Objectives/Goals: Community-based practices have limited research opportunities for providers. As a rural community-based health system, Mayo Clinic Health System (MCHS) sought to create intramural funding mechanisms to help early-stage researchers conduct pilot research so they are more competitive to compete for more robust extramural funding opportunities. Methods/Study Population: We created a Research Seed Grant Program infrastructure across our four MCHS regions (Southwest and Southeast Minnesota, Northwest and Southwest Wisconsin). This model program featured an initial research funding announcement call based on 6 prioritized programs (AI Validation & Stewardship, Cancer, Health Equity, Population Health, Rural Health, Learning Healthcare System [LHS]), with submissions uploaded to a central electronic repository. Proposal review and ranking was organized on a regional basis, with ranking of all proposals by at least 2 clinical scientist reviewers according to the NIH domain-specific framework (i.e., 1.0 best > 9.0 worst). Awards were competitively selected by conformity to prioritized research areas and through ranking of most competitive overall application scores. Results/Anticipated Results: For our inaugural RFA, we received 55 grant application submissions across the MCHS regions. Fifteen of the most highly ranked applications were selected for awards on a per region basis, providing direct funding as well as protected investigator research time of 10% for up to six months. The selected projects address several research priorities including improving access, reducing health disparities, improving behavioral health in our communities, increasing cancer screening and prevention, and community-based pragmatic trials and interventions. Outcomes from these now completed pilot projects remain pending at this time. Funding for this seed grant program was supported by philanthropy, Mayo Clinic Research Administration, Mayo Clinic Comprehensive Cancer Center, and the Mayo Clinic CCaTS Rural Core. Discussion/Significance of Impact: We present this framework for a LHS-focused Seed Grant program model for consideration of adoption by other national/international LHS. Future plans include tracking of outcome metrics (e.g., published peer review articles, extramural grant applications) of this initial cycle and future expansion of this program to support the goals of our LHS.

Objectives/Goals: Clinical relevance of preclinical animal models is commonly in question. Herein, we investigated locoregional tumor immune microenvironment (TIME) differences in tumor-bearing murine oral cancer models, unresponsive to traditional immunotherapy, and also developed an oral tumor resection model to ultimately enhance translational relevance. Methods/Study Population: Here, we utilized carcinogen-induced, HPV-negative preclinical oral cancer models. For TIME studies, ROC1 cells were maintained as published. ROC1 tumors were established in the murine flank and oral cavity of wildtype C57Bl/6 mice, and tumor growth kinetics were assessed at each site. At distinct stages of tumor growth, tumors were harvested, as well as their respective corresponding inguinal and cervical tumor-draining lymph nodes (tdLNs). Multiparameter 28-marker spectral flow cytometry was performed to analyze immune cell populations at each site. For tumor resection studies, MOC2 tumors were similarly maintained and established in the oral cavity. MOC2 tumors were accessed via midline transcervical incisions. Upon tumor excision, wounds were closed with multiple interrupted Vicryl sutures. Results/Anticipated Results: We anticipated no differences between heterotopic and orthotopic tumor sites. Both sites displayed an initial period of delayed ROC1 tumor growth followed by rapid progression. Comprehensive analyses revealed low T cell infiltration overall and increases in select myeloid cells (i.e., macrophages and dendritic cells) over time in both models. Other immune cell types, however, generally increased over time in the flank. Differences between corresponding tdLNs further indicate deviating changes in immunosuppressive phenotypes (i.e., regulatory T cells and macrophages) and immune checkpoint marker expression. Additionally, MOC2 oral tumors were successfully resected with no visible remaining tumor. No subsequent healing complications were observed, and tumor recurrence occurred within 1 week post-surgery. Discussion/Significance of Impact: Tissue-specific TIME and tdLN differences may impact antitumor treatment and response. Ability to resect orthotopic tumors allows for modeling of standard-of-care treatment for oral cancer. These studies can enable tailoring of therapeutic strategies and provide insight into model selection and data interpretation from translational studies.

