OBJECTIVES/GOALS: Childhood food allergy (FA) is a chronic condition that can profoundly impact patient and caregiver quality of life (QoL). Risk factors for impaired FA-related QoL remain largely unknown. This study aims to estimate latent profiles of caregiver attitudes and behaviors, and examine if group membership correlates with established QoL outcomes. METHODS/STUDY POPULATION: This project is subsumed under the FORWARD study (5R01AI130348-04), a multisite longitudinal cohort study conducted at four major pediatric medical centers. Eligible participants include caregivers of children ages 12 years and under who identify as Black or White and have at least one physician-diagnosed FA. Participants complete intake surveys, annual clinical visits, and quarterly surveys administered via REDCap. As of November 2022, 413 Non-Hispanic Black and 486 Non-Hispanic White participants were enrolled. RESULTS/ANTICIPATED RESULTS: We anticipate that specific latent profiles will emerge based on caregiver-reported attitudes and behaviors. We predict these profiles will demonstrate configural, metric, and scalar invariance across key sociodemographic strata (e.g., child race/ethnicity, household income, caregiver educational attainment, and child sex). Relatedly, we anticipate that sociodemographic factors, such as race, sex, ethnicity, parental education, and income, will significantly predict group membership. Finally, we predict that latent profile membership will be associated with different levels of quality of life, as assessed by the parental food allergy-related quality of life questionnaire (FAQLQ-PF-10) and other validated measures of FA-related psychosocial burden. DISCUSSION/SIGNIFICANCE: Given the psychosocial burden associated with FA, and limited mental health resources for patients and families, it is essential to improve understanding of how caregiver attitudes influence behavior and disease management outcomes. In so doing, we will inform the development and implementation of tailored interventions for those at highest risk.

OBJECTIVES/SPECIFIC AIMS: Long-acting reversible contraception (LARC) has been well established as the most cost-effective form of contraception, but LARC usage in developing countries remains low. As part of a multi-center parent study on HIV incidence, we implemented an integrated family planning program to increase LARC uptake in single women in Rwanda and Zambia. We aim to evaluate rates of LARC uptake, LARC discontinuation and incident pregnancy following family planning counseling. METHODS/STUDY POPULATION: We enrolled 3 cohorts of single sexually active HIV-negative women between the ages of 18–45 years: single mothers (SM) in Zambia, female sex workers (FSW) in Zambia and FSW in Rwanda. Participants were followed every 3 months for up to 5 years. At each visit, we discussed fertility goals and counseled participants on HIV risk reduction and contraceptive options. Eligible participants (not pregnant, already using a LARC method, or using a permanent contraceptive method) were offered a LARC method, specifically the copper IUD or Jadelle implant. Data was collected on demographic factors, sexual behavior, sexual and reproductive history, and gynecological exams and laboratory tests were performed if necessary. RESULTS/ANTICIPATED RESULTS: In total, 458 Rwandan FSW, 555 Zambian FSW, and 521 Zambian SM were enrolled, with a median follow-up time of 6 months, 12 months, and 9 months, respectively. Accounting for any LARC uptake during longitudinal follow-up, our preliminary results show an increase in LARC usage from 21% at screening to 51% at the end of follow-up among Rwandan FSW, an increase from 12% to 42% in Zambian FSW and an increase from 18% to 44% in Zambian SM. We hypothesize that demographic factors (e.g., younger age, higher education level) and sexual history (e.g., greater number of sexual partners, any STIs or reproductive health disturbances) will be associated with increased rates of LARC uptake. We also hypothesize that LARC users will have significantly lower proportions of contraceptive method discontinuation and incident pregnancy compared to non-LARC users. DISCUSSION/SIGNIFICANCE OF IMPACT: FSW and SM are disproportionately affected by high rates of unintended pregnancy, which can lead to obstetric complications and poor psychosocial outcomes. It is imperative that family planning interventions in developing countries target these populations to overcome obstacles in reproductive health and promote gender equality. Our study will provide necessary insights to an integrated family planning program, which will guide future efforts to design, implement and evaluate family planning initiatives for high-risk populations.

