Strategies to promote language inclusion at 17 CTSA hubs.

The prioritization of English language in clinical research is a barrier to translational science. We explored promising practices to advance the inclusion of people who speak languages other than English in research conducted within and supported by NIH Clinical Translational Science Award (CTSA) hubs. Key informant interviews were conducted with representatives (n = 24) from CTSA hubs (n = 17). Purposive sampling was used to identify CTSA hubs focused on language inclusion. Hubs electing to participate were interviewed via Zoom. Thematic analysis was performed to analyze interview transcripts. We report on strategies employed by hubs to advance linguistic inclusion and influence institutional change that were identified. Strategies ranged from translations, development of culturally relevant materials and consultations to policies and procedural changes and workforce initiatives. An existing framework was adapted to conceptualize hub strategies. Language justice is paramount to bringing more effective treatments to all people more quickly. Inclusion will require institutional transformation and CTSA hubs are well positioned to catalyze change.

Hematopoietic Stem-Cell Transplantation: Exploring the Latest Advances and Gaps in Disparities, Psychosocial and Symptom Management Interventions, and Chronic Graft-Versus-Host Disease Care.

Although allogeneic hematopoietic cell transplantation (HCT) offers a potential for cure for many patients with advanced hematologic malignancies and bone marrow failure or immunodeficiency syndromes, it is an intensive treatment and accompanied by short- and long-term physical and psychological symptoms requiring specialized care. With substantial advances in therapeutic approaches for HCT and supportive care, HCT survivors experience less morbidity and mortality. However, disparities in both HCT access and outcomes persist, and HCT survivors and their caregivers often lack access to much-needed psychosocial care. Additionally, more medical and psychosocial resources are needed to holistically care for HCT survivors with chronic graft-versus-host disease (GVHD). Hence, this chapter focuses on three areas pertaining to advances and gaps in HCT care: disparities in access to and outcomes of HCT, psychosocial and physical symptom management with supportive care interventions, and GVHD prevention and management.

Harlem Health Advocacy Partners: A Local Health Department's Place-Based Community Health Worker Program.

In January 2015, the New York City Department of Health and Mental Hygiene launched Harlem Health Advocacy Partners (HHAP), a place-based initiative to demonstrate the capacity of a CHW workforce to improve the health of residents of public housing. The long-term goal of HHAP is to improve the population health of residents of public housing in East and Central Harlem and to close racial gaps in health and social outcomes. A variety of evaluation approaches have been used to assess the initiative. This paper describes the HHAP model and methods for evaluating the program.

Characterizing Technology Use and Preferences for Health Communication in South Asian Immigrants With Prediabetes or Diabetes: Cross-Sectional Descriptive Study.

