Objectives/Goals: The Research Participant Advisory Group (RPAG) was born out of the concept that, by creating a structured way for researchers to collaborate with research participants and/or community, we can improve, grow, and support clinical/research-based research, from design to dissemination. Three distinct groups exist across our Academic Health Center (AHC). Methods/Study Population: The RPAG has 3 groups: The Cincinnati Children’s Hospital Research Participant Advisory Council (CCHMC RPAC) addresses clinical research needs, such as research design, recruitment, and consenting. Adult/youth research participants and family members (n = 21) provide feedback about how to improve a research process, form or other research tool. In Cincinnati’s underserved West End, the West End Community Research Advisory Board (WE C-RAB: n = 18) focuses on the needs of underserved minority groups and supports researchers wishing to do community-based research. The newly formed University of Cincinnati RPAC (UC RPAC; n = 17) addresses the UC research needs. All groups meet monthly and are offered a meal and incentive. All members have received training in the responsible conduct of research. Results/Anticipated Results: Over 70 researchers have brought research challenges to the RPAG groups over the last 8 years, leading to improved consent forms, more targeted recruitment, clearer language and a more streamlined screening process. RPAG member surveys indicate a greater understanding of clinical research challenges, critical health issues, and how research can benefit them. The WE C-RAB has improved community recruitment efforts, as well as survey and study design. Researchers highlight the importance of feedback in creating greater study participant engagement, indicating deeper understanding of the community/participant perspective and how to work “with” community. Ongoing WE C-RAB-faculty partnerships have led to at least 3 federally funded grants. Discussion/Significance of Impact: The 3 RPAGs provide the versatility to meet the needs of the diverse research spectrum across the AHC. This includes the type of research as well as the level or degree of participant/community engagement needed. RPAGs create greater connection and understanding leading to better participant experiences and the promise of better health outcomes.

Objectives/Goals: Community gardening can foster healthy behaviors among low-income communities. This project aimed to develop a community garden. The primary objectives of this project are (1) assessing the need for and perspective on a community garden at the childcare center, (2) installing the garden, and (3) engaging children in gardening education. Methods/Study Population: This project took place at a childcare center in Harrisburg, PA. Most (74.6%) residents identified as Black or Hispanic/Latino. Every child at the center was eligible for free or reduced lunch. A listening session was held with directly impacted community members to discuss the need for a community garden. Four caregivers, 1 early childhood educator and a master gardener (n = 6) attended the listening session, in which they shared their personal strengths and challenges in growing food. Attendees provided suggestions on what foods they wanted to grow. Children enrolled in the center’s summer program (n = 50) were then invited to participate in weekly gardening activities for 9 weeks. Activities were targeted to preschoolers (3- to 5-year-olds). Older children enrolled in the summer program were welcome to participate. Results/Anticipated Results: Feedback from the listening session was positive. Attendees provided ideas on what to grow and shared interest in expanding the garden to the broader community. Project staff installed four garden beds and planted a variety of herbs (basil, mint, and lavender), fruits (strawberry and melon), and vegetables (tomato, squash, pepper, and onion). Roughly 20–50 children were engaged in the garden each week. Eight weeks into the project, one member from the broader community noticed the garden’s growth and expressed gratitude to the staff, stating “I saw you when you first started planting. This is great what you are doing for the kids.” Children and the center’s staff responded positively to the activities. The staff expressed verbal gratitude for the project and were enthusiastic about maintaining the garden. Discussion/Significance of Impact: Developing a community garden was feasible in this sample and shows potential to (1) increase children’s food literacy and vegetable acceptance and (2) bridge the gap from farm to early childcare education. The project’s success paves way for future gardening initiatives that address food access issues within other diverse low-income populations.

Despite representing 18% of the world’s population and 20% of the disease burden, only an estimated 2% of global clinical trials include at least one study site in Africa. This underscores the critical need for continued research on how to overcome clinical trial challenges on the continent. In countries with established reputations for clinical trials, Contract Research Organizations (CROs) play a vital role, accounting for half of the research workforce and effectively managing clinical trials for pharmaceutical, biotechnology, and medical device companies. In contrast, the potential of CROs in Africa’s clinical trials ecosystem remains largely unexplored. This narrative review discusses the challenges, opportunities, best practices, emerging trends, and prospects of clinical trials in Africa. Major challenges in clinical trial implementation in Africa stem from gaps in financial and human resources, infrastructure, and regulatory systems, while opportunities are linked to Africa’s large population, genetic diversity, disease burden, lower operating costs, positive economic outlook, and growing interest from global health and research players. Emerging trends, such as the decentralization of clinical trials and conducting trials during public health emergencies, offer promising avenues for maintaining research continuity. Ultimately, the paper proposes a context-specific framework, aimed at maximizing the effectiveness of CROs in the continent’s clinical trials ecosystem.