OBJECTIVES/SPECIFIC AIMS: Brain tumors are the most common solid tumor diagnosed in children and their location predisposes patients to oromotor dysfunction leading to feeding difficulties. Brain tumor patients experience feeding difficulties more frequently than other pediatric malignancies, largely due to central nervous system directed chemotherapy, radiation, and surgery. Treatment increases the risk of malnutrition and increases risk for infection, ICU admissions, and death. Infants and children (less than 3 years of age) are at higher risk for malnutrition due to rapidly changing nutritional requirements and the underdevelopment of motor skills. Incidence and prevalence of malnutrition in pediatric cancer patients is not well known. METHODS/STUDY POPULATION: This is an observational, retrospective study of our center’s pediatric cancer patients. Patients are classified by diagnosis, treatment intensity (ITR-2), vital status, and heights and weights (with standardized Z-scores) will be recorded with through 2 years after diagnosis. Adaptation of Intensity of Treatment Rating ITR-2. Nutrition consultation, ICU admissions, and use of parenteral or enteral nutrition will be recorded. Weight loss greater than a 5-percentile point change or Z-score decrease greater than 0.5 will be treated as a binary outcome and considered significant weight loss. RESULTS/ANTICIPATED RESULTS: Preliminary analysis has identified 465 eligible subjects as described above: brain tumor (n=45) and nonbrain tumor patients (n=420). Patient Schema. This study is still in progress and aims to better identify incidence of malnutrition during pediatric cancer therapy. It is expected that a greater number of nonbrain tumor patients compared with brain tumor patients will be malnourished as defined by decrease in Z-score greater than 0.5 at any point in therapy or falling below the 5th percentile of weight for age. Weight loss will be associated with higher number of ICU admissions and higher treatment intensity score. Finally, we expect to find that patients with a larger decrease in Z-score for age will be more likely to die during therapy. DISCUSSION/SIGNIFICANCE OF IMPACT: In addition to this study being valuable in better defining incidence of malnutrition, this data will serve as preliminary data in defining target populations for focused nutritional intervention during cancer therapy. Using this established and published intensity rating scale, we may be able to identify better methods of identifying and preventing malnutrition during cancer therapy.

OBJECTIVES/GOALS: Full Spectrum Town Halls (FSTH) were organized to bring together patients, scientists, clinicians, advocates and others interested in Hidradenitis Suppurative (HS) – stakeholders across the spectrum of translational research – to infuse patient experiences and voices into designing HS research METHODS/STUDY POPULATION: The Rockefeller University (RU), Clinical Directors Network (CDN), and the HS Foundation organized three hybrid in-person/online HS FSTHs (2018-2023). The 2018 event focused on patients, describing the current state of HS knowledge and new research into HS biology (T2, T3). Patients shared lived experiences in testimonials and a panel discussion. Advocates described community and mental health resources (T4). The 2021 event returned research results (T2, T3) to the community and updates about treatments in the pipeline (T4). The 2023 FSTH targeted clinicians (T4) addressing a critical translational gap in HS care and presenting best practices in diagnosis, surgical, and medical treatments. RESULTS/ANTICIPATED RESULTS: Impact on science: FSTH attendees joined a Community Engagement Studio providing feedback used to refine study variables/procedures. Attendees joined research studies that advanced understanding HS mechanisms of disease, clinical course and treatment.Impact on patient experience: Participants appreciated having a forum to hear/share experiences of shame, mistrust, misdiagnosis and hope. Feedback improved practices for privacy, consenting, and returning study results. Impact on clinical practice and care: FSTH raised awareness of stigma, need for respect and empathy, and advanced learning about in disease mechanisms, effective biologics, importance of epithelial tunnels and surgical care. DISCUSSION/SIGNIFICANCE: HS is a stigmatizing, poorly understood disease. FSTHs fostered bidirectional learning among scientists, clinicians, patients and other stakeholders. Patients engaged with researchers to improve research design and participate in mechanistic and therapeutic clinical research, advancing the field.

OBJECTIVES/GOALS: Particulate matter (PM) and metabolic syndrome (MetSyn) increase risk of World Trade Center-Lung Injury (WTC-LI). Mediterranean-type diets have also been found to improve lung function. Fire Department of New York 1st-responders with a high PM exposure at WTC and MetSyn may have improved lung function after a Mediterranean dietary intervention. METHODS/STUDY POPULATION: Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE) randomized clinical trial (RCT) assessed our hypothesis that a low-calorie Mediterranean (LoCalMed) intervention targeting clinically relevant disease modifiers will improve metabolic risk, subclinical indicators of cardiopulmonary disease, quality of life, and lung function in firefighters with WTC-LI. Primary-outcome targeted a LoCalMed loss of BMI(≥1kg/m2). Secondary-outcomes included lung function, quality of life, and cardiovascular health. Male firefighters with WTC-LI and a BMI>27kg/m2 were randomized to: 1. LoCalMed (n=46); or 2. Usual Care (UC; n=43). Clinicaltrials.gov:NCT03581006. RESULTS/ANTICIPATED RESULTS: LoCalMed’s estimated efficacy on BMI reduction crossed the pre-specified significance boundary on interim analysis compared to UC. In addition, improvements were observed in secondary-outcomes of lung health (FEV1 and FVC), inflammation (WBC), vascular disease (DBP), quality of life (SF-36, health perception) and dietary habits (less cholesterol, carbohydrates, fats, and sweets and increased protein) in the LoCalMed arm. DISCUSSION/SIGNIFICANCE: LoCalMed significantly decreased BMI and alleviated adverse health outcomes in our WTC-exposed first responders. A fully powered RCT is required to determine if this approach is efficacious for the treatment of WTC-associated pulmonary disease, as well as LoCalMed’s generalizability to PM associated disease.