BACKGROUND: Type 2 diabetes disproportionately affects South Asian subgroups. Lifestyle prevention programs help prevent and manage diabetes; however, there is a need to tailor these programs for mobile health (mHealth). OBJECTIVE: This study examined technology access, current use, and preferences for health communication among South Asian immigrants diagnosed with or at risk for diabetes, overall and by sex. We examined factors associated with interest in receiving diabetes information by (1) text message, (2) online (videos, voice notes, online forums), and (3) none or skipped, adjusting for sociodemographic characteristics and technology access. METHODS: We used baseline data collected in 2019-2021 from two clinical trials among South Asian immigrants in New York City (NYC), with one trial focused on diabetes prevention and the other focused on diabetes management. Descriptive statistics were used to examine overall and sex-stratified impacts of sociodemographics on technology use. Overall logistic regression was used to examine the preference for diabetes information by text message, online (videos, voice notes, or forums), and no interest/skipped response. RESULTS: The overall sample (N=816) had a mean age of 51.8 years (SD 11.0), and was mostly female (462/816, 56.6%), married (756/816, 92.6%), with below high school education (476/816, 58.3%) and limited English proficiency (731/816, 89.6%). Most participants had a smartphone (611/816, 74.9%) and reported interest in receiving diabetes information via text message (609/816, 74.6%). Compared to male participants, female participants were significantly less likely to own smartphones (317/462, 68.6% vs 294/354, 83.1%) or use social media apps (Viber: 102/462, 22.1% vs 111/354, 31.4%; WhatsApp: 279/462, 60.4% vs 255/354, 72.0%; Facebook: Messenger 72/462, 15.6% vs 150/354, 42.4%). A preference for receiving diabetes information via text messaging was associated with male sex (adjusted odds ratio [AOR] 1.63, 95% CI 1.01-2.55; P=.04), current unemployment (AOR 1.62, 95% CI 1.03-2.53; P=.04), above high school education (AOR 2.17, 95% CI 1.41-3.32; P<.001), and owning a smart device (AOR 3.35, 95% CI 2.17-5.18; P<.001). A preference for videos, voice notes, or online forums was associated with male sex (AOR 2.38, 95% CI 1.59-3.57; P<.001) and ownership of a smart device (AOR 5.19, 95% CI 2.83-9.51; P<.001). No interest/skipping the question was associated with female sex (AOR 2.66, 95% CI 1.55-4.56; P<.001), high school education or below (AOR 2.02, 95% CI 1.22-3.36; P=.01), not being married (AOR 2.26, 95% CI 1.13-4.52; P=.02), current employment (AOR 1.96, 95% CI 1.18-3.29; P=.01), and not owning a smart device (AOR 2.06, 95% CI 2.06-5.44; P<.001). CONCLUSIONS: Technology access and social media usage were moderately high in primarily low-income South Asian immigrants in NYC with prediabetes or diabetes. Sex, education, marital status, and employment were associated with interest in mHealth interventions. Additional support to South Asian women may be required when designing and developing mHealth interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT03333044; https://classic.clinicaltrials.gov/ct2/show/NCT03333044, ClinicalTrials.gov NCT03188094; https://classic.clinicaltrials.gov/ct2/show/NCT03188094. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-019-3711-y.

Feasibility of a family-oriented mHealth intervention for Chinese Americans with type 2 diabetes: A pilot randomized control trial.

OBJECTIVES: To test the feasibility, acceptability, and potential efficacy of a mHealth intervention tailored for Chinese immigrant families with type 2 diabetes (T2D). METHODS: We conducted a pilot randomized controlled trial (RCT) with baseline, 3-, and 6-month measurements. Participating dyads, T2D patients and families/friends from NYC, were randomized into the intervention group (n = 11) or the wait-list control group (n = 12). Intervention includes 24 videos covering T2D self-management, behavioral techniques, and family-oriented sessions. Feasibility and acceptability were measured respectively by the retention rate and video watch rate, and a satisfaction survey. Patients' HbA1c, weight, and self-management were also assessed to test potential efficacy. RESULTS: Most T2D patients (n = 23; mean age 56.2±9.4 years; 52.2% male) and families/friends (n = 23, mean age 54.6±11.2 years; 52.2% female) had high school education or less (69.6% and 69.6%), annual household income < $25,000 (65.2% and 52.2%), and limited English proficiency (95.7% and 95.7%). The retention rates were not significantly different between the intervention and the control groups for both the patients (90.91% vs 83.3%, p = 0.589); and their families/friends (3-month: 90.9% vs 75%, p = 0.313; 6-month: 90.9% vs 83.3%, p = 0.589). The mean video watch rate was 76.8% (7%). T2D patients and families/friends rated satisfaction as 9.4 and 10 out of 10, respectively. Despite no between-group differences, the intervention group had significantly lower HbA1c (p = 0.014) and better self-management (p = 0.009), and lost 12 lbs. on average at 6 months (p = 0.079), compared to their baseline levels. CONCLUSIONS: A culturally-tailored, family-based mHealth intervention is feasible and acceptable among low-income, limited English-proficient Chinese families with T2D in NYC. Significant changes in HbA1c and self-management within the intervention group indicate this intervention may have potential efficacy. Given the small sample size of this study, a future RCT with adequate power is needed to test efficacy.

