OBJECTIVES/SPECIFIC AIMS: The use of digital practices and approaches can potentially increase the quality and efficiency of all phases of the traditional clinical translational research (CTR) process. The purpose of this qualitative study was to describe key stakeholders’ perspectives on the need to: (A) formalize training in digital practices and approaches among CTR trainees; and (B) develop an aligned educational framework that defines core competencies, educational methods, and evaluation metrics. METHODS/STUDY POPULATION: Participants (n=66) were recruited via email from June to November 2017 using purposive and snowball sampling methods across 4 groups: (1) English speaking national and international experts from academic and private sector institutions with working experience in using digital practices and approaches in research (n=36), (2) CTR educators (n=8), (3) CTR trainees (n=13), and (4) Members of the Southern California Clinical and Translational Science Institute at the University of Southern California (n=9). Online focus groups were conducted using a semi-structured, open-ended interview guide through Google Hangouts and a conference call interface. Sessions were recorded and transcribed verbatim, and 2 research team members performed independent content analyses to identify before and emergent themes using an inductive analytic approach. Kappa was calculated for inter-rater agreement and repeated until agreement was at least 0.70. RESULTS/ANTICIPATED RESULTS: Participants’ average age (41.2 yrs, SD 9.26), gender (59% females), non-Hispanic (97%), race (72% White), and doctoral degree (67%). In total, 85% reported experience in teaching digital practices and approaches in research, although 70% were currently not teaching in this field. Participants reported that complementary teaching in digital practices and approaches across the 15 Clinical and Translational Science Award (CTSA) CTR competency areas was relevant, especially in literature review, research implementation, statistical approaches, biomedical informatics, regulatory support, responsible conduct of research, scientific communication, translational teamwork, cross-disciplinary training, leadership, and community engagement; and less so in literature critique, study design, sources of error, and cultural diversity. Additional competencies were identified, for example, online study recruitment, crowdfunding, team and project management, scholarly impact metrics (Altmetrics), ethical and regulatory guidance for conducting research using digital approaches. Five main educational practices were identified including online training sessions, flexible on-demand modules, in-person consultations and training, and project-oriented hands-on workshops. Among the identified challenges were the need for clear metrics in order to evaluate such a training program. DISCUSSION/SIGNIFICANCE OF IMPACT: There was consistent support for a structured program to help CTR trainees to develop competency in digital research practices and approaches. Our results indicate that an education program focused on digital practices and approaches should include a step-wise approach to meet different research and training goals, allowing attendees to increase their awareness and specialized hands-on practical experience.

OBJECTIVES/SPECIFIC AIMS: To identify areas of variation in primary care clinician responses to secure messaging and to assess the quality of secure messages by clinicians. METHODS/STUDY POPULATION: This mixed-methods study included twenty one primary care clinicians from a Midwestern safety net hospital and Veterans Affairs medical center. Participants were presented with five short clinical vignettes and corresponding secure messages from hypothetical patients and asked to compose responses. Participants were interviewed about their cognitive approach to the responses as well as perspectives on quality of care as related to electronic communications. RESULTS/ANTICIPATED RESULTS: Every participant recalled having patients who misused secure messaging for urgent issues, suggesting the need for more patient education and the possible adverse consequences of overlooked messages. The study also uncovered key differences in several areas, include clinician timeliness, message management, the circumstances in which they would use messaging, and the content of the messages (including patient-centeredness). While participants agreed that messages about clinical issues should not be resolved via secure messaging, there was a lack of consensus regarding emotionally charged messages and messages dealing with medication adjustments. Some participants spoke of the need for more guidance in knowing when best to use secure messaging. “Sometimes,” one physician said, “it feels like we’re just making up [rules for secure messaging].” Although clinician responses were uniformly respectful, the patient-centeredness varied in the use of jargon and social talk, as well as clarity for patients. DISCUSSION/SIGNIFICANCE OF IMPACT: This study revealed variations in provider approaches to secure messaging, and the content of responses. These variations reflect lack of consensus about how care is delivered via secure messaging, and reveal the need for clinician guidance. They also suggest possible negative patient consequences if secure messaging is used ineffectively. The extent to which variations are undesirable remains unknown. Future work will explore the consequences of such variations.