Objectives/Goals: This study aim to identify cervical cancer prevention barriers and facilitators, assess the associations between social determinants of health factors and cervical cancer prevention, and examine the association between levels of health literacy and willingness to undertake HPV vaccine and cervical cancer screening among Black and Hispanic women. Methods/Study Population: To achieve Aim 1, we will conduct a quantitative survey on barriers and facilitators to cancer prevention among non-Hispanic Black and Hispanic women. For Aim 2, we will assess the relationship between Social Determinants of Health and HPV vaccination/cervical cancer screening using the AHC Health-Related Social Needs Screening Tool. For Aim 3, health literacy will be measured using the SAHL–S&E test and its association with willingness to vaccinate or cervical cancer screening. We will analyze the results using chi-square and logistic regression models. Participants will be recruited through multiple methods. We will recruit 250 individuals who were assigned female at birth and identify as non-Hispanic Black or Hispanic, aged 18–26 years, from Caddo and Bossier Parishes. Results/Anticipated Results: We expect to identify several barriers and facilitators to cervical cancer prevention among non-Hispanic Black and Hispanic women, including factors like access to care, cultural beliefs, and knowledge gaps. Social determinants of health (SDOH), such as income, education, and healthcare access, will likely show a strong association with lower HPV vaccination, Pap smear, and HPV screening rates. Additionally, we anticipate that lower health literacy will correlate with reduced willingness to vaccinate or screen for HPV. These findings can bridge the gap between research and practical health applications by guiding the design of community-based behavioral interventions that enhance cervical cancer prevention among minority populations. Discussion/Significance of Impact: This research is the first to assess how SDOH factors impact cervical cancer prevention among Blacks and Hispanic women in North Louisianawhile also exploring the role of health literacy in HPV vaccination and screening. Findings will drive practical interventions to reduce disparities and improve outcomes.

Objectives/Goals: Explore the association of gestational age of LPIs and neurodevelopment delay in children exposed to the neonatal intensive care unit (NICU). Compare between groups if exposure to NICU affects neurodevelopment in children who were born between 34 and 37 weeks of gestation. Methods/Study Population: This is a cross-sectional study design to study the association of gestational age and neurodevelopmental delays in a birth cohort in Puerto Rico of children exposed to the NICU. Their neurodevelopment will be measured with the Bayley III. Statistical analysis will be performed using IBM SPSS Statistics 27.0. Descriptive statistics will be used, and normality distributions among all continuous variables, frequency distribution for categorical variables. We will recruit 30 infants between 18–24 months of age that were born between 34–37 weeks of gestation. Infant will be divided with regard to their exposure to NICU experience. Results/Anticipated Results: We anticipate identifying neurodevelopment delays among children born prematurely between 34 to 37 weeks of gestation. We anticipate that our controlled group will have better outcomes when compared to the controlled expose group. We also expect that gestational age impacts adversely neurodevelopment in children who were born between 34 and 37 weeks of gestation. Discussion/Significance of Impact: Approximately 84% preterm birth are considered LPIs. Prematurity is described as a chronic condition; adverse long-term neurodevelopment consequences. Our study promotes early detection and interventions that can reduce the consequences of the neurodevelopment delays in LPIs.

Objectives/Goals: This study aims to evaluate diversity of participants in GLP-1 T2DKM clinical research with regard to sex, race, and ethnicity by using results data available through the ClinicalTrials.gov database. Sample population estimates for studies were calculated using the 2020 Census and compared within groups with respect to sex, race, and ethnicity. Methods/Study Population: The public ClinicalTrials.gov database was searched for interventional studies with GLP1 inclusion as treatment (n = 2,397). This search was then filtered to studies where results were reported (n = 772). From these studies, 466 studies focused on type 2 diabetes as a condition and thus became the analysis dataset. Participant and protocol information for these 466 studies were obtained from the clinical trials transformation initiative (CTTI) as an AACT data download. Observed to expected ratios were calculated for each subgroup-based population estimates from the 2020 Census and using the baseline counts of participants for studies where sex, race, and ethnicity were provided. In addition to within group comparisons, study characteristics (e.g. phase) were included in models to assess influence of covariates. Results/Anticipated Results: Of the 466 studies, 430 (92%) reported sex, 171 (37%) reported race, and 145 (31%) reported Hispanic ethnicity. Among those found to be underrepresented in studies (defined as a ratio < 1): females (mean  =  0.89, median  =  0.92); Black/African Americans (mean  =  0.88, median  =  0.39). Hispanic or Latinos mean ratio was 1.16 (95% CL: 0.97, 1.35) but had the least available data. When including covariates in the models, there were statistically significant differences in ratios with respect to sex as females had significantly lower odds compared to males (ratio > =  1), with the odds being about 21% of those for males. With respect to race, Black or African American individuals had significantly lower odds (about 32% of those of White individuals) (ratio > =  1). Discussion/Significance of Impact: This study reveals significant underrepresentation of females (mean ratio 0.89) and Black/African Americans (mean ratio 0.88) in clinical trials for GLP-1 drugs in type 2 diabetes. These disparities highlight the need for more inclusive research to ensure diverse populations benefit equally from medical advancements.