A Multi-Stage Dyadic Qualitative Analysis to Disentangle How Dietary Behaviors of Asian American Young Adults are Influenced by Family.

The dietary behaviors of Asian American (AA) young adults, who face a growing non-communicable disease burden, are impacted by complex socio-ecological forces. Family plays a crucial role in the lifestyle behaviors of AA young adults; however, little is known on the methods, contributors, and impact of familial dietary influence. This study aims to deconstruct the mechanisms of AA young adult familial dietary influence through a multi-perspective qualitative assessment. A five-phase method of dyadic analysis adapted from past research was employed to extract nuanced insights from dyadic interviews with AA young adults and family members, and ground findings in behavioral theory (the Social Cognitive Theory, SCT). 37 interviews were conducted: 18 young adults, comprising 10 different AA ethnic subgroups, and 19 family members (10 parents, 9 siblings). Participants described dietary influences that were both active (facilitating, shaping, and restricting) and passive (e.g., sharing foods or environment, mirroring food behaviors). Influences connected strongly with multiple SCT constructs (e.g., behavioral capacity, reinforcements for active influences, and expectations, observational learning for passive influences). Familial influence contributed to changes in the total amount, variety, and healthfulness of foods consumed. Intra-family dynamics were crucial; family members often leveraged each other's persuasiveness or food skills to collaboratively influence diet. AA family-based interventions should consider incorporating both passive and active forms of dietary influence within a family unit, involve multiple family members, and allow for individualization to the unique dynamics and dietary behaviors within each family unit.

The Power of Partnership: NYCEAL Collaborations With Health Agencies and Mobile Vaccination Vans.

New York City experienced a high COVID-19 burden and striking disparities among racial and ethnic minoritized groups. The New York Community Engagement Alliance Against COVID-19 Disparities (NYCEAL) collaborated with health agencies and clinical providers to increase and facilitate COVID-19 vaccinations across New York City. NYCEAL partners and their network of hundreds of community health workers delivered vaccine education, fostered community trust, and supported vaccine uptake among low-income, limited‒English-proficient, and racial and ethnic minoritized communities. With funding from the National Institutes of Health (NIH), the objective of NYCEAL was to reduce COVID-19 disparities by increasing vaccine uptake and promoting trust in science. (Am J Public Health. 2024;114(S1):S92-S95. https://doi.org/10.2105/AJPH.2023.307455).

A Culturally Adapted, Telehealth, Community Health Worker Intervention on Blood Pressure Control among South Asian Immigrants with Type II Diabetes: Results from the DREAM Atlanta Intervention.

BACKGROUND: South Asians face a high prevalence of type II diabetes (DMII) and comorbid hypertension (HTN). Community health worker (CHW) interventions have the potential to improve chronic disease outcomes, yet few have been tailored to South Asian populations in the United States. OBJECTIVE: To test the effectiveness of an evidence-based CHW-led and culturally-tailored HTN and DMII management program for South Asian adults with diabetes and comorbid uncontrolled HTN (systolic blood pressure (SBP) > 130 mmHg or diastolic blood pressure (DBP) > 80 mmHg). DESIGN: Randomized-controlled Trial. PARTICIPANTS: South Asian adults with DMII and comorbid HTN. INTERVENTION: The Diabetes Research, Education, and Action for Minorities (DREAM) Atlanta intervention was a CHW telehealth intervention designed to improve blood pressure (BP). The treatment group received five virtual group-based health education sessions, an action plan, and follow-up calls to assess goal setting activities. The control group received only the first session. Main Measures included: feasibility, improvement in BP control, and decreases in SBP, DBP, weight, and hemoglobin A1c (HbA1c). KEY RESULTS: A total of 190 South Asian adults were randomized (97 to the treatment group and 93 to the control group); 94% of treatment group participants completed all 5 telehealth sessions. At endpoint, BP control increased 33.7% (95% CI: 22.5, 44.9, p < 0.001) in the treatment group and 16.5% (95%: 6.2, 26.8, p = 0.003) in the control group; the adjusted intervention effect was 1.8 (95% CI: 1.0, 3.2, p = 0.055). Mean weight decreased by 4.8 pounds (95% CI: -8.2, -1.4, p = 0.006) in the treatment group, and the adjusted intervention effect was -5.2 (95% CI: -9.0, -1.4, p = 0.007. The intervention had an overall retention of 95%. CONCLUSIONS: A culturally-tailored, CHW-led telehealth intervention is feasible and can improve BP control among South Asian Americans with DMII. GOV REGISTRATION: NCT04263311.

