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

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

Research studies involving human subjects require collection of and reporting on demographic data related to race and ethnicity. However, existing practices lack standardized guidelines, leading to misrepresentation and biased inferences and conclusions for underrepresented populations in research studies. For instance, sometimes there is a misconception that self-reported racial or ethnic identity may be treated as a biological variable with underlying genetic implications, overlooking its role as a social construct reflecting lived experiences of specific populations. In this manuscript, we use the We All Count data equity framework, which organizes data projects across seven stages: Funding, Motivation, Project Design, Data Collection, Analysis, Reporting, and Communication. Focusing on data collection and analysis, we use examples – both real and hypothetical – to review common practice and provide critiques and alternative recommendations. Through these examples and recommendations, we hope to provide the reader with some ideas and a starting point as they consider embedding a lens of justice, equity, diversity, and inclusivity from research conception to dissemination of findings.

OBJECTIVES/GOALS: UNC-Chapel Hill’s CTSA implemented a community feedback session (CFS) service to help researchers gather actionable, authentic, and constructive feedback on their projects from community experts. Simultaneously, we conducted an ongoing, participatory evaluation process to improve the experience for researchers and community members. METHODS/STUDY POPULATION: Informed by the Community Engagement Studio model (Yoosten, 2015), a CFS is a 2-hour consultative session that includes facilitated discussion with community experts around topics or questions posed by a research team. UNC-Chapel Hill’s CTSA staff conducted 7 CFSs during the pilot phase of the service and collected evaluation surveys from researchers and community experts. We held a data party – a participatory evaluation method – to analyze and interpret survey data. Resulting recommendations were used to improve CFS materials and processes. We conducted 11 CFSs after the pilot phase, then analyzed survey data again to gauge improvement and make further adjustments to the service. We also surveyed researchers three months after their last CFS to assess the impact of community experts’ feedback on their studies. RESULTS/ANTICIPATED RESULTS: Since January 2022, 108 community experts have participated in 18 CFSs spanning 9 research projects. Data party interpretations of pilot evaluation data yielded several changes in service delivery; since those changes were instituted, all researchers have highly rated the service, unanimously recommending it to colleagues. Researchers praised well-structured sessions and productive engagement, citing direct benefits to their work and significant impact on recruitment processes 3 months post CFS. Community experts also echoed satisfaction, with 100% finding CFSs worthwhile and 95% desiring to participate again, emphasizing the sessions' supportive atmosphere. A community expert reported that the sessions 'made me feel seen and allowed for a greater understanding of what I have been dealing with.' DISCUSSION/SIGNIFICANCE: The CFS model allows research teams to elicit rapid and meaningful community input, which is key to improving research relevance and impact. Ongoing participatory evaluation of the service ensures continuous improvement, yielding more meaningful interactions and studies that reflect the perspectives of people affected by the research.

Efficient evidence generation to assess the clinical and economic impact of medical therapies is critical amid rising healthcare costs and aging populations. However, drug development and clinical trials remain far too expensive and inefficient for all stakeholders. On October 25–26, 2023, the Duke Clinical Research Institute brought together leaders from academia, industry, government agencies, patient advocacy, and nonprofit organizations to explore how different entities and influencers in drug development and healthcare can realign incentive structures to efficiently accelerate evidence generation that addresses the highest public health needs. Prominent themes surfaced, including competing research priorities and incentives, inadequate representation of patient population in clinical trials, opportunities to better leverage existing technology and infrastructure in trial design, and a need for heightened transparency and accountability in research practices. The group determined that together these elements contribute to an inefficient and costly clinical research enterprise, amplifying disparities in population health and sustaining gaps in evidence that impede advancements in equitable healthcare delivery and outcomes. The goal of addressing the identified challenges is to ultimately make clinical trials faster, more inclusive, and more efficient across diverse communities and settings.

OBJECTIVES/GOALS: Caregivers often identify signs of autism in infancy but face multiple barriers when seeking specialized evaluations and subsequent services. This study sought to understand the experiences of families with early developmental concerns to identify acceptable and feasible strategies to support them during this period of uncertainty. METHODS/STUDY POPULATION: We interviewed 15 families participating in a larger longitudinal project developing telehealth assessments for infants with early developmental concerns. Interviews were conducted virtually following the final toddler-age assessment, and focused on caregivers’ experiences navigating early concerns, appropriateness of existing supports, and suggestions for future directions. Interviews were transcribed and coded across multiple passes, focusing on both phenomenological experience and frequency of specific supports mentioned. RESULTS/ANTICIPATED RESULTS: Core themes expressed across multiple included: (1) Uncertainty; (2) Navigating Supports; (3) Community and Connection; and (4) Information is Power. Caregivers also provided specific suggestions for addressing these areas. These included suggestions for parent coaching topics, modalities for sharing information with parents (e.g., group meetings, online modules), and research practices. DISCUSSION/SIGNIFICANCE: There have been recent efforts to develop pre-diagnostic interventions for infants, but few studies have investigated the needs and priorities of families during this period. Our approach can help bridge the gap between research and practice by identifying family priorities to target when developing interventions.

