OBJECTIVES/GOALS: Evaluate if exposure to violence is associated with post-partum weight retention among WIC participants, which can lead to overweight/obesity due to metabolic adaptations associated to new adapted weight. If confirmed, it would highlight the need for revision of screening for violence exposure as social determinant of health among participants. METHODS/STUDY POPULATION: Nested cohort study among women enrolled in the Baby Act Trial (BAT) who have been enrolled to the active study phase and completed the Accountable Health Communities Health Related Social Needs survey from the Centers for Medicare & Medicaid services as the source of evidence of exposure to violence. BAT recruitment engaged women in their third trimester who were active participants of the Puerto Rico Women, Infants and Children Program (PRWIC), and planned to enroll their infant in the program. Anthropometric measures were documented at the following time points: prior to pregnancy, at delivery, and 12 months post-partum. Of the 530 women recruited to the study, 291 have completed study measures for inclusion into this exploratory analysis from this ongoing trial. RESULTS/ANTICIPATED RESULTS: A Total of 301 participants have met the criteria for inclusion in this preliminary analysis. Mean age among mothers was 26.5 years (SD 5.3), 46.6% had High School level education attainment or less, and 43.3% were actively working at the time of recruitment. Twelve percent of participants had BMI above 35 at 6 months post-partum, while the prevalence of violence exposure was reported as follows for each type of encounter: 3.3% responded yes to physical violence by friends of family, 9.7% reported exposure to insults or inappropriate treatment by any person including family or friends, 2% having been threatened by anyone including family or friends, 6.3% reported having been yelled/cursed at or insulted by anyone including family or friends. Even more concerning is that 7.5% reported severe social vulnerability. DISCUSSION/SIGNIFICANCE: Results reveals importance of providing integrated care in social assistance program. Participants belongs to vulnerable population with social determinants of health that affect the health care they receive. It shows that providing nutritional assistance it’s not enough to being healthy because other components also play a role in overall health.

OBJECTIVES/GOALS: This community-engaged study explores Community Health Workers (CHWs), perspectives on i) barriers to cervical cancer screening and ii) the acceptability and feasibility of CHW-facilitated HPV self-sampling as a means of reducing existing cervical cancer disparities. METHODS/STUDY POPULATION: Semi-structured in-depth interviews were conducted with 15 CHWs in 2021 to gain insights into barriers to cervical cancer screening and the acceptability and feasibility of CHW-facilitated self sampling in their communities. Recruitment began in Lake County then expanded to East Chicago after initial interviews revealed that some community members seek care in this area. An IRB approved email was sent out to community partners’ mailing lists inviting CHWs to join a 30–60 minute interview. Participants received a $25 electronic gift card as compensation. Interviews were audio recorded, transcribed and then analyzed by the study team, using a combination of inductive and deductive coding. The Socio-Ecological Model was used as a guiding framework to analyze multilevel barriers and facilitators to screening. RESULTS/ANTICIPATED RESULTS: CHW-facilitated HPV self-sampling shows promise of mitigating (without eliminating) several existing barriers to cervical cancer screening, with six key considerations. Privacy (for most), time saved, and comfort were perceived to be major facilitators for acceptability, with concerns about the novelty of this approach, trust in provider (as opposed to CHW) expertise, and lack of privacy at home (for some) emerging as barriers. In terms of feasibility, synergies with existing CHW work, and some community members’ prior experience with self-sampling were found to be facilitators, with CHW’s self-efficacy in providing adequate support and limited time constituting areas of concerns for feasibility. Considerations for adoption included CHW training, gender concordance, safety and respect, among others. DISCUSSION/SIGNIFICANCE: In light of national calls to engage CHWs in screening delivery and leverage self-sampling, this study provides CHW perspectives as key stakeholders on a screening model that directly engages them, providing insights that can inform successful implementation to increase screening in Lake County and similarly underserved contexts in the US.

