ABSTRACT IMPACT: This study will help to characterize the root causes of racial and ethnic disparities in viral respiratory outbreaks and determine the extent to which this is unique to the COVID-19 pandemic, so that preventative interventions can be designed for future pandemics and epidemics. OBJECTIVES/GOALS: The causes of racial and ethnic disparities in COVID-19 clinical outcomes are multifactorial but include social inequity driven by structural racism. This study seeks to characterize the patterns of these disparities by linking patient-level EHR data with population-level sociodemographic measures. METHODS/STUDY POPULATION: This retrospective review of adult patients tested for SARS-CoV-2 in the UCHealth System will compare rates of COVID-19 infection, hospitalization, in-hospital mortality and 30-day mortality across racial and ethnic groups. Race and ethnicity are determined by patient self-report in the EHR. Univariable and multivariable regression analyses will be used to assess the association of these outcomes with sociodemographic factors. Potential confounders that will be adjusted for include Charlson Co-morbidity Index, disease severity and likelihood of readmission. Using chi-square tests, we will assess differences in the race/ethnicity distributions between this cohort and those from the 2009 H1N1 Pandemic and the 2018-19 influenza season. RESULTS/ANTICIPATED RESULTS: Of the first 459 patients hospitalized for COVID-19 in March and April 2020, race/ethnicity were: 194 Hispanic (42.3%), 104 non-Hispanic Black (22.6%), 83 non-Hispanic white (18.1%), 43 Asian (9.4%), and 35 other or unknown race (7.6%). There were significant differences in the race/ethnicity distribution compared to the cohort of patients hospitalized for viral respiratory infection during the 2018-19 influenza season (n=254, p <0.001): 58 Hispanic (22.8%), 52 non-Hispanic black (20.4%), 116 non-Hispanic white (45.7%), 15 Asian (6%), and 13 other or unknown race (5.1%). Our anticipated results include further adjusted analyses and comparisons to the 2009 pandemic. We will compare COVID-19 prevalence and outcomes by race/ethnicity with other viral infection outbreaks, adjusting for confounders. DISCUSSION/SIGNIFICANCE OF FINDINGS: Initial hospitalizations for COVID-19 at our institution are notable for a high proportion of Hispanic patients and smaller proportion of non-Hispanic whites, in contrast to the prior year. Our study will demonstrate the extent to which racial and ethnic disparities are typical in viral respiratory outbreaks, which can guide future interventions.

OBJECTIVES/GOALS: To promote diverse research engagement and address health disparities by creating an inclusive tool to collect sexual orientation and gender identity (SOGI) data from potential participants #_msoanchor_1 METHODS/STUDY POPULATION: The Penn State Community Health Equity & Engagement in Research (CHEER) team, part of our Clinical and Translational Science Institute (CTSI), developed inclusive screening guidance to collect SOGI data from potential research participants to fill an identified gap in the literature. Guidance was developed through an iterative feedback process, leveraging expertise from local, regional, and national organizations, healthcare systems, and leaders throughout Clinical & Translational Science Award hubs. By eliciting expert feedback, CHEER co-developed a comprehensive SOGI data collection form, filling an important gap of inclusivity in the consenting process. Training of this new tool was delivered to CHEER’s far-reaching listserv researchers (internal and external) and community partners. RESULTS/ANTICIPATED RESULTS: Feedback collected from our LGBTQ+ expert partners resulted in a total of five inclusive SOGI screening questions; two ‘Gender Identity’ questions, one ‘Sexual Orientation’ question, and two ‘Sex’ questions, with “prefer not to answer” and “another option not listed” provided. The goal of this effort is to equip research teams with a tool that integrates SOGI characteristics that may be particularly important to determine study eligibility respective to a person’s identity or orientation. Additionally, collecting SOGI data in an inclusive way may increase trust worthiness in research from potential research participants, particularly among the LGBTQ+ community, who have been underrepresented yet experience several inequities and disparities across multiple health outcomes. DISCUSSION/SIGNIFICANCE: CHEER’s goal is to reduce health disparities in underrepresented populations, including the LGBTQ+ community, by promoting inclusivity and engagement in research. Developing a community-driven screening that addresses the unique needs of the LGBTQ+ community successfully bridges a gap in equity across all research participants.