The Master of Science in Clinical Research Management program at Rutgers Biomedical Health Sciences underwent significant restructuring aligned with the Clinical and Translational Science Award funding parameters. This evolution necessitated formal evaluation through accreditation by the Commission on Accreditation of Allied Health Education Programs. The years-long accreditation process posed challenges, particularly regarding the collection of course learning outcomes data aligned with accreditation competency standards. The objective of this special communication is to report the rationale behind pursuing accreditation for clinical research degrees, the data collection challenges during the accreditation process, and a potential solution. In order to address existing university metric data gaps, Research Electronic Data Capture (REDCap) software was used to develop a data collection tool that streamlined the accreditation process and reduced the administrative burden. REDCap was effective in allowing faculty to self-report 3 years of course outcomes data for accreditation. There was an elevated level of user satisfaction compared to alternative data collection methods. A SWOT analysis identified the strengths and weaknesses of using REDCap, emphasizing strengths in functionality that include customizability, data validation, and compliance with regulatory standards. Overall, the advantages of leveraging REDCap for accreditation data collection, including customization, data security, and user-friendliness outweigh the key disadvantage of REDCap, which is its limited reporting capabilities.

OBJECTIVES/GOALS: The goal is to use a participatory design approach involving patients and healthcare providers to create an intervention aiming to improve the transition readiness of youth with sickle cell disease (SCD) when going from pediatric to adult care in Ontario. METHODS/STUDY POPULATION: The study employed a participatory design approach, utilizing co-design and community-consulted design practices. The co-design process involved three design sessions with 7 adult participants (3 with SCD, 3 with SCD working in healthcare, and 1 without SCD but working in healthcare) to actively involve them in designing an intervention that addressed their unmet needs. A thematic analysis of the first design session was conducted to gain insight into their experiences. The community-consulted design included three internal research team sessions to synthesize the participants' insights. Zoom was used for all sessions, and Miro as the online collaboration tool for participatory design activities, resulting in a prototype that reflected the collective input of the target users and the broader community. RESULTS/ANTICIPATED RESULTS: With the thematic analysis, one prominent theme emerged, labeled as 'Barriers to Successful Transition,' which consisted of four subthemes: 1) Lack of Education and Awareness; 2) Constraints in Healthcare Delivery, 3) Managing Multiple Transitions; and 4) Racial Bias in Healthcare. The word 'hospital' emerged as the most frequently mentioned word, following closely were the terms 'school,' 'person,' 'sickle cell disease,' and 'education.' This analysis underscores the crucial involvement of hospitals and healthcare providers in facilitating the transition of youth with SCD. Following the design sessions, the most desirable/feasible intervention was to create an accredited digital educational module for adult healthcare providers specifically focusing on youth transitioning with SCD. DISCUSSION/SIGNIFICANCE: 3,500 people in Ontario have SCD, with an average age of 24 years, where one-third are aged 14 or younger. Youth with SCD face unique challenges, so effective communication and comprehensive care coordination are needed from healthcare providers. The digital module will increase awareness and ultimately improve transition readiness.