OBJECTIVES/GOALS: Despite advances in precision medicine and understanding of the molecular pathways, melanoma remains the deadliest skin cancer, warranting identification of novel biomarkers. In this study, we performed bioinformatic analysis of melanoma patient tumors to identify novel dysregulated gene and micro-RNA (miRNA) targets responsible for survival. METHODS/STUDY POPULATION: Genetic sequencing data for 594 patient samples of melanoma and normal skin tissue from 10 databases were accessed using the NCBI Gene Expression Omnibus. Genes and miRNA that were significantly dysregulated (adjusted p-value < 0.05, log fold change > ± 2) in melanoma compared to normal skin were identified using the GEO2R program. Dataset expression profiles were cross-referenced to identify genetic elements dysregulated in at least 50% of datasets and filtered for association with poor survival using R2 Genomics Analysis and Visualization Platform. DAVID 6.8 provided pathway analysis of dysregulated genes. miRTarBase linked genes associated with poor survival and dysregulated miRNA from our database analysis. RESULTS/ANTICIPATED RESULTS: Bioinformatic analysis revealed consistent differential regulation of 205 genes (down=177 and up=28) and 38 miRNA across datasets with fold change >2 (bonf. p<0.05). Pathway analysis indicated that PPAR, phosphatidylinositol signaling, Rap1 signaling, and p53 signaling pathways were enriched by downregulated genes while the NF-kB pathway was enriched up regulated genes. Survival analysis of the differentially regulated genes identified 11 downregulated (ACSL1, CEBPA, CES4A, CRIP1, GATA3, HLADQB2, PTGS1, PYCARD, PPARG, PKP3, RSSF6) and 3 upregulated (DUXAP10, SLC2A3 and PRAME) hub genes to be associated with poor overall survival. Out of the 13 miRNA associated with hub genes, five miRNA (hsa-miR-125b-5p, hsa-miR-130b-3p, hsa-miR-26n-5p, hsa-miR-30b, hsa-miR-30c) were linked to multiple hub genes. DISCUSSION/SIGNIFICANCE: Our analysis identified 14 hub genes (regulators of PPARA, adipocyte differentiation, and transcriptional pathways) as well as miRNAs hsa-miR-30c (regulator of PTGS1 and SLC2A3) and hsa-let-7i-5p (regulator of ASCL1) as potential therapeutic targets. Further studies for validation of the targets are needed for clinical translation in melanoma.

OBJECTIVES/GOALS: The CDC-funded Program to Alleviate National Disparities in Ethnic and Minority Immunizations in the Community intersects two national networks that transform building trust in communities: Cooperative Extension Systems and Clinical and Translational Science Awardees, with the goal of reducing vaccine hesitancy and increasing vaccine uptake. METHODS/STUDY POPULATION: PANDEMIC included North Central Florida; Greater Sacramento, California; Bronx, New York; St. Louis and the Ozarks, Missouri; rural Kentucky; and Minnesota. Our 10 Promising Practices (PPs) focus on the equitable distribution of COVID-19 vaccines and health information, with two detailing collaborative efforts to better achieve health equity: PP3) Bringing Services and Vaccines to People Where They Are & PP5) Creating Coalitions with Trusted Neighborhood Partners. CHWs and Extension Educators, trusted community members, work together to deliver culturally/linguistically diverse health messages in plain language in areas of high vaccine hesitancy and bring vaccines to people where they are. All outreach activities are tracked and categorized by PP affiliation. RESULTS/ANTICIPATED RESULTS: From November 2021 – August 2023, PANDEMIC has administered nearly 11,000 COVID-19 vaccines at over 2,500 outreach events. At events, Community Health Workers (CHWs) listen to community members to assess vaccine perceptions and health needs/concerns. We adapt messaging and outreach initiatives to promote vaccination through data analyses that help us understand perceptions. Responses are calculated for the populations of focus (PoF)–Latino/Hispanic, African American/Black, American Indian/Alaskan Native, Asian, Native Hawaiian/Other Pacific Islander) compared to others (Non-Latino/Hispanic White or unspecified race). Over 16,000 surveys were collected from November 2021 – August 2023 with 60% coming from the PoF. Key differences in perceptions will be shown along with other cross-site metrics. DISCUSSION/SIGNIFICANCE: PANDEMIC offers an innovative model for collaboration among CTSAs and Cooperative Extension Systems to better understand community perceptions and support vaccination efforts and overall health promotion in communities of greatest need, with a focus on racial and ethnic minority communities and underinsured/uninsured populations.

