OBJECTIVES/GOALS: Methods for recruitment and retention of participants in research have been extensively discussed, but procedures to end studies in a way that is respectful to participants and keeps them engaged are seldom described. We relate the procedures to close a study focused on genomic DNA damage and DNA repair capacity in a longitudinal population sample. METHODS/STUDY POPULATION: Data collection, which included the provision of 30 ml blood sample along with a health status survey and anthropometric measurements, was discontinued earlier than anticipated during the fourth of a five-year Community Engaged Research (CEnR) study focused on residents of historically marginalized, low wealth communities. In collaboration with the project’s Community Advisory Board, we devised a strategy to inform study participants of the study closure, which included: 1) attempts at one-on-one contact via phone, 2) provision of a study closure packet, 3) periodic mailing of study updates through study year five, 4) sustained interaction with participants through invitations to participate in additional research projects. RESULTS/ANTICIPATED RESULTS: Among 149 participants (65% female, 99% of African American descent), 106 (71%) have been reached by phone. The communication included: 1) expressions of gratitude for their participation; 2) explanation of study findings to date; and 3) assurance that data analysis continued. Among those reached, 96% agreed to ongoing communication and 97% agreed to be contacted about future studies. We continue procedures to reach the remaining 43 participants. Over the study closure period, two qualitative studies offered opportunities for participants to join in focus groups (FG). The first one queried perceptions of community-based research. The response rate was 66% among 65 persons invited. The second study, focused on COVID-19 knowledge and invited 39 individuals with 24 scheduled to participate (62% response rate). DISCUSSION/SIGNIFICANCE: Translational research views the participant as an active partner. Study closure offers an opportunity to foster a long-lasting participant-research institution partnership, while also promoting participants’ broad engagement and familiarity with research. Respectful research closure is an important step in CEnR.

OBJECTIVES/GOALS: Investigate the perspectives of people experiencing homelessness (PEH) on clinical trials to uncover knowledge gaps and attitudes. This study aims to offer insights for clinical researchers to enhance engagement with this marginalized group, ushering in a more inclusive clinical trial process. METHODS/STUDY POPULATION: A 14-question survey was developed in collaboration with the Street Medicine Team at the University of Southern California and other stakeholders of PEH research. Initial questions assess knowledge of clinical trials, followed by questions gauging sentiments on clinical trial participation, and final questions on the significance, benefits, and risks of clinical trials. Upon approval by the local Institutional Review Board, the survey will be administered in an interview format. Study participants will be from locations within the area of operations of the USC Street Medicine team–in and around Hollywood, South Los Angeles, and/or the Los Angeles Council District 1. RESULTS/ANTICIPATED RESULTS: We anticipate that the results of this study will offer valuable insights into the perspectives of PEH regarding clinical trials. Results will also provide varying levels of knowledge and understanding among PEH about clinical trials, along with their past experiences in clinical trial participation, and willingness for future involvement in such trials. Further, the results will reveal whether respondents feel they are being properly represented in clinical research projects that could impact themselves and their community. This project can also enhance our understanding of the expectations and concerns of PEH regarding their potential participation in clinical trials. DISCUSSION/SIGNIFICANCE: The outcomes of this research project have the potential to lay the groundwork for enhancing the involvement of PEH in translational science research, encompassing aspects from study design to participation. This improvement could benefit not only participants but also various stakeholders involved.

