Implementing a Metabolism-informed approach for smoking cessation in an Alaska Tribal health system: study protocol for a single-arm implementation pilot trial.

BACKGROUND: Individualized treatment for commercial tobacco smoking cessation, such as through the utilization of the nicotine metabolite ratio (NMR), offers potential clinical benefit. NMR is a metabolism-informed biomarker that can be used to guide medication selection. NMR testing is particularly promising for tobacco cessation efforts in populations with high rates of smoking, such as some Alaska Native and American Indian (AN/AI) communities. To date, no prior study has evaluated the implementation of NMR-guided tobacco cessation with AN/AI populations. METHODS: The present "QUIT" protocol is a two-phase study that will occur at Southcentral Foundation (SCF), an Alaska Native-owned health system, serving 70,000 AN/AI people, based in Anchorage, Alaska. In Phase one, qualitative interviews with customer-owners (patients), providers and administrators (n = 36) and a 10-participant beta-test will be used to refine a strategy to implement NMR testing in the health system. Phase two will involve a single-arm pilot trial (n = 50) and qualitative interviews throughout data collection (n = 48) to evaluate the implementation strategy and explore the real-world acceptability and feasibility of NMR testing to guide tobacco cessation with AN/AI populations. DISCUSSION: This study utilizes a community-based participatory approach to refine and implement a nicotine metabolism-informed smoking cessation program in a Tribal healthcare setting. The process and findings from this study will reflect the importance of customer-owner choice and honor the lived experience involved in quitting commercial tobacco. Pilot study data will inform the effect and sample sizes required for a future pragmatic trial of NMR-guided smoking cessation. TRIAL REGISTRATION: This study will be registered with clinicaltrials.gov after the beta test is complete and the final IRB protocol is approved.

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.

Digital Storytelling Intervention for Hemoglobin A1c Control Among Hispanic Adults With Type 2 Diabetes: A Randomized Clinical Trial.

Importance: Hispanic adults with type 2 diabetes (T2D) are more likely to develop complications and die from the disease than the US general population. Digital storytelling interventions are narrative-based videos elicited through a community-based participatory research approach to surface the authentic voices of participants overcoming obstacles to health-promoting behaviors that perpetuate health inequities; research on the effect of digital storytelling on T2D outcomes among Hispanic adults is lacking. Objective: To assess the impact of a digital storytelling intervention on glycemic control and its acceptability among Hispanic patients with poorly controlled T2D. Design, Setting, and Participants: This was a multicenter, randomized clinical trial conducted within 2 primary care networks in Minnesota and Arizona among Hispanic adults with poorly controlled T2D (hemoglobin A1c level ≥8%). Enrollment and follow-up were conducted between February 14, 2019, and November 1, 2023. Intervention: The intervention group viewed a 12-minute digital storytelling video. The video included 4 Spanish-language stories that reinforced 4 diabetes self-management behavioral goals (healthful diet for diabetes, physical activity, medication adherence, and glucose self-monitoring). The control group received printed, culturally tailored T2D education materials. Main Outcomes and Measures: The primary outcome was the mean change from baseline to 3 months for hemoglobin A1c levels, adjusting for baseline hemoglobin A1c, age, gender, education, and income. Acceptability and narrative quality of the intervention were assessed through questionnaires. Results: There were 451 study participants, with 227 (mean [SD] age, 54.3 [9.3] years; 158 [69.3%] women) randomized to the intervention group and 224 (mean [SD] age, 54.5 [9.1] years; 156 [69.3%] women) to the control group. Of these, 390 completed 3-month follow-up of the primary outcome (86% retention). There was a small improvement in the mean (SD) hemoglobin A1c level in the intervention group compared with the control group in the adjusted model (9.1% [1.7] to 8.4% [1.6] vs 9.4% [1.8] to 8.8% [2.0]; P = .04] but not in the unadjusted model. Acceptability and narrative quality of the intervention were high. Conclusions and Relevance: In this randomized clinical trial, a digital storytelling intervention developed with and for Hispanic adults with T2D was highly acceptable and feasibly implemented within primary care settings and resulted in a modest improvement of glycemic control. This was a highly scalable intervention that may be integrated into clinical practice as part of a longitudinal diabetes self-management program for Hispanic adults. Trial Registration: ClinicalTrials.gov Identifier: NCT03766438.

Negative mood is associated with sociobehavioral factors contributing to cardiovascular risk in an immigrant population.