Objectives/Goals: The study is designed to co-develop a genetics education digital platform with community participants. Diverse populations, especially African American communities, are less likely to participate in genetic testing and clinical trials. To increase participation and community input, we want community participants across Louisiana. Methods/Study Population: A cross-sectional, mixed-methods study will be conducted to assess interest in learning about genetics through a digital education platform and to adapt the platform based on participant feedback. Specific Aim 1 will be achieved by recruiting a diverse cohort and collecting demographic data to identify participants’ characteristics. For Specific Aim 2, 35 community participants will be enrolled as a co-design team to complete 5-week educational modules. Feedback from focus groups will guide iterative platform refinements, ensuring the platform is culturally tailored and user-friendly. Results/Anticipated Results: For Specific Aim 1, we anticipate that the majority of participants will express interest in learning about genetics through the digital platform, with demographic data revealing a diverse participant pool, predominantly from African American and Hispanic communities. For Specific Aim 2, we expect that all 35 co-design team members will complete the 5-week modules. Feedback from the focus groups is anticipated to highlight the need for more user-friendly navigation, culturally tailored content, and enhanced visuals. These insights will guide the refinement of the digital platform for improved engagement and accessibility. Discussion/Significance of Impact: This study addresses a critical translational barrier – underrepresentation of African descended communities in genetic testing. By developing a culturally tailored, digital platform to engage these populations, the project aims to reduce health disparities, enhance genetic literacy, and foster inclusivity in genomic research.

Underrepresentation of people of color in clinical trials limits equity in research and treatment outcomes. This study evaluated the impact of a brief, community-focused educational intervention on perceptions and willingness to participate. Participants attended 30-minute sessions (9 virtual, 2 in-person). Identical pre- and post-surveys were analyzed using paired t-tests with Bonferroni correction. Eighty-three participants (90.5% Black, 88.4% female; mean age 46.3) showed significant improvements in comfort with participation, randomization, belief in protections, willingness to participate, and comfort in skin-related trials (all p < 0.05). Brief education may improve understanding and participation attitudes in underrepresented groups.

Objectives/Goals: As the aging population increases, maintaining cognitive and physical health becomes crucial. Executive functions (EF), including reaction time, sustained attention, and spatial memory, are essential for daily life and independence in older adults but tend to decline with age, especially in Alzheimer’s disease (AD) patients. Methods/Study Population: Physical balance (PB) impairments further exacerbate this decline, affecting the quality of life and independence. Balance training (BT) emerges as a potential non-pharmacological intervention to enhance EF. This study aims to 1) assess the association between PB impairments and EF deterioration in older adults with AD; 2) evaluate the impact of BT on EF enhancement in this population; and 3) explore changes in brain-derived neurotrophic factor (BDNF) biomarkers before and after physical activity related to BT. This pilot study employs a cross-sectional design with older Hispanic adults (>65 years) in Puerto Rico, comparing a control group without BT intervention to an experimental group with BT intervention. Both groups will be assessed for EF and BDNF biomarkers pre- and post-physical activity. Results/Anticipated Results: Expected outcomes include identifying significant correlations between PB impairment and diminished EF, demonstrating measurable EF improvements following BT, and evidencing sustained BDNF release post-BT despite PB impairments. By understanding the biological mechanisms linking BT and cognitive improvements, particularly the role of BDNF, this research could inform future strategies to mitigate cognitive decline in AD patients through targeted physical interventions. Discussion/Significance of Impact: The findings of this study could provide valuable insights into the development of new preventive interventions, enhancing the quality of life and independence for older adults.