OBJECTIVES/SPECIFIC AIMS: To establish an in vitro quantitative method for the evaluation of polymeric film disintegration that can be applied to predict in vivo behavior. METHODS/STUDY POPULATION: Two clinically advanced vaginal microbicide film products containing tenofovir and dapivirine were used as model films throughout this work. Films were made using the solvent cast manufacturing method in which polymers, excipients, plasticizer, and APIs were either dissolved or dispersed in water, mixed, and cast on a heated substrate. The novel, quantitative method was developed using a TA.XT Plus Texture Analyzer® (Texture Technologies) in combination with a TA-108S5 fixture and the TA-8A: 1/8″ diameter rounded end ball probe. Exponent® was used as the data analysis software. In this method, the film was placed and secured in the fixture, the probe applied a constant force to the film product, and a biologically relevant amount of fluid was applied to the film. The probe was able to penetrate the film upon disintegration resulting in an applied force of zero at that point. A curve of force Versus time was plotted, and disintegration time was defined as the time between fluid addition until the probe force reached zero. Test parameters were optimized in order to reduce error. Visual observation of film disintegration was conducted in the in vivo macaque model using films that included a water-soluble blue dye for film visualization. Colpophotography was also used to confirm film disintegration. In vitro results were compared with in vivo findings. RESULTS/ANTICIPATED RESULTS: The Texture Analyzer disintegration method developed provided quantitative disintegration times and did not rely on user defined endpoints which is common in many visual disintegration tests. The disintegration method was able to distinguish differences between the 2 clinical film products and produced reproducible disintegration times for the tenofovir and dapivirine films. The tenofovir film had a shorter disintegration time (41.28±2.85 s) compared with that of the dapivirine film (88.3 6±9.82 s). This method was also able to distinguish changes made to these 2 clinical film products in terms of volume and formulation alterations. In vitro and in vivo disintegration times differed by orders of magnitude, with in vitro time being measured in seconds and in vivo time being measured in days, for a variety of factors, mainly the application of constant force to the film product. Regardless of these differences, the rank order of film disintegration remained constant for in vitro and in vivo disintegration and an In Vitro In Vivo Correlation (IVIVC) trend could be seen. DISCUSSION/SIGNIFICANCE OF IMPACT: Standardization of preclinical in vitro assessments which minimize user bias are crucial to the field of pharmaceutical film development. As this field continues to develop and more products advance for pharmaceutical application, this method has the potential to become a standard assessment of film functionality. This study represents a first step in the process of developing an IVIVC. More films will need to be tested using both in vitro and visual methods in order to establish and accurate factor to predict in vivo behavior.

ABSTRACT IMPACT: This work highlighs the significant burden of Trauma in Nigeria and will help inform policy decisions on improving Nigeri’s current Trauma care system OBJECTIVES/GOALS: To evaluate trauma care delivery at the pre-hospital, hospital and health systems level in Nigeria in order to identify the burden of trauma, gaps in the delivery of trauma care, and interventions, implemented or recommended, to improve upon the limitations to trauma care delivery. METHODS/STUDY POPULATION: A two-concept search - one being trauma and the other being Nigeria - of the Pubmed (Medline) and Embase databases, in addition to Global Index Medicus and grey literature was performed between September 2018 and September 2019. The search yielded 3,970 articles that underwent title screening and 331 articles that underwent abstract screening. 101 articles were identified for full text screening and the majority were extracted for inclusion into the review. The extracted literature was grouped into 4 categories - articles outlining the burden of trauma in Nigeria, and articles outlining the delivery of trauma care at the pre-hospital, hospital and health systems level. RESULTS/ANTICIPATED RESULTS: Results were classified as an identified challenge or an intervention, recommended or implemented, to address Nigeria’s trauma care system. There was a highlighted need for pre-hospital infrastructure, training of frontline providers, continued competency assessments of frontline providers, in-hospital diagnostic resources, and trauma care surveillance systems to guide health policy. DISCUSSION/SIGNIFICANCE OF FINDINGS: There is a significant burden of trauma in Nigeria. Coordinated interventions and policies at the pre-hospital level, the hospital level, as well as the health systems level are needed in order to address the gaps in Nigeria’s current trauma care system.

OBJECTIVES/GOALS: Sex differences in aortic stenosis (AS) are vastly underestimated, contribute to disparities in treatment and worse outcomes for women including disproportionately higher mortality rates. This study aims to investigate sex differences in extent of cardiac damage (CD) from pressure overload in AS that may help account for the observed disparities. METHODS/STUDY POPULATION: CD in AS refers to a series of pathologic changes in the myocardium that occur due to chronic pressure overload imposed on the left ventricle by a progressively stenotic aortic valve (AV). These changes are associated with poor outcomes and lower survival in patients with AS. To acquire a deeper understanding of the factors and mechanisms affecting differences in the long-term survival and management of patients with AS, we are proposing to assess baseline stage of CD on echocardiography, and changes in transvalvular hemodynamics and CD stage (Δ CD) over time, in patients with moderate and severe AS at one of 2 large tertiary-care hospitals in MA. We also plan to assess time to and performance of aortic valve replacement (AVR), stratified by hemodynamic severity of stenosis and CD stage, and their interaction with sex. RESULTS/ANTICIPATED RESULTS: We hypothesize that women will have a higher stage of CD on their initial echocardiogram (TTE), demonstrating moderate or greater severity of AS, than men with the same hemodynamic severity of valvular stenosis. We additionally hypothesize that those with more advanced cardiac damage stage will likely have masking of transvalvular progression on echocardiogram. Finally, we anticipate that women will have AVR performed less frequently than men and will have minimal improvement in their Kansas City Cardiomyopathy Questionnaire (KCCQ) scores post-AVR indicative of more heart failure symptoms and a lower quality of life. DISCUSSION/SIGNIFICANCE: This study will seek to better understand sex-based differences in extent of cardiac damage to pressure overload in aortic stenosis (AS) to minimize treatment and outcome disparities for women and allow for more individualized and patient-centered care.