OBJECTIVES/GOALS: Our study aims to 1) examine the link between engagement in CLR Academy and youth diabetes risk factors—physical activity, nutrition, mental health, and weight status; 2) examine CLR’s role in moderating the relationship between perceived discrimination and these risk factors. Includes a program evaluation of CLR & interviews of members. METHODS/STUDY POPULATION: Youth-onset diabetes is rising in American minority communities. Youth sports programs like the Community Leadership Revolution (CLR) Academy in Washtenaw County, MI are emerging responses to this issue. CLR targets diabetes risk factors through team sports by promoting mindfulness and healthy habits. Employing a mixed-methods, pretest-posttest approach, our study focuses on how the frequency of engagement in CLR impacts CLR’s effect on youth’s diabetes risk factors. Considering the discrimination minority youth experience, we also aim to see if CLR potentially buffers the impact of perceived discrimination on diabetes risk factors. A posttest program evaluation of CLR will also include semi-structured interviews with CLR staff and participants. RESULTS/ANTICIPATED RESULTS: There is potential that youth with high engagement in CLR Academy may see enhanced benefits in managing diabetes risk factors compared to less active participants. This may be particularly true for youth experiencing high perceived discrimination, with potential marked improvements in mental health, like reduced anxiety and depression. Additionally, through a program evaluation and semi-structured interviews, our study aims to uncover the factors contributing to CLR’s success as a community-led intervention while also identifying areas for enhancement. Post-study, CLR will receive financial support to integrate these insights into their program, furthering their effectiveness in youth diabetes prevention and overall well-being. DISCUSSION/SIGNIFICANCE: This study may provide significant insights into the relationship between sports participation, diabetes risk factors, and perceived discrimination. The findings could help CLR improve its program and guide more effective diabetes prevention strategies in minority youth through other youth sports programs.

OBJECTIVES/GOALS: Contingency management (CM), wherein patients earn prizes for behavior change, is the gold-standard for reducing stimulant misuseand has been shown to improve medication adherence.We aim to describe the feasibility, acceptability, and effectiveness of CM to reduce stimulant use and optimize ART adherence in Women’s HIV primary care. METHODS/STUDY POPULATION: Using the ADAPT-ITT model for adapting evidence-based HIV interventions, we implemented the CoMBostudy at the Ward 86 Women’s Clinic at San Francisco General Hospital. Inclusion criteria are (1) adult age women with HIV, (2) suboptimal ART adherence, (3) stimulant use disorder with goal of reduced-use. Participants receive weekly CM for 12 weeks with escalating incentives for point-of-care urine testing negative for stimulants and positive for tenofovir ART. We use mixed methods to evaluate feasibility and acceptability ofCoMBowith quantitative process measures, sequential explanatory in-depth interviews with participants and staff, and effectiveness by proportion of point-of-care urine tests without stimulants and with tenofovir. RESULTS/ANTICIPATED RESULTS: CoMBoStudy enrollment began in September 2023; n=10 participants have enrolled with an additional n=20 planned.We will report feasibility and acceptability using:1) the number of women with HIV, stimulant use disorder, and suboptimal ART adherence enrolled vs. recruited, 2) the number and proportion of CM sessions attended/missed, 3) cost per participant, and 4) participant-reported facilitators and barriers to CM engagement. We will report preliminary effectiveness based on: 1) proportion of POC tests negative for stimulants, positive for ART, and 2)trend in self-reported stimulant use assessed weekly during CM. DISCUSSION/SIGNIFICANCE: Women with comorbid HIV and stimulant use disorder have demonstrated poor outcomes including reduced ART adherence and faster progression to AIDS. This work aims to expand access to evidence-based treatment for stimulant use disorder for women with HIV and share key opportunities and challenges for doing so in the women’s health HIV primary setting.

Evaluation of benefits beyond quantitative academic outputs is essential in determining translational research value. We used the Translational Science Benefits Model (TSBM) to examine the impact of the QUARTET USA trial using 30 benefits across 4 domains: Clinical, Community, Economic, and Policy. We found that the QUARTET USA trial demonstrated impact in six areas within the Clinical, and Community domains and had potential impact in two additional areas within the Community and Economic domains. Use of the TSBM supports the value of the QUARTET USA trial, which can be used as a template for future cardiovascular trials.

OBJECTIVES/GOALS: LGBTQIA2+ patients experience many healthcare inequities and often do not seek healthcare due to stigma andprevioustraumatic experiences in the healthcare system. A paucity of healthcare centersprovidesreduced-fee or free healthcare to LGBTQIA2+ individuals. METHODS/STUDY POPULATION: This project was initiated by the primary author who volunteered at an established student-run free clinic in Columbus, OH. The primary author engaged other students and faculty members, including the co-authors. A needs assessment was conducted by the authors, highlighting the unique needs of LGBTQIA2+ patients in central Ohio. In April 2022, members of the community and volunteer faculty providers established the Rainbow Clinic. The Rainbow Clinic provides primary care services including sexual health/STI testing and gynecology care. The Rainbow Clinic exclusively serves members of the LGBTQIA2+ community in central Ohio and creates a safe and inclusive space to educate medical and nurse practitioner students on the care of LGBTQIA2+ patients in a culturally sensitive way. RESULTS/ANTICIPATED RESULTS: The Rainbow Clinic has provided care for 60 patients equating to 78 visits. Most patients sought care for general primary care (17.9%), gynecological care (11.5%) or STI testing and treatment (7.7%). In addition to medical services, social work services are also provided as part of available mental health services and to provide additional linkage to care. To our knowledge, The Rainbow Clinic is the first student-run free clinic in Ohio to offer pre-exposure HIV prophylaxis (PrEP) medication as well as the required laboratory monitoring. The Rainbow Clinic has ongoing research evaluating patient comfortability throughout their encounters and has launched research studies to evaluate how best to address social determinants of health that affect the health and healthcare of the LGBTQIA2+ community. DISCUSSION/SIGNIFICANCE: The Rainbow Clinic deliversfree healthcareand social work servicesto patients who experience healthcare inequities anddisparities.Additionally, the Rainbow Clinic is a source of education for medical and nurse practitionerstudents to ensure their cultural humility in treating future LGBTQ+ patients.