OBJECTIVES/SPECIFIC AIMS: Rheumatoid arthritis (RA) is one of the most prevalent systemic autoimmune diseases. It is caused by a combination of genetic and environmental factors. In humans, the intestinal microbe Prevotella copri strongly correlates with RA in previously untreated new-onset rheumatoid arthritis (NORA) patients. Metagenomic assembly of P. copri from NORA patients and healthy controls suggests genetic differences between P. copri from each group. In order to test the hypothesis that genetic differences in P. copri from arthritis patients promote arthritis, I am performing genomic comparison of primary P. copri isolates from NORA patients and healthy controls, and analysis of the immune response to P. copri in mice. Mice colonized with P. copri have increased susceptibility to DSS-induced weight loss and death compared with uncolonized controls. Future experiments will assess the local and systemic immune response in P. copri-colonized, DSS-treated mice. If this work is successful, then it may be possible to exploit genetic variation in P. copri. This could lead to new biomarkers for human disease or even insight into drug metabolism. METHODS/STUDY POPULATION: To validate a strategy to screen for the presence of P. copri in feces, qPCR primers were designed to amplify 8 regions across the 3.5 Mb P. copri reference genome using NCBI PrimerBlast. Primers were validated with DNA from feces for which P. copri abundance was previously determined by 16S rDNA sequencing. P. copri genome-specific primers were used to screen bacterial isolates from NORA patients and healthy controls. The 16S V3-V4 region was sequenced and compared with the P. copri reference 16S sequence to confirm >97% similarity. Genomes of 2 NORA patient isolates were sequenced on Illumina MiSeq, and sequences were compared with the reference genome. A strategy was developed to colonize mice with P. copri: 3-week-old C57BL/6 mice were treated with antibiotics in drinking water for 2 weeks, then switched to water for 2 days before oral gavage with P. copri; 6–7 days after inoculation, P. copri colonization was assessed by plating feces from inoculated mice, and by qPCR of fecal DNA with P. copri-specific primers. A systemic immune response to P. copri was assessed by microbe-specific ELISA for IgG and IgA in the sera of colonized mice. RESULTS/ANTICIPATED RESULTS: P. copri was detected in the stool of 20% of healthy individuals and 50% of NORA patients. P. copri was isolated form 4 healthy individuals and 6 NORA patients. Whole genomes of 96 primary isolates from NORA patients and healthy controls will be sequenced on the Illumina HiSeq platform, and their genomes will be assembled and compared using Spades software. For 2 P. copri isolates for a NORA patient, 89% of 250 bp reads aligned >95% to the P. copri reference genome. Mice can be colonized with P. copri gavaged at >106 CFU. P. copri-specific IgG and IgA were detected in the sera of colonized mice. DISCUSSION/SIGNIFICANCE OF IMPACT: Several primary isolates of P. copri have been collected from healthy controls and NORA patients, which will enable whole genome comparison of these isolates. For the 2 P. copri isolates sequenced, 89% of 250 bp reads aligned >95% to the P. copri reference genome, indicating variability between NORA patient P. copri strains and the P. copri reference genome. The establishment of colonization of mice with P. copri will allow further characterization of the immune response to P. copri at steady state and under pro-inflammatory conditions. Further, the systemic immune response to P. copri indicates that this microbe may have potential to play a role in systemic disease.