Objectives/Goals: Despite persistent health disparities, rural individuals are underrepresented in clinical trials, due in part to access barriers. We investigated if targeted strategies enhanced recruitment, engagement, and retention of rural adolescents in the TEENS+ randomized clinical trial, a 4-month family-based behavioral weight loss intervention. Methods/Study Population: Adolescents (12–16 y) and parents with obesity were eligible for TEENS+. Treatment converted to virtual in COVID-19, allowing eligibility to expand to more rural areas. We leveraged Informatics, a practice-based research network, and direct marketing to identify potential rural participants. Targeted engagement strategies included: rural physician outreach, physician-endorsed letters, providing tablets and mobile hotspots, reimbursing travel, and offering in-person or remote assessment visits. Chi-square tests evaluated differences in screener completion and enrollment of rural families before (T0) and after (T1) changes were made. Noninferiority tests evaluated rural vs. nonrural retention and engagement (% attendance, % dietary self-monitoring) and engagement based on digital tool receipt. Results/Anticipated Results: N = 211 dyads enrolled (n = 54 in T1: 48% male; 41% Black). Screener completion by rural families significantly increased from T0 (9.8%) to T1 (15.1%; p = .043). Yet, there was no significant change in rural adolescent enrollment (T0 = 10%; T1 = 9%; p = .844). Sixteen adolescents (30%) received study tablets, and none needed mobile hotspots. Mean adolescent attendance was 75%±28% for group and 94%±18% for individual sessions, with no significant differences based on rural status or tablet use. Rural adolescent self-monitoring (via app) was 28%, compared with 50% for non-rural adolescents (p = .074). Retention was 94% at 4m and 89% at 8m for T1 participants, with no differences based on rural status. At the primary endpoint (12 m), retention was significantly higher for rural (100%) vs. non-rural (87%) participants; p = .013. Discussion/Significance of Impact: Rural adolescent screener hits increased yet enrollment was unchanged. However, rural attendance was comparable and retention exceeded, compared to nonrural participants. Strategies to yield equitable representation and engagement in clinical trials are essential for geographic generalizability and to reduce rural health disparities.

Objectives/Goals: Inclusive physical activity (PA) interventions could improve trans and gender diverse (TGD) adolescents’ PA levels, perceived social support from peers and adults, and mental health, but no stakeholder-informed interventions exist. We describe parents’ impressions of TGD adolescent children’s PA experiences and advice for a PA intervention. Methods/Study Population: We conducted individual Zoom interviews with parents of 13- to 20-year-old TGD adolescents (n = 15). All parents were recruited from a gender healthcare clinic. All children self-identified as TGD, an umbrella term including people who have a gender identity different from social expectations for their assigned sex. We asked questions regarding children’s current and historical participation in PA, parents’ perceptions of barriers to PA for their TGD children, and parents’ desired intervention components. After each interview, parent participants were compensated $100 for their time. We analyzed interview transcripts, focusing on insights to incorporate in an intervention. This study was approved by the University’s Institutional Review Board. Results/Anticipated Results: Parents shared rich histories of their children’s PA participation, compounding barriers to PA, numerous benefits of PA, and a range of preferences for program activities and inclusive practices (e.g., safety protocols, training for adult leaders). They also emphasized the need for TGD youth to build social connectedness through PA. Discussion/Significance of Impact: We gathered concrete advice from parents on creating a PA intervention, which we will use to build a social PA program that meets TGD adolescents’ needs. Addressing health disparities and improving PA, social support, and mental health among TGD adolescents will require such stakeholder input to improve upon existing PA and sports opportunities.