Objectives/Goals: There has been a significant increase in the engagement of researchers with persons with lived and living experience, driven by a growing recognition of the invaluable insights and expertise these individuals bring to the research process. However, there remains a need for research teams to learn how to engage with patients and community partners. Methods/Study Population: The EMPOWER project is a collaborative of members with lived/living expertise of substance use during pregnancy. EMPOWER meets three times per month in support of their goals of patient-centered research, changing the narrative through conversations, and building the capacity of persons with lived experience to co-lead research. Through over 4 years of active collaboration and co-learning, EMPOWER has identified and created methods that support meaningful patient engagement and capacity building. Results/Anticipated Results: EMPOWER has identified the following methods that support meaningful engagement and capacity building: Mind-Mapping Exercises, Personal and Collective Journey Mapping, 8-month research training curriculum, Digital Storytelling, Learning Labs, and World Cafe Meetings. These methods have led to a collaborative of 20 individuals with lived experience of substance use to identify research gaps, prioritize research questions, design data collection tools, analyze research data, disseminate research results, and consult with healthcare teams in efforts to improve clinical care. To-date EMPOWER have given over 10 invited presentations and is currently writing manuscripts. Discussion/Significance of Impact: Meaningful patient and community engagement is critical to developing and implementing healthcare interventions. Unfortunately, engagement efforts are often lack in building capacity of patients and community, which impedes their ability to fully engage in all phases of research.

Objectives/Goals: To determine the acceptability of a mobile/school-based diabetes and prevention clinic to overcome transportation barriers and improve attendance at endocrinology appointments for youth with type 1 diabetes, type 2 diabetes, MODY diabetes, and obesity living in socially vulnerable communities Methods/Study Population: This study utilized a 3-phase implementation process focused on feasibility, demand, and acceptability. Phase 1: identified high-need areas using patient volume and disease control metrics. Collaborated with school districts to define needs, enrolled them through a memorandum of understanding, and subsequently recruited and consented existing patients attending these schools. Phase 2 piloted the program to refine logistics and workflows. Semi-structured interviews and surveys were conducted with caregivers to assess program acceptability and satisfaction. Phase 3 is ongoing and will track clinical outcomes including glycemic control, appointment attendance, hospital admissions, emergency department visits, and self-management metrics. Results/Anticipated Results: Demand for the program was high with 91% (10/11) of approached districts agreeing to participate. District enrollment was staggered, starting with 1 district in August 2023, expanding to 5 in September, 7 in October, and reaching 8 districts by May 2024. From August 2023 to July 2024, the school-based mobile clinic conducted 355 individual clinical encounters addressing diabetes and obesity. The encounters included 180 for type 1 diabetes, 69 for type 2 diabetes, 8 for MODY diabetes, and 98 for obesity. Interviews and surveys with 36 caregivers are ongoing to evaluate program satisfaction. Discussion/Significance of Impact: The data suggest that this innovative healthcare delivery model is feasible. District-level enrollment demonstrates a demand for the program. Results from the interviews and surveys will further characterize the program’s acceptability among caregivers and lay the groundwork for future efficacy testing.

Translational science methods often fall short due to the complexity of the healthcare delivery environment. We developed a methodology that involves multiple interest holders working within a pre-competitive consortium to develop solutions to translational barriers. The methodology supports innovative collaboration in a stepwise fashion: elucidating challenges, designing solutions, enabling implementation, monitoring, learning, disseminating, and catalyzing. Cases that benefit most from a structured collaborative methodology are those where diverse needs require elucidation and alignment. Application of the methodology to develop regulatory, clinical, and business innovations has shown the importance of an innovation facilitator and the capacity-building potential of collective skill enhancement.

Objectives/Goals: Pregnancy increases vulnerability to stress and mental health symptoms, particularly among Hispanic women in Puerto Rico (PR), a population with unique socioenvironmental adversities, such as poverty and natural disasters. This study examined the relationships between life adversities and psychological distress in this at-risk population. Methods/Study Population: Participants (n = 50) in this cross-sectional study were recruited from an obstetrician’s office in Southern PR. All participants provided written consent and completed the Adverse Life Experiences Scale (ALES, Cronbach’s alpha = 0.71) to identify lifelong adversities faced and the overall duration (chronicity). Measures of psychological distress included the Perinatal Anxiety Screening Scale (PASS, Cronbach’s alpha = 0.96), the Edinburg Postnatal Depression Scale (EDPS, Cronbach’s alpha = 0.87), the Perceived Stress Scale (PSS, Cronbach’s alpha = 0.79), and the Brief Resilience Scale (BRS, Cronbach’s alpha = 0.86). Descriptive and Spearman’s rho correlation analyses were conducted. Results/Anticipated Results: The mean age of the participants was 27.90 years (SD = 6.05), with most in the first trimester (66.0%). On average, participants reported 4.32 (SD = 3.1) out of 23 lifetime adversities. The most common adversities were natural disasters (60.0%), loss of a beloved (58.0%), and financial difficulties (38.0%). Nearly half (44.0%) experienced five or more adversities. A significant number of participants met the clinical threshold for anxiety (38.0%, PASS), depression risk (22.0%, EPDS), moderate-to-severe perceived stress (52.0%, PSS), and low resilience (24.0%, BRS). The overall duration of adversities was significantly associated with anxiety (rs = 0.50, p = 0.001) and stress (rs = 0.50, p = 0.007). Discussion/Significance of Impact: Hispanic pregnant women in PR face high levels of adversity and distress, which can negatively affect both maternal health and fetal development, influencing long-term child outcomes. Early identification and targeted interventions addressing adversities, can improve maternal mental health and child health-development outcomes.