OBJECTIVES/SPECIFIC AIMS: I would like to make clinicians aware about prescription opioid use and glycemic control among patients with diabetes. This is a quality of care issue that increases the disease burden for two conditions opioid dependence and diabetic complications. Big data analytics can bring out this quality of care issue and help in changing clinical practice through precision medicine METHODS/STUDY POPULATION: This is a population health study of patients on prescription opioid pain medications in Erie county medical center and local out patient clinic. The electronic data from the hospital records and Outpatient were collected, merged and de identified. The database was saved in a protected environment and made accessible to researchers through a secure login. The data was queried for the number of patients with diabetes. The glycohemoglobin levels were collected and then the analysis was made RESULTS/ANTICIPATED RESULTS: It was found that only 63 of the 89 patients with DPN and 156 of the 570 patients without DPN had any measurement of HbA1c in our data. It was found that 86 out of 156 patients without DPN had suboptimal glycemic control with a glycohemoglobin level > 7% while 36 out of 63 patients with DPN had a glycohemoglobin > 6.7%. The odds of patients with DPN having poor glycemic control is 0.57 while the odds of having poor glycemic control without DPN is.55. The relative risk being 1.03. DISCUSSION/SIGNIFICANCE OF IMPACT: Our population study revealed suboptimal glycemic control among a large set of patients in Western New York with a diagnosis of diabetes mellitus and a concurrent prescription for an opioid pain medication. A significant percentage of patients in our study population with a diagnosis of DPN might benefit in terms of decreased painful symptoms of neuropathy from monitoring and attempting to improve glycemic control. Additionally, in our patient population, there were no patients with diabetic peripheral neuropathy prescribed pregabalin or duloxetine, the first-line FDA-approved medications for painful DPN, Based on our population study, the quality of care for diabetic patients with DPN who are prescribed opioid pain medications should be monitored closely. First-line, FDA approved anticonvulsants and antidepressants should be considered for the treatment of painful symptoms when necessary. Attention should be directed towards monitoring and improving glycemic control in patients without DPN receiving opioid pain medications to attempt to prevent or delay the microvascular complications of diabetes, including the onset of painful peripheral neuropathy.

