North Carolina Central University (NCCU) and Duke Cancer Institute implemented an NCI-funded Translational Cancer Disparities Research Partnership to enhance translational cancer research, increase the pool of underrepresented racial and ethnic group (UREG) researchers in the translational and clinical research workforce, and equip UREG trainees with skills to increase diversity in clinical trials. The Cancer Research Education Program (C-REP) provided training for UREG graduate students and postdoctoral fellows at Duke and NCCU. An innovative component of C-REP is the Translational Immersion Experience (TIE), which enabled Scholars to gain knowledge across eight domains of clinical and translational research (clinical trials operations, data monitoring, regulatory affairs, UREG accrual, biobanking, community engagement, community outreach, and high-throughput drug screening). Program-specific evaluative metrics were created for three broad domains (clinical operations, basic science/lab research, and population-based science) and eight TIE domains. Two cohorts (n = 13) completed pre- and post-surveys to determine program impact and identify recommendations for program improvement. Scholars reported statistically significant gains in knowledge across three broad domains of biomedical research and seven distinct areas within TIE. Training in translational research incorporating immersions in clinical trials operation, biobanking, drug development, and community engagement adds value to career development of UREG researchers.

OBJECTIVES/GOALS: Limited access to medication and poor medication adherence exacerbate chronic diseases following disasters. Experts recommend individuals in disaster-prone areas be prepared to manage their chronic diseases in the event of resource disruption. This study’s goal is to identify factors underlying personal medical preparedness. METHODS/STUDY POPULATION: A cross-sectional survey of 120 insured adults age ≥50 in Southeast Louisiana with hypertension and ≥1 daily medication during the 2023 Atlantic Hurricane Season is underway. The survey includes the Household Emergency Preparedness Index Access and Functional Needs Section (HEPI AFN), a validated measure of medical preparedness that accounts for special circumstances including refrigerated medication and electricity-dependent medical equipment. The mean score of the 9-item tool ranges from 0 to 1, with higher scores indicating more preparedness. The survey also includes 3 open-ended questions where participants can explain difficulties with medication adherence during hurricanes in their own voice. Data collection is ongoing. This interim analysis provides descriptive statistics. RESULTS/ANTICIPATED RESULTS: An interim analysis of the first 50 respondents included 46% women, 52% Black, mean age 61.2 (SD=7.3) years, and mean 52.5 (SD=16.2) years living in a hurricane-impacted area. Participants had a median of 1 comorbid condition; 72% reported taking >5 daily medications. Most respondents (94%) stated their household was at least “somewhat prepared” to handle a disaster and reported medical preparedness on an average of 82% of HEPI-AFN items (mean score = 0.82, SD=0.18); 90% reported that they had never had a healthcare worker talk to them about personal medical preparedness. On open response questions, participants cited insurance restrictions as the primary barrier to having extra medication on hand. In the final sample, regression models will be used to examine factors associated with increased preparedness. DISCUSSION/SIGNIFICANCE: While most participants in this insured, disaster-experienced preliminary sample are medically prepared, few have discussed preparedness with a healthcare provider. Identifying socio-demographic factors associated with preparedness will help to strengthen mitigation strategies addressing widening of health disparities during disasters.

OBJECTIVES/SPECIFIC AIMS: The purposes of this study are to examine the relationships among sleep characteristics (duration, efficiency), stress biomarkers, and child behavior problems among toddlers living in socioeconomically disadvantaged homes and how these characteristics change over time from age of 12 months to 24 months. Aim 1: examine changes in subjective and objective sleep characteristics from 12 to 24 months of age. Aim 2: examine changes in stress biomarkers from 12 to 24 months of age. Aim 3: examine the cross sectional and longitudinal relationships between sleep characteristics and stress response. Aim 4: examine the cross sectional and longitudinal relationships between sleep characteristics and toddlers’ child behavior problems. METHODS/STUDY POPULATION: In this cross-sectional study we are recruiting parents with healthy toddlers from early head start programs and a community clinic to prospectively examine the relationships among sleep characteristics, stress biomarkers, and children’s health. Data on sleep characteristics will include subjective and objective measures of sleep duration and efficiency and parental interactive bedtime behaviors to assist their toddlers’ sleep initiation. Multisystemic biomarkers of stress including cortisol, CRP, IL-6, and BMI, will be measured individually. The associations between sleep characteristics and the biomarkers, considered as a latent variable of the stress response, will be explored. Health measures will include secretory IgA and parent-reported behavioral problems. Generalized linear models will be used in the data analysis. RESULTS/ANTICIPATED RESULTS: To date we have obtained objective (9 days/nights of actigraphy) measures of 33 toddlers’ sleep and subjective measures of parenting interactive behaviors. Using the Parental Interactive Bedtime Behavior (PIBB) Survey and subscales [active physical comforting, encourage autonomy, settle by movement, passive physical comforting (PPC), social comforting], we are currently reporting on the associations between PIBB and toddler’s sleep characteristics. The sample included 33 toddlers (mean age=1.33 years, SD=0.54). The toddlers’ sleep duration averaged 8.22 hours (SD=0.86). There were statistically significant moderate associations between sleep duration and parents’ PPC (r=−0.41, p=0.02). Intra-individual variability in the amount of wake after sleep onset was also significantly associated with total PIBB and PPC (r=0.37, p=0.05; r=0.52, p=0.002, respectively). Intra-individual variability in the amount of sleep fragmentation within toddlers was significantly associated with total PIBB (r=0.36, p=0.05). DISCUSSION/SIGNIFICANCE OF IMPACT: Although active physical comforting (eg, rocking to sleep, patting or rubbing child’s back) is most commonly associated with sleep patterns in infancy and toddlerhood among samples of higher socio-economic status, findings from this study suggest a stronger association between PPC (eg, presence of the parent in the room to fall asleep) and less sleep duration and more individual variability in night wakings. The biomarker data are currently being analyzed and results will be presented within the year. Taken together, these preliminary results and pending results will inform future intervention development that may address the role of parenting behavior in promoting health sleep early in life.

