Faculty Bibliography

BACKGROUND:Individuals involved in the criminal legal system represent one of the most disproportionately affected populations in the opioid overdose crisis. Despite evidence of medications for opioid use disorder (MOUD) reducing overdose mortality, illicit opioid use, and recidivism, most correctional facilities do not offer these treatments. Sublocade and Brixadi, two distinct, branded, formulations of extended-release buprenorphine (XR-B), offer a promising approach to improving MOUD treatment adherence and reducing post-release overdose deaths. METHODS:This hybrid pilot study will utilize a partially randomized preference trial (PRPT) design to compare the preliminary effectiveness, feasibility, acceptability and other outcomes between Sublocade and Brixadi initiation. We aim to enroll 60 incarcerated individuals with opioid use disorder who are interested in XR-B and have a scheduled release within 120 days. Participants will choose their preferred injectable treatment or, if ambivalent, be randomly assigned. All participants will receive monthly XR-B injections pre-release and continue for three months post-release, with additional administrative follow-up for another three months. The primary outcome is post-release treatment retention; other outcomes will be assessed using the Proctor taxonomy. Data will be collected using clinical assessments, surveys, and administrative databases. DISCUSSION/CONCLUSIONS:This study explores differences in XR-B formulations during the high-risk time of transition out of prison. It combines a hybrid implementation science and preference trial design-two methodologies that can help address the specific challenges of research in carceral environments. By understanding implementation of XR-B in a prison setting, findings can provide valuable insights to guide other facilities in adopting this life-saving treatment.

IMPORTANCE/UNASSIGNED:Medication nonadherence is present in nearly half of patients with hypertension but is underrecognized in clinical care. Data linkages between electronic health records and pharmacies have created opportunities for scalable assessment of medication adherence at the point of care. OBJECTIVE/UNASSIGNED:To test the effectiveness of a multicomponent intervention that identified patients with uncontrolled hypertension and medication nonadherence using linked electronic health record-pharmacy data combined with team-based care to address adherence barriers. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:TEAMLET (Leveraging Electronic Health Record Technology and Team Care to Address Medication Adherence) was a pragmatic, 2-arm, cluster randomized clinical trial conducted between October 2022 and November 2024 in 10 primary care sites in New York. The study included adults with uncontrolled hypertension and low medication adherence, defined as proportion of days covered (PDC) less than 80%. Data analysis was performed from November 2024 to January 2025. INTERVENTION/UNASSIGNED:The intervention consisted of the following: (1) automated identification of patients with medication nonadherence at the time of the visit; (2) prompting of medical assistants to screen for barriers to adherence; (3) clinical decision support alerting the primary care physicians and nurse practitioners to barriers to adherence; and (4) adherence discussion between the primary care physician or nurse practitioner and the patient. The comparator was usual care. MAIN OUTCOMES AND MEASURES/UNASSIGNED:The primary outcome was change in PDC from baseline to 12 months. RESULTS/UNASSIGNED:Among 1726 patients (mean [SD] age, 67.2 [13.9] years; 887 [51.4%] female), the mean (SD) baseline PDC was 33.2% (30.5%) overall (32.4% [30.4%] in the intervention group and 34.0% [30.6%] in the control group). The mean (SD) PDC at 12 months was 51.1% (39.5%) for the intervention group and 53.1% (39.6%) for the control group. No difference was found in the change in PDC from baseline to 12 months between the intervention and control groups (mean [SD] absolute change in PDC, 18.5 [41.1] vs 18.2 [40.9] percentage points, respectively; adjusted difference, -0.15 percentage point; 95% CI, -4.06 to 3.76 percentage points). Change in systolic blood pressure and patients who became adherent (PDC ≥80%) at 12 months were also similar between groups. CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this pragmatic trial, an intervention that combined team-based primary care with automated identification of patients with antihypertensive medication nonadherence did not lead to improvements in adherence or blood pressure. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT05349422.