OBJECTIVES/GOALS: The objectives of the Academy of Community Reviewers (ACR) serve to: (1) provide comprehensive education and training to community members about clinical research and the community review process for clinical research grants; and (2) collaborate with the community in the development of the training to ensure benefice and meaningful engagement. METHODS/STUDY POPULATION: This training targets community members who will serve as future grant reviewers for The Ohio State University Center for Clinical Translational Science (CCTS) pilot grant submissions, other grant submissions and as expert consultants on other projects needing community perspectives. In 2019 and 2020, this training was offered as a live session. Thirty-eight community reviewers were trained and have served as grant reviewers and consultants on over 70 projects. Based on feedback of former graduates, time demands, logistics, and technology advances warranted transitioning the course to an online learning platform. ACR graduates were consulted in course redesign and updates. Course revisions include material on DEIA, implicit bias and health equity in clinical research with narrated lectures. RESULTS/ANTICIPATED RESULTS: Each of the 7 modules (including a total of 15 submodules) will have a brief summary knowledge check. The module “How to incorporate diversity, equity, inclusion and accessibility in health research” will invite trainees to independently explore their own social identity and biases through a guided exercise. The last (7th) module will have interactive opportunities for submitting grant reviews and participation in an online grant review session, geared to The Ohio State University CCTS. ACR graduates have been invited to consult on educational material and pilot the new course. Demographic, knowledge assessments and module evaluations will be collected. An overall course evaluation and focus group interviews with graduates will also be analyzed for quality improvement and contributions in grant reviews. DISCUSSION/SIGNIFICANCE: The increased accessibility of the ACR course will foster more inclusive community engagement and support the development of clinical and translational research that is innovative, efficient, equitable, and relevant to its beneficiaries. This in depth community reviewer training has been designed to be used and customized to other CTSA Hubs.

OBJECTIVES/GOALS: Women and healthcare providers from underserved rural and urban communities participated in Community Engagement (CE) studios to offer perspectives for increasing research participation of women from diverse backgrounds prior to initiating recruitment for a randomized-controlled trial comparing treatments for urgency urinary incontinence. METHODS/STUDY POPULATION: CE studios are listening sessions to gather patient or community input on specific study areas of interest before implementation. Ten CE studios were held via Zoom at five study sites (Rhode Island, Washington DC, Alabama, New Mexico, and Southern California). Each site held two studios: 1) women living with urgency urinary incontinence, 2) clinicians providing care in their areas. Participants gave recommendations on ways to increase study participation of women from diverse racial and ethnic backgrounds with a focus on recruitment and retention, identification of barriers to participation, and suggested approaches to overcome those barriers. Summaries were compiled from each CE studio to identify similar and contrasting recommendations across sites. RESULTS/ANTICIPATED RESULTS: A total of 80 participants (47 community women experiencing urgency urinary incontinence, and 33 healthcare professionals) participated across all sites. Studio participants discussed anticipated barriers for participant recruitment and retention with a focus on solutions to those barriers. Based on these suggestions, we created recruitment materials using pictures, videos, and simple terminology. We created educational content to help providers with current best practices for urinary urgency incontinence. We have allowed most study visits to be conducted virtually, identified affiliated clinics in various locations to improve proximity to undeserved communities, and have earmarked additional funds to help offset travel costs including gas, public transportation, and childcare. DISCUSSION/SIGNIFICANCE: CE studios have provided pragmatic patient- and provider-centered recommendations that have been incorporated into functional strategies to improve research participation and diversity. CTSA CE core expertise can support successful CE studio planning and implementation.