OBJECTIVES/GOALS: Recent studies suggest nulliparous patients benefit from low dose aspirin (LDA), yet there are limited studies examining MFM providers adherence to USPSTF guidelines and predictors of adherence. We identified demographic, obstetric, and clinical characteristics associated with guideline concordant counseling on LDA in nulliparous women. METHODS/STUDY POPULATION: Retrospective cohort study of pregnant nulliparous patients who received MFM prenatal care at a single tertiary center (1/1/2019-6/30/2020). Multiple gestations, > 2 spontaneous or therapeutic abortions, and contraindications to LDA were excluded. Maternal demographic and clinical characteristics were abstracted from the electronic medical record. The primary outcome was documented LDA counseling based on USPSTF guidelines. Data were analyzed using bivariate analysis and logistic regression using R 4.1.0 (R Core Team, 2021). RESULTS/ANTICIPATED RESULTS: Among 394 records in the analysis cohort, 316 met USPSTF guidelines for LDA. 164 (51.9%) meeting guidelines had documented LDA counseling. 67.4% of individuals with ?1 major USPSTF risk factors were counseled and 50.7% with ?2 moderate risk factors were counseled (Table 1). Age at the estimated due date (EDD), Black or Other race, chronic hypertension, and obesity are significantly associated with higher odds of aspirin counseling (Table 2). Patients with chronic hypertension had 4.15 higher odds of receiving low dose aspirin counseling compared to non-hypertensive patient (Table 2). DISCUSSION/SIGNIFICANCE: Our results suggest that only 51.9% of patients eligible for LDA received counseling despite MFM care. Increasing MFM provider awareness about the USPSTF guidelines and creating tools that facilitate guideline concordant counseling may increase the number of eligible patients who are counseled about LDA.

OBJECTIVES/SPECIFIC AIMS: Determine whether GABA-A receptor binding is abnormal and linked to dystonia symptoms in cervical dystonia (CD). METHODS/STUDY POPULATION: There is increasing evidence that a key pathophysiological mechanism in adult-onset focal dystonia is a reduction in inhibitory control over the sensorimotor network. Results from a recent 11C-flumazenil PET imaging study suggest that abnormal inhibitory signaling in genetic and sporadic forms of dystonia may be due to reduced GABA-A binding. It remains unknown whether CD, the most common form of adult-onset focal dystonia, is associated with abnormal GABA-A binding. The goal of this research is to determine if GABA-A receptor binding is abnormal and linked to dystonia symptoms in CD. RESULTS/ANTICIPATED RESULTS: We investigated whole brain GABA-A binding in 15 CD patients (11F; 64±8 y) and 15 healthy controls (10F; 64±9 y) using 60-minute dynamic 11C-flumazenil PET scans. GABA-A receptor binding potential (BP) was estimated using a simplified reference tissue model. A 2-sample t-test was used to identify voxel-wise GABA-A BP differences between groups, and a regression analysis used to test for correlations between GABA-A BP and disease severity as measured with the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). A conventional region of interest analysis was also conducted to quantify BP changes within the sensorimotor network using the automated anatomical labeling atlas. DISCUSSION/SIGNIFICANCE OF IMPACT: CD patients have reduced GABA-A receptor binding compared with healthy controls, with the greatest reduction seen within the sensorimotor region of the thalamus. Furthermore, reductions in GABA-A binding in brain regions associated with coupling sensory and motor information predict motor severity. These findings support that reduced GABAergic signaling within sensorimotor integration regions is a key mechanism underlying dystonic symptoms in CD and could help inform the development of better, more targeted treatment options.