BACKGROUND:Unmet structural and social needs create barriers to breast cancer screening and treatment. The impact of the intersection of these barriers on screening participation and timeliness of breast cancer care remains poorly understood. METHODS:People identifying as women participating in a breast cancer navigation program for screening or treatment were included. Patient navigators administered survey questions that addressed potential barriers to care access using the Health Leads Screening Toolkit. Odds ratios were calculated for unadjusted bivariate associations, and Cox proportional hazards were used to examine the relationship between barriers and time to treatment. RESULTS:A total of 2804 women (mean age, 53 years) enrolled in navigation for screening or cancer treatment participated in the survey about barriers to care. Of those, 435 (16%) reported unstable housing, 610 (23%) reported poor health literacy, and 164 (6%) reported feeling depressed. Limited transportation was significantly associated with unstable housing (odds ratio [OR] = 26.5, 95% confidence interval [CI] 19.9-35.4, p < 0.00001), poor health literacy (OR = 11.5, 95% CI 9.3-14.2, p < 0.0001), and depression (OR = 2.9, 95% CI 2.1-4.0, p < 0.00001). Individual barriers were not associated with a longer time to treatment, but an increasing number of barriers was associated with a longer time to treatment (Coef = 0.9, p < 0.05). CONCLUSIONS:Compounding structural and social barriers limit participation in breast cancer screening, and women with increasing unmet social needs face delays in treatment for breast cancer. Navigation programs may help women overcome barriers to care; however, understanding and targeting the intersectionality of unmet needs is essential for targeted interventions through breast cancer care navigation programs to be effective.

This article reviews the development and evolution of Fogarty International Center-funded research ethics training programs in West Africa over the past decade. In response to local and global challenges in bioethics and biomedical research, these programs are fostering ethical awareness, shaping local and national ethics review systems, and enhancing bioethics capacity in the region. These efforts have expanded alongside increased democratic governance, technological advances, and significant increases in global research funding and international research collaborations, particularly related to HIV/AIDS and malaria. We believe that the West Africa Bioethics (WAB) Training Program in Nigeria played a central role in this growth, serving as a model for subsequent programs in Ghana, Mali, and The Gambia. This paper describes the nature, successes, and challenges of these programs. It also outlines an agenda and strategies for future work to enhance research ethics and bioethics capacities in the region, both in terms of education and governance.

INTRODUCTION/BACKGROUND:Secondhand exposure to e-cigarettes represents a potential population health risk given e-cigarette's prevalence and their unknown health effects, particularly among vulnerable populations such as pregnant people. OBJECTIVES/OBJECTIVE:To explore metabolomic differences between pregnant people exposed vs. not exposed to secondhand e-cigarette aeresols, to identify possible biomarkers of exposure and metabolic pathways perturbed by e-cigarettes. METHODS:Exposed participants (n = 19) from the NYU Children's Health and Environment Study were matched to unexposed participants (n = 57) at a 1:3 ratio on age, hospital of recruitment, and race/ethnicity. Early-pregnancy urine samples were analyzed via an untargeted metabolomics platform using reverse-phase liquid chromatography mass-spectrometry. Feature-exposure associations were estimated using conditional logistic regression to adjust for matching factors. A sensitivity analysis was conducted adjusting for secondhand tobacco exposure. RESULTS:Among features enriched in the exposed group were flavonoids and flavor-related compounds including homoeriodictyol and naringenin-7-O-beta-D-glucuronide, 3-acetomidocoumarin, and guaiacol pentosylglucoside; synthetic drugs such as the endocannabinoid AM1172 and the stimulant alpha-PVP; and metabolites associated with lipid metabolism, including 2,4-undecadiene-8,10-diynoic acid isobutylamide, palmitamide, glycerol trihexanoate, and tetradecyl phosphonate. Among features negatively associated with exposure were xanthines. CONCLUSION/CONCLUSIONS:This study is the first untargeted metabolomics study investigating metabolomic markers of e-cigarette exposure, including secondhand exposure, in a pregnant cohort. Despite this study's small size and exploratory nature, the results of this work suggest that flavoring components could be biomarkers for e-cigarette exposure, and that co-exposure to e-cigarettes and other drugs may be prevalent.