Objectives/Goals: The objective of this project is to develop a tool for evaluating clinical trial (CT) eligibility criteria for demonstrated “gender literacy,” defined as the recognition that biologically assigned “sex” is distinct from personally defined “gender identity,” as a way to quantify the inclusion of gender minority populations. Methods/Study Population: The study is validating an assessment scale that evaluates gender literacy based on CT eligibility criteria (EC). Two health professionals will serve as “coders,” tasked with grading 15 CTs. EC for all CTs will be exported from clinicaltrials.gov. Once trained with using the scale, each coder will give a score for each trial. After this first scoring period, coders will share their scores and experiences using the scale. Coders will be tasked again with grading 15 new CTs. This second scoring period will yield final scores to calculate the inter-rater reliability (IRR), or the extent to which qualitative measurements are consistent and not due to random chance. IRR will be quantified by Cohen’s kappa to validate the scale. Results/Anticipated Results: Cohen’s kappa is on a continuous interval from 0 to 1, where 0 means no agreement and 1 means perfect agreement. It is expected that the Cohen’s kappa for this assessment scale will exceed 0.80. Such validation is necessary to ensure the scale is robust and dynamic for multiple use-cases and consistent across any coder. By having a discussion after the initial scoring period, we can identify confusions or challenges with the scale early on and correct them before the secondary scoring period. In comparing these two coders’ performance, it is expected that the second scores will be more similar, thus a kappa closer to 1. However, if the kappa is low, this may be because gender literacy is a learned skill, through the internalized recognition that gender is truly different from sex. Discussion/Significance of Impact: Systemic barriers and exclusionary language have excluded gender minorities from CT spaces for too long. Tools such as these, paired with standardized language for sex and gender eligibility criteria, will greatly bolster the representation of this population and spark change for a more inclusive future.

Objectives/Goals: This scoping review examines common characteristics of Community Engagement Studios, defined as custom panels bringing together community partners with lived experience around a health issue to provide highly tailored feedback to a research team. The authors also identify health service fields that most commonly use community engagement studios. Methods/Study Population: This scoping review will follow procedures outlined in the Joanna Briggs Institute Manual for Evidence Synthesis. Inclusion criteria are limited to peer reviewed manuscripts published between 2010 and 2024. Key word searches for terms related to Community Engagement Studios will be conducted within Embase, MEDLINE, CINAHL, and Web of Science. Experimental, quasi-experimental, observational studies, process and conceptual manuscripts published in English or Spanish meet inclusion criteria. Two reviewers will reach consensus about article inclusion. Data analysis will include content analysis and descriptive statistics. Results/Anticipated Results: The results for studies that meet inclusion criteria will be summarized through descriptive tables of study characteristics, the number of studies excluded at the full-text review stage, and reasons for the exclusion of any studies that met the initial inclusion criteria. The results will also include a summary of common elements in the design of CE studios, the health disciplines for which CE Studios are most frequently conducted, and the aspect/phase of research design for which CE Studios are most frequently requested. Discussion/Significance of Impact: To date, no work exists examining key elements of Community Engagement Studios and the fields within health services using this valuable research tool. This scoping review is a critical first step to develop guidelines, standards, and best practices around consistent procedures and characteristics to include in the design and conduct of CE Studios.