Clinical trials conducted with incarcerated populations are rare. We present a case example of one such jail-based cancer prevention clinical trial to demonstrate the importance of including a theory-driven approach to intervention framing, novel experimental designs to boost access to low-risk trials, and retention strategies for long-term follow-up of hard-to-reach populations. As such we offer a social determinant of health framework to ensure cancer prevention research is conducted through the lenses of health promotion and health equity. Deviations from the gold-standard randomized control design, transparent systematic allotment, and street-based outreach retention strategies contribute to the feasibility of conducting clinical trials in carceral settings and after people leave jail. Best practices presented can be used in design and conduct of future clinical trials with criminal legal system-involved populations.

OBJECTIVES/GOALS: Community Engagement Advisory Boards (CEAB) serve as a vital resource for engaging and partnering with communities in research. The purpose of this project is to describe the perspectives of members of a long-standing CEAB in providing input and promoting research that aligns with the needs, experiences, and concerns of the communities they represent METHODS/STUDY POPULATION: Three 90-minute focus groups were conducted with a subset of a CEAB(n=17)(M years spent with CEAB =7.3) affiliated with the Center for Clinical and Translational Science at the University of Illinois-Chicago. Members areas of expertise include perspectives from faith-based organizations, community organizing, public health and working with diverse populations. Transcribed audio recordings of the focus groups were coded using thematic analysis wherein two authors coded independently, followed by audited discussion and final consensus codes. Main themes were identified after reviewing final codes. RESULTS/ANTICIPATED RESULTS: CEAB members described the bi-directional nature of their role serving as a conduit between research institutions and their communities, identified strategies to promote research literacy in communities, called for researchers to take a proactive approach in forming and sustaining community partnerships, and helped identify opportunities to promote community engagement in more creative and feasible ways. Additionally, CEAB members identified perceived opportunities for the board as a whole to be more involved in Chicago communities to further their role as a liaison between the university and the community. DISCUSSION/SIGNIFICANCE: These findings may have implications for investigators to better address community priorities in research by understanding unique local realities as well as help other CTSA hubs’ to leverage their communities’ expertise.

Infants with congenital heart disease (CHD) may have impaired cerebral autoregulation (CA) associated with cerebral fractional tissue oxygen extraction (FTOE). We conducted a pilot study in nine CHD neonates to validate a noninvasive CA measure, cerebrovascular stability index (CSI), by eliciting responses to postural tilts. We compared CSI to an invasive measure of CA and to FTOE collected during tilts (FTOESpot). FTOESpot correlated with CSI, as did the change in FTOE during tilts, but CSI’s correlation with impaired CA did not reach significance. Larger trials are indicated to validate CSI, allowing for noninvasive CA measurements and measurements in outpatient settings.

OBJECTIVES/GOALS: Partner with the entertainment industry to build trust in science and research, especially among high-disparity and underserved communities, through inclusion of research themes on popular television shows. METHODS/STUDY POPULATION: To date, our partnerships with TV writers have led to inclusion of clinical research storylines on 10 popular TV shows (e.g., Grey’s Anatomy with an audience of 7M). We are now conducting research on show popularity among diverse audiences, and interviewing medical and entertainment experts to understand health priorities and potential entry-points to deliver targeted outreach. We are also analyzing keywords in scripts to assess frequency and sentiment of medical topics in entertainment. Our team also consults with the TV community regarding storylines and public service announcements on health and innovations in medicine. RESULTS/ANTICIPATED RESULTS: We anticipate reporting insights into current and shifting narratives around future-of-medicine topics. Building on work that reached over 64M viewers, more frequent and accurate depictions will likely be related to positive changes in attitudes, behaviors, and trust regarding health and science. The overall goal is to foster attitudes among high-disparity and underserved populations that will increase service utilization and early screenings, foster trust in research and evolving medical technologies, and combat misinformation. DISCUSSION/SIGNIFICANCE: By working with television writers of shows proven to be popular among key audiences, this initiative has the potential to reach millions of viewers in their homes with important and timely information modeling healthy behavior, providing accurate facts, depicting cutting edge research, and emphasizing diversity in medical research.

