics: Prevalence and Associations with Health Behavior Beliefs.

Cardiovascular disease (CVD) persists as the leading cause of death and disability in many Americans including Hispanics. Primary prevention for CVD may be achieved through regular aspirin use in high risk individuals. This study examined regular aspirin use and specific attitudes and social norms toward CVD and aspirin use within an urban Hispanic population in Minnesota. A sample of primary prevention Hispanics aged 45-79 years were surveyed about CVD history and risk factors, aspirin use, demographic characteristics, and health beliefs and social norms in relation to CVD and aspirin. Relative risk estimation using Poisson regression with robust error variance was used to examine associations with aspirin use. In this sample of 152 Hispanics (55% women), the mean age was 53 years, 70% had a regular healthcare provider, and 22% used aspirin. Aspirin discussions with a regular healthcare provider were strongly associated with aspirin use (adjusted risk ratio 3.02, 95% CI 1.20-7.60). There was a positive association between health beliefs and social norms that affirm preventive behaviors and aspirin use (adjusted linear risk ratio 1.23, 95% CI 1.04-1.45) while uncertainty about the role of aspirin for individual use and in the community was negatively associated with aspirin use (adjusted linear risk ratio 0.85, 95% CI 0.70-1.03). This growing population may benefit from health education about CVD risk and the role of aspirin in prevention.

Emergency Preparedness and Risk Communication Among African American Churches: Leveraging a Community-Based Participatory Research Partnership COVID-19 Initiative.

The coronavirus disease 2019 (COVID-19) crisis has disproportionately affected the African American population. To mitigate the disparities, we deployed an emergency preparedness strategy within an existing community-based participatory research (CBPR) partnership among African American churches to disseminate accurate COVID-19 information. We used the Centers for Disease Control and Prevention Crisis and Emergency Risk Communication framework to conduct a needs assessment, distribute emergency preparedness manuals, and deliver COVID-19-related messaging among African American churches via electronic communication platforms. A needs assessment showed that the top 3 church emergency resource needs were financial support, food and utilities, and COVID-19 health information. During an 8-week period (April 3-May 31, 2020), we equipped 120 churches with emergency preparedness manuals and delivered 230 messages via social media (Facebook) and email. For reach, we estimated that 6,539 unique persons viewed content on the Facebook page, and for engagement, we found 1,260 interactions (eg, likes, loves, comments, shares, video views, post clicks). Emails from community communication leaders reached an estimated 12,000 church members. CBPR partnerships can be effectively leveraged to promote emergency preparedness and communicate risk among under-resourced communities during a pandemic.

Aspirin Use for Cardiovascular Disease Prevention in an African American Population: Prevalence and Associations with Health Behavior Beliefs.

Cardiovascular disease (CVD) is a leading cause of morbidity and mortality in the United States, disproportionately affecting African Americans. Aspirin is an effective, low cost option to reduce cardiovascular events. This study sought to describe the use of aspirin for CVD prevention in African Americans and evaluate associations with demographics, cardiovascular risk factors and health behaviors and beliefs. A total of 684 African Americans adults ages 45-79 years completed surveys and were included in this analysis. Proportions of aspirin use were stratified by primary and secondary prevention and by number of CVD risk factors in the primary prevention population. Logistic regression was used to evaluate associations with aspirin use. Secondary prevention aspirin use was 62%. Primary prevention aspirin use was 32% overall and increased to 54% in those with > 2 CVD risk factors. A history of diabetes [adjusted odds ratio (aOR) 3.42, 95% CI 2.18-5.35] and hypertension (aOR 2.25, 95% CI 1.39-3.65) were strongly associated with primary prevention aspirin use, but a conversation with a health care provider was even stronger (aOR 6.41, 95% CI 4.07-10.08). Participants who answered positively to statements about people similar to them taking aspirin or that close contacts think they should take aspirin, were much more likely to take aspirin (aOR 4.80; 95% CI 2.58-8.93 and aOR 7.45; 95% CI 4.70-11.79 respectively). These findings support a hypothesis that aspirin use may increase by encouraging conversations with health care providers and creating a supportive social environment for aspirin use. Further studies need to be done to test this hypothesis.