Objectives/Goals: Cervical cancer is preventable through HPV vaccination and the detection/removal of precancerous lesions. Incidence and mortality rates have only decreased by 3–4% in the past decade. Despite having the tools to prevent all cervical cancers, they are not being fully utilized. Our goal is to identify barriers and design strategies to overcome them. Methods/Study Population: Women in urban (750) and rural (750) settings will be screened for the presence of high-oncogenic risk HPV (hrHPV) by self-vaginal swab, complete the Monitoring Blunting Style Scale, a validation scale to determine attentional style, and a structural barrier to care survey. A subset (Results/Anticipated Results: The study, launched in September 2024 at the Medicine Primary Care Clinic at UMC in New Orleans, has enrolled 16 women. Sample adequacy was high (82%), with 5 women having hrHPV present. Participants expressed high satisfaction and acceptance of the self-administered vaginal swab, with most samples demonstrating high quality. Surveys have been collected, and hrHPV-positive women have been referred for gynecological follow-up. Shreveport site will recruit women across over 20 rural clinical sites using a Mobile Health Unit to increase access in rural and underserved communities. Discussion/Significance of Impact: The baseline study will take 12–18 months. We will identify and address key barriers to follow-up gynecological care, including logistical issues (improving access and navigation), educational needs (developing culturally sensitive materials), and emotional support. We will create a care delivery model to eliminate cervical cancer in Louisiana.

Objectives/Goals: The primary objectives of this project were to create a user-friendly website that • Shares details of ongoing studies in an easily searchable and filterable format. • Provides lay summaries of study results. • Highlights our volunteer registry. • Offers a platform for community engagement and feedback on research interests. Methods/Study Population: The website, developed using DRUPAL 10 and launched in June 2024, was created with input from faculty, staff, research participants, and community partners. It targets potential participants, community members, providers, and other Academic Medical Centers. The development process included focus groups to identify design and feature needs, design iterations and usability testing, and an external accessibility review. Study information is automatically updated from the Study Information Portal (SIP) in OnCore and a custom REDCap survey. Features include a research volunteer registry, study results in lay terms, educational content about research, and multiple ways for community engagement. The site supports English and Spanish and follows best practices for accessibility. Results/Anticipated Results: Community feedback on the site has been very positive, with positive comments about ease of navigation and the improved appearance of the website. It is still early, but we have seen a notable increase in enrollment in the Volunteer Registry since the launch of the website. We track referral sources for the registry, and to date, we have seen 98 individuals enrolled who were directed to us through the website since it launched. This equates to an average of 5 people a week, more than any other referral source. This rate increases to almost 7 per week if we look solely at the period since we started the promotion of the website in early August. As the site awareness expands, we will also be getting feedback from individual studies and are tracking email communication generated from the site as well. Discussion/Significance of Impact: The development of this website represents a significant step toward improving community engagement in clinical research at Duke. By providing a centralized platform for study information, results, and community feedback, we aim to foster a more informed and involved participant base, ultimately enhancing the impact and reach of our research.

Objectives/Goals: This qualitative study evaluated facilitators and barriers to clinical research participation among lower-income, predominately racial/ethnic minority communities to inform a Co-Learning series. The Co-Learning series of community members, stakeholders, and researchers developed strategies to improve diversity in research. Methods/Study Population: Community focus group (FG) participants were recruited from urban communities experiencing poverty, whereas stakeholder FGs included diverse community leaders and researchers. The Social Ecological Model was used as the guiding theoretical framework throughout the qualitative design. Directed content analysis using three independent coders reaching 100% consensus identified prominent factors for increasing diversity in research. The co-learning series was comprised of community members, stakeholders, and researchers who discussed the prominent FG factors over seven in-person meetings to develop a toolkit to increase diversity in research. Results/Anticipated Results: Community (n = 51) and stakeholder (n = 50) FG participants were 54.0±16.0 years of age, 81.2% female, 39.6% Black/African American, 51.5% Hispanic, and 60% had Discussion/Significance of Impact: Due to the lack of inclusivity in clinical research, findings are typically not applicable to health disparity populations limiting the benefit of research to all. This study provides practical community-driven strategies to increase diversity in clinical research, highlighting the role of trust, relationships, and cultural relevancy.