OBJECTIVES/GOALS: The Institute of Translational Health Science (ITHS)Remote Technologies for Research Reference Center (REMOTECH) aims to ease the use of remote technologies in research, addressing barriers to research participation related to in-person and onsite assessments METHODS/STUDY POPULATION: We engaged with stakeholders in our CTSA catchment area to understand the use and impact of remote research: implementation practices, participant acceptability, and impact on accrual. This environmental scan consisted of three parts: (1) Facilitated discussion groups with clinical trial regulatory and implementation experts regarding 10 key areas of research operations using composite case studies of research using remote technologies; (2) Semi-structured interviews with research teams who have successfully implemented remote technologies, querying about specific technologies, expected and actual barriers, and impact on the study population; and (3) A survey distributed to 900+ faculty and staff identifying prevalence of hybrid or fully remote research and describing specific remote technologies. RESULTS/ANTICIPATED RESULTS: Discussion group preliminary findings show experts recommended prioritizing the assessment of value and burden for both research participants and the research team, that equity and diversity should not be sacrificed to accommodate cost and efficiency, and the importance of evaluating the impact of implementing remote technologies on data collection and analysis. Seventeen of 30 interviews are complete, mid-point analysis shows researchers wanting formal best practices and training in remote research, desire increasing diversity through remote options, and expressing concerns about participant burden. 46% of survey respondents report implementation barriers, including participant burden and confusing regulatory pathways. 17% thought remote technologies were not appropriate for their studies. DISCUSSION/SIGNIFICANCE: We plan to leverage a multidisciplinary team to address the identified barriers and disseminate through a public remote technology information portal. Coding and further analysis is underway, including additional interviews targeting researchers working with adolescents and older adults with an increased focus on equity and diversity.

OBJECTIVES/GOALS: Gender affirming medical care such as hormone therapy surgery can greatly impact the emotional wellbeing and quality of life of transgender and gender-nonconforming individuals. In the US, insurance coverage for these services vary greatly. This project will focus on how insurance denial of gender affirming care can impact emotional wellbeing. METHODS/STUDY POPULATION: Data was collected via the LITE Connect study, a multi-institutional cross-sectional survey conducted among transgender and gender non-conforming adults in the United States and Puerto Rico from 2020 to 2021. The survey collected 2,125 responses concerning demographic data, insurance status, desire to access gender affirming care, history of insurance denial of gender affirming care, psychological distress (measured via Kessler 6 scale), self-harm, and suicide. The study population consisted of respondents who have sought GAMC in their lifetime, and further separated into individuals who have had insurance denial of gender affirming care versus those without insurance denial. Odds ratios were examined for categorical variables and linear regression was conducted for Kessler 6 score. RESULTS/ANTICIPATED RESULTS: Of the 2125 respondents, 1274 (61%) have sought out GAMC. Of those seeking GAMC, 451 (35.4%) have experienced an insurance denial. Preliminary analysis of the odds ratios of insurance denial versus demographic identifiers found no significantly increased odds ratios with respect to race, gender, or age. Given the impact GAMC has on quality of life, we theorize that difficulty accessing gender affirming care would be associated with greater psychological distress. Linear regression found a statistically significant impact of insurance denial of GAMC on Kessler 6 responses (Beta = 0.9684, R^2 = 0.0069). With adjustments for age, gender identity, race, and insurance status, linear regression found denial of GAMC led to a 1.28 increase in Kessler 6 score (CI [0.59, 1.98], p < 0.05). DISCUSSION/SIGNIFICANCE: This study examined the association between access gender affirming care and emotional wellness as measured by the Kessler 6 scale. We have found a statistically significant correlation between insurance denial of GAMC and psychological distress, indicating an avenue for intervention for a vulnerable population.