BACKGROUND: After settling in the United States (US), immigrants often accumulate obesity and cardiovascular risk factors. As mood is often associated with health behaviors in the US population, mood may be an important mediating factor in immigrant populations. METHODS: The Healthy Immigrant Community (HIC) study, set in southeast Minnesota, enrolled 475 adult participants in a weight loss intervention designed to reduce cardiovascular risk. Baseline questionnaires assessed mood, nutrition, physical activity, self-efficacy for healthy eating and physical activity, social support, and cohesion. A single-item mood rating of poor or fair was considered "negative", while ratings of good, very good, or excellent were considered "positive". RESULTS: Hispanic/Latino (n = 268) and Somali (n = 181) adults enrolled in HIC completed baseline measures and were included in this analysis. Participants endorsing negative mood compared to positive mood had lower healthy eating scores (p = 0.02), lower physical activity levels (p = 0.03), lower confidence in eating a healthy diet (p = 0.001), and felt less of a sense of belonging to their community (p = 0.01). Those endorsing negative mood reported receiving less social support to eat healthy (p = < 0.001) and be physically active (p = 0.01). They also accessed community resources for healthy eating (p = 0.001) and physical activity (p = < 0.01) less frequently than participants endorsing positive mood. CONCLUSIONS: On self-report, negative mood was associated with less healthy nutrition, lower confidence in eating healthy, sedentary lifestyle, and perceived lack of belonging to the community. Integrating mood management and self-efficacy strategies may enhance the effectiveness of lifestyle interventions to reduce obesity and cardiovascular risk among immigrants who report negative mood. TRIAL REGISTRATION: ClinicalTrials.gov registration: NCT05136339; April 23, 2022.

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.

Evidence-based screening, clinical care and health education recommendations for Alaska Native peoples with prediabetes living in southcentral Alaska: findings from the Alaska EARTH follow-up study.

Pre-diabetes (pre-DM) is a strong predictor of diabetes (DM) over time. This study investigated how much of the recent increase in pre-DM identified among Alaska Native (AN) peoples living in urban southcentral Alaska may be due to changes in diagnostic methods. We used clinical and demographic data collected at baseline between 2004 and 2006 and at follow-up collected between 2015 and 2017 from the urban southcentral Alaska Education and Research Towards Health (EARTH) cohort. We used descriptive statistics and logistic regression to explore differences in demographic and clinical variables among the identified pre-DM groups. Of 388 participants in the follow-up study, 243 had A1c levels indicating pre-DM with only 20 demonstrating pre-DM also by fasting blood glucose (FBG). Current smoking was the sole predictor for pre-DM by A1c alone while abdominal obesity and elevated FBG-predicted pre-DM by A1c+FBG. No participants had an elevated FBG without an A1c elevation. A substantial portion of the rise in pre-DM found among urban southcentral AN peoples in the EARTH follow-up study was due to the addition of A1c testing. Pre-DM by A1c alone should be used to motivate behavioural changes that address modifiable risk factors, including smoking cessation, physical activity and weight management.

The C2DREAM framework: Investigating the structural mechanisms undergirding racial health inequities.

Racism shapes the distribution of the social determinants of health (SDoH) along racial lines. Racism determines the environments in which people live, the quality of housing, and access to healthcare. Extensive research shows racism in its various forms negatively impacts health status, yet few studies and interventions seriously interrogate the role of racism in impacting health. The C2DREAM framework illuminates how exposure to racism, in multiple forms, connects to cardiovascular disease, hypertension, and obesity. The goal of the C2DREAM framework is to guide researchers to critically think about and measure the role of racism across its many levels of influence to better elucidate the ways it contributes to persistent health inequities. The conceptual framework highlights the interconnectedness between forms of racism, SDoH, and the lifecourse to provide a greater context to individual health outcomes. Utilizing this framework and critically contending with the effects of racism in its multiple and cumulative forms will lead to better research and interventions.

Adapting a Financial Incentives Intervention for Smoking Cessation With Alaska Native Families: Phase 1 Qualitative Research to Inform the Aniqsaaq (To Breathe) Study.