OBJECTIVES/SPECIFIC AIMS: Background: Failure to involve hard-to-reach populations in clinical research denies the potential benefits of research to the excluded groups, perpetuating health disparities. Employing community health workers (CHWs) may be an effective strategy to increase outreach and engagement of marginalized groups. CHWs are members of the target communities with a personal commitment to help their neighbors, and who serve as informants and communicators among their peers. CHWs may be particularly effective in addressing individual and cultural barriers to research participation. Because of their unique background and community-based roles, tailored training programs for CHWs are needed. The Recruitment, Retention, and Community Engagement Program at the UIC Center for Clinical and Translational Sciences seeks to train CHWs to be involved in the recruitment and enrollment of participants in clinical trials. We developed an 8-hour training that covers basic research methods (e.g., randomized clinical trials, longitudinal studies); research activities (e.g., surveys, interviews); and research ethics. The training focuses on the development of communication skills necessary for ethical recruitment and informed consent, providing strategies for addressing mistrust, fear and misunderstanding around the research process. Aim 1: To evaluate the feasibility of the CHW training by assessing. Aim 1.1: Recruitment of participants; Aim 1.2: Completion of training session (8 hr). Aim 2: To evaluate acceptability of training by assessing. Aim 2.1: Satisfaction with training; Aim 2.2: Cultural competence of training content; Aim 2.3: Participant self-efficacy in reproducing information. Aim 3: To collect performance measures by assessing. Aim 3.1: Knowledge gain and retention; Aim 3.2: Self-efficacy in identifying and addressing negative beliefs about research; Aim 3.3: Participants’ readiness to refer and/or recommend participation in clinical trials. METHODS/STUDY POPULATION: Methods: This is a pilot study with a single-group repeated-measures design with assessments at baseline, 1 week post-test, and 3- and 6-month follow-ups. We aim to recruit 25 CHWs working with organizations serving the needs of ethnic minorities in Chicago. We will evaluate feasibility (recruitment, completion of training and assessments) and acceptability of the training (satisfaction with training, cultural appropriateness of content and delivery, participant self-efficacy in reproducing information). Performance measures assessed through self-administered surveys at baseline, 1 week post-training, 3 months, and 6 months will include knowledge, attitudes toward research, and self-efficacy in identifying and addressing barriers to participation. Readiness to recruit and obtain informed consent will be assessed during an observed simulation activity with a standardized participant. Data analysis: Demographic data will be collected, and descriptive and inferential analyses will be conducted. Pretest and post-test questionnaire data will be compared using t-tests. In the informed consent simulation, individuals will be scored on whether they adequately addressed required elements of the informed consent process. Data gathered from the informed consent simulation will also be used for program evaluation and formative purposes; feedback on strengths and areas for improvement will be provided to participants. RESULTS/ANTICIPATED RESULTS: Expected results: It will be feasible to implement the training of CHWs, reaching the expected goal of 25 participants, with at least 70% of them completing the 8-hour training. We expect to collect data demonstrating acceptability of the training with a score of “good” or “excellent” by 70% of participants. At least 70% will rate the training as “culturally acceptable” or better, and will show improved self-efficacy in the delivery of information from pretest to post-test by at least 30%. Performance measures will demonstrate improvements in research knowledge by 30% from pretest to post-test; increased self-efficacy in identifying and addressing negative beliefs about research process, by at least 30%. A minimum of 70% of participants will demonstrate readiness to refer and/or recommend participation in clinical trials by scoring at or above 70% in evaluation of performance with standardized participants. Evaluation of knowledge retention at 3 and 6 months post-training will not take place before the Translational Science Conference in March 2018. DISCUSSION/SIGNIFICANCE OF IMPACT: Discussion/Impact. The outcomes of this evaluation may advance our knowledge of community obstacles to participation in research, and shed light on successful strategies to address them. Information obtained will be used to address limitations of the training. Even though the sample is small we expect to identify trends in quantitative measures that will support an application for funding for a larger randomized study. Once we have developed an effective training model, we expect to disseminate it to other CTSAs for broad implementation.

OBJECTIVES/GOALS: Rural recovery community organizations (RCOs) are key to fostering people’s resilience in the face of the nation’s substance use crisis. However, their development is often a black box. METHODS/STUDY POPULATION: A community-engaged multiple-methods approach was conducted to elucidate stakeholders' perspectives about the creation of two RCOs through a consortium intended to build peer recovery support services in a rural Southern Indiana designated health professional shortage area. Document review (e.g., meeting minutes, event photography, and administrative reports) were extracted to map activities, products, and milestones of the development of the RCOs. Consortium members, RCO leadership and staff, and community members identified by consortium or RCO leadership/staff participated in one-on-one interviews or community roundtable sessions were held to reflect on the evolving development of the RCOs. Procedures were approved by the Institutional Review Board of Indiana University. RESULTS/ANTICIPATED RESULTS: This designated health professional shortage area is unique as it is the nonmetropolitan county with two accredited RCOs. Each RCOs has its own distinct brand. One RCO primarily provide support services to prepare justice-involved individuals who are re-entering the community from jail or probation. The second RCO operates a recovery café – a drug free space that offers accountability groups (recovery circles), volunteer opportunities, and multiple pathway (e.g., 12-steps, referral to medication assisted treatment) meetings. Services are facilitated through peer recovery coaches. Services are provided by certified peer recovery coaches (individuals who has lived experience with addiction and recovery) who offers informational, socio-emotional, and instrumental/basic needs support. DISCUSSION/SIGNIFICANCE: This collaborative rural-based model features recovery community organizations as emerging lead agencies in providing informational, socio-emotional, and basic needs for individuals living in long-term recovery as well as individuals using substances and is not yet in recovery services or acknowledging an addiction is present.

ABSTRACT IMPACT: Future exercise interventions for people with mobility disability should be tailored to the level of the individual and responsive to intervention adherence. A promising area of research is the use of adaptive interventions as a mechanism for tailoring and 'titrating’ the intervention based on data obtained during early intervention stages. OBJECTIVES/GOALS: The purpose of the study was to understand adherence to a home-based exercise trial delivered to people with a mobility disability. The objective was to develop a multi-dimensional model for engaging and retaining participants not adhering to an exercise trial by using a grounded theory approach involving both qualitative and quantitative data. METHODS/STUDY POPULATION: An exercise trial utilized telehealth technology to deliver a home-based exercise intervention for adults with a mobility disability. In order to understand factors of adherence to the exercise trial, a mixed methods study design was used involving baseline data and semi-structured interviews. Maximum variation sampling was used to select participants based on level of adherence, gender, race, and functional level. Categorization based on adherence to exercise videos during the first 12 weeks of the intervention included 3 groups: 1) high adherence (≥80% weekly median exercise video minutes viewed), 2) sub-optimal adherence (< 80% but ≥20%), and 3) low adherence (< 20%). Interviews were conducted with 10 participants in each group (n = 30) and data were analyzed using a grounded theory approach. RESULTS/ANTICIPATED RESULTS: A sample of 30 participants from a large pragmatic, home-based exercise trail have completed interviews. All interviews were transcribed and uploaded to NVivo software for coding. Emerging codes include lack of time to exercise, inappropriate exercise intensity, and lack of support for exercise. Using grounded theory approach, results include: 1) identifying risk factors for low adherence to a home-based exercise program delivered to people with mobility disability, 2) discovering themes for not responding to program activities in a home-based exercise program for adults with physical disabilities, and 3) determining the relationships between variables that emerge from thematic and statistical analyses. A model for adherence to home exercises among people with mobility disability will be presented. DISCUSSION/SIGNIFICANCE OF FINDINGS: People with a mobility disability are more susceptible to adopting sedentary lifestyles, which result in poor psychosocial and physical health outcomes. There is a clear and pressing need for designing future home-based exercise interventions with a greater level of customization for participants who have low to non-adherence.