ABSTRACT IMPACT: This public health work contributes to the development and implementation of best practices for working with sex trafficked youth who experience placement instability and justice involvement. OBJECTIVES/GOALS: Youth removed from their home into foster care or a group home (i.e., placement instability) are vulnerable to sex trafficking. This study examines whether placement instability predicts mental health, behavioral and justice-related outcomes among sex-trafficked girls. METHODS/STUDY POPULATION: Placement instability occurs when children are temporarily or permanently removed from their home and placed in foster care or a group home. Domestic minor sex trafficking is exploitation and abuse of children for commercial sexual purposes in exchange for money or other goods/services. We hypothesize that sex trafficked girls who experience placement instability will report more mental health challenges, substance use, abuse history and justice involvement than those without placement instability. Data came from participant files in a specialty court program from 2012-2014 (N=184). Multiple sources contribute to the information contained court files; all data extracted by the research team come solely from the court files. Descriptive, bivariate, and logistic regression analyses were performed. RESULTS/ANTICIPATED RESULTS: All participants were (cis)female, 74% were African American, 96% US citizens, with average age of 16 years. Three-quarters of participants had a documented mental health challenge, such as depression and 88% reported substance use. Eighty-one percent of participants had been in a placement, with a group average of 4.5 placements. Girls with placement instability reported more mental health challenges (p<.001), substance use (p<.001), abuse (p<.001), running away (p<.001) and bench warrants (p<.001) than girls without placement instability. Logistic regression estimated housing instability was positively associated with mental health challenge, substance use, running away, number of bench warrants, and number of citations. DISCUSSION/SIGNIFICANCE OF FINDINGS: Among girls who have been trafficked, placement instability places them at greater risk for personal and behavioral challenges, including increased justice involvement. Comprehensive trauma-informed services should be provided to the family to help mitigate issues in the home.

OBJECTIVES/GOALS: Biliary atresia (BA) is a progressive congenital disease that is characterized by periductular inflammation and fibrosis that leads to bile duct destruction and cholestasis in neonates. Galectin-3 (Gal3) plays a key role in inflammation and fibrosis. The aim of this study was to evaluate plasma Gal3 levels in early and late BA. METHODS/STUDY POPULATION: Samples from our institutional Pediatric Liver Biobank were used for this study. Patients were categorized as early BA (at diagnosis), late BA (at liver transplant), early other cholestatic liver disease (CLD), late other CLD, or controls without cholestasis or structural liver disease. Plasma Gal3 levels were measured by standard ELISA. Inflammatory cytokines were measured in a subset of samples using MSD Proinflammatory Panel 1 multiplex ELISA. Liver fibrosis was categorized as none (Ishak or METAVIR 0), mild (Ishak 1-2 or METAVIR 1), moderate (Ishak 3-4 or METAVIR 2-3), and severe (Ishak 5-6 or METAVIR 4) based on histology. Data are presented as median (IQR) and compared using Kruskal-Wallis test. Spearmans correlation was used to assess the relationship between Gal3 and clinical and inflammatory markers. RESULTS/ANTICIPATED RESULTS: Samples from 10 controls, 26 early BA, 24 late BA, 13 early other CLD, and 8 late other CLD patients were used for this study. Gal3 levels in late BA (20.8 [12.4-30.5] ng/mL) and late other CLD (21.8 [16.9 – 27.2] ng/mL) were significantly higher than in controls (10.2 [7.6 – 14.5] ng/mL, p < 0.02) and early BA (11.3 [8.7 – 16.8] ng/mL, p < 0.01), but not significantly different from early other CLD (15.7 [11.9 – 21.4] ng/mL, p > 0.05). Gal3 positively correlated with fibrosis score (rho 0.3, p = 0.01), total bilirubin (rho 0.3, p = 0.002), ALT (rho 0.3, p = 0.01), AST (rho 0.3, p = 0.005), and APRI score (rho 0.3, p = 0.009), and negatively correlated with albumin (rho -0.3, p = 0.01). Out of the 10 cytokine proinflammatory panel, Gal3 was significantly correlated with IL-6 (rho 0.3, p = 0.006). DISCUSSION/SIGNIFICANCE: Gal3 is elevated in late BA and other CLD at time of transplant and correlated with degree of fibrosis, suggesting it may play a role in disease progression to cirrhosis. If targeted in the early disease stage, blocking Gal3 in pediatric cholestatic liver diseases may help delay the progression to cirrhosis and need for transplant.