INTRODUCTION: Alaska Native and American Indian (ANAI) peoples in Alaska currently experience a disproportionate burden of morbidity and mortality from tobacco cigarette use. Financial incentives for smoking cessation are evidence-based, but a family-level incentive structure has not been evaluated. We used a community-based participatory research and qualitative approach to culturally adapt a smoking cessation intervention with ANAI families. AIMS AND METHODS: We conducted individual, semistructured telephone interviews with 12 ANAI adults who smoke, 12 adult family members, and 13 Alaska Tribal Health System stakeholders statewide between November 2022 and March 2023. Through content analysis, we explored intervention receptivity, incentive preferences, culturally aligned recruitment and intervention messaging, and future implementation needs. RESULTS: Participants were receptive to the intervention. Involving a family member was viewed as novel and aligned with ANAI cultural values of commitment to community and familial interdependence. Major themes included choosing a family member who is supportive and understanding, keeping materials positive and encouraging, and offering cash and noncash incentives for family members to choose (eg, fuel, groceries, activities). Participants indicated that messaging should emphasize family collaboration and that cessation resources and support tips should be provided. Stakeholders also reinforced that program materials should encourage the use of other existing evidence-based cessation therapies (eg, nicotine replacement, counseling). CONCLUSIONS: Adaptations, grounded in ANAI cultural strengths, were made to the intervention and recruitment materials based on participant feedback. Next steps include a beta-test for feasibility and a randomized controlled trial for efficacy. IMPLICATIONS: This is the first study to design and adapt a financial incentives intervention promoting smoking cessation among ANAI peoples and the first to involve the family system. Feedback from this formative work was used to develop a meaningful family-level incentive structure with ANAI people who smoke and family members and ensure intervention messaging is supportive and culturally aligned. The results provide qualitative knowledge that can inform future family-based interventions with ANAI communities, including our planned randomized controlled trial of the intervention.

Negative Mood is Associated with Sociobehavioral Factors Contributing to Cardiovascular Risk in an Immigrant Population.

Background: Immigrants to the United States, on average, accumulate cardiovascular risk after resettlement, including obesity. There is a need to co-create interventions to address these disparities, and mood may be an important mediating factor. Methods: The Healthy Immigrant Community (HIC) study, set in southeast Minnesota, enrolled 475 adult participants in a weight loss intervention to reduce cardiovascular risk. Baseline questionnaires assessed mood, nutrition, physical activity, self-efficacy for healthy eating and physical activity, social support, and cohesion. A single-item mood rating of poor or fair was considered "negative", while ratings of good, very good, or excellent were considered "positive". Results: A total of 449 HIC participants (268 Hispanic/Latino and 181 Somali) with complete baseline measures and were included in this analysis. Participants endorsing negative mood compared to those endorsing positive mood had lower scores for healthy eating (p = 0.02) and physical activity levels (p = 0.03), lower confidence in eating a healthy diet (p = 0.001), and felt less of a sense of belonging to their community (p = 0.01). Those endorsing negative mood also reported receiving less social support from their family and friends to eat healthy (p = < 0.001) and be physically active (p = 0.01), and less often accessed community resources for healthy eating (p = 0.001) and physical activity (p = < 0.01) compared to participants reporting positive mood. Conclusions: Negative mood was associated with less healthy nutrition, lower confidence in eating healthy, sedentary lifestyle, and perceived lack of belonging to the community. Integrating mood management and self-efficacy strategies may enhance the effectiveness of lifestyle interventions among immigrants who report negative mood. ClinicalTrialsgov registration: NCT05136339; April 23, 2022.

Prospective Association of Psychological Distress and Sexual Quality of Life Among Hematopoietic Stem Cell Transplant Survivors.

Sexual health concerns are one of the most common late effects facing hematopoietic stem cell transplant (HSCT) survivors. The current study tested whether self-reported depression and anxiety symptoms before transplant were associated with embedded items assessing two specific areas of sexual health-sexual interest and sexual satisfaction-one year post-HSCT. Of the 158 study participants, 41% were diagnosed with a plasma cell disorder (n = 60) and most received autologous transplantation (n = 128; 81%). At post-HSCT, 21% of participants reported they were not at all satisfied with their sex life, and 22% were not at all interested in sex. Greater pre-HSCT depressive symptomology was significantly predictive of lower sexual interest (ß = -.27, p < .001) and satisfaction (ß = -.39, p < .001) at post-HSCT. Similarly, greater pre-HSCT trait anxiety was significantly predictive of lower sexual interest (ß = -.19, p = .02) whereas higher levels of state and trait anxiety were both predictive of lower satisfaction (ß = -.22, p = .02 and ß = -.29, p = .001, respectively). Participant sex significantly moderated the relationship between state anxiety and sexual satisfaction (b = -.05, t = -2.03, p = .04). Additional research examining the factors that contribute to sexual health post-HCST is needed to inform and implement clinical interventions to address these commonly overlooked survivorship concerns.