Associations Between Incarceration History and Risk of Hypertension and Hyperglycemia: Consideration of Differences among Black, Hispanic, Asian and White Subgroups.

BACKGROUND: Studies have shown that adults with a history of incarceration have elevated cardiovascular (CVD) risk. Research on racial/ethnic group differences in the association between incarceration and CVD risk factors of hypertension and hyperglycemia is limited. OBJECTIVE: To assess racial/ethnic group differences in the association between incarceration and hypertension and hyperglycemia. DESIGN: We performed a secondary data analysis using the National Longitudinal Survey of Adolescent to Adult Health (Add Health). Using modified Poisson regression, we estimated the associations between lifetime history of incarceration reported during early adulthood with hypertension and hyperglycemia outcomes measured in mid-adulthood, including incident diagnosis. We evaluated whether associations varied by self-reported race/ethnicity (non-Hispanic White, non-Hispanic Black, Hispanic, and Asian). PARTICIPANTS: The analytic sample included 4,015 Add Health respondents who self-identified as non-Hispanic White, Non-Hispanic Black, Hispanic, and Asian, and provided incarceration history and outcome data. MAIN MEASURES: Outcome measures included (1) hypertension (2) systolic blood pressure ≥ 130 mmHg, and (3) hyperglycemia. KEY RESULTS: In non-Hispanic Black and non-Hispanic White participants, there was not evidence of an association between incarceration and measured health outcomes. Among Hispanic participants, incarceration was associated with hyperglycemia (Adjusted Risk Ratio (ARR): 2.1, 95% Confidence Interval (CI): 1.1-3.7), but not with hypertension risk. Incarceration was associated with elevated systolic blood pressure (ARR: 3.1, CI: 1.2-8.5) and hypertension (ARR: 1.7, CI: 1.0-2.8, p = 0.03) among Asian participants, but not with hyperglycemia risk. Incarceration was associated with incident hypertension (ARR 2.5, CI 1.2-5.3) among Asian subgroups. CONCLUSIONS: Our findings add to a growing body of evidence suggesting that incarceration may be linked to chronic disease outcomes. Race/ethnic-specific results, while limited by small sample size, highlight the need for long-term studies on incarceration's influence among distinct US groups.

The development of a clinical research educational training for community health workers using the joint task force for clinical trial competency framework.