OBJECTIVES/GOALS: Time restricted feeding (TRF) in diet induced obesity (DIO) has several health benefits, including improved metabolic rhythms and inflammation. Our lab has shown that TRF in DIO significantly reduces renal and aortic damage. The main goal of our research is to understand how TRF impacts aortic function, organ damage, and T cell activation in DIO. METHODS/STUDY POPULATION: We will use a 20-week DIO model, where mice will be on 20 weeks of normal fat diet (ND) or high fat diet (HFD). During weeks 18-20, mice will go through TRF intervention where food is restricted to the 12-hour active period or continue ad libitum feeding. At the end of the 2-week TRF intervention or continued ad libitum feeding, aortic stiffness will be measured via pulse wave velocity measurements. We will also collect kidney, aorta, and small intestine at the end of the 20-week protocol for flow cytometric analysis of tissue T cell activation as well as histological assessments. This will allow us to determine the relationship with organ damage, organ function, and the T cell response. We will also analyze tissue and circulating levels of inflammatory T cell-derived cytokines such as interleukin-17A (IL-17A) via ELISA. RESULTS/ANTICIPATED RESULTS: DIO mice showed significantly increased aortic stiffness (measured by pulse wave velocity) compared to mice on ND. Interestingly, TRF intervention in DIO mice reduced aortic stiffness compared to DIO ad libitum. Histological assessments also showed that TRF abolished aortic and kidney fibrosis suggesting a role for the timing of feeding in regulating aortic function and organ damage from chronic HFD. We have several ongoing experiments to determine the T cell response with TRF in DIO mice. We predict that TRF in DIO mice will significantly decrease inflammatory T cells and reduce cytokine abundance in target organs. DISCUSSION/SIGNIFICANCE: Our lab has shown that TRF reduces aortic thickness and aortic and kidney fibrosis, but the driving mechanisms are unknown. We propose that TRF reduces T cell activation in DIO mice leading to reduced organ damage. Our work will provide insight on how TRF in DIO regulates the T cell response and may improve inflammation in the kidney and aorta.