Objectives/Goals: This scoping review examines how socioeconomic status (SES) and sociodemographic status (SDS) disparities are considered in transition interventions for congenital heart disease (CHD) patients. By identifying gaps, it aims to guide future research and interventions to address inequities in transitional care. Methods/Study Population: A systematic search of the literature was performed using PubMed, Scopus, and Web of Science. Literature was searched from January 1990 to October 2024 and revealed 823 articles. Upon initial screening, 71 duplicates, 76 non-SES focused articles, and an additional 128 irrelevant articles were excluded. A total of 548 full-text articles were reviewed. Articles that did not focus on transition interventions for CHD patients were excluded. Studies were analyzed for factors affecting care transitions with special attention to SDS and SES factors. SDS factors were defined as age, gender, race/ethnicity, and geographic location, while SES factors were defined as income level, education, employment status, and access to care. Results/Anticipated Results: Out of 548 articles reviewed, only 18 addressed SES factors, and 10 examined SDS factors in the transition from pediatric to adult care. The most common interventions were patient education (33%), care coordination (29%), and family support (21%), but they lacked tailoring to SES/SDS factors. Patients from low-income households were 50% more likely to experience care discontinuities and 40% less likely to participate in transition programs. Health literacy interventions were generic, overlooking socioeconomic differences. Tailored transition programs are needed to address low health literacy and financial barriers, potentially improving outcomes for disadvantaged patients in rural and underserved areas. Discussion/Significance of Impact: This review exposes the limited focus on SES and SDS disparities in CHD transition interventions. Disadvantaged patients face barriers like limited access to care and low health literacy. Developing tailored programs to address these gaps is crucial for enhancing transitions and improving long-term outcomes for vulnerable CHD patients.

Objectives/Goals: Evaluate the effectiveness of ChatGPT as a complementary tool for addressing the mental health needs of Hispanic LGBTTQI+ young adult patients. We will also explore the experience of clinical healthcare providers with the integration of ChatGPT as a complementary tool in psychotherapy with Hispanic LGBTTQI+ young adults. Methods/Study Population: In this mixed-method study, we will create hypothetical clinical cases that reflect common mental health challenges experienced by LGBTTQI+ Hispanic population. These cases will be presented to three groups: 1) ChatGPT app, 2) clinical mental health care providers, and 3) clinical mental health care providers collaborating with ChatGPT. Each group will provide a diagnosis and a treatment plan based on the case information. A panel of experts will evaluate each plan using a standardized rubric to provide a score on clinical accuracy and on the ability to address specific needs of Hispanic LGBTTQI+ patients. Statistical analysis will be used to evaluate the differences in the scores of each domain and qualitative content analysis to evaluate the experience of clinical mental health care providers using ChatGPT. Results/Anticipated Results: The results will provide evidence of the effectiveness of ChatGPT as a supportive tool in mental health care. We anticipated that the combination of a clinical mental health care provider and ChatGPT to develop a diagnosis and treatment plan would produce better outcomes than either ChatGPT or the clinical mental health care provider working independently. We will also expect to find a positive attitude toward the integration of ChatGPT applications, viewing them as useful tools that complement traditional psychological interventions for Hispanic LGBTTQI+ young adults. The study will provide evidence of the effectiveness of ChatGPT to complementing clinical practice involving Hispanic LGBTTQI+ young adults. Those results in a preclinical phase are preconditions to a more applied intervention. Discussion/Significance of Impact: We aim to improve the quality of life for LGBTTQI+ Hispanics by developing innovative psychological treatments enhanced by AI apps. By developing innovative treatments, we are addressing and mitigating health disparities within the LGBTTQI+ Hispanic community in Puerto Rico and contributing to a broader effort of inclusivity and health equity.

Objectives/Goals: The expanding emphasis on translational science necessitates a rethinking of traditional academic formats. To align with the central themes of CTS, we have redesigned our PhD journal club and WIP sessions, introducing novel and innovative approaches that enhance the relevance of these activities to real-world scientific and clinical challenges. Methods/Study Population: The newly adapted journal club format for CTS Predoctoral students at Mayo Clinic maintains the traditional focus on literature review but now incorporates a structured analysis of the clinical implications and potential applications of the research. This innovation aims to foster a deeper understanding of how basic research findings can be translated into improved patient outcomes and healthcare practices. Similarly, the WIP sessions have been restructured to offer an engaging and dynamic learning environment designed to empower clinical and translational science predoctoral students to effectively present their research while emphasizing the challenges they have overcome, demonstrating the translational potential of their findings, and enhancing their communication skills. Results/Anticipated Results: Feedback from participants demonstrates strong support for the new format. Students report a greater engagement with the material and a clearer understanding of how their research can contribute to improving patient outcomes. Discussion/Significance of Impact: These changes accommodate the diverse projects in CTS and embody a commitment to pushing the boundaries of knowledge in CTS. This dual transition marks a significant advancement in preparing PhD students for careers in translational science, ensuring that their research is not only rigorous but also impactful in the real world.

