Faculty Bibliography

BACKGROUND:A number of studies have identified patient-, provider-, and community-level barriers to effective diabetes management among South Asian Americans, who have a high prevalence of type 2 diabetes. However, no multi-level, integrated community health worker (CHW) models leveraging health information technology (HIT) have been developed to mitigate disease among this population. This paper describes the protocol for a multi-level, community-clinical linkage intervention to improve glycemic control among South Asians with uncontrolled diabetes. METHODS:The study includes three components: 1) building the capacity of primary care practices (PCPs) to utilize electronic health record (EHR) registries to identify patients with uncontrolled diabetes; 2) delivery of a culturally- and linguistically-adapted CHW intervention to improve diabetes self-management; and 3) HIT-enabled linkage to culturally-relevant community resources. The CHW intervention component includes a randomized controlled trial consisting of group education sessions on diabetes management, physical activity, and diet/nutrition. South Asian individuals with type 2 diabetes are recruited from 20 PCPs throughout NYC and randomized at the individual level within each PCP site. A total of 886 individuals will be randomized into treatment or control groups; EHR data collection occurs at screening, 6-, 12-, and 18-month. We hypothesize that individuals receiving the multi-level diabetes management intervention will be 15% more likely than the control group to achieve ≥0.5% point reduction in hemoglobin A1c (HbA1c) at 6-months. Secondary outcomes include change in weight, body mass index, and LDL cholesterol; the increased use of community and social services; and increased health self-efficacy. Additionally, a cost-effectiveness analysis will focus on implementation and healthcare utilization costs to determine the incremental cost per person achieving an HbA1c change of ≥0.5%. DISCUSSION/CONCLUSIONS:Final outcomes will provide evidence regarding the effectiveness of a multi-level, integrated EHR-CHW intervention, implemented in small PCP settings to promote diabetes control among an underserved South Asian population. The study leverages multisectoral partnerships, including the local health department, a healthcare payer, and EHR vendors. Study findings will have important implications for the translation of integrated evidence-based strategies to other minority communities and in under-resourced primary care settings. TRIAL REGISTRATION/BACKGROUND:This study was registered with clinicaltrials.gov: NCT03333044 on November 6, 2017.

BACKGROUND:Digital mental health interventions are being used more than ever for the prevention and treatment of psychological problems. Optimizing the implementation aspects of digital mental health is essential to deliver the program to populations in need, but there is a lack of validated implementation outcome measures for digital mental health interventions. OBJECTIVE:The primary aim of this study is to develop implementation outcome scales of digital mental health for different levels of stakeholders involved in the implementation process: users, providers, and managers or policy makers. The secondary aim is to validate the developed scale for users. METHODS:We developed English and Japanese versions of the implementation outcome scales for digital mental health (iOSDMH) based on the literature review and panel discussions with experts in implementation research and web-based psychotherapy. The study developed acceptability, appropriateness, feasibility, satisfaction, and harm as the outcome measures for users, providers, and managers or policy makers. We conducted evidence-based interventions via the internet using UTSMeD, a website for mental health information (N=200). Exploratory factor analysis (EFA) was conducted to assess the structural validity of the iOSDMH for users. Satisfaction, which consisted of a single item, was not included in the EFA. RESULTS:The iOSDMH was developed for users, providers, and managers or policy makers. The iOSDMH contains 19 items for users, 11 items for providers, and 14 items for managers or policy makers. Cronbach α coefficients indicated intermediate internal consistency for acceptability (α=.665) but high consistency for appropriateness (α=.776), feasibility (α=.832), and harm (α=.777) of the iOSDMH for users. EFA revealed 3-factor structures, indicating acceptability and appropriateness as close concepts. Despite the similarity between these 2 concepts, we inferred that acceptability and appropriateness should be used as different factors, following previous studies. CONCLUSIONS:We developed iOSDMH for users, providers, and managers. Psychometric assessment of the scales for users demonstrated acceptable reliability and validity. Evaluating the components of digital mental health implementation is a major step forward in implementation science.

BACKGROUND:PD-1 marks exhausted T cells, with weak effector functions. Adults living with HIV have increased levels of PD-1+ CD8 T cells that correlate with HIV disease progression, yet little is known about the role of PD-1+ CD8 T cells in children with perinatal HIV. METHODS:We enrolled 76 Kenyan children with perinatal HIV and 43 children who were HIV unexposed and quantified PD-1 levels on CD8 T cells, their coexpression with immune checkpoints (IC) 2B4, CD160 and TIM3, correlates with immune activation and HIV disease progression and HIV-specific and non-specific proliferative responses. RESULTS:PD-1+ CD8 T cell frequencies are elevated in children with perinatal HIV and associated with disease progression. The majority of PD-1+ CD8 T cells coexpress additional ICs. ART initiation lowers total PD-1 levels and coexpression of multiple ICs. The frequency of PD-1 + 2B4+CD160+TIM3- in PD-1+ CD8 T cells, predicts weaker HIV-specific proliferative responses, suggesting this subset is functionally exhausted. CONCLUSION/CONCLUSIONS:Children with perinatal HIV have high PD-1+ CD8 T cells that are a heterogeneous population differentially coexpressing multiple ICs. Understanding the complex interplay of ICs is essential to guide the development of PD-1 directed immunotherapies for pediatric HIV remission and cure.