A randomized, controlled trial comparing the efficacy and safety of aqueous subcutaneous progesterone with vaginal progesterone for luteal phase support of in vitro fertilization.

STUDY QUESTION: Is the ongoing pregnancy rate with a new aqueous formulation of subcutaneous progesterone (Prolutex(®)) non-inferior to vaginal progesterone (Endometrin(®)) when used for luteal phase support of in vitro fertilization? SUMMARY ANSWER: In the per-protocol (PP) population, the ongoing pregnancy rates per oocyte retrieval at 12 weeks of gestation were comparable between Prolutex and Endometrin (41.6 versus 44.4%), with a difference between groups of -2.8% (95% confidence interval (CI) -9.7, 4.2), consistent with the non-inferiority of subcutaneous progesterone for luteal phase support. WHAT IS KNOWN ALREADY: Luteal phase support has been clearly demonstrated to improve pregnancy rates in women undergoing in vitro fertilization (IVF). Because of the increased risk of ovarian hyperstimulation syndrome associated with the use of hCG, progesterone has become the treatment of choice for luteal phase support. STUDY DESIGN, SIZE, DURATION: This prospective, open-label, randomized, controlled, parallel-group, multicentre, two-arm, non-inferiority study was performed at eight fertility clinics. A total of 800 women, aged 18-42 years, with a BMI of ≤ 30 kg/m(2), with <3 prior completed assisted reproductive technology (ART) cycles, exhibiting baseline (Days 2-3) FSH of ≤ 15 IU/L and undergoing IVF at 8 centres (seven private, one academic) in the USA, were enrolled from January 2009 through June 2011. PARTICIPANTS/MATERIALS, SETTING, METHODS: In total, 800 women undergoing IVF were randomized after retrieval of at least three oocytes to an aqueous preparation of progesterone administered subcutaneously (25 mg daily) or vaginal progesterone (100 mg bid daily). Randomization was performed to enrol 100 patients at each site using a randomization list that was generated with Statistical Analysis Software (SAS(®)). If a viable pregnancy occurred, progesterone treatment was continued up to 12 weeks of gestation. MAIN RESULTS AND THE ROLE OF CHANCE: Using a PP analysis, which included all patients who received an embryo transfer (Prolutex = 392; Endometrin = 390), the ongoing pregnancy rate per retrieval for subcutaneous versus vaginal progesterone was 41.6 versus 44.4%, with a difference between groups of -2.8% (95% CI -9.7, 4.2), consistent with the non-inferiority of subcutaneous progesterone for luteal phase support. In addition, rates of initial positive ß-hCG (56.4% subcutaneous versus 59.0% vaginal; 95% CI -9.5, 4.3), clinical intrauterine pregnancy with fetal cardiac activity (42.6 versus 46.4%; 95% CI -10.8, 3.2), implantation defined as number of gestational sacs divided by number of embryos transferred (33.2 versus 35.1%; 95% CI -7.6, 4.0), live birth (41.1 versus 43.1%; 95% CI -8.9, 4.9) and take-home baby (41.1 versus 42.6%; 95% CI -8.4, 5.4) were comparable. Both formulations were well-tolerated, with no difference in serious adverse events. Analysis with the intention-to-treat population also demonstrated no difference for any outcomes between the treatment groups. LIMITATIONS, REASONS FOR CAUTION: The conclusions are limited to the progesterone dosing regimen studied and duration of treatment for the patient population examined in this study. WIDER IMPLICATIONS OF THE FINDINGS: Subcutaneous progesterone represents a novel option for luteal phase support in women undergoing IVF who for personal reasons prefer not to use a vaginal preparation or who wish to avoid the side effects of vaginal or i.m. routes of administration. STUDY FUNDING/COMPETING INTERESTS: The study was funded by Institut Biochimique SA (IBSA). CAJ, BC, ST and CJ are employees of IBSA. FH currently consults for IBSA. TRIAL REGISTRATION NUMBER: NCT00828191.