Wiidookaage'Win: A Community-Based Qualitative Approach to Developing a Facebook Group Intervention for Native Women to Support Recovery From Opioid Use.

PURPOSE: To develop a culturally-tailored American Indian/Alaska Native (AI/AN) women's Facebook group supporting opioid recovery as an adjunct to medication. DESIGN: Community-based, qualitative approach. SETTING: Minnesota, U.S. PARTICIPANTS: AI/AN women in opioid recovery, interested parties, and a Community Advisory Committee (CAC) of AI/AN women with lived experience, health care providers, and community members. INTERVENTION: We developed evidence-based content focusing on stress/trauma and substance use, mindfulness, responding to triggers, and supportive community resources. Additional content centered on AI/AN culture was also selected. METHOD: Interviews were conducted by two women, then transcribed and coded using content analysis with NVivo software. Results were presented to CAC for further content refinement. RESULTS: CAC members (n = 10) guided study methods, intervention development, and dissemination activities. 14 AI/AN women (mean age 36.4 years; mean 6.7 months opioid abstinence) and 12 interested parties (7 men, 5 women) were receptive to an AI/AN gender-specific Facebook group, preferring content with AI/AN people and/or text resonating with AI/AN culture (e.g., Native traditions, family, personal stories, historical trauma). Recommendations included (1) protect confidentiality, (2) retain positivity, (3) incorporate resources and exercises to build coping skills, and (4) moderators should be authentic and relatable to build trust. CONCLUSIONS: Our approach provides a model for developing culturally tailored, appealing and effective social media interventions to support AI/AN women in recovery from opioid use disorder.

Health Disparities, Clinical Trials, and the Digital Divide.

In the past few years, there have been rapid advances in technology and the use of digital tools in health care and clinical research. Although these innovations have immense potential to improve health care delivery and outcomes, there are genuine concerns related to inadvertent widening of the digital gap consequentially exacerbating health disparities. As such, it is important that we critically evaluate the impact of expansive digital transformation in medicine and clinical research on health equity. For digital solutions to truly improve the landscape of health care and clinical trial participation for all persons in an equitable way, targeted interventions to address historic injustices, structural racism, and social and digital determinants of health are essential. The urgent need to focus on interventions to promote health equity was made abundantly clear with the coronavirus disease 2019 pandemic, which magnified long-standing social and racial health disparities. Novel digital technologies present a unique opportunity to embed equity ideals into the ecosystem of health care and clinical research. In this review, we examine racial and ethnic diversity in clinical trials, historic instances of unethical research practices in biomedical research and its impact on clinical trial participation, and the digital divide in health care and clinical research, and we propose suggestions to achieve digital health equity in clinical trials. We also highlight key digital health opportunities in cardiovascular medicine and dermatology as exemplars, and we offer future directions for development and adoption of patient-centric interventions aimed at narrowing the digital divide and mitigating health inequities.

Psilocybin history, action and reaction: A narrative clinical review.

Hallucinogenic mushrooms have been used in religious and cultural ceremonies for centuries. Of late, psilocybin, the psychoactive compound in hallucinogenic mushrooms, has received increased public interest as a novel drug for treating mood and substance use disorders (SUDs). In addition, in recent years, some states in the United States have legalized psilocybin for medical and recreational use. Given this, clinicians need to understand the potential benefits and risks related to using psilocybin for therapeutic purposes so that they can accurately advise patients. This expert narrative review summarizes the scientific basis and clinical evidence on the safety and efficacy of psilocybin-assisted therapy for treating psychiatric disorders and SUDs. The results of this review are structured as a more extensive discussion about psilocybin's history, putative mechanisms of action, and recent legislative changes to its legal status. There is modest evidence of psilocybin-assisted therapy for treating depression and anxiety disorders. In addition, early data suggest that psilocybin-assisted therapy may effectively reduce harmful drinking in patients with alcohol use disorders. The evidence further suggests psilocybin, when administered under supervision (psilocybin-assisted therapy), the side effects experienced are mild and transient. The occurrence of severe adverse events following psilocybin administration is uncommon. Still, a recent clinical trial found that individuals in the psilocybin arm had increased suicidal ideations and non-suicidal self-injurious behaviors. Given this, further investigation into the safety and efficacy of psilocybin-assisted therapy is warranted to determine which patient subgroups are most likely to benefit and which are most likely to experience adverse outcomes related to its use.