OBJECTIVES/SPECIFIC AIMS: Lung cancer claims 160,000 lives in the United States every year, and lung adenocarcinoma (LADC) is the most frequent type. Early diagnosis is crucial. Computed tomography (CT) is very sensitive in identifying early-stage lung nodules, but has low specificity. Increased glucose uptake is a hallmark of cancer measurable in vivo by fluorodeoxyglucose (FDG) positron-emission tomography (PET). FDG PET is widely used for cancer staging but has low sensitivity in the diagnosis of solitary lung nodules. We have previously identified an alternative glucose transporter, SGLT2, expressed in different types of cancer but not detected by FDG PET. SGLT2 activity can be measured in vivo with the PET tracer methyl-4-fluorodeoxyglucose (Me4FDG). The objective of this study was to test the hypothesis that SGLT2 is a novel diagnostic and therapeutic target in FDG-negative, early stage LADC. METHODS/STUDY POPULATION: To study glucose transporter expression in LADC, we performed immunohistochemistry with SGLT2- and GLUT1-specific antibodies in human lung pre-malignant lesions and LADC samples. To verify the possibility of detecting SGLT2 activity in vivo, we performed microPET imaging with the SGLT-specific tracer Me4FDG in a Kras-driven, p53-null genetically engineered mouse model and in patient-derived xenografts of LADC. Finally, we performed therapeutic trials in genetically engineered and patient-derived mouse models of LADC with the FDA-approved SGLT2 inhibitor canagliflozin. RESULTS/ANTICIPATED RESULTS: We observed a switch in the modality of glucose transport during lung carcinogenesis: SGLT2 was highly expressed in pre-malignant lesions and well-differentiated LADC, whereas GLUT1 was upregulated in advanced, poorly differentiated lesions. This pattern was observed both in human samples and in murine models. This observation led us to hypothesize that early-stage LADCs are often negative on FDG PET because this imaging modality does not detect the activity of SGLT2, which is expressed in early lesions. Therefore, we performed PET imaging with the tracer Me4FDG, that measures SGLT2 activity, in our mouse model, and observed that Me4FDG accumulated in small nodules that were negative with FDG. We confirmed the functionality of SGLT2 in human LADC by Me4FDG PET in patient-derived xenografts. To investigate the role of SGLT2-mediated glucose uptake in the early stages of LADC development, we treated both genetically engineered mice and patient-derived xenografts with FDA-approved SGLT2 inhibitors, showing that SGLT2 inhibition effectively reduced LADC growth and prolonged survival in mouse models. In addition, Me4FDG uptake predicted response to SGLT2 inhibition. DISCUSSION/SIGNIFICANCE OF IMPACT: Our results show that sodium-dependent glucose transport is a critical metabolic supply strategy in the early stages of lung adenocarcinoma development, and that Me4FDG is a novel biomarker of early LADC and of SGLT-dependent tumor growth. The discovery of SGLT2 in LADC highlighted the need for a re-interpretation of FDG-negative lung nodules, which might rely on SGLT2 for glucose uptake, and therefore may be detected by the new tracer Me4FDG. We anticipate our findings will lead to clinical studies evaluating Me4FDG as a diagnostic tracer for solitary lung nodules and early LADC, and as a biomarker for the selection of patients eligible for treatment with SGLT2 inhibitors.

There is a paucity of educational resources for potential clinical trial participants, particularly resources in plain language, attentive to health literacy principles and translated into native languages. The New England Research Subject Advocacy Group was formed to explore common issues, interests, and concerns related to the experience of participation in clinical research and research participant safety. Specifically, the group sought to increase community awareness and trust through the development and distribution of publicly accessible informational resources. In support of these aims, the group developed a robust library of high-quality, plain-language educational materials covering topics in health research, research participation, and common research procedures, and translated the majority of the materials into an additional 15 languages. These resources have been downloaded over 130,000 times. After English, the most common languages downloaded are Vietnamese, Spanish, and Korean.

Historically underrepresented groups in biomedical research have continued to experience low representation despite shifting demographics. Diversity fosters inclusive, higher quality, and innovative team science. One avenue for diversifying research teams is integrating diversity-focused initiatives into Clinical and Translational Science Award (CTSA) Programs, such as the integrated Translational Health Research Institute of Virginia (iTHRIV). In 2020, iTHRIV participated in Building Up, developed by the University of Pittsburgh CTSA, and intended to increase representation and improve career support for underrepresented groups in the biomedical workforce. Drawing lessons from this study, iTHRIV implemented the “inspiring Diverse Researchers in Virginia” (iDRIV) program. This yearlong program provided education, coaching, mentoring, and sponsorship for underrepresented early career investigators in the biomedical workforce. To date, 24 participants have participated in the program across three cohorts. Participants have been predominantly female (92%), with 33% identifying as Hispanic/Latinx, 29% as Black, and 13% as Asian. Notably, 38% of scholars have subsequently achieved at least one accomplishment, such as receiving a local research honor or award and an extramural funding award from a foundation or federal agency. The iTHRIV iDRIV program serves as a model for providing career support to developing investigators from underrepresented backgrounds, with the overall goal of improving patient health.

Although team science has expanded with far-reaching benefits, universities generally have not established criteria to recognize its value in faculty promotion and tenure. This paper recommends how institutions might weigh a faculty member’s engagement in team science in the promotion and tenure process. Seventeen team science promotion and tenure criteria are recommended based on four sources – an evaluation framework, effectiveness metrics, collaborative influences, and authorship criteria. Suggestions are made for adaptation of the 17 criteria to committee guidelines, faculty team science portfolios, and the roles of individuals and institutions participating in large, cross-disciplinary research projects. Future research recommendations are advanced.