Stroke prevention education in African Americans: Lessons learned from a community based participatory feasibility study.

PURPOSE: To present information on the feasibility and acceptability of a Stroke Champion "train-the-trainer" program, including lessons learned, for dissemination of stroke prevention knowledge and resources among African Americans (AA) residing within the Minneapolis-St. Paul, MN metropolitan area. DESIGN: One arm pre-post-test design. METHODS: Twelve AA "Stroke Champions" were recruited to assess the feasibility and acceptability of an online stroke prevention education curriculum and peer-to-peer education. RESULTS: We successfully designed, developed, and implemented a stroke prevention education website for community use. All Stroke Champions completed initial training and evaluation, and reported the usefulness and usability of the website., However, they also reported that they needed more facilitation support from our research team to deliver education in the community. CONCLUSION: Engaging Stroke Champions is potentially beneficial in increasing stroke prevention knowledge. However, Stroke Champions need more support to effectively engage, educate, and disseminate knowledge among peers.

Rationale, design, and participant characteristics of the FAITH! Heart Health+ study: An exploration of the influence of the social determinants of health, stress, and structural racism on African American cardiovascular health.

BACKGROUND: African Americans (AAs) face cardiovascular health (CVH) disparities linked to systemic racism. The 2020 police killing of Mr. George Floyd in Minneapolis, Minnesota, alongside the COVID-19 pandemic, exacerbated adverse psychosocial factors affecting CVH outcomes among AAs. This manuscript describes the study protocol and participant characteristics in an ancillary study exploring the relationship between biopsychosocial factors and CVH among AAs. METHODS: Using a community-based participatory approach, a mixed-methods ancillary study of 58 AA participants from an overarching randomized control trial (RCT) was conducted. Baseline RCT health assessments (November 2020) provided sociodemographic, medical, and clinical data. Subsequent health assessments (February-December 2022) measured sleep quality, psychosocial factors (e.g., high-effort coping), biomarkers (e.g., cortisol), and cardiovascular diagnostics (e.g., cardio-ankle vascular index). CVH was assessed using the American Heart Association Life's Simple 7 (LS7) (range 0 to 14, poor to ideal) and Life's Essential 8 (LE8) scores (range 0 to 100, low to high). Correlations between these scores will be examined. Focus group discussions via videoconferencing (March to April 2022) assessed psychosocial and structural barriers, along with the impact of COVID-19 and George Floyd's killing on daily life. RESULTS: Participants were predominantly female (67%), with a mean age of 54.6 [11.9] years, high cardiometabolic risk (93% had overweight/obesity and 70% hypertension), and moderate LE8 scores (mean 57.4, SD 11.5). CONCLUSION: This study will enhance understanding of the associations between biopsychosocial factors and CVH among AAs in Minnesota. Findings may inform risk estimation, patient care, and healthcare policies to address CVD disparities in marginalized populations.

Factors Associated With COVID-19 Vaccine Acceptance Among Patients Receiving Care at a Federally Qualified Health Center.

BACKGROUND: COVID-19 vaccine hesitancy in the United States is high, with at least 63 million unvaccinated individuals to date. Socioeconomically disadvantaged populations experience lower COVID-19 vaccination rates despite facing a disproportionate COVID-19 burden. OBJECTIVE: To assess the factors associated with COVID-19 vaccine acceptance among under-resourced, adult patients. METHODS: Participants were patients receiving care at a Federally Qualified Health Center (FQHC) in St. Paul, Minnesota. Data were collected via multiple modes over 2 phases in 2020 (self-administered electronic survey) and 2021 (study team-administered survey by telephone, self-administered written survey) to promote diversity and inclusion for study participation. The primary outcome was COVID-19 vaccine acceptance. Using logistic regression analysis, associations between vaccine acceptance and factors including risk perception, concerns about the COVID-19 vaccine, social determinants of health (SDOH), co-morbidities, pandemic-induced hardships, and stress were assessed by adjusted odds ratios (AORs) and 95% confidence intervals (CI). RESULTS: One hundred sixty-eight patients (62.5% female; mean age [SD]: 49.9 [17.4] years; 32% <$20 000 annual household income; 69%

mHealth Intervention for Promoting Hypertension Self-management Among African American Patients Receiving Care at a Community Health Center: Formative Evaluation of the FAITH! Hypertension App.