OBJECTIVES/SPECIFIC AIMS: This poster will present preliminary results from a study examining whether person-centered care planning—a new innovation in community mental health care—responds to the culture of, and helps reduce health disparities among, Latinx and Asian populations. METHODS/STUDY POPULATION: The study was funded by an NIMH/NIH Administrative Supplement for Minority Health and Mental Health Disparities Research and approved by the Institutional Review Board of the authors’ university. Participants included 26 mental health clients and 12 mental health providers of diverse backgrounds. The study employed empirical qualitative methods to explore client understandings of mental health, client experiences of culture and discrimination, and the process of care engagement and care planning from both client and provider perspectives. The analysis team itself included people of Latinx and Asian background, as well as a person with lived experience of mental health recovery. RESULTS/ANTICIPATED RESULTS: We anticipate that the results will show ways in which person-centered care successfully incorporates clients’ goals, but that there will also be evidence of ways in which the clinical encounter struggles to incorporate more social, collective, and cultural values and approaches. DISCUSSION/SIGNIFICANCE OF IMPACT: The poster will present up-to-date findings on this project, which speaks to pressing issues of health equity and community engagement for 2 of the fastest growing populations in the country.

OBJECTIVES/GOALS: Community-based participatory research is a “gold standard” methodology, yet many researchers lack the experience or resources to implement this approach. To make engagement more accessible, we developed and implemented a 3-part training series highlighting engagement as a spectrum with many options to meaningfully engage partners. METHODS/STUDY POPULATION: Staff at UNC-Chapel Hill’s CTSA and Cancer Center collaborated with patient and community partners to co-develop training content, structure, and delivery. Sessions were free and open to the public and covered key components of research engagement and its benefits, debunked common myths and misconceptions about engagement, outlined specific methods along the spectrum of engagement (from low to high touch), and described nuances of building and maintaining partnerships. Partners determined how to best incorporate their perspectives, developed content (including videos, audio clips, and quotes), and co-presented with UNC staff. Evaluations were collected after each session and feedback was incorporated into future iterations. RESULTS/ANTICIPATED RESULTS: 194 individuals from over 20 institutions have participated in the training. Of all survey respondents to date (n=74), 93% were very or extremely satisfied, 77% felt the training was very or extremely relevant to their work, and 76% were very or extremely likely to use information learned in the next year. Most helpful parts of the training were differentiating research engagement from participation; explaining engagement as a spectrum with varied methodologies; providing tools and resources to implement different approaches; and hearing directly from community co-presenters about their experiences engaging in research. Based on feedback, we created a workshop for researchers to develop engagement plans and an additional training for partners to build capacity and knowledge about engaging in research. DISCUSSION/SIGNIFICANCE: Engaging partners who are impacted by research can be instrumental to the success of a study. This training can help researchers identify engagement approaches that align with their goals, experience, and resources, as well as the interests and capacity of potential partners, and can serve as a model for those interested in training co-development.