Introduction: The NYU Clinical & Translational Science Institute, in collaboration with a number of community-engaged initiatives, developed a training for community health workers (CHWs) to enhance health literacy about clinical research. This innovative research training provides CHWs with a basic level of competency in clinical research to convey the importance of research to communities and better advocate for their health needs. CHWs are an underutilized resource to engage diverse populations in clinical research. The training also addresses the need to expand and diversify the clinical research workforce-integrating CHWs into research teams and connecting underserved populations with research opportunities to enhance quality of care. Methods: Structured individual interviews and focus group sessions were held with CHWs as well as clinical research faculty and staff to identify knowledge gaps in clinical research and identify best practices for educating community members on research. Using the Joint Task Force (JTF) for Clinical Trial Competency framework, an online course was developed consisting of 28 modules offered asynchronously for internal and external audiences. Topics include the fundamentals of clinical research, scientific concepts and research design, research ethics, study management, clinical study operations, communications, and teamwork, as well as the importance of diversity and equity in research and the barriers to participation. Results: Learning was evaluated using multiple choice questions after each module to ensure the fundamental level of knowledge was obtained. A separate survey, completed at the conclusion of the course, evaluated the quality of training. Discussion: The course aims to enhance the knowledge and skills of CHWs to help promote greater understanding of clinical research within the communities they serve, including the risks and benefits of clinical research and opportunities for participation. As members of the research team, community stakeholders can help design interventions tailored to the unique needs, culture, and context of their communities. In addition, this research training equips trainees with skills to engage the community actively, involving them in the research process and ensuring community priorities are represented in research through more community engaged processes.

Community-Based Organizations as Trusted Messengers in Health.

Trust is a key component in delivering quality and respectful care within health care systems. However, a growing lack of confidence in health care, particularly among specific subgroups of the population in the United States, could further widen health disparities. In this essay, we explore one approach to building trust and reaching diverse communities to promote health: engaging community-based organizations (CBOs) as trusted community messengers. We present case studies of partnerships in health promotion, community education, and outreach that showcase how CBOs' programs build and leverage trust in health care systems through their workforce, services, and engagement with the community.

Integrating Community Health Workers' Dual Clinic-Community Role in Safety-Net Primary Care: Implementation Lessons from a Pragmatic Diabetes-Prevention Trial.

BACKGROUND: Over a third of US adults carry a diagnosis of prediabetes, 70% of whom may progress to type 2 diabetes mellitus ("diabetes"). Community health workers (CHWs) can help patients undertake healthy behavior to prevent diabetes. However, there is limited guidance to integrate CHWs in primary care, specifically to address CHWs' dual clinic-based and community-oriented role. OBJECTIVE: Using evidence from CHWs' adaptations of a diabetes-prevention intervention in safety-net hospitals in New York City, we examine the nature, intent, and possible consequences of CHWs' actions on program fidelity. We propose strategies for integrating CHWs in primary care. DESIGN: Case study drawing on the Model for Adaptation Design and Impact (MADI) to analyze CHWs' actions during implementation of CHORD (Community Health Outreach to Reduce Diabetes), a cluster-randomized pragmatic trial (2017-2022) at Manhattan VA and Bellevue Hospital. PARTICIPANTS: CHWs and clinicians in the CHORD study, with a focus in this analysis on CHWs. APPROACH: Semi-structured interviews and focus group discussion with CHWs (n=4); semi-structured interviews with clinicians (n=17). Interpretivist approach to explain CHWs' adaptations using a mix of inductive and deductive analysis. KEY RESULTS: CHWs' adaptations extended the intervention in three ways: by extending social assistance, healthcare access, and operational tasks. The adaptations were intended to improve fit, reach, and retention, but likely had ripple effects on implementation outcomes. CHWs' focus on patients' complex social needs could divert them from judiciously managing their caseload. CONCLUSIONS: CHWs' community knowledge can support patient engagement, but overextension of social assistance may detract from protocolized health-coaching goals. CHW programs in primary care should explicitly delineate CHWs' non-health support to patients, include multiprofessional teams or partnerships with community-based organizations, establish formal communication between CHWs and clinicians, and institute mechanisms to review and iterate CHWs' work to resolve challenges in their community-oriented role.

The Health Implications of Perceived Anti-Muslim Discrimination Among South Asian Muslim Americans.