OBJECTIVES/SPECIFIC AIMS: Describe (1) the components of the research navigation service and consultation/onboarding program, (2) use and adoption of the services, and (3) the overall satisfaction from the research community. METHODS/STUDY POPULATION: Duke offers 2 programs to support researchers: Research Navigation and Researcher Onboarding. The services aim to connect researchers to resources, offices, funding opportunities, and other collaborators. The general Research Navigation Service is an on-demand “hotline,” where navigators answer questions from researchers across the institution, helping them understand processes, best practices, and how to locate resources or potential collaborators. Navigators can be reached via the myRESEARCHhome portal, email, or by phone. The researcher onboarding program is a free 1:1 consultative service, focused on the researcher’s individual portfolio, stage of career, and immediate plans in the research arena. The goal is to equip researchers “from the start” to be successful. Researchers are identified via the new faculty hire list, or by referral. Both services are provided by the myRESEARCHnavigators team, who are trained in a variety of research areas, from basic to clinical to social sciences, and are familiar with Duke. RESULTS/ANTICIPATED RESULTS: Use of both services has increased substantially over the year. Of the almost 200 faculty members hired into the School of Medicine in 2017, ~75% have taken part in the onboarding program, and 91% have rated the service as 5-stars. The content of the sessions will be described. The Research Navigation service has fielded hundreds of calls since its inception, with topics including Equipment and Facilities (55 requests), Study start up (44 requests), Innovation and Technology (15 requests), and Regulation and Policy (25 requests). Categorization of requests, users of the services, and other information about the programs will be described. DISCUSSION/SIGNIFICANCE OF IMPACT: The navigation and onboarding services are proving to be a successful way to increase efficiency and understanding of processes and resources across the institution. Feedback from the users, coupled with high referral rates to the programs, suggests that the program is helping researchers feel better equipped with regard to their research planning, conduct, and analysis.

Objectives/Goals: The importance of interprofessional communication in healthcare is well documented. However, there has yet to be a theoretical framework for understanding this complex phenomenon. The purpose of this project was to develop a situation-specific theory about the culture of communication in the interprofessional healthcare setting. Methods/Study Population: We conducted individual virtual qualitative interviews with 16 healthcare professionals at different levels and from various disciplines. Participants were practicing clinicians at a tertiary care academic medical center. We transcribed audio-recordings of the interviews verbatim and aligned each transcript for accuracy, confidentiality, and representativeness. Data analysis was conducted using dimensional analysis, including open- and theoretical-coding utilizing an explanatory matrix for theory generation. Results/Anticipated Results: Our findings produced a situation-specific theory on the culture of interprofessional communication in the healthcare setting. Participants described the environments in which they practiced in terms of hierarchical system structures and through a conceptual perspective of resource investment. In other words, they viewed their time and their effort as valuable – and notably, scarce – resources, which they invest in patient care, interprofessional communication, and other tasks. There are two key pathways that characterize the culture of interprofessional communication: collaborative communication and transactional interactions, depending on whether an individual perceives the goals of another person, department, or level of the hierarchical institution as aligned with their own goals. Discussion/Significance of Impact: Positive cultures of interprofessional communication in the healthcare setting depend on perceived goal alignment among individuals, departments, and leadership. Future research can explore how perceptions of goal alignment are developed and empirically test this situation-specific theory in other healthcare system settings.