OBJECTIVES/SPECIFIC AIMS: 1.Identify barriers to pursuing research for physician trainees 2.Develop a sustainable pipeline of physician-scientists at Duke 3.Coordinate physician-scientist development programs across the School of Medicine under one central Office 4.Provide infrastructure and resources for all physician-scientists 5.Increase the number of MDs and MD/PhDs who pursue, succeed, and are retained in research METHODS/STUDY POPULATION: To establish a baseline understanding of the needs and concerns of physician-scientist trainees at Duke, we conducted focus groups using a standardized interview guide and thematic analysis. Findings from these focus groups were used to develop a framework for support, leading to the creation of the Office of Physician-Scientist Development (OPSD) housed centrally within the Duke School of Medicine. The OPSD integrates programs and resources for multiple populations including medical students, residents, fellows, junior faculty, and faculty mentors. Pipeline programs will also be developed to enhance research engagement in targeted student populations prior to medical school. RESULTS/ANTICIPATED RESULTS: A total of 45 students and faculty participated in the focus groups and structured interviews (1st year medical student, n=11; 4th year medical students, n=11; residents/fellows, n=13; junior faculty, n=11). While participants raised a number of specific issues, one key message emerged: non-PhD MDs in basic research felt they lacked opportunities for directed training. Moreover, they felt the need to teach themselves many critical skills through trial and error. This has led to perceptions that they cannot compete effectively with PhDs and MD-PhD scientists for research funding and positions. Consensus recommendations included: better guidance in choosing mentors, labs, and projects; central resource for information relevant to physician scientists; training specifically tailored to physician scientists conducting laboratory-based research; improved infrastructure and well-defined training pathways; and assistance with grant preparation. To-date, over 90 students, residents, and fellows have been identified who identify as laboratory-based physician scientists. Additional efforts are underway to identify and characterize the broader range of physician-scientist students and trainees at Duke. DISCUSSION/SIGNIFICANCE OF IMPACT: Our planning study revealed specific steps forward toward developing a robust community of physician-scientists at Duke. As a first step, the Dean of the School of Medicine has appointed an Associate Dean of Physician-Scientist Development to oversee a new Office of Physician-Scientist Development (OPSD) being launched in December of 2018. The OPSD will offer four primary programs. 1) A concierge mentoring program will assist new trainees in identifying research areas of interest and mentors. Trainees will receive periodic contact to provide additional support as needed and promote success. 2) A physician-scientist training program is being created to provide training specific to laboratory research skills as well as career and professional development training to complement existing clinical and translational research programs. 3) Integrated training pathways will provide additional mentored research training for those pursuing research careers. Pathways will capitalize on existing resources from R38 programs, while pursuing additional R38 and R25 support. 4) An MD-Scientist funding program has been developed to provide additional research funding and protected time for students pursuing a second research year. Through the support and programming offered by the OPSD, we anticipate decreased perceptions of barriers to pursuing a physician-scientist career and increased satisfaction with training opportunities. Over time, we expect such support to increase the number of MD students pursuing research as a career and the number of residents, fellows, and MD junior faculty remaining in research careers.

OBJECTIVES/SPECIFIC AIMS: To establish a state-wide research registry of diverse participants. METHODS/STUDY POPULATION: We garnered broad institutional and community support by involving TRI’s Community Engagement team, its Community Advisory Board (CAB), and 3 UAMS patient CABs in selecting Web site content, images, and colors. Using this feedback, the TRI Recruitment Unit (RU), in conjunction with UAMS Communications and the Center for Health Literacy, developed the materials and crafted comprehensive communication and recruitment strategies. The UAMS Center for Pacific Islander Health, Hispanic faculty, and CAB members translated materials. UAMS IT programmed the user-friendly site to allow registration from smartphones and i-Pads and linked to UAMS patient electronic health messages. RESULTS/ANTICIPATED RESULTS: The RU committee implemented successful innovative strategies, including recruiting at the Arkansas State Fair and ballgames, attended by people of all races, ages, and socio-economic levels. Using i-Pads at the sites, recruitment took <5 minutes/registrant. Within 8 months, >2400 participants from across Arkansas had joined the registry: 14% African-Americans, 8% Pacific Islanders, 5% Hispanic, and 3% Native American. DISCUSSION/SIGNIFICANCE OF IMPACT: Involving CAB multidisciplinary input to design and implement recruitment materials was highly successful. Despite challenges of recruiting under-represented groups, the registry includes 30% minorities. By tracking registrants’ demographics with Lime Survey software, the RU will prioritize future recruitment events to maximize diversity of registrants.