Objectives/Goals: This poster details the development, implementation, and assessment of a comprehensive competency-based curriculum crosswalk and training plan aimed at enhancing the mentorship and skill development of translational research mentees within the National Institutes of Health (NIH) KL2 and TL1 Career Development Award programs. Methods/Study Population: The Center for the Improvement of Mentored Experiences in Research (CIMER) Mentoring Up for Early Career Investigators program, first developed by the University of Wisconsin-Madison, was further adapted by the Frontiers Clinical and Translational Science Institute (Frontiers CTSI). A competency crosswalk illustrates connections between a training curriculum and expected competencies. Developing a competency-based training crosswalk is a strategic approach designed to align mentoring practices with established NIH competencies, including the Seven Characteristics of a Translational Scientist, Mentoring Competency Assessment, Responsible Conduct of Research, Translational Teams, and TeamMAPPS. Results/Anticipated Results: The KL2 and TL1 Award Programs serve as ideal platforms for applying the developed curriculum. Implementing a competency-based, evidence-based, and culturally responsive curriculum for research mentee training has shown substantial benefits. Our pilot tests and full-scale implementation within the KL2 and TL1 Award Programs have demonstrated marked improvements in mentee competencies, such as technical skills, research design, and professional development as shown through evaluation feedback. Integrating the new Frontiers CTSI curriculum has fostered more effective and supportive mentoring relationships. Mentees have reported high satisfaction levels with the training program, particularly appreciating the interactive didactics, continuous feedback mechanisms, and reflective practices. Discussion/Significance of Impact: By adopting these recommendations, Clinical and Translational Science Awards (CTSA) and similar programs can improve research mentorship quality and impact, fostering a diverse cohort of skilled researchers. Implementing these strategies in CTSA mentorship programs offers a model for broader application in research training.

Objectives/Goals: Skilled clinical research professionals are essential to efficient and effective research teams, but many undergraduate students are not aware of staff-level careers in the field. To address this, the Michigan Institute for Clinical and Health Research launched the Clinical and Health Research Professional (CHRP) Pathways Program. Methods/Study Population: The 10-week hybrid CHRP Pathways Program was piloted in Summer 2024. Undergraduate students interested in research careers were recruited from local universities and community colleges. The program consisted of 8 hours/week of didactic curriculum guided by ECRPTQ competencies and 32 hours/week of mentored work experience on research teams. Classroom activities were completed with participants from a partner program within the university. Surveys were administered at 3 weeks and 10 weeks along with an end-of-program focus group to assess acceptability and self-reported learning outcomes. Results/Anticipated Results: The pilot CHRP Pathways Program enrolled 3 students and was well-received by participating students and mentor research teams. Students agreed that they would recommend the program to their classmates. Students indicated that the program helped them understand the role of a study coordinator, provided insight into research career paths, and helped them form professional relationships. Self-reported confidence levels in a range of research competencies increased. Two students who completed the 10-week program chose to continue working part-time with their research teams while continuing their undergraduate studies. Discussion/Significance of Impact: Experiences like the CHRP Pathways Program provide valuable exposure to staff-level research career opportunities for students engaged in health science studies. They can address an existing workforce gap by equipping college graduates with relevant work experience and basic research competencies.