OBJECTIVES/GOALS: Inflammatory bowel diseases (IBD) are most often diagnosed in adolescence and young adulthood, affecting 10 in 100,000 pediatric patients in the US and Canada. Adolescents with IBD are vulnerable to poorer outcomes and higher health costs, partially attributable to disruptions in the continuity of care in the transition from pediatric to adult care settings. There is currently no consensus among providers about the timing of initiation and completion of the transition process for adolescents and young adults with IBD, and access to structured pediatric transition readiness programs are lacking, with a paucity of research to evaluate relevant clinical outcomes in such existing programs. While prior studies have primarily examined barriers and facilitators of successful transitions from the provider perspective, only few studies have systematically examined such factors from the patient and caregiver perspective. We wish to better understand the experience of living with IBD for adolescents and young adults, as well as their parents, to understand barriers and facilitators of successful transitions in care. Ultimately, we wish to articulate best practices in this domain in order to create and evaluate a transitions program for patients and parents at the Mount Sinai IBD Center. METHODS/STUDY POPULATION: We are recruiting 15-25 patient-parent dyads to complete our study. At recruitment, we collect baseline quantitative metrics from patients pertaining to demographics, disease characteristics, transition-readiness, self-efficacy, resilience, disease-specific health knowledge, and health literacy. From parents, we collect demographic information, concordance metrics (e.g. how parents perceive their children’s resilience, self-efficacy), parenting style questionnaires, and others. These data are used to understand the characteristics of the young adults and parents within our sample to ensure that the results of our study will be generalizable to a diverse range of patients and families. We then train our patient-parent dyads in Photovoice, the primary method of our study. Photovoice is a community based participatory research (CBPR) methodology used in health education and other fields. The method employs photography for participants to capture their experiences living with IBD, or being a parent to a child with IBD. We then interview all participants about the photos using a standard script employed in Photovoice. All surveys are transcribed and coded for thematic analysis. Based on our findings, we hope to determine phenotypes of patient-parent dyads who are likely undergo successful transitions as well as those at higher risk, understand competencies necessary for successful transitions, and create a comprehensive transitions program for the IBD Center that can be applied with all patients undergoing transitions from pediatric to adult GI care. RESULTS/ANTICIPATED RESULTS: We currently have 26 patients and 25 parents (1 pair of siblings) aged 14-25 enrolled in the study. We hypothesize that adolescents with higher baseline resilience, efficacy, disease-specific health knowledge, and less active disease will have more successful transitions than adolescents with lower scores on these metrics. Similarly, we predict that adolescents with lower baseline resilience, self-efficacy, disease-specific health knowledge and more active disease will be ideal candidates for a more robust transition-readiness program. Further, we hypothesize that children of more authoritarian parents will be less prepared for transition than those with assertive parents. We are currently in the process of conducting patient/parent interviews, and have collected 6 interviews thus far. We will begin the qualitative coding process once we have four interviews from each cohort. Themes emerging thus far involve: medication management, psychiatric co-morbidity, social support, direct communication with doctors, the role of surgery, school absences, travel, and others. DISCUSSION/SIGNIFICANCE OF IMPACT: Transition-readiness is defined as a series of skills in the realms of knowledge, information gathering, self-management, and decision-making that must be mastered by a patient in preparation for a healthcare transition, such as that from pediatric to adult IBD care. It has been shown that many clinicians who rely on subjective measures such as perceived health literacy overestimate transition readiness in their IBD patients. Many pediatric gastroenterologists who use more objective measures rely on a validated self-report questionnaire, the Transition Readiness Assessment Questionnaire (TRAQ) to assess readiness for transition and to facilitate discussions around the skills necessary to transition, including appointment keeping, tracking health issues, managing medications, talking with providers, and managing daily activities. However, the TRAQ has been shown to be limited in its ability to predict transition readiness independently of age, and ignores both provider and family perspectives. Given the critical role of parents in medical decision making, and the differential emphasis of the caregiver role in pediatric versus adult IBD care paradigms, it is vitally important to identify barriers to transition as well as differences in perspectives between adolescents living with IBD and their parents. Our study is the first to employ Photovoice, a method that ‘gives a voice to the voiceless’ in the gastroenterology space, in order to understand the needs that adolescents and young adults themselves perceive as critical in promoting transition-readiness. We include parents in this inquiry in order to understand how parental perceptions of their children’s transition-readiness promote or stifle successful transitions and independent disease self-management. We will ultimately use this data to create a Transitions program to evaluate in our center for adolescents with IBD and their parents.

OBJECTIVES/SPECIFIC AIMS: Educate the general public, investigators, and institutional leadership on the importance of clinical trial registration and results reporting. Share success as a means to develop national best practices. METHODS/STUDY POPULATION: Developed a Project Charter; Spoke to several peer institutions; Update institutional policy. RESULTS/ANTICIPATED RESULTS: Since launching the Program in June 2016, the number of records submitted to ClinicalTrials.gov has increased 14% (852–971). At the same time, compliance with late results has increased by over 92% (111–9). DISCUSSION/SIGNIFICANCE OF IMPACT: Clinical Trial registration and results reporting is sub-par at many institutions. We have established a successful program that others can emulate. Institutions can increase transparency of clinical trials as well as prevent civil monetary penalties ($11,569/d/study) and loss of grant funding.

OBJECTIVES/GOALS: The Translational Science Benefits Model (TSBM) offers an approach for evaluating research impact on public health and society. Since its development in 2017, there has been an increased focus on science’s impacts on equity. This poster describes efforts to integrate equity into the TSBM. METHODS/STUDY POPULATION: Adaptation of the TSBM includes 3 phases: 1) literature scan of equity impacts, 2) community engagement listening sessions, and 3) model refinement. First, we conducted a scan of the clinical and translational sciences literature for articles that measured equity impacts associated with the TSBM. From the articles, we extracted both equity considerations related to existing TSBM benefits and potential equity-focused benefits. Next, we will present the dimensions of new and existing benefits to several community member panels engaged in research and evaluation. We will use their input to prioritize and refine adaptations to the model (phase 3). RESULTS/ANTICIPATED RESULTS: Our literature scan identified equity dimensions of the original 30 TSBM benefits and 15 potential benefits for inclusion in the model, including community partnerships, community capacity building, workforce development, and social determinants of health, among others. To ensure that community priorities also inform identification of equity impacts of clinical and translational research, we will review and refine the model through a series of community engagement sessions planned for Fall 2023. The sessions will inform final adaptations, which will result in an expanded approach evaluating the impact of scientific activities to include impacts on health equity. DISCUSSION/SIGNIFICANCE: The TSBM provides a framework for clinical and translational scientists to plan for, track, and demonstrate the broader impacts of their work. Including equity impacts can help increase consideration of equity in science and help to more clearly make the link between research and equity impact.