BACKGROUND: African American individuals are at a higher risk of premature death from cardiovascular diseases than White American individuals, with disproportionate attributable risk from uncontrolled hypertension. Given their high use among African American individuals, mobile technologies, including smartphones, show promise in increasing reliable health information access. Culturally tailored mobile health (mHealth) interventions may promote hypertension self-management among this population. OBJECTIVE: This formative study aimed to assess the feasibility of integrating an innovative mHealth intervention into clinical and community settings to improve blood pressure (BP) control among African American patients. METHODS: A mixed methods study of African American patients with uncontrolled hypertension was conducted over 2 consecutive phases. In phase 1, patients and clinicians from 2 federally qualified health centers (FQHCs) in the Minneapolis-St Paul, Minnesota area, provided input through focus groups to refine an existing culturally tailored mHealth app (Fostering African-American Improvement in Total Health! [FAITH!] App) for promoting hypertension self-management among African American patients with uncontrolled hypertension (renamed as FAITH! Hypertension App). Phase 2 was a single-arm pre-post intervention pilot study assessing feasibility and patient satisfaction. Patients receiving care at an FQHC participated in a 10-week intervention using the FAITH! Hypertension App synchronized with a wireless BP monitor and community health worker (CHW) support to address social determinants of health-related social needs. The multimedia app consisted of a 10-module educational series focused on hypertension and cardiovascular risk factors with interactive self-assessments, medication and BP self-monitoring, and social networking. Primary outcomes were feasibility (app engagement and satisfaction) and preliminary efficacy (change in BP) at an immediate postintervention assessment. RESULTS: In phase 1, thirteen African American patients (n=9, 69% aged ≥50 years and n=10, 77% women) and 16 clinicians (n=11, 69% aged ≥50 years; n=14, 88% women; and n=10, 63% African American) participated in focus groups. Their feedback informed app modifications, including the addition of BP and medication tracking, BP self-care task reminders, and culturally sensitive contexts. In phase 2, sixteen African American patients were enrolled (mean age 52.6, SD 12.3 years; 12/16, 75% women). Overall, 38% (6/16) completed ≥50% of the 10 education modules, and 44% (7/16) completed the postintervention assessment. These patients rated the intervention a 9 (out of 10) on its helpfulness in hypertension self-management. Qualitative data revealed that they viewed the app as user-friendly, engaging, and informative, and CHWs were perceived as providing accountability and support. The mean systolic and diastolic BPs of the 7 patients decreased by 6.5 mm Hg (P=.15) and 2.8 mm Hg (P=.78), respectively, at the immediate postintervention assessment. CONCLUSIONS: A culturally tailored mHealth app reinforced by CHW support may improve hypertension self-management among underresourced African American individuals receiving care at FQHCs. A future randomized efficacy trial of this intervention is warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT04554147; https://clinicaltrials.gov/ct2/show/NCT04554147.

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.

Safety and Efficacy of the FLECTOR (Diclofenac Epolamine) Topical System in Children with Minor Soft Tissue Injuries: A Phase IV Non-randomized Clinical Trial.