OBJECTIVE:People who inject drugs (PWID) have high hepatitis C virus (HCV) infection prevalence but low rates of HCV treatment uptake. To better harness the potential of peer-led social network-based interventions to increase HCV treatment uptake among PWID, simple tools that can help identify individuals with the potential to function effectively as peer-mentors who support network members to get HCV tested and linked to care are needed. METHODS:Data from a survey administered to index PWID enrolled in a social network-based intervention, in which they were invited to recruit drug use network members for HCV testing and linkage to care, was analyzed. Constructs derived from exploratory factor analysis were validated through confirmatory factor analysis (CFA). We used logistic regression analysis to assess the association between scores in identified constructs and subsequent effectiveness in the peer mentor role, defined as recruiting at least one network member for HCV testing and linkage to care in the 12 weeks following survey completion. RESULTS:Among 100 PWID with median age 53 years, 74% male, and 71% Black, CFA resulted in a multidimensional three-factor survey with 4 questions related to opinion leadership, 3 questions related to perceived HCV-related stigma, and 3 questions related to HCV communication comfort and care support willingness. Only self-designated opinion leadership was associated with effectiveness in the peer mentor role (adjusted odds ratio 3.76 (95% Confidence interval CI 1.01, 14.0)). CONCLUSION/CONCLUSIONS:We developed and validated a simple tool with potential to ease and improve the efficiency of peer-led social network interventions.

BACKGROUND:In regions with weak healthcare systems, critical shortages of the healthcare workforce, and increasing prevalence of dual disease burdens, there is an urgent need for the implementation of proven effective interventions and strategies to address these challenges. Our mixed-methods hybrid type II effectiveness-implementation study is designed to fill this evidence-to-practice gap. This study protocol describes a cluster randomized controlled trial which evaluates the effectiveness of an implementation strategy, practice facilitation (PF), on the integration, adoption, and sustainability of a task-strengthening strategy for hypertension control (TASSH) intervention within primary healthcare centers (PHCs) in Lagos State, Nigeria. DESIGN/METHODS:Guided by the Consolidated Framework for Implementation Research (CFIR) and the Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM), this study tests the impact of a proven effective implementation strategy to integrate hypertension management into the HIV care cascade, across 30 PHCs. The study will be conducted in three phases: (1) a pre-implementation phase that will use CFIR to develop a tailored PF intervention for integrating TASSH into HIV clinics; (2) an implementation phase that will use RE-AIM to compare the clinical effectiveness of PF vs. a self-directed condition (receipt of information on TASSH without PF) on BP reduction; and (3) a post-implementation phase that will use RE-AIM to evaluate the effect of PF vs. self-directed condition on adoption and sustainability of TASSH. The PF intervention components comprise (a) an advisory board to provide leadership support for implementing TASSH in PHCs; (b) training of the HIV nurses on TASSH protocol; and (c) training of practice facilitators, who will serve as coaches, provide support, and performance feedback to the HIV nurses. DISCUSSION/CONCLUSIONS:This study is one of few, if any trials, to evaluate the impact of an implementation strategy for integrating hypertension management into HIV care, on clinical and implementation outcomes. Findings from this study will advance implementation science research on the effectiveness of tailoring an implementation strategy for the integration of an evidence-based, system-level hypertension control intervention into HIV care and treatment. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov ( NCT04704336 ). Registered on 11 January 2021.

Background Ankle-brachial index (ABI) is used to identify lower-extremity peripheral artery disease (PAD). However, its association with severe ischemic leg outcomes (eg, amputation) has not been investigated in the general population. Methods and Results Among 13 735 ARIC (Atherosclerosis Risk in Communities) study participants without clinical manifestations of PAD (mean age, 54 [SD, 5.8] years; 44.4% men; and 73.6% White) at baseline (1987-1989), we quantified the prospective association between ABI and subsequent severe ischemic leg outcomes, critical limb ischemia (PAD with rest pain or tissue loss) and ischemic leg amputation (PAD requiring amputation) according to discharge diagnosis. Over a median follow-up of ≈28 years, there were 221 and 129 events of critical limb ischemia and ischemic leg amputation, respectively. After adjusting for demographics, ABI ≤0.90 versus 1.11 to 1.20 had a ≈4-fold higher risk of critical limb ischemia and ischemic leg amputation (hazard ratios, 3.85 [95% CI, 2.09-7.11] and 4.39 [95% CI, 2.08-9.27]). The magnitude of the association was modestly attenuated after multivariable adjustment (hazard ratios, 2.44 [95% CI, 1.29-4.61] and 2.72 [95% CI, 1.25-5.91], respectively). ABI 0.91 to 1.00 and 1.01 to 1.10 were also associated with these severe leg outcomes, with hazard ratios ranging from 1.7 to 2.0 after accounting for potential clinical and demographic confounders. The associations were largely consistent across various subgroups. Conclusions In a middle-aged community-based cohort, lower ABI was independently and robustly associated with increased risk of severe ischemic leg outcomes. Our results further support ABI ≤0.90 as a threshold diagnosing PAD and also suggest the importance of recognizing the prognostic value of ABI 0.91 to 1.10 for limb prognosis.