OBJECTIVES/OBJECTIVE:Edentulism and diabetes mellitus (DM) are frequently seen among older adults. However, the joint effect of edentulism and DM on mortality was understudied. We aim to examine the joint effect of edentulism and DM on all-cause mortality and to what extent the joint effect varies by race/ethnicity. METHODS:Analysis of US Health and Retirement Study (HRS) data (2006-2018) included 11,813 non-Hispanic Whites, 2216 non-Hispanic Blacks, and 1337 Hispanics aged ≥ 50 years old. Mortality data came from the National Death Index or HRS surveys. Edentulism was self-reported and DM was determined by self-reported diagnosis, medication use, or glycosylated hemoglobin. Cox proportional-hazard models with inverse probability treatment weighting were applied. RESULTS:During mean follow-up of 9.6 years, 2874 Whites, 703 Blacks, and 441 Hispanics died. DM was associated with higher mortality across all groups (Whites: HR = 1.43, 95% CI = 1.25-1.64; Blacks: HR = 1.62, 95% CI = 1.28-2.04; Hispanics: HR = 1.46, 95% CI = 1.07-1.99). However, edentulism predicted higher mortality only in Whites (HR = 1.65, 95% CI = 1.51-1.80). Having both conditions showed highest mortality risk in all groups (Whites: HR = 2.31, 95% CI = 1.56-3.42; Blacks: HR = 1.94, 95% CI = 1.45-2.59; Hispanics: HR = 1.77, 95% CI = 1.16-2.70), with a significant additive interaction observed only in Whites (relative excess risk due to interaction = 0.22, p < 0.05). CONCLUSIONS:DM and edentulism pose an additive risk for mortality in Whites, and there are racial/ethnic differences in edentulism-related mortality.

OBJECTIVE:This study examined racial and ethnic differences in percent total weight loss (%TWL) and glycemic improvement following sleeve gastrectomy (SG) and explored the role of socioeconomic and psychosocial factors in postsurgical outcomes. METHODS:This longitudinal study included patients who underwent SG between 2017 and 2020, with follow-up visits over 24 months. RESULTS:Non-Hispanic Black (NHB) participants had lower %TWL at 3, 12, and 24 months compared with Hispanic (H) and non-Hispanic White (NHW) participants. Fat mass index was initially lower in NHB, with smaller reductions over time and significant group differences persisting at 24 months. NHB participants had higher baseline fat-free mass index values; by 24 months, fat-free mass index values were lower in H participants. Hemoglobin A1c decreased across all groups but remained consistently higher in NHB and H compared with NHW at 24 months. NHB participants reported higher perceived discrimination, sleep disturbance, and perceived stress than H and NHW participants at all time points. Employment status predicted %TWL at 12 months. There was a significant interaction between race and ethnicity and employment status observed at 12 and 24 months, suggesting that employment-related disparities could impact surgical outcomes. CONCLUSIONS:NHB participants experienced less favorable outcomes following SG, emphasizing the need for tailored interventions addressing socioeconomic and psychosocial disparities.

OBJECTIVE:To examine whether patient sociodemographic and clinical characteristics and prior interactions with the healthcare system were associated with opening patient portal messages related to cancer genetic services and beginning services. STUDY SETTING AND DESIGN/METHODS:The trial was conducted in the University of Utah Health (UHealth) and NYU Langone Health (NYULH) systems. Between 2020 and 2023, 3073 eligible primary care patients aged 25-60 years meeting family history-based criteria for cancer genetic evaluation were randomized 1:1 to receive a patient portal message with a hyperlink to a pretest genetics education chatbot or information about scheduling a pretest standard of care (SOC) appointment. DATA SOURCES AND ANALYTIC SAMPLE/UNASSIGNED:Primary data were collected. Eligible patients had a primary care visit in the previous 3 years, a patient portal account, no prior cancer diagnosis except nonmelanoma skin cancer, no prior cancer genetic services, and English or Spanish as their preferred language. Multivariable models identified predictors of opening patient portal messages by site and beginning pretest genetic services by site and experimental condition. PRINCIPAL FINDINGS/RESULTS:Number of previous patient portal logins (UHealth average marginal effect [AME]: 0.32; 95% CI: 0.27, 0.38; NYULH AME: 0.33; 95% CI: 0.27, 0.39), having a recorded primary care provider (NYULH AME: 0.15; 95% CI: 0.08, 0.22), and more primary care visits in the previous 3 years (NYULH AME: 0.09; 95% CI: 0.02, 0.16) were associated with opening patient portal messages about genetic services. Number of previous patient portal logins (UHealth AME: 0.14; 95% CI: 0.08, 0.21; NYULH AME: 0.18; 95% CI: 0.12, 0.23), having a recorded primary care provider (NYULH AME: 0.08; 95% CI: 0.01, 0.14), and more primary care visits in the previous 3 years (NYULH AME: 0.07; 95% CI: 0.01, 0.13) were associated with beginning pretest genetic services. Patient sociodemographic and clinical characteristics were not significantly associated with either outcome. CONCLUSIONS:As system-level initiatives aim to reach patients eligible for cancer genetic services, patients already interacting with the healthcare system may be most likely to respond. Addressing barriers to accessing healthcare and technology may increase engagement with genetic services.