BACKGROUND AND OBJECTIVE: A topical formulation of diclofenac (FLECTOR diclofenac epolamine topical system (FDETS)) is approved in adults for the treatment of acute pain due to minor strains, sprains, and contusions; however, its safety and efficacy have not been investigated in a pediatric population. This study assessed the safety and efficacy of the FLECTOR (diclofenac epolamine) topical system in children. METHODS: This was an open-label, single-arm, phase IV study at ten USA-based family medicine or pediatric practices in children aged 6-16 years with a clinically significant minor soft tissue injury sustained within the preceding 96 h and at least moderate spontaneous pain on the Wong-Baker FACES® Pain Rating Scale. The FLECTOR topical system was applied twice daily until pain resolution or Day 14. The primary endpoint was local tolerability and systemic safety. Key secondary endpoints were diclofenac plasma concentrations and analgesic efficacy. RESULTS: 104 patients were enrolled; 52 were 6-11 years old, and 52 were 12-16 years old (mean age 11.6 years). The maximum tolerability score experienced by any patient was 1 (faint redness). Fourteen adverse events (none serious) in nine patients (8.7%) were considered possibly treatment-related. Reduction in pain during the study was somewhat greater for patients aged 6-11 versus 12-16 years (p < 0.011). The diclofenac plasma concentration tended to be higher in the younger age group compared with older patients: 1.83 versus 1.46 ng/mL at the first assessment and 2.49 versus 1.11 ng/mL at the last assessment (p = 0.002). CONCLUSION: The FLECTOR topical system safely and effectively provided pain relief for minor soft tissue injuries in the pediatric population, with minimal systemic nonsteroidal anti-inflammatory drug exposure and low potential risk of local or systemic adverse events. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02132247.

In this post-marketing clinical trial, the safety and efficacy at relieving pain of the FLECTOR diclofenac epolamine topical system (FDETS), a nonsteroidal anti-inflammatory drug (NSAID) formulation in a medicated patch, was assessed in a pediatric population (aged 6­16 years) with clinically significant minor soft tissue injuries. The safety and efficacy profiles in the pediatric population were consistent with previous data in adults. Both diclofenac plasma concentrations and reduction in pain during the study were greater for younger patients (aged 6­11 vs. 12­16 years), but plasma concentrations were much less than after diclofenac was taken orally in previous studies. This study shows that FDETS can safely and effectively provide pain relief for soft tissue injuries in children, with minimal systemic NSAID exposure and a low potential risk of either local or systemic adverse events.

Sign of the times: Community engagement to refine a cardiovascular mHealth intervention through a virtual focus group series during the COVID-19 Pandemic.

Background: African-Americans are underrepresented in mobile health intervention research studies which can perpetuate health inequities and the digital divide. A community-based, user-centered approach to designing mobile health interventions may increase their sociocultural relevance and effectiveness, especially with increased smartphone use during the coronavirus disease 2019 pandemic. We aimed to refine an existing mobile health intervention via a virtual focus group series. Methods: African-American community members (n = 15) from churches in Minneapolis-St. Paul and Rochester, Minnesota were enrolled in a virtual (via videoconferencing), three-session focus group series over five months to refine a cardiovascular health-focused mobile health application (FAITH! [Fostering African-American Improvement in Total Health!] App). Participants accessed the app via their smartphones and received a Fitbit synced to the app. Participants engaged with multimedia cardiovascular health-focused education modules, a sharing board for social networking, and diet/physical activity self-monitoring. Participant feedback on app features prompted iterative revisions to the FAITH! App. Primary outcomes were app usability (assessed via Health Information Technology Usability Evaluation Scale range: 0-5) and user satisfaction. Results: Participants (mean age [SD]: 56.9 [12.3] years, 86.7% female) attended a mean 2.8 focus groups (80% attended all sessions). The revised FAITH! App exceeded the goal Health Information Technology Usability Evaluation Scale score threshold of ≥4 (mean: 4.39, range: 3.20-4.95). Participants positively rated updated app content, visual appeal, and use of social incentives to maintain engagement. Increasing user control and refinement of the moderated sharing board were identified as areas for future improvement. Conclusions: Community-partnered, virtual focus groups can optimize usability and increase participant satisfaction of mobile health lifestyle interventions that aim to promote cardiovascular health in African-Americans.

Association of Cardiovascular Disease Risk Factors With Sociodemographic Characteristics and Health Beliefs Among a Community-Based Sample of African American Adults in Minnesota.