OBJECTIVES/GOALS: Gender affirming medical care such as hormone therapy surgery can greatly impact the emotional wellbeing and quality of life of transgender and gender-nonconforming individuals. In the US, insurance coverage for these services vary greatly. This project will focus on how insurance denial of gender affirming care can impact emotional wellbeing. METHODS/STUDY POPULATION: Data was collected via the LITE Connect study, a multi-institutional cross-sectional survey conducted among transgender and gender non-conforming adults in the United States and Puerto Rico from 2020 to 2021. The survey collected 2,125 responses concerning demographic data, insurance status, desire to access gender affirming care, history of insurance denial of gender affirming care, psychological distress (measured via Kessler 6 scale), self-harm, and suicide. The study population consisted of respondents who have sought GAMC in their lifetime, and further separated into individuals who have had insurance denial of gender affirming care versus those without insurance denial. Odds ratios were examined for categorical variables and linear regression was conducted for Kessler 6 score. RESULTS/ANTICIPATED RESULTS: Of the 2125 respondents, 1274 (61%) have sought out GAMC. Of those seeking GAMC, 451 (35.4%) have experienced an insurance denial. Preliminary analysis of the odds ratios of insurance denial versus demographic identifiers found no significantly increased odds ratios with respect to race, gender, or age. Given the impact GAMC has on quality of life, we theorize that difficulty accessing gender affirming care would be associated with greater psychological distress. Linear regression found a statistically significant impact of insurance denial of GAMC on Kessler 6 responses (Beta = 0.9684, R^2 = 0.0069). With adjustments for age, gender identity, race, and insurance status, linear regression found denial of GAMC led to a 1.28 increase in Kessler 6 score (CI [0.59, 1.98], p < 0.05). DISCUSSION/SIGNIFICANCE: This study examined the association between access gender affirming care and emotional wellness as measured by the Kessler 6 scale. We have found a statistically significant correlation between insurance denial of GAMC and psychological distress, indicating an avenue for intervention for a vulnerable population.

OBJECTIVES/GOALS: Low birth weight and preterm birth are significant contributors to infant mortality in the United States that disproportionally impact Black pregnant persons and their offspring. Although these outcomes are linked to chronic stress, the contribution of race-related stress remains largely understudied. METHODS/STUDY POPULATION: We investigated the effect of race-related stress on weight and gestational age at birth in a prospective cohort of 115 pregnant Black persons recruited at Grady Memorial Hospital in Atlanta, Georgia. The Index of Race-Related Stress Brief (IRRS-Brief), Perceived Stress Scale (PSS), and Stressful Events Questionnaire (SEQ) were collected at study enrollment during pregnancy. Neonatal birth weights and gestational age were collected via standardized medical record abstraction. We conducted linear regressions to determine whether greater race-related stress was associated with lower weight and gestational age at birth, while controlling for sources of prenatal stress. RESULTS/ANTICIPATED RESULTS: Global racism (total IRRS score) was significantly associated with birth weight when controlling for prenatal perceived stress and stressful life events within the last six months since study enrollment (beta=−16.7, p=.035). Neonatal gestational age was associated with both global racism (beta=-0.03, p=.028) and individual racism (IRRS’Individual’ subscale score) (beta=-0.09, p=.032) when controlling for prenatal perceived stress and stressful life events within the last six months since study enrollment. These results suggest that greater race-related stress contributes to lower weight and gestational age at birth in pregnant Black persons. DISCUSSION/SIGNIFICANCE: Future studies are necessary to determine the mechanisms by which race-related stress contributes to these adverse birth outcomes and to inform the development risk-assessment tools and interventions to mitigate the threat of race-related stress on adverse birth outcomes in high-risk populations.

The purpose of the article is to describe the progress of the Clinical and Translational Science Award (CTSA) Program to address the evaluation-related recommendations made by the 2013 Institute of Medicine’s review of the CTSA Program and guidelines published in CTS Journal the same year (Trochim et al., Clinical and Translational Science 2013; 6(4): 303–309). We utilize data from a 2018 national survey of evaluators administered to all 64 CTSA hubs and a content analysis of the role of evaluation in the CTSA Program Funding Opportunity Announcements to document progress. We present four new opportunities for further strengthening CTSA evaluation efforts: (1) continue to build the collaborative evaluation infrastructure at local and national levels; (2) make better use of existing data; (3) strengthen and augment the common metrics initiative; and (4) pursue internal and external opportunities to evaluate the CTSA program at the national level. This article will be of significant interest to the funders of the CTSA Program and the multiple stakeholders in the larger consortium and will promote dialog from the broad range of CTSA stakeholders about further strengthening the CTSA Program’s evaluation.

