The COVID-19 global pandemic required the rapid development of vaccines with a quick start up of phase 1–3 studies with large enrollment targets. The University of California San Diego was identified as a site for the phase 3 trial of the mRNA-1273-SARS-CoV-2 vaccine. There were many challenges with scaling up a large-scale clinical trial in such a short time. This report describes the processes and procedures that were implemented to successfully complete the enrollment target in under 10 weeks. This required the team to identify existing tools that could rapidly be accessed to develop a database, scheduling system, effective communication, document management, staff time tracking/efficiency, subject scheduling/tracking, project management, and accrual/study performance. The outcome of these efforts resulted in rapid enrollment and study completion in a short time. The lessons learned from this experience can be used by other clinical trial sites faced with similar challenges.

OBJECTIVES/GOALS: 1. Describe the importance of community engaged research. 2. Explore the impact of participating in Community Engagement Studios from the perspective of the community expert. 3. Explain how Community Engagement Studios can positively impact clinical and translational sciences. METHODS/STUDY POPULATION: Stakeholders who participate in CE Studios are defined as community experts (CEs); care-givers, patients, researchers, etc. They are not classified as research participants, but rather consultants, who are designated with the task of providing input on the specified research study. CEs were recruited in a variety of formats such as clinics, social media, and other community-based settings. To be eligible for the study, CEs had to participate in at least one CE Studio prior to data collection. Data was collected from an online survey from April to September of 2019. One hundred and fifteen CEs participated in the study. We conducted thematic analysis on a total of 233 participant responses to three open-ended questions assessing attitudes towards research, desire to engage in research, and understanding of research. RESULTS/ANTICIPATED RESULTS: Ten major themes emerged from the data: involvement, togetherness, trust, value, confidence, community engagement, community connectedness, encouraging others to participate, increase knowledge and awareness, and respect. A major overarching theme of inclusion was presented in the data. Findings from this study indicate that CE Studios provide a space for CEs to gain a better understanding of the multi-faceted research process, offer insight into ways to include historically excluded populations, and increase trust, confidence and respect for researchers and the research process. Moreover, community experts felt connected to their community by participating in CE Studios and expressed interest in encouraging others to participate. DISCUSSION/SIGNIFICANCE: CEs are a crucial component of the research process, and their experiences should be utilized and reflected upon as we work to reduce health disparities. CE Studios serve to build trust, identify strategic areas of improvement in research, and provide a foundation to introduce community members to the multiple ways to engage in research.

OBJECTIVES/GOALS: To increase vaccination rates in Black and Latino communities, specifically in South LA and the Eastside of LA. METHODS/STUDY POPULATION: Multimedia campaign combined with vaccine navigation and assistance, led by the SC CTSI and conducted by an interdisciplinary team from 14 schools at USC and CHLA, >160 community partners. RESULTS/ANTICIPATED RESULTS: VaccinateLA was a highly interdisciplinary and multifaceted project that demonstrated increased vaccination rates in Black and Latino communities in South LA and Eastern part of LA. We vaccinated over 1000 people, facilitated vaccines for almost 10k people and reached 1.37M people through our digital campaign. DISCUSSION/SIGNIFICANCE: We have used community vaccine navigators, pop-up clinics, narrative storytelling and other unique approaches to encourage vaccine uptake in communities of color. We plan to expand activities to parents and children in these communities, encourage booster uptake, and evaluate and disseminate the program widely.