Real-World Implementation of Best-Evidence Cancer Distress Management: Truly Comprehensive Cancer Care.

BACKGROUND: Cancer distress management is an evidence-based component of comprehensive cancer care. Group-delivered cognitive behavioral therapy for cancer distress (CBT-C) is the first distress treatment associated with replicated survival advantages in randomized clinical trials. Despite research supporting patient satisfaction, improved outcomes, and reduced costs, CBT-C has not been tested sufficiently within billable clinical settings, profoundly reducing patient access to best-evidence care. This study aimed to adapt and implement manualized CBT-C as a billable clinical service. PATIENTS AND METHODS: A stakeholder-engaged, mixed-methods, hybrid implementation study design was used, and the study was conducted in 3 phases: (1) stakeholder engagement and adaptation of CBT-C delivery, (2) patient and therapist user testing and adaptation of CBT-C content, and (3) implementation of practice-adapted CBT-C as a billable clinical service focused on evaluation of reach, acceptability, and feasibility across stakeholder perspectives. RESULTS: A total of 40 individuals and 7 interdisciplinary group stakeholders collectively identified 7 primary barriers (eg, number of sessions, workflow concerns, patient geographic distance from center) and 9 facilitators (eg, favorable financial model, emergence of oncology champions). CBT-C adaptations made before implementation included expanding eligibility criteria beyond breast cancer, reducing number of sessions to 5 (10 total hours), eliminating and adding content, and revising language and images. During implementation, 252 patients were eligible; 100 (40%) enrolled in CBT-C (99% covered by insurance). The primary reason for declining enrollment was geographic distance. Of enrollees, 60 (60%) consented to research participation (75% women; 92% white). All research participants completed at least 60% of content (6 of 10 hours), with 98% reporting they would recommend CBT-C to family and friends. CONCLUSIONS: CBT-C implementation as a billable clinical service was acceptable and feasible across cancer care stakeholder measures. Future research is needed to replicate acceptability and feasibility results in more diverse patient groups, test effectiveness in clinical settings, and reduce barriers to access via remote delivery platforms.

Rural and urban residents' attitudes and preferences toward COVID-19 prevention behaviors in a midwestern community.

Rural populations are more vulnerable to the impacts of COVID-19 compared to their urban counterparts as they are more likely to be older, uninsured, to have more underlying medical conditions, and live further from medical care facilities. We engaged the Southeastern MN (SEMN) community (N = 7,781, 51% rural) to conduct a survey of motivators and barriers to masking to prevent COVID-19. We also assessed preferences for types of and modalities to receive education/intervention, exploring both individual and environmental factors primarily consistent with Social Cognitive Theory. Our results indicated rural compared to urban residents performed fewer COVID-19 prevention behaviors (e.g. 62% rural vs. 77% urban residents reported wearing a mask all of the time in public, p<0.001), had more negative outcome expectations for wearing a mask (e.g. 50% rural vs. 66% urban residents thought wearing a mask would help businesses stay open, p<0.001), more concerns about wearing a mask (e.g. 23% rural vs. 14% urban were very concerned about being 'too hot', p<0.001) and lower levels of self-efficacy for masking (e.g. 13.9±3.4 vs. 14.9±2.8, p<0.001). It appears that masking has not become a social norm in rural SEMN, with almost 50% (vs. 24% in urban residents) disagreeing with the expectation 'others in my community will wear a mask to stop the spread of Coronavirus'. Except for people (both rural and urban) who reported not being at all willing to wear a mask (7%), all others expressed interest in future education/interventions to help reduce masking barriers that utilized email and social media for delivery. Creative public health messaging consistent with SCT tailored to rural culture and norms is needed, using emails and social media with pictures and videos from role models they trust, and emphasizing education about when masks are necessary.

Connecting Vietnamese-Speaking Immigrants who Smoke to the Asian Smokers Quitline: A Feasibility Pilot of Proactive Outreach Interventions.