The potential for physicians, clinicians, and health professionals to contribute to the advancement of medical therapies through clinical research is significant. Yet, a lack of exposure to, or practical training in, the conduct of clinical research can inhibit health profession trainees from considering research careers, thus perpetuating the already limited influx of new talent. To enhance the sustainability of career pathways into research for all trainees, including those from traditionally underrepresented communities, trainees must experience early exposure to research concepts through robust training and hands-on opportunities. In 2015, the Duke Office of Clinical Research created a Research Immersion elective for Duke’s Master in Biomedical Sciences program, which prepares students for additional health professional training. The course trained students through didactic and practical experiences, with a unique interprofessional mentorship team including both principal investigator and clinical research professional mentors. Following eight cohorts of iterative course optimization, students’ confidence increased in all 24 research competencies assessed. A cross-sectional analysis of post-course outcomes in May 2024 revealed 40.4% of students had continued in research after the program and 60.6% had continued their health professions education. We attributed this success to applied learning and clear expectations and guidelines to support the mentor-student relationship.

Despite having the same underlying genetic etiology, individuals with the same syndromic form of intellectual developmental disability (IDD) show a large degree of interindividual differences in cognition and IQ. Research indicates that up to 80% of the variation in IQ scores among individuals with syndromic IDDs is attributable to nongenetic effects, including social-environmental factors. In this narrative review, we summarize evidence of the influence that factors related to economic stability (focused on due to its prevalence in existing literature) have on IQ in individuals with syndromic IDDs. We also highlight the pathways through which economic stability is hypothesized to impact cognitive development and drive individual differences in IQ among individuals with syndromic IDDs. We also identify broader social-environmental factors (e.g., social determinants of health) that warrant consideration in future research, but that have not yet been explored in syndromic IDDs. We conclude by making recommendations to address the urgent need for further research into other salient factors associated with heterogeneity in IQ. These recommendations ultimately may shape individual- and community-level interventions and may inform systems-level public policy efforts to promote the cognitive development of and improve the lived experiences of individuals with syndromic IDDs.

OBJECTIVES/GOALS: As the clinical and translational research enterprise evolves toward addressing health equity and the science of translational science, the CE Brokers are exploring new avenues for impacting the CTSA consortium. METHODS/STUDY POPULATION: Since 2013, managers of Community Engagement (CE) programs across the NCATS CTSA institutes have met monthly to build connections, share knowledge, and advocate for the boundary spanner role. As the clinical and translational research enterprise evolves toward addressing health equity and the science of translational science, the CE Brokers are exploring new avenues for impacting the CTSA consortium. The CE Brokers are composed of 140 individuals from 58 CTSA-associated institutions, and have a long history that has fostered rich, trusting relationships. The growth and strength of this group has primed it to pivot with the new NCATS direction to contribute meaningfully to the science of community engagement and continue the work of improving health equity within the communities we serve. RESULTS/ANTICIPATED RESULTS: In 2022; we surveyed its members about their roles and responsibilities; the ways the network has contributed to their hub’s adoption and development of best practices and innovations; resources and lessons learned; the creation of opportunities for members to collaboratively conduct and disseminate original research; and research on the science of CE. Grounding ourselves in this initial data, we have developed interview questions to take the inquiry further, by gathering qualitative data on the impact of the group: How the Brokers group impacted them personally and professionally; How the Brokers impacted the work of their CTSA; In three words, describe the group; How could the CE Brokers contribute to the science of community engagement? DISCUSSION/SIGNIFICANCE: Together, we will identify themes supported by quotes to inform how the CE Broker group is most effectively moving the CTSAs’ mission forward and how it can be improved. These will be shared at the Translational Science Meeting, 2023.