OBJECTIVES/SPECIFIC AIMS: Exosomes are living nanoscale vesicles that can shuttle large amounts of bioactive cargo for intercellular communication. The potential of these nanovesicles to serve as both biomarkers for disease diagnosis and vehicles for delivery of therapeutics has only begun to be explored. To realize these potentials, molecular tools for effective exosome tracking and capturing must be invented in order to advance basic research and clinical translation. METHODS/STUDY POPULATION: We utilize a surface display strategy that enables exosome modification in living mammalian systems. By reconfiguring the surface protein CD63 or viral envelope glycoprotein VSV-G, we generate 3 topologically distinctive protein chimeras for exosome imaging and capture in mammalian systems. RESULTS/ANTICIPATED RESULTS: We have shown that these genetically encoded protein chimeras have the ability to correctly target and integrate into exosomes in cultured human cells. Furthermore, we have demonstrated that the secreted exosomes could be successfully captured by an affinity peptide intentionally displayed on the outer surface of exosomes. DISCUSSION/SIGNIFICANCE OF IMPACT: Our study highlights the potential of these fusion proteins for exosome tracking and provides novel genetic tools for exosome research and translation, one of which is loading protein therapeutics for targeted delivery.

OBJECTIVES/SPECIFIC AIMS: To assess the effect of cannabis on impaired judgment and health outcomes among heart failure patients in the emergency room. METHODS/STUDY POPULATION: Patients with heart failure presenting to the emergency room. Cannabis with confounders such as income level, insurance type, tobacco use, and age. Discharged against medical advice to assess impaired judgment. Hospitalization rates, length of stay, and death rate to assess health outcomes. Multivariate logistic regression to access the odds of each of these outcomes from cannabis RESULTS/ANTICIPATED RESULTS: Cannabis is associated with impaired outcome (increase in discharge against medical advice). Cannabis have poorer health outcome in terms of more hospitalizations from the emergency department. Cannabis also have better health outcome in terms of shorter length of stay and death rate among cannabis users Versus nonusers. DISCUSSION/SIGNIFICANCE OF IMPACT: This is crucial to inform health care providers to ensure better counseling of cannabis users. This result should also be considered to interpret other publications that shows better outcomes in patients taking cannabis. Cannabis users might only seem to have a better outcome because they tend to discharge against medical advice and thereby die outside the hospital, etc.

Objectives/Goals: To assess the effect on the immune response to COVID-19 in children exposed to pesticides. The hypothesis is that increased pesticide exposure results in different immunological response to COVID-19. The goal of the proposal is to improve scientific knowledge on factors affecting COVID-19 and identify a modifiable factor to reduce these disparities. Methods/Study Population: A cross-sectional analysis of children (aged 5–17 years) with asthma to assess pesticide exposure and immune markers of SARS-CoV-2. SARS-CoV-2 infection or vaccination was determined with blood exposome RNA analyses assessed from blood samples taken at baseline. Immunological response was measured using neutralizing, phagocytizing, and NK-activating antibody responses biomarkers using plasma antibody isotyping, effector functions, T-cell activation-induced marker (AIM), and recall cytokine secretion assays on lysed, whole blood. Pesticide exposure was assessed as concentration of four urinary metabolites in a spot urine sample adjusted for creatinine. Unadjusted regression models were created to assess the effect of 3-phenoxy benzoic acid, a common pyrethroid pesticide, on immune markers. Results/Anticipated Results: Children’s (N = 30) average age was 10 years (interquartile range: 8–11) A majority of children were male (63%) and Non-Hispanic Black (73%). The majority of children had markers of SARS-CoV-2 infection (77%). Of the 4 pesticide metabolites assessed, only 3-PBA was commonly found (77% of samples > LOQ). Higher urinary concentrations of 3-PBA are associated with a significant (p Discussion/Significance of Impact: Significant associations in cytokine and inflammatory marker may indicate a Th2-skewed response, and dysregulated cytokine responses can lead to severe disease. A suggested increase in T-cell activation markers (e.g., CD4, CD8) may indicate potential exhaustion if excessively activated.