ABSTRACT IMPACT: Access to intracranial recording in our epileptic sample provides a unique opportunity to characterize neurological activation patterns associated with attention and implicit learning; this foundational physiological understanding will serve to better guide cognitive rehabilitation techniques in TBI patients that aim to improve functioning across these cognitive domains. OBJECTIVES/GOALS: 1) Investigate the network level interactions of attention and learning during an attention network task (ANT) and an implicit learning contextual cueing (CC) task. 2) Assess the effect that attention rehabilitation strategies have on behavioral and neural responses pre/post-attentional intervention. METHODS/STUDY POPULATION: This study involves refractory epilepsy patients (rEP) with implanted intracranial electrodes and moderate-to-severe traumatic brain injury (m/sTBI) survivors. In rEP, we are identifying network level modulations of cortical regions via the ANT, which probes components of attention (alerting, orienting, and executive control) and a CC task that probes implicit learning. We hypothesize that modulation of attention and learning can be seen at the neuronal level. In TBI we will assess improvement following two behavioral attention rehabilitation paradigms; and use our results from epileptic patients to guide measurement of treatment-related neuroplastic change via scalp electroencephalography. RESULTS/ANTICIPATED RESULTS: Preliminary behavioral results from the rEP cohort are in line with previous studies and the intracranial data is suggestive of region- and task-specific modulations in memory and attention related systems. Following completion of recruitment, we expect to more concretely identify regions and networks that exhibit modulatory effects associated with attention and implicit learning. Additionally, we anticipate that deficits in attention will be mitigated following training and hypothesize that implicit learning rate will improve in TBI patients as a result of both attentional rehabilitation paradigms. DISCUSSION/SIGNIFICANCE OF FINDINGS: Characterizing intracranial activity in epilepsy patients will give electrophysiology data unattainable in TBI patients. This intracranial perspective will enable us to propose mechanisms of action that may result from our interventions and enable critique of current rehabilitation treatments.

OBJECTIVES/GOALS: To determine the relationship between race/ethnicity, geospatial (place-based) social determinants of health (SDOH; rurality and child opportunity index (COI)), and asthma-related adverse events (AAE: hospitalizations, emergency department (ED) visits) among children with asthma in Arkansas. METHODS/STUDY POPULATION: Using the Arkansas All-Payer Claims Database, we conducted a retrospective analysis of children (5-18 years). Medicaid-enrolled children with, 1 asthma diagnosis (ICD-10 J45.xx) for any type of medical event in 2019 were included. Race/ethnicity were self-reported (non-Hispanic White, non-Hispanic Black, Hispanic/Latino). Due to small sample size, all other racial/ethnic groups were classified as Other. Rural-Urban Commuting Area (RUCA) codes were used to determine rural-urban designation using 4-category classification by zip code. COI level was determined by zip code (scale: very low- to very-high opportunity). AAEs were identified using 2019 medical claims. RESULTS/ANTICIPATED RESULTS: The cohort (n=25,198) included 38.7% White, 32.9% Black, 6.0% Hispanic, 5.1% Other, and 17.3% Missing race/ethnicity children. Overall, 61.2% live in rural and 38.8% live in urban areas. Among rural children, 33.1% were in very-low, 34.4% low, 20.8% moderate, 11.6% high, and 0.1% very-high opportunity areas. Among urban children, 32.6% were in very-low, 12.4% low, 17.5% moderate, 19.5% high, and 18.0% very-high opportunity areas. Overall, Black children more frequently lived in very-low or low opportunity areas (75.4%). Among rural children, 9.3% had an AAE. White children had highest rates of AAE. Overall, AAE rates were variable by rurality/urbanity and COI level. DISCUSSION/SIGNIFICANCE: Differences in asthma outcomes by race/ethnicity, rurality, and COI level were unexpected, with similar rates of poor outcomes across the cohort. These finding underscore the complexity of the relationships between race/ethnicity, geospatial SDOH, and asthma outcomes.

OBJECTIVES/GOALS: To improve our delivery of HIV prevention services by evaluating associations between self-perceived risk of HIV, objective risk for HIV based on sexual risk, and self-reported lifetime PrEP use. This will expand our current understanding of an essential component of decision making for PrEP uptake in young men who have sex with men (YMSM). METHODS/STUDY POPULATION: The population consists of participants in the Healthy Young Men (HYM) observational cohort study (16-24-year-old YMSM of color at risk for HIV in Los Angeles). Secondary analysis was conducted using an existing data set to test associations between self-perceived risk of HIV, behavioral sexual risk, and self-report of lifetime PrEP use at baseline. RESULTS/ANTICIPATED RESULTS: The HYM cohort consists of 397 HIV-negative young men who have sex with men from Los Angeles; 21% identify as African American/Black, 59% as Latinx, and 20% as multiethnic. Of these participants, 90% were aware of PrEP and 86% were eligible for PrEP according to CDC behavioral risk criteria; however, only 23% had ever been prescribed PrEP. We hypothesize that those who have utilized PrEP will report higher self-perceived risk of HIV infection and will have stronger correlation between self-perceived and objective risk for HIV. Associations will be tested using appropriate chi-square tests. DISCUSSION/SIGNIFICANCE: Self-perceived risk of HIV is proposed as a strong predictor of engagement in HIV prevention. This has been widely understudied in youth in the context of accessing PrEP. A better understanding of the role of self-perceived risk is essential to create and improve interventions to increase PrEP uptake as well as to improve PrEP service delivery for youth.