OBJECTIVES/GOALS: Non-operative management is preferred for pediatric solid organ injury (SOI). Despite this children treated at adult trauma centers (ATC) are more likely to be treated surgically and have worse outcomes than those treated at pediatric trauma centers (PTC). We hypothesize there are disparities by sex and race in management of pediatric SOI at ATC vs PTC. METHODS/STUDY POPULATION: Retrospective review of the National Trauma Data Bank (NTDB) from 2010-2018 was conducted. Inclusion criteria were age£18 and injury to spleen, liver or kidney. Outcomes at American College of Surgeons accredited ATC, PTC, and combined ATC/PTC trauma centers were evaluated. The primary outcome was operative management. Secondary outcomes include length of stay, and in-hospital complications. Multivariate logistical regression adjusting for race, sex, and insurance type will be performed. RESULTS/ANTICIPATED RESULTS: 40,111 children were treated for SOI from 2010-2018. 39.3% were treated at an ATC and 26.4% at a PTC. Of children treated at an ATC, 62% were White, 17% were Black, and 1% were Asian. Children treated at the PTC were 60% White, 20% Black, and 0.9% Asian. Primary insurance type was Medicaid for 33% of patients at an ATC and 39% at PTC. Median length of stay at ATC and PTC was 4 days (2-7) and 3 days (2-6) respectively. 3.85% of patients at ATC underwent splenectomy compared to 0.8% at PTC. It is anticipated that further analysis will demonstrate that ICU admission, transfusion, embolectomy, and other operative interventions will be more prevalent at ATC than MTC. Moreover, we anticipate that multivariate logistical regression will show the odds of receiving operative management at each center differ by race, sex and insurance type. DISCUSSION/SIGNIFICANCE: Initial analysis of the NTDB from 2010-2018 shows that children treated for SOI at ATC receive operative interventions more often than those treated at PTC. Elucidating disparities in SOI care is an important step towards minimizing the impact of these disparities and better allocating resources such that they may be eliminated.

OBJECTIVES/GOALS: To evaluate access to Pre-Exposure Prophylaxis (PrEP) medications for transgender individuals examining how systemic and sociocultural obstacles play a role. Additionally, analyzing the impact of trans-exclusion in clinical trials investigating PrEP efficacy on the trans-HIV care model. METHODS/STUDY POPULATION: By examining the clinicaltrials.gov database, inclusion and exclusion criteria will be collected for Phase III trials of FTC/TAF (Descovy) and FTC/TDF (Truvada) as PrEP for Human Immunodeficiency Virus (HIV). Secondly, trends of physicians’ prescription of PrEP will be analyzed to track post-approval usage and deduce the acceptance and adherence of PrEP by transgender patients. Thirdly, post-approval marketing strategies of PrEP medications will be documented to see key demographics that biopharmaceutical companies are targeting. Finally, relevant literature about trans healthcare will be analyzed to identify key short fallings to support conclusions and justify recommendations for greater transgender clinical trial enrollment and reformations to current standard practices. RESULTS/ANTICIPATED RESULTS: After a preliminary literature review of published Phase III trials for Descovy and Truvada , there is a marked lack of transgender patient enrollment. Contemporary literature argues that this lag in enrollment has downstream effects on trust and acceptance of PrEP as safe and effective by cohorts in the transgender community. The examination of prescribing information for Descovy and Truvada for PrEP reveals a minimal effort to advise doctors of the increased risk for infection in the transgender demographic. Through continued research, I expect to elaborate on the cross-discipline impacts of trans-exclusion, including increased rates of HIV infection, sociocultural and financial barriers to PrEP, and stigmatizing doctor interactions with transgender patients. DISCUSSION/SIGNIFICANCE: The current trans-HIV treatment paradigm lags behind in its sensitivity and nuance, preventing the most equitable distribution of care. Only with more inclusion of transgender individuals in clinical trials can we hope to promote greater awareness and trust for PrEP as effective for HIV.