INTRODUCTION: Cigarette smoking is highly prevalent among Asian American immigrant subgroups. Previously, Asian-language telephone Quitline services were only available in California. In 2012, the Centers for Disease Control and Prevention (CDC) funded the national Asian Smokers' Quitline (ASQ) to expand Asian-language Quitline services nationally. However, there are relatively few calls to the ASQ from outside California. AIMS AND METHODS: This pilot study assessed the feasibility of two proactive outreach interventions to connect Vietnamese-speaking participants who smoke to the ASQ. Both interventions, (1) proactive telephone outreach with a counselor trained in motivational interviewing (PRO-MI) and (2) proactive telephone outreach with interactive voice response (PRO-IVR), were adapted to be culturally and linguistically appropriate for Vietnamese-speaking participants. Participants were randomly assigned 2:1 to PRO-IVR versus PRO-MI. Assessments were conducted at baseline and 3 months post-enrollment. Feasibility indicators were the recruitment rate and initiation of ASQ treatment. RESULTS: Using the HealthPartners electronic health record, a large health system in Minnesota, we identified approximately 343 potentially eligible Vietnamese participants who were mailed invitation letters and baseline surveys with telephone follow-up. We enrolled 86 eligible participants (25% recruitment rate). In the PRO-IVR group 7/58 participants were directly transferred to the ASQ (12% initiation rate) and in the PRO-MI group 8/28 participants were warm transferred to the ASQ (29% initiation rate). CONCLUSIONS: This pilot study demonstrates the feasibility of our recruitment methods and of implementing proactive outreach interventions to promote the initiation of smoking cessation treatment with the ASQ. IMPLICATIONS: This pilot study contributes novel data on the uptake of Asian Smokers' Quitline (ASQ) services among Vietnamese-speaking people who smoke (PWS) with two proactive outreach interventions: (1) proactive telephone outreach with a counselor trained in motivational interviewing (PRO-MI) and (2) proactive telephone outreach with interactive voice response (PRO-IVR). We found that it is feasible to implement these proactive outreach interventions to promote the initiation of ASQ cessation treatment among Vietnamese-language speaking PWS. Future large trials are needed to rigorously compare PRO-MI and PRO-IVR and conduct budget impact analyses to understand the most efficient strategies for incorporation into health system settings.

Community engagement strategies to promote recruitment and participation in clinical research among rural communities: A narrative review.

Residents of rural areas are underrepresented in research. The aim of this narrative review was to explore studies describing the effectiveness of community engagement strategies with rural communities to promote participant recruitment and participation in clinical research. Following PRISMA guidelines, this narrative review was conducted in June 2020. Our search strategy was built around keywords that included community-engaged research, rural community, and recruitment strategies into clinical research. Content-related descriptive statistics were summarized. The selected articles were distributed into categories of levels of community engagement: inform, consult, involve, collaborate, or co-lead. The search resulted in 2,473 identified studies of which forty-eight met inclusion criteria. Of these, 47.1% were randomized controlled trials. The most common levels of engagement were consultation (n = 24 studies) and collaboration (n = 15), while very few focused on informing (n = 2) and co-leadership (n = 2). Strategies, limitations, and findings are discussed for each level of community engagement. This narrative addressed a gap in knowledge regarding participant recruitment in rural communities in relation to assistance from community members. Community engagement contributed to the success of the research, especially in recruitment, participation, and building trust and partnership.

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.

Aniqsaaq (To Breathe): Study protocol to develop and evaluate an Alaska Native family-based financial incentive intervention for smoking cessation.

Background: Alaska Native and American Indian (ANAI) communities in Alaska are disproportionately affected by commercial tobacco use. Financial incentive interventions promote cigarette smoking cessation, but family-level incentives have not been evaluated. We describe the study protocol to adapt and evaluate the effectiveness and implementation of a remotely delivered, family-based financial incentive intervention for cigarette smoking among Alaskan ANAI people. Methods: The study has 3 phases: 1) qualitative interviews with ANAI adults who smoke, family members, and stakeholders to inform the intervention, 2) beta-test of the intervention, and 3) randomized controlled trial (RCT) evaluating intervention reach and effectiveness on verified, prolonged smoking abstinence at 6- and 12-months post-treatment. In the RCT, adult dyads (ANAI person who smokes [index participant] and family member) recruited throughout Alaska will be randomized to a no-incentives control condition (n = 328 dyads) or a 6-month incentive intervention (n = 328 dyads). All dyads will receive cessation support and family wellness materials. Smoking status will be assessed weekly for four weeks and at three and six months. Intervention index participants will receive escalating incentives for verified smoking abstinence at each time point (maximum $750 total); the family member will receive rewards of equal value. Results: A community advisory committee contributed input on the study design and methods for relevance to ANAI people, particularly emphasizing the involvement of families. Conclusion: Our study aligns with the strength and value AIAN people place on family. Findings, processes, and resources will inform how Indigenous family members can support smoking cessation within incentive interventions. Clinical Trials Registry: NCT05209451.