OBJECTIVES/GOALS: Participating in out-of-school activities (i.e., sports) is associated with improved physical and mental health, but racial/ethnic and income disparities persist. Our goal was to describe parent perspectives to understand how to enhance family engagement in these activities, especially in low-income Black and Latinx communities. METHODS/STUDY POPULATION: We recruited parents through a large urban parks and recreation department located in Los Angeles County (LAC) and two community-based organizations who provide services primarily to low-income Black and Latinx residents in LAC. We conducted semi-structed English or Spanish interviews with parents of children ages 6-17 about the impact of activities on families, experiences making it difficult or easier for their child to be involved, and recommendations to meet their needs and facilitate family engagement. We coded the interviews using Dedoose and then performed thematic analysis. RESULTS/ANTICIPATED RESULTS: We completed 34 interviews (17 English, 17 Spanish). Parents shared these central ideas about out-of-school activities: (1) they support families and promote healthy child development; (2) they must create a safe environment and promote a sense of belonging for all families; and (3) service delivery changes reduced barriers, but activities often remained inaccessible. Barriers included lack of awareness about low-cost options, online enrollment, financial costs, waitlists, program timing, inaccessible parks/pools, safety, inconsistent quality, few opportunities for families to participate together, and a desire for more inclusive practices around race, culture, language, gender, children with special needs, and parent involvement. Parents offered recommendations to increase family engagement. DISCUSSION/SIGNIFICANCE: Involving parents in optimizing out-of-school activities may improve access, uptake, and quality of these health-promoting activities in low-income Black and Latinx communities.

ABSTRACT IMPACT: Practical evaluation approaches using case studies and success stories present a chain of evidence to demonstrate to stakeholders that resources are being used as required and producing desired results and effectively document the impact of clinical and translational research. OBJECTIVES/GOALS: This project describes the overall evaluation plan of the Miami CTSI by combining the Translational Sciences Benefits Model (TSBM) and the Kirkpatrick Model to evaluate scientific outcomes and impact of CTSI-supported research, and education and training programs developed by the CTSI. METHODS/STUDY POPULATION: Using case studies, the TSBM framework will be applied to CTSI-supported projects to evaluate scientific outcomes and impact on domains that include: clinical and medical; community and public health; economic; legislative and policy. We will apply the framework to projects that have received funding through CTSI’s Pilot and Translational Studies and Mentored Translational Scholars KL2 Programs, and that have at least one publication. Application of the Kirkpatrick model will be demonstrated by using the four levels of evaluation - reaction, learning, behavior, and results - to assess training outcomes and impact of the KL2 and the I-Corps Programs. RESULTS/ANTICIPATED RESULTS: About 20 pilot projects and 8 KL2 research projects will be assessed using the TSBM framework. We anticipate that all projects will show potential or demonstrated benefits in at least two of the four domains of the model. KL2 Program evaluation was conducted by collecting data on all the four levels of the Kirkpatrick model. Reaction and learning were assessed through feedback from KL2 scholars. Behavior was assessed using semi-annual updates on research and training progress of the scholars and the program. Results were measured using indicators such as program graduates that continue to engage in clinical and translational research and their transition to research independence. DISCUSSION/SIGNIFICANCE OF FINDINGS: Our evaluation approach using the two models is well aligned with overall CTSI aims and its three focus areas - infrastructure, education and culturalization/community engagement and will allow us to conduct a comprehensive yet practical evaluation of Miami CTSI programs.

OBJECTIVES/SPECIFIC AIMS: Diabetic retinopathy is the leading cause of blindness in adults aged 25–64 years. The prevalence of diabetic retinopathy is projected to increase 4-fold by 2050. Racial and ethnic minorities have a higher prevalence and greater severity of diabetic retinopathy. Over 50% of racial and ethnic minorities are not screened for diabetic retinopathy per guidelines. With timely diagnosis and sight-saving treatment, blindness from diabetic retinopathy is largely preventable. The objective of this study is to identify racial and ethnic disparities in the population that do not know they have diabetic retinopathy and to compare those disparities to those in the population that do know they have diabetic retinopathy. METHODS/STUDY POPULATION: Specifically, we have identified a nationally representative survey and clinical examination data to estimate the prevalence of undiagnosed diabetic retinopathy, to identify racial and ethnic disparities in that population, and to compare those disparities in the population with known diabetic retinopathy. We hypothesize that racial and ethnic disparities will be higher in the population with undiagnosed diabetic retinopathy in comparison to the population with known diabetic retinopathy. RESULTS/ANTICIPATED RESULTS: We hypothesize that racial and ethnic disparities will be higher in the population with undiagnosed diabetic retinopathy in comparison to the population with known diabetic retinopathy. The results of that analysis will instruct qualitative interviews that will advance the understanding of the factors that contribute to the decision whether to be screened for diabetic retinopathy. A decision tree will be created to categorize the hierarchy of barriers and facilitators. DISCUSSION/SIGNIFICANCE OF IMPACT: A better understanding of the population with undiagnosed diabetic retinopathy and the factors that influence the decision to get screened will help us not only to address disparities in diabetic retinopathy, but also to prevent blindness from retinopathy.