OBJECTIVES/GOALS: This proposed qualitative study aims to explore the perspectives about PrEP among heterosexual, cisgender Black women currently enrolled at an HBCU. Specifically, this study will elucidate this populations knowledge, attitudes, and beliefs surrounding PrEP uptake and marketing. METHODS/STUDY POPULATION: The Health Belief Model adapted from Chandler, Hull et al. (2020) will be utilized as the conceptual framework to guide this study. Multiple virtual semi structured focus groups will be conducted with individuals at two HBCUs. Study participants (n=20-25) will meet the following inclusion criteria: (a) self-identifies as Black/African American, (b) was assigned female at birth, (c) is enrolled at Morgan State University or Spelman College, (d) is 18 years or older, (e) is sexually active (anal, oral, vaginal, or experimental), (f) is HIV negative, (g) has multiple sexual partners and/or has inconsistent condom usage. A qualitative data analysis will be conducted utilizing MAXQDA software to perform a thematic analysis by creating a codebook and identifying prominent themes related to perceptions and use of PrEP. RESULTS/ANTICIPATED RESULTS: The research is on-going pending IRB approval. Data collection will include questions focused on topics surrounding PrEP, barriers/facilitators to participation in a proposed PrEP campaign, and sexual/reproductive health. These findings will characterize the awareness of PrEP among Black HBCU women, identify factors that may facilitate or cause barriers to Black HBCU womens knowledge and uptake of PrEP, and identify best practices for successful marketing strategies for PrEP campaigns targeting uptake among HBCU women DISCUSSION/SIGNIFICANCE: Findings from this study can help the public health community tailor PrEP campaigns designed for college-age Black women thereby curtailing HIV transmission among this at-risk group.

OBJECTIVES/GOALS: Fertility preservation (FP) allows transgender and gender diverse (TGD) patients undergoing gender-affirming therapy to pursue genetic parenthood. Barriers to care exist leading to its underutilization; while these barriers to care have been investigated, the true utilization rates of FP services by TGD patients are unknown. METHODS/STUDY POPULATION: This study includes a retrospective chart review of adult and pediatric patients from Mayo Clinics Transgender and Intersex Specialty Care Clinic who have provided research authorization. We will assess if FP was discussed and review if the patients proceeded to make appointments with either the Department of Reproductive Endocrinology & Infertility or the Department of Urology. FP terms include semen cryopreservation, sperm extraction, sperm aspiration, testicular tissue cryopreservation, oocyte cryopreservation, embryo cryopreservation, and ovarian tissue cryopreservation. Patient demographic data will be collected to determine associations between utilization rate and age, sex recorded at birth, gender identity, race, ethnicity, and variables related to socioeconomic determinants of health. RESULTS/ANTICIPATED RESULTS: We hypothesize that the rate of FP utilization will be higher for patients who begin to affirm their gender at the age of 25 or older, and for those seeking feminization treatment in comparison to pre-pubescent adolescents, young adults, and transgender men. Of FP options, semen cryopreservation will be most utilized, followed by oocyte cryopreservation; both will be more utilized than embryo cryopreservation, sperm extraction, sperm aspiration, testicular tissue cryopreservation, and ovarian tissue cryopreservation. Employment, and insurance status and coverage, will play a role in FP service utilization after initial consult. This study was approved by Mayo Clinics Institutional Review Board. Data on N=611 patients is expected to be abstracted and analyzed prior to Translation 2022. DISCUSSION/SIGNIFICANCE: This study will be one of the first to examine the rate of FP utilization by TGD patients with respect to the age and timing of gender-affirming therapy initiation. Understanding the rate of utilization of FP services will allow for the creation of age-appropriate education materials for TGD patients pursuing gender affirmation and FP at Mayo Clinic.

OBJECTIVES/GOALS: This study examines the impact of COVID restrictions on the process of engagement in the Ohio-HCS site. The goals are to: examine the impact of COVID restrictions on the process of engagement; 2) determine differences in process measures by geographic region (rural, urban). METHODS/STUDY POPULATION: Engagement activities collected as part of the Ohio HCS include an engagement log, coalition meeting type and attendance, tracker of implementation strategies. Study period: January 2020 to October 31, 2021. Measures are defined below. Meeting occurrence, type by month: Data report on whether a meeting occurred, was scheduled and cancelled, or a scheduled off-month. The meeting platform was also recorded (in-person, hybrid, virtual). Coalition meeting attendance by month: Number of community members in attendance. Engagement communications by type, by month: Counts and percent (types: email, calls, zoom, or in person). Evidence-Based Practices(EBP) delivery option: in person, virtual, or hybrid. Counties: 9 Ohio counties, 5 rural, 4 urban. RESULTS/ANTICIPATED RESULTS: Coalition meetings were cancelled in 40% of rural counties; none in the urban counties. Two rural counties switched back to in person or hybrid meetings by late 2020; urban counties remain 100% virtual. Rural counties had a drop-off in attendance in June 2021 with no decrease seen in urban counties. During first two months of 2020 engagement in rural and urban communities occurred in person; by March that shifted to 80% by email, which continued within rural counties. In urban counties that dropped to 50% by August of 2020, with zoom calls accounting for 30%. In-person strategies for naloxone distribution remained high in both county types (90%); urban counties use of in-person only strategies for medication for OUD (rural: 83%, urban 52%) and safer prescribing (rural:74%, urban:10%) were much lower than rural counties. DISCUSSION/SIGNIFICANCE: Results show that rural counties continue to rely on in person engagement strategies, making COVID restrictions more disruptive for rural counties. These results suggest that new supports and strategies may be needed to assure that rural regions are equally equipped to engage in research in a virtual environment.