Introduction: Anti-Muslim discrimination in the U.S. has increased exponentially since 2001, but the impact of anti-Muslim discrimination has yet to be fully examined because of limited data available on this topic and population. The objectives of this study were to (1) examine the association between perceived anti-Muslim discrimination and health risk behaviors, with depressive symptoms as a potential mediator, among South Asian Muslim Americans and (2) examine the association between other forms of perceived discrimination and health risk behaviors, with depressive symptoms as a potential mediator, among South Asian Muslim Americans. Methods: Data were collected using an online survey, which was disseminated on subscriber e-mail lists for organizations that serve South Asian or Muslim communities. Participants were asked about perceived discrimination, depressive symptoms, diet, physical activity, tobacco use, and alcohol consumption. Data were analyzed using structural equation modeling in Mplus 8. Results: Societal anti-Muslim discrimination had a positive association with depressive symptoms (0.19, p<0.05), as did interpersonal anti-Muslim discrimination (0.20, p<0.05) and other forms of discrimination (0.22, p<0.05). None of the discrimination scales were associated with dietary patterns, tobacco use, or alcohol consumption. Conclusions: Study results demonstrated a link between discrimination and depressive symptoms. Further research is needed to examine associations with other adverse health outcomes and potential buffers against discrimination.

The Prevalence and Correlates of Diabetes Distress among South Asians Living in New York City (NYC): Baseline Results from a Randomized Trial.

Background: Type 2 diabetes (T2D) disproportionately affects South Asians in the United States (US). Living with T2D can be challenging due to the distress it can create for an individual. Distress associated with diabetes, commonly known as diabetes distress (DD), may lead to complications and challenges with the management of diabetes. This study aims to describe the prevalence of DD among a sample of South Asians in New York City (NYC) seeking care in community-based primary care settings and its association with sociodemographic characteristics and clinical measures. Methods: This study utilized baseline data from the Diabetes Research, Education, and Action for Minorities (DREAM) Initiative, an intervention designed to reduce hemoglobin A1C (HbA1c) among South Asians with uncontrolled T2D in NYC. DD was measured using the Diabetes Distress Scale (DDS). First, descriptive statistics were used to analyze sociodemographic variables. Chi-square tests assessed categorical variables and Wilcoxon Rank Sum tests assessed continuous variables using a Type I error rate of 0.05. Logistic regression was performed to determine if HbA1c and mental health, along with other covariates, were associated with dichotomized DDS subscales. Results: Overall, 415 participants completed the DDS at baseline. Median age was 56 years (IQR: 48-62). A total of 25.9% had high emotional burden distress, 6.6% had high physician-related distress, and 22.2% had high regimen-related distress based on subscales. In adjusted analyses, individuals with any days of poor mental health had significantly higher odds of overall distress (OR:3.7, p=0.014), emotional burden distress (OR:4.9, p<0.001), and physician-related distress (OR:5.0, p=0.002) compared to individuals with no days of poor mental health. Individuals with higher HbA1c had significantly higher odds of regimen-related distress (OR:1.31, p=0.007). Conclusions: Findings suggest that DD is prevalent among this sample of South Asians with diagnosed T2D in NYC. Screening for DD in patients with prediabetes/diabetes should be considered by providers to help provide mental and physical health services during primary care visits. Future research can also benefit from a longitudinal analysis of the impact of DD on diabetes self-management, medication adherence, and mental and physical health. Trial registration: This study uses baseline data from "Diabetes Management Intervention For South Asians" (NCT03333044), which was registered with clinicaltrials.gov on 6/11/2017.

Stakeholder Perspectives on the Impact of COVID-19 on the Implementation of a Community-Clinic Linkage Model in New York City.