ABSTRACT IMPACT: Antibiotic stewardship guidelines should consider the barriers clinicians in low- and middle-income countries face due to limited biomarkers for determining the etiologic pathogen for viral infections like respiratory syncytial virus (RSV) that have a similar presentation to bacterial infections. OBJECTIVES/GOALS: We aimed to evaluate antibiotic administration practices in children who were hospitalized at a government-run hospital in Amman, Jordan, where point-of-care testing is limited. We hypothesized those with RSV are more likely to be administered antibiotics during their hospitalization than children without RSV. METHODS/STUDY POPULATION: We conducted a cross-sectional cohort study in Jordanian children hospitalized with history of acute respiratory symptoms and/or fever from 2010 to 2013. Admitting diagnoses were dichotomized into suspected viral- (e.g., bronchiolitis) and bacterial-like infection (e.g., sepsis, pneumonia). Stratifying by sex, we performed a polytomous logistic regression adjusting for age, underlying medical condition, maternal education, and region of residence to estimate prevalence odds ratios (PORs) and 95% confidence intervals for macrolides, broad-, and narrow-spectrum antibiotics during hospitalization. Sensitivity and specificity of admission diagnoses and laboratory results were compared. RESULTS/ANTICIPATED RESULTS: Children with a suspected viral-like admission diagnosis, compared to those with suspected bacterial-like, were 89% less likely to be administered a narrow-spectrum antibiotic (POR: 0.11; p<0.001). There were slight differences by sex with males having a lower prevalence than females of narrow-spectrum or broad-spectrum antibiotic administration; but they had a higher prevalence of macrolide administration. Overall, children with RSV had a 30% probability (sensitivity) of being assigned to a suspected viral infection; whereas RSV-negative children had an 85% probability (specificity) of being assigned to a suspected bacterial infection. DISCUSSION/SIGNIFICANCE OF FINDINGS: Children with a suspected viral-like infection were less likely to receive an antibiotic; however, when evaluating the accuracy of admission diagnosis to RSV-laboratory results there were considerable misclassifications. These results highlight the need for developing antibiotic interventions for Jordan and the rest of the Middle East.

OBJECTIVES/GOALS: The grant writing process provides investigators with critical thinking, problem solving, and communication skills, crucial for personal and professional development. However, opportunities for junior faculty to learn these skills are highly variable. Thus, we developed a grant writing program to assist in the preparation of an NIH R proposal. METHODS/STUDY POPULATION: The R Club Grant Program was implemented in 2021 for junior faculty of the University of Cincinnati’s College of Medicine and Center for Clinical & Translational Science & Training (CCTST). The program consists of a series of workshops (e.g., How to Craft a Specific Aims Page, How to Construct a Competitive R01 Proposal) utilizing examples of successful proposals and grant review criteria to demonstrate how to translate a conceptual framework into a research proposal (level 1). All participants can receive constructive feedback on a Specific Aims page from an experienced grant writer (level 2), and for a select cohort, the program provides comprehensive scientific content edits and iterative feedback on a full research proposal, with a focus on grantsmanship, presentation, and overall competitiveness (level 3). RESULTS/ANTICIPATED RESULTS: Over three NIH grant cycles, the program to date has provided 38 early-career investigators with multi-level grant writing support. All participants attended the workshops and received supporting documents, 21 received feedback on a Specific Aims page, and 6 received one-on-one writing assistance on their full research proposal. Of the 6 investigators who received the greatest level of support, 3 have received NIH scientific review, with a 66.6% funding success rate for either an original (R01, n=1) or subsequent overlapping (R35, n=1) proposal. In a survey sent to workshop attendees, 100% of respondents (n=23) reported ( Strongly Agreed or Agreed ) that the training was a worthwhile investment in their professional development and 96% stated that they will be able to apply the knowledge and skills learned. DISCUSSION/SIGNIFICANCE: Initial evaluation measures suggest that grant writing support programs have great potential to enhance funding success rates. As the program evolves it will be crucial to evaluate both qualitative and quantitative feedback measures to ensure efforts are directed to the appropriate level(s) of service to maximize the funding success of our faculty.