OBJECTIVES/SPECIFIC AIMS: 1. To assess the acceptability and feasibility and of an online self-assessment version of the Community REsearch Activity Assessment Tool (CREAT), an instrument to measure research capacity of CBOs. 2. To elicit CBO perspectives on their research and knowledge generation activities. METHODS/STUDY POPULATION: Thirteen CBOs who had previously partnered with an academic course on practice-based community health research were contacted and asked to participate in the field testing of the CREAT and provide feedback on areas of strength and areas for potential improvement. Eleven organizations completed the field testing, which began and ended with an in-person semi-structured interview with the online self-administration of the CREAT in the middle. The semi-structured interviews were audio-recorded with questions pertaining to topics such as: strengths and challenges of previous academic research partnerships, perceptions around the importance of research within the organization, thoughts and reactions to the CREAT, and general feedback about the CREAT. Results from the self-administered CREAT were used to test a scoring algorithm. Semi-structured interviews are being transcribed, pre-post responses to questions of strengths and challenges in engaging in research partnerships will be compared, and overall qualitative transcripts will be coded using grounded theory. RESULTS/ANTICIPATED RESULTS: Anticipated Results: The CREAT was acceptable and self-administration was feasible. Average time for completion of the online CREAT was 41 ± 13 min, and respondents did not need assistance from the interviewer to complete the online instrument. Suggestions for improvements focused on word choices and scale options. Respondents were aware of the importance of research activities for their CBOs, particularly for optimizing programmatic quality and services. Access to staff and financial resources were key barriers to strengthening research capacity, and respondents noted that engaging in research partnerships can also bring in additional resources. Interview transcription is still in progress along with the refinement of the codebook for the qualitative data collected. In alignment with objectives/goals outlined above, the results will be separated into the following four sections: CBO Research and Knowledge Generation Activities, Acceptability of the Tool, Feasibility of the Tool, and Refinement of the Tool. DISCUSSION/SIGNIFICANCE OF IMPACT: The online, self-administered CREAT instrument is acceptable and feasible for CBO respondents. Availability of a validated tool to assess research capacity of CBOs, developed and refined with input from community researchers, will support targeted research capacity building for CTSAs, community organizations and partners, thus strengthening collaborations. Translational scientists, public health systems and community health improvement depend on CBOs as partners in community-engaged research (CEnR). The CREAT will allow community members to more fully contribute their expertise to the development, implementation and evaluation of interventions, and to develop more equitable partnerships with researchers.

OBJECTIVES/GOALS: Human-centered design (HCD) provides a practical, collaborative approach to integrating diverse perspectives throughout the translational research process. We highlight two CTSAs with established HCD teams who are utilizing varied approaches to accelerate the use of HCD in health intervention design and community engagement. METHODS/STUDY POPULATION: The CTSAs at the University of Michigan (MICHR) and the University of Pittsburgh (Pitt CTSI) have dedicated teams of human-centered designers that assist investigators with the application of HCD in their studies. MICHR’s service approach utilizes facilitated Design Sprints with study teams, guiding them from early conception of a research question through the co-design of interventions and innovations with end-users. Pitt CTSI’s training and consultation approach employs a two-day intensive training with group coaching sessions that provide investigators and research staff with skills and knowledge needed to implement HCD within translational research projects. Both hubs offer consultations on methodology for investigators interested in pursuing funding for studies utilizing HCD. RESULTS/ANTICIPATED RESULTS: Research teams at both hubs are pursuing HCD to co-design health research interventions and mHealth technologies with end-users locally and internationally, to facilitate meaningful engagement within advisory boards and collaboratives, and to enhance team science. To date, MICHR has conducted 13 research study-focused Design Sprints with 73 participants, as well as providing consultations to 26 research teams. Pitt CTSI has trained 164 investigators and staff and provided 146 consultations with research teams. Requests for HCD training have increased at MICHR while requests for HCD service provision have increased at Pitt CTSI. Both hubs are now building capacity to enact a more holistic approach to HCD that combines service delivery and training approaches to better meet the needs of investigators. DISCUSSION/SIGNIFICANCE: Increasing CTSA hub capacity to support the use of HCD in translational research by offering service and training opportunities can position investigators to conduct high impact health research that elevates the voices of those most likely to benefit from interventions, treatments, and innovations.