Objectives/Goals: Effective research relies on a well-trained study coordinator workforce, but mentorship programs are lacking. Retaining and empowering career development for skilled research staff is challenging. To address this, the Michigan Institute for Clinical and Health Research launched the STEP.up program. Methods/Study Population: The Staff Enrichment Program for Research Professionals (STEP.up) was created in 2018. To increase knowledge and awareness of our program, we developed an implementation guide to share best practices and open access to our program structure and content. We identified seven critical elements integral to program success. The implementation guide provides a description and rationale for these elements. We partnered with an instructional designer to build a descriptive and easy-to-use guide that describes insights into the successful implementation of the program, practical strategies for program management, and adaptable resources for institutions to use and tailor to their unique needs. Results/Anticipated Results: In the STEP.up program, early career, new-to-role, or new-to-organization research staff members are paired with senior research professionals in a 9-month structured mentorship and career development experience to promote professional development, job satisfaction, and retention for individuals currently working as research professionals. Of the 82 participants from 2018 to 2024, 76 (93%) have remained in their roles as study coordinators. The STEP.up program implementation guide provides the tools, resources, and insights senior research professionals need to implement this program successfully at their sites. Discussion/Significance of Impact: STEP.up program materials are available as an open-source resource on the DIAMOND portal. This resource can encourage others to invest in structured mentorship for research professionals to help establish a culture of growth and cultivate a resilient, skilled, and committed research workforce.

Objectives/Goals: Create a supportive Clinical Research Coordinator (CRC) and Clinical Research Nurse consortium at UF. Facilitate mentorship groups to enhance knowledge on key topics. Build strong professional relationships among members. Empower members through collaboration. Develop future leaders and mentor in clinical research. Methods/Study Population: The CRC Group Mentorship Program at UF’s Gainesville and Jacksonville campuses addresses mentorship needs identified in a recent needs assessment, reflecting strong interest among CRC/CRNs. Small groups are formed using the Group Mentorship and Co-Mentoring Circles models, meeting bimonthly for six months on shared research interests. Co-lead mentors guide learning, peer support, communication skills, and goal setting while tracking progress. Mentees engage in peer learning, skill development, and networking. A dedicated Microsoft Teams platform provides resources to enhance confidence in Joint Task Force Clinical Trial Competencies and fosters collaboration through Q&A sessions, activities, assessments, and meetings, improving real-time and asynchronous interactions. Results/Anticipated Results: To measure mentor program impact, pre- and post-program surveys assess changes in knowledge, skills, and confidence among mentors and mentees, providing insights into effectiveness and areas for improvement. Monthly, the program features two meetings focusing on Joint Task Force competencies: a workshop for all groups on essential mentorship and CRC/CRN competencies, followed by evaluations, quizzes, and continuing education credits. The second meeting is group-specific, led by co-lead mentors, requiring submissions that demonstrate the application of learned knowledge and skills. This structure ensures continuous relevance and quality enhancement in future programs. Discussion/Significance of Impact: The program meets CRCs and CRNs’ critical needs through structured mentorship, fostering a supportive environment. It promotes continuous learning and professional development, enhancing job satisfaction and ensuring the sustainability of valuable research professionals.

Objectives/Goals: To support the growing number of clinical research professionals (CRP) working in behavioral and social science contexts, relevant formative assessments of research skills are needed. This study examines the development of an objective formative assessment designed to assess skills relevant to conducting social and behavioral research. Methods/Study Population: A multidisciplinary group at the University of Michigan was convened to develop the assessment. Case studies depicting clinical and translational research conducted in behavioral and social science contexts were used to measure proficiency in seven of the eight ECRPTQ competencies: Scientific Concepts & Research Design, Ethical & Participant Safety Concerns, Clinical Trial Operations (Good Clinical Practice), Study & Site Management, Data Management & Informatics, Leadership & Professionalism, Communication, and Teamwork & Team Science. Three difficulty levels of questions were developed: basic, intermediate, and advanced. To reinforce knowledge and skill development, the assessment was designed to give respondents formative feedback after responding to each question. Results/Anticipated Results: A preliminary “pre-pilot” test was conducted with three postdoctoral scholars to ensure that the assessment items were understandable. The assessment was then pilot tested with a larger group of 40 clinical research professionals (CRP) to test for the clarity and difficulty level of the items. A smaller group of 20 of these CRPs agreed to participate in focus groups to obtain feedback on their user experience. Data regarding years of experience as a CRP, types of studies engaged with, and information regarding professional certification were collected and used in the analyses. Demographic data collected were not connected to user responses. Results of the pilot test and focus groups were used to revise the questions on the final version of the assessment. Discussion/Significance of Impact: To our knowledge, this is the first objective assessment of research skills for CRP working in behavioral and social science contexts. We will discuss how other institutions can use this instrument to evaluate the training needs of their social and behavioral research workforce.