Clinical trials are essential in the translation of biomedical discoveries to new clinical interventions and therapeutics. Successful multisite clinical trials require qualified site investigators with an understanding of the full spectrum of processes and requirements from trial identification through closeout. New site investigators may be deterred by competing demands on their time, the complexity of administrative and regulatory processes for trial initiation and conduct, and limited access to experienced mentor networks. We established a Clinical Trialist Training Program (CTTP) and complimentary Clinical Trials Bootcamp at our institution to address these barriers and increase the number of local site investigators enabled to lead successful clinical trials. An initial cohort of four CTTP scholars received salary support with protected time, didactic training, assistance with study identification and start-up navigation, and quarterly progress meetings. By the end of the 12-month program, this initial cohort identified 33 new trials, utilized feasibility assessments, and reported being on target to sustain their protected time from new clinical trials. Bootcamp attendees demonstrated increased knowledge of resources, offices, and processes associated with clinical trial conduct. Our results support providing compensated protected time, training, and access to experienced clinical research professionals to enable clinicians to become successful site investigators.

OBJECTIVES/GOALS: The Association for Clinical and Translational Science (ACTS) offers important inter-institutional communities through Special Interest Groups (SIGs). New to the SIG ecosystem is the Justice, Equity, Diversity, and Inclusion (JEDI) SIG. METHODS/STUDY POPULATION: Formed in 2022, the JEDI SIG is a growing community of individuals seeking to develop papers and products relating to improving health equity and workforce diversity within the Translational Science Community. Within this context, diversity is broadly defined to include groups at a negative power differential within US society. RESULTS/ANTICIPATED RESULTS: Comprised of 54 individuals spanning 29 institutions as of our first meeting in October 2022, the JEDI SIG is a welcoming group for ACTS members looking to make a difference. We have developed working groups to develop SIG-directed projects, and we look forward to expanding our activities in the future. DISCUSSION/SIGNIFICANCE: In this poster we will share key information about the new JEDI SIG including monthly meeting times, current activities, and ideas for future work.

OBJECTIVES/GOALS: As the clinical and translational research enterprise evolves toward addressing health equity and the science of translational science, the CE Brokers are exploring new avenues for impacting the CTSA consortium. METHODS/STUDY POPULATION: Since 2013, managers of Community Engagement (CE) programs across the NCATS CTSA institutes have met monthly to build connections, share knowledge, and advocate for the boundary spanner role. As the clinical and translational research enterprise evolves toward addressing health equity and the science of translational science, the CE Brokers are exploring new avenues for impacting the CTSA consortium. The CE Brokers are composed of 140 individuals from 58 CTSA-associated institutions, and have a long history that has fostered rich, trusting relationships. The growth and strength of this group has primed it to pivot with the new NCATS direction to contribute meaningfully to the science of community engagement and continue the work of improving health equity within the communities we serve. RESULTS/ANTICIPATED RESULTS: In 2022; we surveyed its members about their roles and responsibilities; the ways the network has contributed to their hub’s adoption and development of best practices and innovations; resources and lessons learned; the creation of opportunities for members to collaboratively conduct and disseminate original research; and research on the science of CE. Grounding ourselves in this initial data, we have developed interview questions to take the inquiry further, by gathering qualitative data on the impact of the group: How the Brokers group impacted them personally and professionally; How the Brokers impacted the work of their CTSA; In three words, describe the group; How could the CE Brokers contribute to the science of community engagement? DISCUSSION/SIGNIFICANCE: Together, we will identify themes supported by quotes to inform how the CE Broker group is most effectively moving the CTSAs’ mission forward and how it can be improved. These will be shared at the Translational Science Meeting, 2023.