OBJECTIVES/GOALS: The overarching objective is to assess the value of promoting team science practices across a diverse clinical translational science community through the development of learning modules. We aim to share lessons learned to help inform best practices for CTSA hubs interested in promoting team science. METHODS/STUDY POPULATION: We recently created a series of self-paced learning modules focused on the science of team science, which include a variety of text and multimedia content. A preliminary assessment was conducted to determine the perceived value of six video team science Learning Shots and to identify areas for improvement. Significant content revisions are underway based on respondent feedback. In early 2022, a follow up survey will solicit feedback from a larger sample of researchers to reassess the learning modules and to ensure that desired improvements were achieved. We will incorporate continuous improvement cycles to gather future feedback, track improvements, and identify potential future direction for new content. RESULTS/ANTICIPATED RESULTS: The preliminary assessment identified the most effective aspects of the modules to be the variety and knowledge of speakers, diversity of topics, organization of the content, and appropriateness of length. Least effective aspects included a desire for more information in some content areas and not enough focus on the challenges of team science for junior faculty. Suggested areas for improvement include a desire for supplemental descriptive text, links to tools that enable teams to be productive, and additional examples from researchers. The follow up study is expected to yield more detailed information on the impacts of the improvements and the overall effectiveness of the modules. DISCUSSION/SIGNIFICANCE: This project provides insights for CTSA Hubs interested in promoting team science and best practices when developing learning modules. Results contribute to what is known about researchers interest in learning about team science and the effectiveness of using online formats for delivery.

OBJECTIVES/GOALS: While the evolving treatment paradigm for Glioblastoma (GBM) leverages different modalities to improve outcomes, treatment access might be limited by cost and disparities. This study explores the influence of race and social determinants of health (SDoH) on healthcare access and outcomes of GBM patients in a large metropolitan area over a decade. METHODS/STUDY POPULATION: Our institution’s tumor registry (2009-2019) was queried to identify our GBM cohort. Data were supplemented by electronic health records to include demographics, outcome, NCI Comorbidity Index, and the Agency for Healthcare Research and Quality (AHRQ) socioeconomic status (SES) index. RESULTS/ANTICIPATED RESULTS: Of the 559 GBM records, 361 unique patients met the inclusion criteria, and 43% were Non-White. Non-White patients predominantly comprised the lowest AHRQ SES index quartile and had longer hospital stays (LOS; p<0.001). White patients accounted for 61% of privately insured patients (p<0.001). Private insurance (p= 0.02) and age < 65 years (p= 0.039) were associated with a higher rate of home discharge. Patients diagnosed with GBM in the emergency department were more likely to be discharged to acute rehab than home (p<0.001). At 2 years, privately insured patients had longer OS (HR= 1.46; p= 0.04). DISCUSSION/SIGNIFICANCE: In contrast to previous studies, the study demonstrates that GBM affected a higher proportion of Non-White patients. Our data show that SDoH influences multiple outcomes in GBM patients. Efforts to identify and correct these barriers are needed to improve the care of all GBM patients.