Community-clinical linkage models (CCLM) have the potential to reduce health disparities, especially in underserved communities; however, the COVID-19 pandemic drastically impacted their implementation. This paper explores the impact of the pandemic on the implementation of CCLM intervention led by community health workers (CHWs) to address diabetes disparities among South Asian patients in New York City. Guided by the Consolidated Framework for Implementation Research (CFIR), 22 stakeholders were interviewed: 7 primary care providers, 7 CHWs, 5 community-based organization (CBO) representatives, and 3 research staff. Semi-structured interviews were conducted; interviews were audio-recorded and transcribed. CFIR constructs guided the identification of barriers and adaptations made across several dimensions of the study's implementation context. We also explored stakeholder-identified adaptations used to mitigate the challenges in the intervention delivery using the Model for Adaptation Design and Impact (MADI) framework. (1) Communication and engagement refers to how stakeholders communicated with participants during the intervention period, including difficulties experienced staying connected with intervention activities during the lockdown. The study team and CHWs developed simple, plain-language guides designed to enhance digital literacy. (2) Intervention/research process describes intervention characteristics and challenges stakeholders faced in implementing components of the intervention during the lockdown. CHWs modified the health curriculum materials delivered remotely to support engagement in the intervention and health promotion. (3) community and implementation context pertains to the social and economic consequences of the lockdown and their effect on intervention implementation. CHWs and CBOs enhanced efforts to provide emotional/mental health support and connected community members to resources to address social needs. Study findings articulate a repository of recommendations for the adaptation of community-delivered programs in under-served communities during a time of public health crises.

Challenges and recommendations to improve institutional review boards' review of community-engaged research proposals: A scoping review.

Academic and community investigators conducting community-engaged research (CEnR) are often met with challenges when seeking Institutional Review Board (IRB) approval. This scoping review aims to identify challenges and recommendations for CEnR investigators and community partners working with IRBs. Peer-reviewed articles that reported on CEnR, specified study-related challenges, and lessons learned for working with IRBs and conducted in the United States were included for review. Fifteen studies met the criteria and were extracted for this review. Four challenges identified (1) Community partners not being recognized as research partners (2) Cultural competence, language of consent forms, and literacy level of partners; (3) IRBs apply formulaic approaches to CEnR; & (4) Extensive delays in IRB preparation and approval potentially stifle the relationships with community partners. Recommendations included (1) Training IRBs to understand CEnR principles to streamline and increase the flexibility of the IRB review process; (2) Identifying influential community stakeholders who can provide support for the study; and (3) Disseminating human subjects research training that is accessible to all community investigator to satisfy IRB concerns. Findings from our study suggest that IRBs can benefit from more training in CEnR requirements and methodologies.

Implementation fidelity to a behavioral diabetes prevention intervention in two New York City safety net primary care practices.

BACKGROUND: It is critical to assess implementation fidelity of evidence-based interventions and factors moderating fidelity, to understand the reasons for their success or failure. However, fidelity and fidelity moderators are seldom systematically reported. The study objective was to conduct a concurrent implementation fidelity evaluation and examine fidelity moderators of CHORD (Community Health Outreach to Reduce Diabetes), a pragmatic, cluster-randomized, controlled trial to test the impact of a Community Health Workers (CHW)-led health coaching intervention to prevent incident type 2 Diabetes Mellitus in New York (NY). METHODS: We applied the Conceptual Framework for Implementation Fidelity to assess implementation fidelity and factors moderating it across the four core intervention components: patient goal setting, education topic coaching, primary care (PC) visits, and referrals to address social determinants of health (SDH), using descriptive statistics and regression models. PC patients with prediabetes receiving care from safety-net patient-centered medical homes (PCMHs) at either, VA NY Harbor or at Bellevue Hospital (BH) were eligible to be randomized into the CHW-led CHORD intervention or usual care. Among 559 patients randomized and enrolled in the intervention group, 79.4% completed the intake survey and were included in the analytic sample for fidelity assessment. Fidelity was measured as coverage, content adherence and frequency of each core component, and the moderators assessed were implementation site and patient activation measure. RESULTS: Content adherence was high for three components with nearly 80.0% of patients setting ≥ 1 goal, having ≥ 1 PC visit and receiving ≥ 1 education session. Only 45.0% patients received ≥ 1 SDH referral. After adjusting for patient gender, language, race, ethnicity, and age, the implementation site moderated adherence to goal setting (77.4% BH vs. 87.7% VA), educational coaching (78.9% BH vs. 88.3% VA), number of successful CHW-patient encounters (6 BH vs 4 VA) and percent of patients receiving all four components (41.1% BH vs. 25.7% VA). CONCLUSIONS: The fidelity to the four CHORD intervention components differed between the two implementation sites, demonstrating the challenges in implementing complex evidence-based interventions in different settings. Our findings underscore the importance of measuring implementation fidelity in contextualizing the outcomes of randomized trials of complex multi-site behavioral interventions. TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov on 30/12/2016 and the registration number is NCT03006666 .