OBJECTIVES/GOALS: To evaluate access to Pre-Exposure Prophylaxis (PrEP) medications for transgender individuals examining how systemic and sociocultural obstacles play a role. Additionally, analyzing the impact of trans-exclusion in clinical trials investigating PrEP efficacy on the trans-HIV care model. METHODS/STUDY POPULATION: By examining the clinicaltrials.gov database, inclusion and exclusion criteria will be collected for Phase III trials of FTC/TAF (Descovy) and FTC/TDF (Truvada) as PrEP for Human Immunodeficiency Virus (HIV). Secondly, trends of physicians’ prescription of PrEP will be analyzed to track post-approval usage and deduce the acceptance and adherence of PrEP by transgender patients. Thirdly, post-approval marketing strategies of PrEP medications will be documented to see key demographics that biopharmaceutical companies are targeting. Finally, relevant literature about trans healthcare will be analyzed to identify key short fallings to support conclusions and justify recommendations for greater transgender clinical trial enrollment and reformations to current standard practices. RESULTS/ANTICIPATED RESULTS: After a preliminary literature review of published Phase III trials for Descovy and Truvada , there is a marked lack of transgender patient enrollment. Contemporary literature argues that this lag in enrollment has downstream effects on trust and acceptance of PrEP as safe and effective by cohorts in the transgender community. The examination of prescribing information for Descovy and Truvada for PrEP reveals a minimal effort to advise doctors of the increased risk for infection in the transgender demographic. Through continued research, I expect to elaborate on the cross-discipline impacts of trans-exclusion, including increased rates of HIV infection, sociocultural and financial barriers to PrEP, and stigmatizing doctor interactions with transgender patients. DISCUSSION/SIGNIFICANCE: The current trans-HIV treatment paradigm lags behind in its sensitivity and nuance, preventing the most equitable distribution of care. Only with more inclusion of transgender individuals in clinical trials can we hope to promote greater awareness and trust for PrEP as effective for HIV.

New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or “hybrid” trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.

OBJECTIVES/GOALS: To identify insights and challenges in community engaged research for the academy and community. To develop an online platform to match academic and community partners; promote networking; and provision of key resources. METHODS/STUDY POPULATION: Using a human-centered design approach, 19 interviews were conducted with academics, community organizations and members, and other CTSAs. The interviews focused on understanding CEnR challenges and processes in partnership formation. RESULTS/ANTICIPATED RESULTS: Findings revealed the following 10 challenges to and insights about CEnR: (1) time intensive; (2) lack of knowledge; (3) differing motivations; (4) connections occur through networking; (5) topic area, proximity, and readiness influence partnerships; (6) organizational turnover; (7) promotion pressure; (8) collaboration throughout; (9) navigator for partnership; and (10) lack of shared language. Also, a CEnR system flowchart revealed the following five phases of an effective partnership: 1) generating interest; 2) learning process; 3) connecting with the right partner; 4). Defining the research question; and 5) implementing research as a partnership. DISCUSSION/SIGNIFICANCE: In conclusion, input from academicians and community members support the need for an online platform like M-REACH to facilitate CEnR partnerships, networking, and resources to address significant public health issues through translational research.

Despite understanding its impact on organizational effectiveness, practical guidance on how to train translational team (TT) leaders is lacking. Previously, we developed an evolutionary learning model of TT maturation consisting of three goal-directed phases: (1). team assembly (Formation); (2). conducting research (Knowledge Generation); and (3). dissemination and implementation (Translation). At each phase, the team acquires group-level knowledge, skills, and attitudes (KSAs) that enhance its performance. Noting that the majority of team-emergent KSAs are promoted by leadership behaviors, we examine the SciTS literature to identify the relevant behaviors for each phase. We propose that effective team leadership evolves from a hierarchical, transformational model early in team Formation to a shared, functional leadership model during Translation. We synthesized an integrated model of TT leadership, mapping a generic “functional leadership” taxonomy to relevant leadership behaviors linked to TT performance, creating an evidence-informed Leadership and Skills Enhancement for Research (LASER) training program. Empirical studies indicate that leadership behaviors are stable across time; to enhance leadership skills, ongoing reflection, evaluation, and practice are needed. We provide a comprehensive multi-level evaluation framework for tracking the growth of TT leadership skills. This work provides a framework for assessing and training relevant leadership behaviors for high-performance TTs.