OBJECTIVES/GOALS: The COVID-19 pandemic may have affected the relationship/experience of the mother-child dyad (Provenzi et al., 2021). Our objective is to identify the association of pandemic related maternal stress with child development. We will further evaluate the role of bonding, attachment, and trauma on this association. METHODS/STUDY POPULATION: We aim to recall a prospective cohort (n=200) of Latinx/Hispanic mothers from an ongoing study, power analysis will estimate minimum sample size (power=0.80 and alpha =0.05). Assessments of pandemic related maternal stress (PRMS) will be done with the COVID-19 and Perinatal Experiences Interview, perceived stress scale, and Parental Stress Index. Bonding, attachment, and trauma history will be assessed with psychological questionnaires and Childs behaviors with the Ackerman-CBCL questionnaire. Descriptive statistical analysis will be done. Correlations will identify associations and multivariate models will assess the role of parental bonding and effects of maternal attachment/trauma on associations to PRMS and child behavioral outcomes (controlling for confounding effects). RESULTS/ANTICIPATED RESULTS: First, we expect to find that mothers will report higher levels of stress (pandemic related, perceived, and parental) which will be associated with less bonding behaviors towards her child. Second, we expect that mothers levels of PRMS will be mediated by poorer bonding characteristics thus leading to negative child behavioral outcomes (i.e., poor regulation, crying spells, alterations in physiological patterns, and social-emotional developmental outcomes). Further mothers insecure attachment traits and trauma history will moderate perception of stress and negative child behavioral outcomes. DISCUSSION/SIGNIFICANCE: Results will describe stress in Latinx/Hispanics mothers during the pandemic and effects on child development. Identifying the role of maternal bonding/attachment will point to how this formative relationship has transformed during the pandemic, providing knowledge of mother-child resiliency.

OBJECTIVES/SPECIFIC AIMS: Mesh properties, such as stiffness, porosity, and weight have been shown to correlate with the degree of mesh integration with vaginal tissue. Previous research in rhesus macaques implanted with polypropylene mesh differing in stiffness, porosity, and weight showed differences in vaginal deterioration following mesh implantation. These differences were correlated with a foreign body response, consisting primarily of activated, proinflammatory M1 macrophages. Previous studies have determined that the early macrophage polarization profile following biomaterial implantation is a strong indicator of overall tissue integration downstream. However, these early responses have not been previously observed in the appropriate surgical models. Prior work from our laboratory in developing a cytokine delivery system has shown that shifting the macrophage response at the host-implant interface from a pro-inflammatory M1 phenotype to an anti-inflammatory M2 phenotype in the first 14 days postimplantation resulted in enhanced integration of the mesh with the surrounding tissues. The present study develops an in vivo model clinically relevant surgical model to investigate the modulation of the host response to mesh. Utilizing a moderately-sized animal, we can feasibly implant mesh using the “gold standard” abdominal sacrocolpopexy procedure and evaluate the changes in the host immunologic response at early (14 d) and tissue remodeling outcomes at late stages (90 and 180 d) of implantation. METHODS/STUDY POPULATION: Commercially available heavyweight and lightweight mesh was used to investigate the modulation of the immune response. A custom MTI SILAR Automated Dip Coating machine is used to uniformly coat the mesh in a reproducible manner. An adapted radio frequency glow discharge method is used to create a stable negative charge on the surface of the mesh, followed by the sequential deposition of polycationic and polyanionic polymers to provide a stable, conformal, nanoscale coating. Chitosan served as the polycation, chosen because of its known antimicrobial and biocompatibility properties. Dermatan sulfate served as the polyanion, chosen for its important role in regulating extracellular matrix components and enhancing the activity of cytokines. Interleukin-4 (IL-4) is incorporated into the coating to be released in a controlled manner upon implantation. In vitro controlled release profiles were assessed to demonstrate efficient and local release of IL-4. Utilizing a New Zealand white rabbit surgical model, we implant mesh using the “gold standard” abdominal sacrocolpopexy procedure and evaluate the changes in the host immunologic response at early (14 d) and tissue remodeling outcomes at late stages (90 and 180 d) of implantation. The mesh-tissue complex was removed from each rabbit and processed for histological staining as well as immunolabeling of immune cells, such as macrophages. Determination of matrix metalloproteinases and fibrotic capsule formation also helps characterize the overall inflammatory response associated with each implant. RESULTS/ANTICIPATED RESULTS: We have developed a clinically relevant rabbit surgical model to implant different conditions of surgical mesh into 2 different sites, including the vagina and the abdomen. The results of this study show that implants into vaginal tissues elicited an increased host inflammatory response at 14 days as compared with those in the abdominal wall. However, at chronic time points the inflammatory response in the vagina was reduced as compared to that in the abdominal cavity. The present study also demonstrates the scale-up of a previous methodology for nano-scale coating. We present a nanometer thickness, tunable, and uniform coating capable of releasing bioactive IL-4. In vitro assays confirm the bioactivity and the controlled local release allowing for shifts in the immune response to promote implant integration. Improved remodeling has been observed to correlate with a shift in the early host response from an M1 to an M2 phenotype, however, there is limited information on the exact mechanism. Our strategy to achieve enhanced tissue remodeling demonstrate outcomes such as minimal changes to the structural properties of the mesh and a controlled release profile to sufficiently polarize macrophages around the mesh to a pro-remodeling state. DISCUSSION/SIGNIFICANCE OF IMPACT: Pelvic organ prolapse is a condition where the pelvic floor muscles weaken over time resulting in the downward shift of the pelvic organs into the vaginal canal. Moreover, factors such as obesity, age, and vaginal birth increase the susceptibility of being diagnosed with pelvic organ prolapse. Direct costs of reconstructive procedures exceed $1 billion each year in the United States. Synthetic mesh has been used to repair abdominal hernias for over half a century. Biomedical companies, through 510k and the 1976 Medical Device Amendments Act, were able to resell their hernia repair mesh as a treatment for pelvic organ prolapse. However, women who have had vaginal mesh implants have reported an increasing number of complications including chronic pain and mesh erosion/exposure at rates as high as 10%–20%. In fact, in 2008 and 2011, the US Food and Drug Administration issued warnings to doctors and patients about the mesh. In January 2016, the FDA officially had to reclassify surgical mesh for transvaginal repair of pelvic organ prolapse from a class II, moderate risk device, to a class III, high-risk device. Presently, data for the use of synthetic mesh has largely derived from abdominal hernia repair, instead of vaginal repair of prolapse. In the rodent model, the vagina is too small to implant mesh in an analogous manner to human implantation. Instead, implantations are done in the abdomen, a different tissue composition and host response profile than the vagina. Primate models of pelvic organ prolapse have been utilized, but are associated with high costs and investigation of acute immune responses are not considered ethical due to the short time of survival. Thus, our presented work will not only show the development of an improved material for implantation, but also the development of an in vivo model clinically relevant to understanding the early host response to mesh.