BACKGROUND:The COVID-19 pandemic has exerted a significant toll on the lives of people who use opioids (PWUOs). At the same time, more flexible regulations around provision of opioid use disorder (OUD) services have led to new opportunities for facilitating access to services for PWUOs. In the current scoping review, we describe new services and service modifications implemented by treatment and harm reduction programs serving PWUO, and discuss implications for policy and practice. METHODS:Literature searches were conducted within PubMed, LitCovid, Embase, and PsycInfo for English-language studies published in 2020 that describe a particular program, service, or intervention aimed at facilitating access to OUD treatment and/or harm reduction services during the COVID-19 pandemic. Abstracts were independently screened by two reviewers. Relevant studies were reviewed in full and those that met inclusion criteria underwent final data extraction and synthesis (n = 25). We used a narrative synthesis approach to identify major themes around key service modifications and innovations implemented across programs serving PWUO. RESULTS:Reviewed OUD treatment and harm reduction services spanned five continents and a range of settings from substance use treatment to street outreach programs. Innovative service modifications to adapt to COVID-19 circumstances primarily involved expanded use of telehealth services (e.g., telemedicine visits for buprenorphine, virtual individual or group therapy sessions, provision of donated or publicly available phones), increased take-home medication allowances for methadone and buprenorphine, expanded uptake of long-acting opioid medications (e.g. extended-release buprenorphine and naltrexone), home delivery of services (e.g. MOUD, naloxone and urine drug screening), outreach and makeshift services for delivering MOUD and naloxone, and provision of a safe supply of opioids. CONCLUSIONS:The COVID-19 pandemic has posed multiple challenges for PWUOs, while simultaneously accelerating innovations in policies, care models, and technologies to lower thresholds for life-saving treatment and harm reduction services. Such innovations highlight novel patient-centered and feasible approaches to mitigating OUD related harms. Further studies are needed to assess the long-term impact of these approaches and inform policies that improve access to care for PWUOs.

Early in the pandemic, in the North American epicenter, we investigated associations between sociodemographic factors and rates of pediatric COVID-19 diagnoses in a non-clinical setting and whether symptoms varied by child age. From 20 April-31 August 2020, COVID-19-related data were collected on 2694 children aged ≤ 18 years living in households participating in the New York University Children's Health and Environment Study. We examined differences in rates of subjective and objective diagnoses according to sociodemographic characteristics and differences in reported symptoms by child age. Children of women who were non-Hispanic White, had private health insurance, higher income, or more education were more likely to be diagnosed via WHO criteria or healthcare provider. Children of women who were Hispanic or Asian, reported low income, had less education, or were/lived with an essential worker were more likely to test positive. Older children were less likely to experience cough or runny nose and more likely to experience muscle/body aches, sore throat, headache, and loss of smell or taste than younger children. In conclusion, relying on subjective disease ascertainment methods, especially in the early stage of an outbreak when testing is not universally available, may misrepresent the true prevalence of disease among sociodemographic subgroups. Variations in symptoms by child age should be considered when determining diagnostic criteria.

OBJECTIVE:Little is known about clinicians' decision-making about decreasing active surveillance (AS) testing/converting patients to watchful waiting (WW), nor are there any guidelines. The objective of this study was to identify factors that clinicians consider when decreasing AS testing/converting to WW for men with prostate cancer. DESIGN:Exploratory qualitative study. SETTING:All participants practiced in various institutions in the USA. PARTICIPANTS:Eligible clinicians had to provide clinical care for patients with prostate cancer in the USA and speak English. Clinicians could be either urologists or radiation oncologists. Of the 24 clinicians, 83% were urologists representing 11 states, 92% were men and 62% were white. METHODS:This qualitative study used data from semi-structured interviews. Purposive sampling was used to ensure geographical variation in the USA. Data collection continued until thematic saturation was achieved. Framework analysis guided coding and identification of themes. Two researchers coded all transcripts independently, met to discuss and reached consensus. RESULTS:Interviews with clinicians demonstrated that testing or monitoring for AS or transitioning to WW is happening in practice, whether intentionally or unintentionally. Decisions to decrease AS were personalised and tailored to patients' health status. Life expectancy was the dominant factor that influenced decision, but clinicians were generally hesitant to specify an age when they would decrease AS or transition to WW. Fear that poor adherence could lead to missed progression and concerns about the medico-legal issue of not doing enough were cited as barriers to decreasing AS. CONCLUSIONS:These findings suggest that in certain situations, AS frequency is reduced or transitioned to WW, yet decisions appear to be inconsistent and there are no significant barriers. These findings could inform further areas to explore when drafting recommendations that consider patients' values and preferences when making decisions about decreasing AS/converting to WW.