Objectives/Goals: Here, we utilize deep learning to automate the analysis of dual X-ray absorptiometry (DEXA) scans in the UK Biobank (UKB) imaging dataset to enable a large-scale assessment of lumbar spine disc degeneration, low back pain, and socioeconomic status. Methods/Study Population: Study Population: The UKB is a biomedical database that includes lateral spine DEXA imaging for 50,000 participants. Deep Learning Model Development: A computer vision model was developed that receives a DEXA scan as input and outputs a quadrilateral that corresponds to the corners of 5 lumbar vertebral bodies. The model is a deep, fully convolutional, encoder–decoder network using DeepLabV3. Statistical Analysis: To determine our preliminary model accuracy, we used the intersection over union (IoU) metric.We analyzed data using an ordinal regression model to determine the relationship between income/ neighborhood level multiple deprivation index (MDI) and low back pain (LBP), as well as a mixed effects model to estimate the relationship between income/MDI and disc height index (DHI). Results/Anticipated Results: Our model predicted vertebral body quadrilaterals in training and unseen test data (train IoU  =  0.96, test IoU  = .91) and was used to infer data for 10,440 participants. Confirming previous studies, there were significant relationships (p0.05) between income or MDI and DHI (Figure 2). Discussion/Significance of Impact: Low back pain is the world’s leading cause of disability, and socioeconomic factors play an important role. We found no relationship between disc height index and socioeconomic status. Thus, disc degeneration may not be a factor in this low back pain phenotype.

Rural America remains deeply under-represented in clinical trials. St Lawrence Health (SLH) was the sole rural site and one of the top recruiters in the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-1 trial, which was a large international trial that studied the efficacy of three immune modulators in hospitalized patients with COVID-19. In this article, we analyze the structural and clinical factors that enabled SLH’s success in the context of previously described barriers to research participation in rural areas. We conclude with lessons learned from the SLH experience and offer a broader replicable model for developing clinical research capacity in rural areas. SLH’s success in ACTIV-1 can be attributed to early and sustained support from the ACTIV-1 network, a small and integrated inpatient COVID-19 treatment team, regular and consistent communication between this team and the clinical research team at SLH, and SLH’s ongoing support and development of its clinical research department. SLH was, in turn, able to overcome several known barriers to implementation of clinical trials at community sites, including lack of provider time and a lack of trained research and clinical staff, and its experience in ACTIV-1 offers a replicable model for developing clinical research capacity in rural communities.

Objectives/Goals: To develop an informatics framework that will allow study of environmental effects on stillbirth at large scale (i.e., US-level) and leverage recent advances in machine learning and artificial intelligence to produce reproducible results that can be compared across multiple institutional settings. Methods/Study Population: Experimental exposure data are often available in “absolute time,” where a clinical event can be anchored using a timeline transformation. We associate each stillbirth event with a set of {ti…ti+1}L shapelets [1] associated with a location, L, and time intervals for the entire dataset. These shapeless are aggregated using a state-of-the-art shapelet classifier [2]. An autoencoder is used to reduce the dimensionality of the stillbirth classification and to cluster stillbirth events according to their corresponding exposure patterns. The stillbirth cluster can be analyzed for other nonexposure (i.e., genetic, SDoH, and demographics) factors, which may be enriched and/or depleted. Results/Anticipated Results: The framework we are developing leverages a shapelet-based approach to produce clusters of stillbirth events according to their corresponding exposure patterns. These clusters can be analyzed for depletion or enrichment of nonenvironmental factors. This analysis will inform how to formulate (or not) class models of exposure that can be more informative and have better predictive power than overall population models. Moreover, the finding of depletion and enrichment of physiological properties of the individuals may lead to novel physiological hypotheses to better understand the injury mechanisms that the environmental exposure profile produces. Discussion/Significance of Impact: Nearly 20,000 babies are stillborn in the USA each year [3]. Environmental exposures, usually studied as time averages over certain periods of time, have produced mixed results for stillbirth risk [4]. However, temporal profiles matter [1], and we argue that they can be assessed using shapelet technology.