A multilevel framework to investigate cardiovascular health disparities among South Asian immigrants in the United States.

PURPOSE: Prior studies of cardiovascular health (CVH) disparities among immigrants of South Asian origin in the United States have examined South Asians as one homogenous group, focused primarily on Indian-origin immigrants, and examined risk at the individual level. METHODS: We present current knowledge and evidence gaps about CVH in the three largest South Asian-origin populations in the United States-Bangladeshi, Indian, and Pakistani-and draw on socioecological and lifecourse frameworks to propose a conceptual framework for investigating multilevel risk and protective factors of CVH across these groups. RESULTS: The central hypothesis is that CVH disparities among South Asian populations exist due to differences in structural and social determinants, including lived experiences like discrimination, and that acculturation strategies and resilience resources (e.g., neighborhood environment, education, religiosity, social support) ameliorate stressors to act as health protective factors. RESULTS: Conclusions: Our framework advances conceptualization of the heterogeneity and drivers of cardiovascular disparities in diverse South Asian-origin populations. We present specific recommendations to inform the design of future epidemiologic studies on South Asian immigrant health and the development of multilevel interventions to reduce CVH disparities and promote well-being.

Integrating Community Health Workers into Community-Based Primary Care Practice Settings to Improve Blood Pressure Control Among South Asian Immigrants in New York City: Results from a Randomized Control Trial.

BACKGROUND: Blood pressure (BP) control is suboptimal in minority communities, including Asian populations. We evaluate the feasibility, adoption, and effectiveness of an integrated CHW-led health coaching and practice-level intervention to improve hypertension control among South Asian patients in New York City, Project IMPACT (Integrating Million Hearts for Provider and Community Transformation). The primary outcome was BP control, and secondary outcomes were systolic BP and diastolic BP at 6-month follow-up. METHODS: A randomized-controlled trial took place within community-based primary care practices that primarily serve South Asian patients in New York City between 2017 and 2019. A total of 303 South Asian patients aged 18-85 with diagnosed hypertension and uncontrolled BP (systolic BP ≥140 mm Hg or diastolic BP ≥90 mm Hg) within the previous 6 months at 14 clinic sites consented to participate. After completing 1 education session, individuals were randomized into treatment (n=159) or control (n=144) groups. Treatment participants received 4 additional group education sessions and individualized health coaching over a 6-month period. A mixed effect generalized linear model with a logit link function was used to assess intervention effectiveness for controlled hypertension (Yes/No), adjusting for practice level random effect, age, sex, baseline systolic BP, and days between BP measurements. RESULTS: Among the total enrolled population, mean age was 56.8±11.2 years, and 54.1% were women. At 6 months among individuals with follow-up BP data (treatment, n=154; control, n=137), 68.2% of the treatment group and 41.6% of the control group had controlled BP (P<0.001). In final adjusted analysis, treatment group participants had 3.7 [95% CI, 2.1-6.5] times the odds of achieving BP control at follow-up compared with the control group. CONCLUSIONS: A CHW-led health coaching intervention was effective in achieving BP control among South Asian Americans in New York City primary care practices. Findings can guide translation and dissemination of this model across other communities experiencing hypertension disparities. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03159533.