OBJECTIVES/GOALS: We sought to explore how the COVID-19 pandemic impacted community and stakeholder engagement in research from both researcher and stakeholder partner perspectives and to identify challenges, strategies, and other facilitators affecting their experience, including those related to virtual engagement. METHODS/STUDY POPULATION: We conducted semi-structured interviews with ten researchers and eight stakeholder partners who conducted or collaborated on stakeholder-engaged health research during the COVID-19 pandemic (March 2020 onwards). Potential participants were identified purposively and through snowball sampling. Interviews were conducted via Zoom, recorded, and transcribed for analysis. The transcribed data were qualitatively analyzed through an iterative process involving memoing and consensus coding using inductive and deductive codes. We reviewed memos and code reports to identify and describe key categories and themes. RESULTS/ANTICIPATED RESULTS: The challenges and facilitators identified varied based on factors such as geographic scope of the partnership (local vs national) and previous engagement type (virtual vs in-person). Many challenges were related to virtual engagement, such as dealing with distractions, limited access to Internet, or difficulty forming relationships online, or to wellbeing and personal circumstances, such as feeling burnt out, managing increased caregiving responsibilities, or concern about risk of illness if conducting in-person activities. Facilitators identified included having strong existing partnerships, utilizing strategies to enhance virtual engagement, adapting activities to manage risk of in-person interactions, and showing support to stakeholder partners. DISCUSSION/SIGNIFICANCE: By better understanding challenges and facilitators affecting experiences of both researchers and stakeholder partners engaging in research during the COVID-19 pandemic, we can develop strategies and resources to better support research partnerships during future health emergencies.

OBJECTIVES/GOALS: Accumulating evidence supports the involvement of immune and inflammatory pathways in Bipolar Disorder (BD) pathophysiology. This pilot study aims to determine if altered peripheral IL-2, TNF-a, IL-4, IL-6, IL-10, IFN-y, IL-17A levels are associated with BD across mood episodes (euthymic, manic, depressive), and worsen neurocognitive function. METHODS/STUDY POPULATION: Twenty-eight participants (17 cases and 11 controls) were recruited. We assessed the clinical features and cytokine plasma levels of participants. Cytokines were measured using Flow Cytometry. All subjects were interviewed by a trained psychiatrist. Each participant was fasting before the blood sample was taken. Neuropsychological tests were used to measure verbal fluency, speed processing, working memory/attention, visuospatial skills, verbal learning, executive functions, and motor skills. Descriptive statistics were used to calculate the demographic characteristics of the sample. An independent-sample Kruskal-Wallis Test and Mann-Whitney Test were carried out using SPSS version 21. RESULTS/ANTICIPATED RESULTS: Serum biomarker concentration showed a decrease in levels of IL-4 (anti-inflammatory) in BD patients vs healthy controls (p < .05). There was a major concentration of IL-6 (pro-inflammatory) on bipolar patients vs controls (p = .003). When we analyze the results with the mood episodes, we found that patients with bipolar depression showed decreased levels of IL-4 (p = .046) and increase levels of IL-6 (p = .020) in comparison to the manic or euthymic episodes. In the neurocognitive tests, we found that the control participants had better performance in the working memory domain (p = .038) and also in the general performance (p = .036) in comparison to bipolar patients. We found also a positive significant correlation between IL-4 and verbal learning in the control sample (.829, p = .003). DISCUSSION/SIGNIFICANCE: The findings evidence a significant immune activation in bipolar patients, in particular during the depressive episode. Participants with BD have a decrease in the protective levels of IL-4 combined with high levels of IL-6 when compared to healthy controls. Worse neurocognitive functioning was found in bipolar patients.