OBJECTIVE: To assess cardiovascular disease (CVD) and CVD risk factors and their association with sociodemographic characteristics and health beliefs among African American (AA) adults in Minnesota. METHODS: A cross-sectional analysis was conducted of a community-based sample of AA adults enrolled in the Minnesota Heart Health Program Ask About Aspirin study from May 2019 to September 2019. Sociodemographic characteristics, health beliefs, and self-reported CVD and CVD risk factors were collected. Prevalence ratio (PR) estimates were calculated using Poisson regression modeling to assess the association between participants' characteristics and age- and sex-adjusted CVD risk factors. RESULTS: The sample included 644 individuals (64% [412] women) with a mean age of 61 years. Risk factors for CVD were common: hypertension (67% [434]), hyperlipidemia (47% [301]), diabetes (34% [219]), and current cigarette smoking (25% [163]); 19% (119) had CVD. Those with greater perceived CVD risk had a higher likelihood of prevalent hyperlipidemia (PR, 1.34; 95% CI, 1.14 to 1.57), diabetes (PR, 1.61; 95% CI, 1.30 to 1.98), and CVD (PR 1.61; 95% CI, 1.16 to 2.23) compared with those with lower perceived risk. Trust in health care provider was high (83% [535]) but was not associated with CVD or CVD risk factors. CONCLUSION: In this community sample of AAs in Minnesota, CVD risk factors were high, as was trust in health care providers. Those with greater CVD risk perceptions had higher CVD prevalence. Consideration of sociodemographic and psychosocial influences on CVD and CVD risk factors could inform development of effective cardiovascular health promotion interventions in the AA Minnesota community.

Community-based participatory research application of an artificial intelligence-enhanced electrocardiogram for cardiovascular disease screening: A FAITH! Trial ancillary study.

Objective: With the emergence of artificial intelligence (AI)-based health interventions, systemic racism remains a concern as these advancements are frequently developed without race-specific data analysis or validation. To evaluate the potential utility of an AI-based cardiovascular diseases (CVD) screening tool in an under-resourced African-American cohort, we reviewed the AI-enhanced electrocardiogram (ECG) data of participants enrolled in a community-based clinical trial as a proof-of-concept ancillary study for community-based screening. Methods: Enrollees completed cardiovascular testing including standard 12-lead ECG and a limited echocardiogram (TTE). All ECGs were analyzed using previously published institution-based AI algorithms. AI-ECG predictions were generated for age, sex, and decreased left ventricular ejection fraction (LVEF). Diagnostic accuracy of the AI-ECG for decreased LVEF and sex was quantified using area under the receiver operating characteristic curve (AUC). Correlation between actual age and AI-ECG predicted age was assessed using Pearson correlation coefficients. Results: Fifty-four participants completed both an ECG and TTE (mean age 55 years [range 31-87 years]; 66.7% female). All participants were in sinus rhythm, and the median LVEF of the cohort was 60-65%. The AI-ECG for decreased LVEF demonstrated excellent performance with an AUC of 0.892 (95% confidence interval [CI] 0.708-1); sensitivity=50% (95% CI 9.5-90.5%; n=1/2) and specificity=96% (95% CI 86.8-98.9%; n=49/51). The AI-ECG for participant sex demonstrated similar performance with AUC of 0.944 (95% CI 0.891-0.998); sensitivity=100% (95% CI 82.4-100.0%; n=18/18) and specificity=77.8% (95% CI 61.9-88.3%; n=28/36). The AI-ECG predicted mean age was 55 years (range 26.9-72.6 years) with a strong correlation to actual age (R=0.769; p<0.001). Conclusion: Our analyses of previously developed AI-ECG algorithms for prediction of age, sex, and decreased LVEF demonstrated reliable performance in this community-based, African-American cohort. This novel, community-centric delivery of AI could provide valuable screening resources and appropriate referrals for early detection of highly-morbid CVD for under-resourced patient populations.