OBJECTIVES/SPECIFIC AIMS: To build capacity for community engaged, translational research in faculty across the university. METHODS/STUDY POPULATION: Each year, the Community Engagement Research Core (CERC) of the Penn State CTSI invites applications for one to two Community Engagement Faculty Fellowships. Applicant teams are comprised of a junior or mid-level investigator seeking to expand their work into the CEnR arena under the mentorship of a senior investigator with expertise in community engaged scholarship. The fellow must develop a plan for the mentoring year, including a timeline, activities to be undertaken together, knowledge to be acquired, deliverables, and a budget. The funding supports two course releases or the clinical equivalent for the fellow, and a small budget to support the mentor’s research program. Proposals are evaluated using NIH scientific merit criteria. RESULTS/ANTICIPATED RESULTS: We are in our second year of the fellowship program. Two highly qualified fellows are currently working with established community-based mentors. The 2017-2018 fellowship team showcases how an effective mentor-fellow partnership can help move a fellow’s work along the translational spectrum. By working with her mentor, our first fellow’s research has expanded from basic discovery science in a university hospital to development of a neonatal intensive care unit intervention to be employed with parents in the community. The 2018-2019 scholar, who utilized the community engagement research core (CERC) of the PSU CTSI in preparation of a PCORI grant, has since received the PCORI award and is working with her mentor to bring her innovative mental health screenings to the public schools. We are currently evaluating applications for the third year of the program, and please to have engaged applicants from across several Penn State campuses and disciplines. DISCUSSION/SIGNIFICANCE OF IMPACT: The fellowship is enjoying early success in terms of fellow productivity, expanding translational research expertise, and fueling interest across the Penn State campuses in community engagement research. Future work will focus on sustainability planning for this type of program, metrics for tracking success, and plans for integrating fellows into a growing community of engaged scholars at the university.

OBJECTIVES/GOALS: We have shown that small extracellular vesicles (exosomes) isolated from patients with a history of ACS disrupt the endothelium in vitro. Sequencing of miRNA contents of these vesicles suggested that miR let-7c was differentially expressed. The current study was designed to determine the relationship between miR let-7c levels and ACS. METHODS/STUDY POPULATION: We identified 16 subjects from the SCD Lungomics biobank at the University of Chicago Comer and La Rabida Childrens Hospitals who had samples obtained at baseline. Among them, 9 had a history of ACS (ACS(+)) and 7 did not (ACS(-)). For all subjects, we reviewed clinical data relevant to their SCD and laboratory data (including hemoglobin, absolute reticulocyte count, white blood cell count) obtained at the same time as the baseline samples. RNA was isolated from the plasma and miR let7c was quantified using quantitative RT-PCR. RESULTS/ANTICIPATED RESULTS: Subjects were similar clinically, except that those with a history of ACS were more likely to be on hydroxyurea (p<0.05) and to have obstructive sleep apnea (p<0.05). Hematologic laboratory values were similar irrespective of ACS history. The mean miR let-7c level was 2-fold less in subjects with a history of ACS than in those who had never had ACS (p<0.05). A plasma miR let-7c level < 1 (normalized to the control subjects) had a positive predictive value of 0.78 for history of ACS and a sensitivity of 78% and specificity of 71%. Among subjects with a history of ACS, the let7c levels did not correlate with time since the last ACS event. However, among subjects who developed ACS following the baseline samples, higher miR let-7c levels correlated with increased length of time to next ACS event (R=0.8). DISCUSSION/SIGNIFICANCE: Our results in a group of subjects with SCD show that plasma miR let-7c levels are decreased in subjects with a history of ACS. They suggest that miR let-7c may be protective against development of ACS and that measurement of its levels could be a useful biomarker to assess or predict risk for this complication of SCD.