OBJECTIVES/GOALS: Penn instituted a Professional Development Core (PDC) to complement existing CTS education programs. Sessions were designed to advance participant knowledge and skills in key competency areas including communication, expectation setting, implicit bias and organizational structure, self-efficacy and resilience in order to enhance abilities to successfully execute career and research goals. METHODS/STUDY POPULATION: The PDC enrolled 4 cohorts totaling 87 trainees and scholars from 2016-2019. This included 35% predoctoral trainees (27 MD, 3 PhD), 39% postdoctoral trainees (29 MD, 3 PhD, 2 VMD/DVM), and 26% junior faculty (16 MD, 6 MD/PhD, 1 PhD). The two-year curriculum consists of 14 lunchtime sessions held bimonthly during academic terms. Session structures include a variety of interactive presentations, activities and facilitated discussions as well as reading material, assessment tools, and case studies. Facilitators include topic experts in academia, entrepreneurship, communications, and professional and personal development. The program is evaluated qualitatively through student satisfaction surveys after each session. RESULTS/ANTICIPATED RESULTS: Of the 2018-2019 participants, 90.8% rated the overall quality of PDC sessions as Very Good (56.05%) or Outstanding (34.75%). DISCUSSION/SIGNIFICANCE OF IMPACT: Feedback indicates that the group benefited from combining predoctoral and postdoctoral trainees, although not all content was immediately relevant to early stage trainees. Trainees appreciated the opportunity to engage with experts in disciplines typically considered outside of traditional science but critical to CTS career success. The flexibility of the curriculum allowed for inclusion of timely topics, newer suites of sessions focus on the multiple dimensions of valuing your science.

CTSI Career Development Award (KL2) programs provide junior faculty with protected time and multidisciplinary, mentored research training in clinical and translational science research. The KL2 Visiting Scholars Program was developed to promote collaborative cross-CTSA training, leverage academic strengths at host CTSAs, and support the career development of participating scholars through experiential training and the development of new partnerships. This manuscript provides a detailed programmatic description and reports outcomes from post-visit and outcomes surveys. Since 2016, 12 scholars have completed the program, with 6 scheduled to complete it in 2021. Post-visit surveys (n = 12) indicate all scholars reported the program valuable to career development, 11 reported benefit for research development, and 11 expansion of collaborative networks. Outcomes surveys (n = 11) revealed subsequent scholar interaction with host institution faculty for 10 scholars, 2 collaborative grant submissions (1 funded), 2 planned grant submissions, 1 published collaborative manuscript, and 3 planned manuscript/abstract submissions. The Visiting Scholars Program is a cost- and time-efficient program that leverages the academic strengths of CTSAs. The program enhanced KL2 scholar training by expanding their professional portfolio, promoting research development, and expanding collaborative networks. Resources to support the program are shared in this report to expedite the development of similar programs at regional and national levels.

The African American population of Buffalo, New York experiences striking race-based health disparities due to adverse social determinants of health. A team of community leaders and university faculty determined that a community dialogue was needed to focus research and advocacy on the root causes of these disparities. In response, we organized the annual Igniting Hope conference series that has become the premier conference on health disparities in the region. The series, now supported by an R13 conference grant from NCATS, has been held four times (2018–2021) and has attracted community members, community leaders, university faculty, and trainees. The agenda includes talks by national leaders and breakout/working groups that led to a new state law that has reduced disproportionate traffic-ticketing and drivers' license suspensions in Black neighborhoods; mitigation of the disproportionate COVID-19 fatalities in Black communities; and the launching of a university-supported institute. We describe the key elements of success for a conference series designed by a community–university partnership to catalyze initiatives that are having an impact on social determinants of health in Buffalo.