OBJECTIVES/GOALS: The modified Atkins diet (MAD) is used in the management of drug-resistant epilepsy in adults. Some patients on MAD show an increase in serum levels of total cholesterol and low-density lipoprotein (LDL) cholesterol. We explored whether dietary fat composition predicts short-term elevations in serum lipid levels in diet-naïve adults who begin MAD. METHODS/STUDY POPULATION: Participants self-reported their diet intake with 3-day food records at baseline, 1 month and 2 months. Food records were analyzed using Nutrition Data System for Research software. Fasting serum levels of total cholesterol (TC), high-density lipoprotein (HDL) cholesterol, and triglycerides were also collected and LDL level calculated at baseline, 1 month, and 2 months. RESULTS/ANTICIPATED RESULTS: 38 patients submitted complete food records at each study visit (baseline, 1 month, and 2 month). Compared to baseline diet intake, there was a significant reduction in daily carbohydrate intake at 1 and 2 months months (p<0.001). There was also a significant increase in daily saturated fatty acid (SFA) intake at 1 and 2 months (p<0.001), daily mono-unsaturated fatty acid (MUFA) intake at 1 and 2 months (p<0.001), and daily cholesterol intake at 1 month (p<0.05) and 2 months (p<0.001), but no change in daily poly-unsaturated fatty acid (PUFA) intake over time. Compared to baseline, there was a significant increase in serum LDL at 1 month (p<0.001) and 2 months (p<0.01) and an increase in serum TC at 1 month (p<0.01) but not 2 months. DISCUSSION/SIGNIFICANCE OF IMPACT : Despite a significant increase in total fat, saturated fat and mono-unsaturated fat intake as well as an increase in total cholesterol and LDL levels following MAD initiation, dietary fat composition appears to minimally predict serum lipid values in the short term. CONFLICT OF INTEREST DESCRIPTION: Tanya McDonald has received speaking honoraria from Nutricia North America. Bobbie Henry-Barron receives grants from Johns Hopkins Institute for Clinical and Translational Research (ICTR) which is funded in part by Grant Number UL1 TR 001079 from the National Center for Advancing Translational Sciences (NCATS) a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research, Nutricia and Vitaflo. Diane Vizthum receives grants from the Johns Hopkins Institute for Clinical and Translational Research (ICTR) which is funded in part by Grant Number UL1 TR 001079 from the National Center for Advancing Translational Sciences (NCATS) a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research. Mackenzie C. Cervenka has received grant support from Nutricia North America, Vitaflo, Army Research Laboratory, The William and Ella Owens Medical Research Foundation and BrightFocus Foundation. She receives speaking honoraria from LivaNova, Epigenix, Nutricia North America and the Glut1 Deficiency Foundation and performs consulting with Nutricia North America and Sage Therapeutics and receives Royalties from Demos Health.

OBJECTIVES/GOALS: Racial and ethnic minority populations have been historically underrepresented in clinical trials, which limits the external validity of study findings. We analyze data from the ACTIV-6 trial to assess whether inclusion efforts were effective in increasing participation from minority groups. METHODS/STUDY POPULATION: ACTIV-6 is a decentralized randomized placebo-controlled platform trial investigating repurposed drugs for the treatment of mild to moderate COVID-19. Study participants could either self-refer online or be recruited through a study site. Two inclusion efforts were introduced to increase participation from racial or ethnic minority populations: targeted advertising and outreach, and strategic selection of study sites that serve diverse populations. We assessed the effectiveness of these interventions by analyzing enrollment trends over time. We also assessed whether participants from racial or ethnic minority populations experienced higher loss to follow-up. RESULTS/ANTICIPATED RESULTS: At the start of the trial, enrollment of non-Hispanic White participants outpaced enrollment from racial or ethnic minority populations. At 4 months, only 108 participants (20.5%) were from racial or ethnic minority populations, but greatly increased by 28 months to 3,544 participants (46.4%), nearly half of all participants. This increase was predominantly due to recruitment through study sites rather than self-referral. In particular, certain sites recruited large numbers of minority participants. We also observed that participants from racial or ethnic minority populations were more likely to drop out of the study before receiving the study drug (3% vs 1%). DISCUSSION/SIGNIFICANCE: Our results suggest that strategic site selection is an effective strategy for recruiting a study population that represents racial and ethnic populations. The benefits of targeted advertising and outreach were less clear. Retention efforts remain important to reduce loss to follow-up.