ABSTRACT IMPACT: Rapid launch of a virtual internship can address clinical and translational science training needs of the New Jersey Alliance for Clinical and Translational Science (NJ ACTS) workforce during a pandemic. OBJECTIVES/GOALS: The global pandemic has necessitated innovate strategies for training clinical and translational scientists. With trainees largely restricted from campus, the Workforce Development Core of the NJ ACTS Hub sought to develop and evaluate a virtual 8-week internship program for professional and graduate students within the NJ ACTS community. METHODS/STUDY POPULATION: Establishment of the internship required a systematic approach to 1) recruiting projects and supervisors, 2) collecting and evaluating 90 applications, 3) screening and selecting finalists, and 4) onboarding interns that spanned 7 weeks. Core Leads and Researchers within NJ ACTS developed 8 projects to be performed remotely by 11 interns. Leads and co-leads from the Team Science, Special Populations, Community Engagement, Informatics, and TL1 Cores and Programs designed projects. During the internship, participants engaged in a series of career development training and one-on-one mentoring through weekly meetings. The internship culminated in a final symposium open to the entire clinical and translational science community. RESULTS/ANTICIPATED RESULTS: Interns spanned different educational programs - pharmacy (36%), medicine (18%), and undergrad (9%)/graduate education (36%). Interns included women (63%), students from underrepresented backgrounds (27%) and students who were first in their family to pursue advanced education (18%). Project topics included competency assessment, COVID-19 clinical trials, marketing materials, community engagement salons, eSource for clinical trials, team science projects, and REDCap utilization. Using a 4-point Likert scale to evaluate competencies, the baseline strengths of interns included team-based science (mean/SD: 3.5 ±0.7). Trainings were designed to address gaps in intern skills including developing written and graphical abstracts (mean/SD: 2.2 ±0.9) and effective LinkedIn pages (mean/SD: 2.4 ±1.0). DISCUSSION/SIGNIFICANCE OF FINDINGS: Taken together, the rapid development and launch of a virtual internship program can increase participation of trainees in CTSA Hub research activities and address gaps in their clinical and translational skill set. Plans are to host virtual internships each semester to enhance workforce training and collaboration across Hub Cores.

OBJECTIVES/GOALS: The Stanford CTSA Program has started to create Clinical Research Units (CRUs) with the goal to establish CRUs in all clinical departments by the end of 2020. CRUs will be responsible for managing the portfolio of projects proposed and conducted by faculty within departments. CRUs will be responsible for reviewing all clinical research studies. METHODS/STUDY POPULATION: CRUs will be an integral part of the Stanford’s research infrastructure, tasked with 5 key functions to ensure clinical research conducted by Stanford investigators: scientific merit, feasibility, funding, compliance, progress. Each CRU will review all clinical research projects proposed by investigators within the department prior to moving forward with IRB review. Studies will be evaluated annually to ensure compliance with the protocol, applicable laws and regulations, and recruitment goals. The Stanford CTSA will provide guidelines, SOPs and personnel to assist CRUs. In fall 2019, a landscape analysis of SoM clinical departments was conducted to identify:

1. 1) similar existing CRU-like systems,

2. 2) unique needs of departments/divisions for developing CRUs and

3. 3) barriers to implementation.

RESULTS/ANTICIPATED RESULTS: Challenges the pilot CRU has faced include communication and concerns regarding additional obstacles to conducting research. However, as study teams moved through the initial CRU formation, the feedback was overwhelmingly positive. Study teams were appreciative of the constructive feedback and the support for setting up studies. Results from the landscape analysis identified CRU-like systems in 5 departments and highlighted concerns regarding resources needed to implement CRUs. Based on feedback from the landscape analysis, a faculty and operational lead was identified in each clinical department to oversee CRU implementation. Facilitated by CTSA personnel, CRU leads have met quarterly since April 2019. Meetings consist of discussing expectations, sharing ideas and identifying potential roadblocks. DISCUSSION/SIGNIFICANCE OF IMPACT: CRUs will constitute a new organizational structure that consists of teams of investigators and staff to promote high quality, efficient clinical research and enhance collaborative opportunities. The CRU leadership will champion new initiatives in CTR and create pathways for investigators to access research infrastructure and resources. CONFLICT OF INTEREST DESCRIPTION: NA.