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

ABSTRACT IMPACT: Recommendations for increasing trainee productivity will be highlighted. OBJECTIVES/GOALS: Using a combination of qualitative (interview) and quantitative (publications tracking) data, we undertook to describe the hurdles and concerns impeding academic accomplishments among T and K awardees at one CTSA hub and to examine whether hurdles at 6 months would predict academic output within one year following completion of the training program. METHODS/STUDY POPULATION: Semi-structured interviews were conducted with 29 trainees (28 TL1 and 8 KL2) 6 months into their training. Interview transcripts were analyzed using Atlas.ti to identify hurdles (factors that had already impeded research progress) and concerns (future challenges anticipated by the trainee). PubMed searches yielded the number of publications within one year of exiting the training program. Frequencies of hurdles and concerns were examined to characterize the factors most likely to impact trainee progress during the first 6 months of their training program. Among 18 trainees who had completed their training, the mean number of publications within one year of exiting the program (identified via verified PubMed searches) was compared across the total number of hurdles reported at 6 months (range = 0 to 3). RESULTS/ANTICIPATED RESULTS: The thematic analysis yielded 19 categories of hurdles and 14 categories of concerns. The top three hurdles were technological challenges (e.g., issues with equipment or data reduction; reported by 63% of trainees), professional competing responsibilities (40%), and navigating collaborations (30%). The top three concerns were future funding (33%), potential as an independent researcher (27%), and institutional context (e.g., departmental structure; 23%). The number of hurdles reported at 6 months significantly predicted number of publications one year post-exit (F (3,14) = 3.14, p < .05). Trainees reporting zero hurdles generated a mean of 8.67 publications; those with 3 hurdles generated a mean of 2.4 publications. DISCUSSION/SIGNIFICANCE OF FINDINGS: Future concerns were completely different from past hurdles, suggesting that the issues impeding research progress are not anticipated. Results suggest trainees would benefit from training related to how to balance competing professional responsibilities and navigate collaborations and that early attention to hurdles may enhance productivity.

OBJECTIVES/GOALS: Approximately 10% of COVID-19 patients experience multiple symptoms weeks and months after the acute phase of infection. Our goal was to use advanced machine learning methods to identify PASC phenotypes based on their symptom profiles, and their association with critical adverse outcomes, with the goal of designing future targeted interventions. METHODS/STUDY POPULATION: Data. All COVID-19 outpatients from 12 University of Minnesota hospitals and 60 clinics. Independent variables consisted of 20 CDC-defined PASC symptoms extracted from clinical notes using NLP. Covariates included demographics, and outcomes included New Psychological Diagnostic Evaluation, and Number of PASC Hospital Visits (>=5). Cases (n=3235) consisted of patients with at least one symptom, and controls (n=3034) consisted of patients with no symptoms. Method. (1) Used bipartite network analysis and modularity maximization to identify patient-symptom biclusters. (2) Used multivariable logistic regression (adjusted for demographics and corrected through Bonferroni) to measure the odds ratio of each patient bicluster to adverse outcomes, compared to controls, and to each of the other biclusters. RESULTS/ANTICIPATED RESULTS: The analysis identified 6 PASC phenotypes (http://www.skbhavnani.com/DIVA/Images/Fig-1-PASC-Network.jpg), which was statistically significant compared to 1000 random permutations of the data (PASC=.31, Random Median=.27, z=11, P<.01). Three of the clusters (Cluster-1, Cluster-4, and Cluster-5 encircled with ovals in Fig. 1) contained CNS-related symptoms, which had statistically significant risk for one or both of the adverse outcomes. For example, Cluster-1 with critical CNS symptoms (depression, insomnia, anxiety, brain-fog/difficulty-thinking), had a significantly higher OR compared to the controls for New Psychological Diagnostic Evaluation (OR=6.6, CI=4.9-9.1, P-corr<.001), in addition to having a significantly higher ORs for the same outcome compared to all the other clusters. DISCUSSION/SIGNIFICANCE: The results identified distinct PASC phenotypes based on symptom profiles, with three of them related to CNS symptoms, each of which had significantly higher risk for specific adverse outcomes compared to controls. We will test whether these phenotypes replicate in the N3C data, and explore their translation into triage and treatment strategies.