ABSTRACT IMPACT: Identifying factors associated with opioid overdoses will enable better resource allocation in communities most impacted by the overdose epidemic. OBJECTIVES/GOALS: Opioid overdoses often occur in hotspots identified by geographic and temporal trends. This study uses principles of community engaged research to identify neighborhood and community-level factors associated with opioid overdose within overdose hotspots which can be targets for novel intervention design. METHODS/STUDY POPULATION: We conducted an environmental scan in three overdose hotspots’‘ two in an urban center and one in a small city’‘ identified by the Rhode Island Department of Health as having the highest opioid overdose burden in Rhode Island. We engaged hotspot community stakeholders to identify neighborhood factors to map within each hotspot. Locations of addiction treatment, public transportation, harm reduction programs, public facilities (i.e., libraries, parks), first responders, and social services agencies were converted to latitude and longitude and mapped in ArcGIS. Using Esri Service Areas, we will evaluate the service areas of stationary services. We will overlay overdose events and use logistic regression identify neighborhood factors associated with overdose by comparing hotspot and non-hotspot neighborhoods. RESULTS/ANTICIPATED RESULTS: We anticipate that there will be differing neighborhood characteristics associated with overdose events in the densely populated urban area and those in the smaller city. The urban area hotspots will have overlapping social services, addiction treatment, and transportation service areas, while the small city will have fewer community resources without overlapping service areas and reduced public transportation access. We anticipate that overdoses will occur during times of the day when services are not available. Overall, overdose hotspots will be associated with increased census block level unemployment, homelessness, vacant housing, and low food security. DISCUSSION/SIGNIFICANCE OF FINDINGS: Identifying factors associated with opioid overdoses will enable better resource allocation in communities most impacted by the overdose epidemic. Study results will be used for novel intervention design to prevent opioid overdose deaths in communities with high burden of opioid overdose.

OBJECTIVES/GOALS: Youth experience worse health and behavioral outcomes the longer they are in the juvenile justice system. This study examines whether age at entry and length of time in a specialty juvenile court program predicts citations, bench warrants, and running away among sex-trafficked girls. METHODS/STUDY POPULATION: Domestic minor sex trafficking (DMST) is exploitation and abuse of children for commercial sexual purposes in exchange for money or other goods/services. Historically, the response to DMST has been punitive, resulting in youth being cited and detained for offenses like prostitution. The specialty court offers enhanced physical/mental health services to trafficked youth. Data come from case files in the specialty court for program participants from 2012-2014 (N = 184). Descriptive, bivariate, and Poisson regression analyses were performed to examine risk profile measures: bench warrants, citations, running away, and foster placements. RESULTS/ANTICIPATED RESULTS: All were (cis)female, 74% were African-American, 96%, US citizens, with average age of 16. Participants lived in approximately 4.5 group homes or foster placements prior to program entry; 56% of youth had run away. Youth also averaged nearly two bench warrants before specialty court participation. Bivariate analysis indicates older age at entry into juvenile court was associated with fewer episodes of running away (p<.02) and new citations (p<.001). Poisson regression estimated older age at entry into the juvenile justice system was associated with fewer bench warrants, citations, foster placements, but not running away while in the program. Additionally, longer duration between time at first citation and entry into the program was associated with fewer bench warrants, running away, and citations. DISCUSSION/SIGNIFICANCE OF IMPACT: Younger girls may be particularly vulnerable to trafficking and recidivism without early and persistent intervention. Youth experiencing sex trafficking need to be diverted away from juvenile justice to comprehensive trauma informed services.

The Motivation Assessment for Team Readiness, Integration, and Collaboration (MATRICx) is a psychometric instrument that measures individual motivation for collaboration. It was validated using Rasch Analysis to create an indicator hierarchy on two dimensions: cooperation and collaboration. Six domains provide the basis for the tool to identify team member readiness for collaboration and a means by which to understand motivational strengths in a team based on degree of past self-reported experience. This brief report provides an overview of the development of the tool, how science teams may use it, and how to interpret results to advance team member readiness for greater collaboration. The paper also draws attention to ongoing work in progress to develop learning interventions to accompany the MATRICx instrument.

Residents of rural areas are underrepresented in research. The aim of this narrative review was to explore studies describing the effectiveness of community engagement strategies with rural communities to promote participant recruitment and participation in clinical research. Following PRISMA guidelines, this narrative review was conducted in June 2020. Our search strategy was built around keywords that included community-engaged research, rural community, and recruitment strategies into clinical research. Content-related descriptive statistics were summarized. The selected articles were distributed into categories of levels of community engagement: inform, consult, involve, collaborate, or co-lead. The search resulted in 2,473 identified studies of which forty-eight met inclusion criteria. Of these, 47.1% were randomized controlled trials. The most common levels of engagement were consultation (n = 24 studies) and collaboration (n = 15), while very few focused on informing (n = 2) and co-leadership (n = 2). Strategies, limitations, and findings are discussed for each level of community engagement. This narrative addressed a gap in knowledge regarding participant recruitment in rural communities in relation to assistance from community members. Community engagement contributed to the success of the research, especially in recruitment, participation, and building trust and partnership.