OBJECTIVES/SPECIFIC AIMS: Explore perceptions of Flint stakeholders on the water crisis regarding trust and the capacity of faith and community-based organizations providing public health services to address community needs. Analyze the community’s voice shared at (1) 17 key community communications (community/congressional meetings and events), and (2) during 9 focus group sessions, in which residents, faith-based leadership and other stakeholders discuss issues and concerns on the Flint Water Crisis, and recommend ways to address them. Develop a framework that defines core theories, concepts and strategies recommended by the community to help rebuild trust and the quality of life in Flint, Michigan, and support other communities experiencing environmental stress. METHODS/STUDY POPULATION: Study population: faith-based leaders, seniors, youth, Hispanic/Latino and African American stakeholders, and others experiencing inequities in the city of Flint. Convene 9 focus group sessions (recorded and transcribed) to learn community perceptions on trust and ways to address it. Validate accuracy of the transcriptions with community consultants to reconcile any inaccurate information. Through a community engaged research (CEnR) process, review and analyze qualitative data from the 9 focus group sessions, and quantitative data from 2 surveys documenting (1) demographic backgrounds of focus group participants, and (2) their perceptions on trust and mistrust. Prepare a codebook to qualitatively analyze the focus group data summarizing community input on trust, mistrust, changes in service delivery among community and faith-based organizations, and ways to re-build trust in the city of Flint. Transcribe the community’s voice shared during 17 key events, identified by a team of community-academic stakeholders (i.e., UM Flint water course, congressional and community events, etc.), in which residents and other stakeholders discuss issues and concerns on the Flint Water Crisis, and recommend ways to address it. Qualitatively analyze the transcriptions, using a CEnR process to prepare a codebook on key themes from the community’s voice shared at these events, and recommendations on ways to address it. Compare and contrast findings between the two codebooks developed from (1) the focus group data and (2) qualitative analysis of community voice during public meetings and events. Synthesize this information into a framework of core theories, concepts and rebuilding strategies for Flint, Michigan. RESULTS/ANTICIPATED RESULTS: It is important to note many undocumented immigrant populations in Flint fear deportation and other consequences, hampering their ability to obtain service and provide community voice. Through our purposive sampling approach, we will hear from community voices not often included in narratives (i.e., seniors, youth, Hispanic/Latino residents). The presentation will present findings documenting levels of trust and mistrust in the city of Flint; and a framework of recommendations, core theories and concepts on ways to reduce, rebuild and eliminate stress that will be helpful to other communities experiencing distress. DISCUSSION/SIGNIFICANCE OF IMPACT: To our knowledge, levels of trust and mistrust in Flint have not been documented thus far. We will compare and contrast common themes presented by the community at public meetings and events with themes presented in our focus group effort on trust. Faith and community-based providers were among the first responders to the Flint Water Crisis. The effort will also share perceptions on changes in public health service delivery, and observations on preparedness for these roles that occurred among community and faith-based providers. Finally, the effort will (1) support the design of a research agenda, (2) define a framework of core theories, concepts and recommendations developed by the community to help rebuild trust in Flint, Michigan; and (3) support other communities addressing environmental distress.

OBJECTIVES/SPECIFIC AIMS: Translational researchers often require the use of informatics methods in their work. Lack of an understanding of key informatics principles and methods limits the abilities of translational researchers to successfully implement Findable, Accessible, Interoperable, Reusable (FAIR) principles in grant proposal submissions and performed studies. In this study we describe our work in addressing this limitation in the workforce by developing a competency-based, modular course in informatics to meet the needs of diverse translational researchers. METHODS/STUDY POPULATION: We established a Translational Research Informatics Education Collaborative (TRIEC) consisting of faculty at the University of Utah (UU) with different primary expertise in informatics methods, and working in different tiers of the translational spectrum. The TRIEC, in collaboration with the Foundation of Workforce Development of the Utah Center for Clinical and Translational Science (CCTS), gathered informatics needs of early investigators by consolidating requests for informatics services, assistance provided in grant writing, and consultations. We then reviewed existing courses and literature for informatics courses that focused on clinical and translational researchers [3–9]. Using the structure and content of the identified courses, we developed an initial draft of a syllabus for a Translational Research Informatics (TRI) course which included key informatics topics to be covered and learning activities, and iteratively refined it through discussions. The course was approved by the UU Department of Biomedical Informatics, UU Graduate School and the CCTS. RESULTS/ANTICIPATED RESULTS: The TRI course introduces informatics PhD students, clinicians, and public health practitioners who have a demonstrated interest in research, to fundamental principles and tools of informatics. At the completion of the course, students will be able to describe and identify informatics tools and methods relevant to translational research and demonstrate inter-professional collaboration in the development of a research proposal addressing a relevant translational science question that utilizes the state-of-the-art in informatics. TRI covers a diverse set of informatics content presented as modules: genomics and bioinformatics, electronic health records, exposomics, microbiomics, molecular methods, data integration and fusion, metadata management, semantics, software architectures, mobile computing, sensors, recruitment, community engagement, secure computing environments, data mining, machine learning, deep learning, artificial intelligence and data science, open source informatics tools and platforms, research reproducibility, and uncertainty quantification. The teaching methods for TRI include (1) modular didactic learning consisting of presentations and readings and face-to-face discussions of the content, (2) student presentations of informatics literature relevant to their final project, and (3) a final project consisting of the development, critique and chalk talk and formal presentations of informatics methods and/or aims of an National Institutes of Health style K or R grant proposal. For (3), the student presents their translational research proposal concept at the beginning of the course, and works with members of the TRIEC with corresponding expertise. The final course grade is a combination of the final project, paper presentations and class participation. We offered TRI to a first cohort of students in the Fall semester of 2018. DISCUSSION/SIGNIFICANCE OF IMPACT: Translational research informatics is a sub-domain of biomedical informatics that applies and develops informatics theory and methods for translational research. TRI covers a diverse set of informatics topics that are applicable across the translational spectrum. It covers both didactic material and hands-on experience in using the material in grant proposals and research studies. TRI’s course content, teaching methodology and learning activities enable students to initially learn factual informatics knowledge and skills for translational research correspond to the ‘Remember, Understand, and Apply’ levels of the Bloom’s taxonomy [10]. The final project provides opportunity for applying these informatics concepts corresponding to the ‘Analyze, Evaluate, and Create’ levels of the Bloom’s taxonomy [10]. This inter-professional, competency-based, modular course will develop an informatics-enabled workforce trained in using state-of-the-art informatics solutions, increasing the effectiveness of translational science and precision medicine, and promoting FAIR principles in research data management and processes. Future work includes opening the course to all Clinical and Translational Science Award hubs and publishing the course material as a reference book. While student evaluations for the first cohort will be available end of the semester, true evaluation of TRI will be the number of trainees taking the course and successful grant proposal submissions. References: 1. Wilkinson MD, Dumontier M, et al. The FAIR Guiding Principles for scientific data management and stewardship. Sci Data. 2016 Mar 15. 2. National Center for Advancing Translational Sciences. Translational Science Spectrum. National Center for Advancing Translational Sciences. 2015 [cited 2018 Nov 15]. Available from: https://ncats.nih.gov/translation/spectrum 3. Hu H, Mural RJ, Liebman MN. Biomedical Informatics in Translational Research. 1 edition. Boston: Artech House; 2008. 264 p. 4. Payne PRO, Embi PJ, Niland J. Foundational biomedical informatics research in the clinical and translational science era: a call to action. J Am Med Inform Assoc JAMIA. 2010;17(6):615–6. 5. Payne PRO, Embi PJ, editors. Translational Informatics: Realizing the Promise of Knowledge-Driven Healthcare. Softcover reprint of the original 1st ed. 2015 edition. Springer; 2016. 196 p. 6. Richesson R, Andrews J, editors. Clinical Research Informatics. 2nd ed. Springer International Publishing; 2019. (Health Informatics). 7. Robertson D, MD GHW, editors. Clinical and Translational Science: Principles of Human Research. 2 edition. Amsterdam: Academic Press; 2017. 808 p. 8. Shen B, Tang H, Jiang X, editors. Translational Biomedical Informatics: A Precision Medicine Perspective. Softcover reprint of the original 1st ed. 2016 edition. S.l.: Springer; 2018. 340 p. 9. Valenta AL, Meagher EA, Tachinardi U, Starren J. Core informatics competencies for clinical and translational scientists: what do our customers and collaborators need to know? J Am Med Inform Assoc. 2016 Jul 1;23(4):835–9. 10. Anderson LW, Krathwohl DR, Airasian PW, Cruikshank KA, Mayer RE, Pintrich PR, Raths J, Wittrock MC. A Taxonomy for Learning, Teaching, and Assessing: A Revision of Bloom’s Taxonomy of Educational Objectives, Abridged Edition. 1 edition. New York: Pearson; 2000.

OBJECTIVES/GOALS: Characterize formal informatics methods and approaches for enabling reproducible translational research. Education of reproducible methods to translational researchers and informaticians. METHODS/STUDY POPULATION: We performed a scoping review [1] of selected informatics literature (e.g. [2,3]) from PubMed and Scopus. In addition we reviewed literature and documentation of translational research informatics projects [4–21] at the University of Utah. RESULTS/ANTICIPATED RESULTS: The example informatics projects we identified in our literature covered a broad spectrum of translational research. These include research recruitment, research data requisition, study design and statistical analysis, biomedical vocabularies and metadata for data integration, data provenance and quality, and uncertainty. Elements impacting reproducibility of research include (1) Research Data: its semantics, quality, metadata and provenance; and (2) Research Processes: study conduct including activities and interventions undertaken, collections of biospecimens and data, and data integration. The informatics methods and approaches we identified as enablers of reproducibility include the use of templates, management of workflows and processes, scalable methods for managing data, metadata and semantics, appropriate software architectures and containerization, convergence methods and uncertainty quantification. In addition these methods need to be open and shareable and should be quantifiable to measure their ability to achieve reproducibility. DISCUSSION/SIGNIFICANCE OF IMPACT: The ability to collect large volumes of data collection has ballooned in nearly every area of science, while the ability to capturing research processes hasn’t kept with this pace. Potential for problematic research practices and irreproducible results are concerns.

Reproducibility is a core essentially of translational research. Translational research informatics provides methods and means for enabling reproducibility and FAIRness [22] in translational research. In addition there is a need for translational informatics itself to be reproducible to make research reproducible so that methods developed for one study or biomedical domain can be applied elsewhere. Such informatics research and development requires a mindset for meta-research [23].

The informatics methods we identified covers the spectrum of reproducibility (computational, empirical and statistical) and across different levels of reproducibility (reviewable, replicable, confirmable, auditable, and open or complete) [24–29]. While there are existing and ongoing efforts in developing informatics methods for translational research reproducibility in Utah and elsewhere, there is a need to further develop formal informatics methods and approaches: the Informatics of Research Reproducibility.

In this presentation, we summarize the studies and literature we identified and discuss our key findings and gaps in informatics methods for research reproducibility. We conclude by discussing how we are covering these topics in a translational research informatics course.

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