Story is the oldest known way of sharing knowledge and information and engages us in our collective humanity. In research settings, story brings meaning to complex ideas, making them feel palpable and connects us with our audience. Historically, the disciplines that take a research interest in the importance of narrative have been largely in fields like the philosophy of science/medicine, medical humanities, and sociology though story is “always already” a part of scientific research. Humanities have gained traction in medical and science education, and researchers are seeking such curricula to communicate more effectively with the public and their students. We believe that story is an effective tool to enable CTS investigators to be effective educators and communicators of translational science. Story-based interdisciplinary pedagogy emphasizes an approach encouraging clinical researchers to keep the human story as the driving force of research design, dissemination, and application of research to diverse audiences. In this article, we provide backgrounds on successful programs that have used story in science communication and education as well as a tool researchers can use to incorporate the structure of story into their own work.

OBJECTIVES/GOALS: Stigma may be a barrier to care for Latinx children with autism, given lasting effects on individuals and families in other disorders. No study has explored autism stigma and its effect in this group. We explore the Latinx community’s beliefs and stigmatizing attitudes towards and the effect of stigma on Latinx individuals with autism and their family. METHODS/STUDY POPULATION: Approximately 30 Latinx parents of typically-developing children recruited from Portland, Oregon and Birmingham, Alabama will complete a 60-90 minute interview and demographics questionnaire in Spanish. Participants will receive $50 for completion of the study. Using a phenomenological approach, a coding framework will be developed for the qualitative interview data. Structural coding will establish a set of predetermined codes that characterize the data generally. An emergent coding approach will be used to create new codes exploring each predetermined global characterization more precisely. Interviews and coding will cease when thematic saturation is achieved. RESULTS/ANTICIPATED RESULTS: Research exploring perspectives of parents of children with autism has suggested that autism stigma is high in the Latinx population and results in social isolation. However, results regarding developmental disability stigma in the general Latinx population have shown low rates of reported stigma. This suggests: 1.) stigma is not as high as reported by parents of children with autism, 2.) those perpetuating stigma are not reporting it explicitly on quantitative measures, and/or 3.) those perpetuating stigma are not aware that these attitudes are stigmatizing. A qualitative approach allows for a better characterization of this understudied phenomenon and explores the disconnect between the stigmatized and the stigmatizing. DISCUSSION/SIGNIFICANCE: By answering: “How do Latinx community members view autism?” and “How does stigma affect social support?” we open avenues for research, including: utilizing collectivistic culture in linguistically- and culturally-sensitive ways to spread knowledge of autism, provide social support for families, and increase inclusivity.

OBJECTIVES/GOALS: Translating Research into Practice (TRIP), a hybrid implementation pragmatic clinical trial and CTSA collaboration, aims to implement a standardized breast cancer patient navigation protocol across five sites in Boston, MA. The goal of this study was to assess individual and institutional barriers and facilitators to implementing this protocol. METHODS/STUDY POPULATION: From November 2019 to August 2020, researchers conducted ethnographic observations of Patient Navigators (PN) at three of the five participating sites. Each PN at each site was observed for two, four-hour blocks by researchers trained in ethnographic research. Observers took notes using TRIPs 11 Step Protocol as a guide, which includes identifying patients at risk for delays in care, screening and referring patients to resources for health-related social needs, and tracking patients across the care continuum. Fieldnotes were uploaded into Dedoose and coded deductively by four researchers using a comparison and consensus approach. Researchers analyzed the data to identify barriers and facilitators to both implementing each protocol step and maximizing navigations ability to promote health equity. RESULTS/ANTICIPATED RESULTS: Across all sites, PNs faced barriers to adhering to the TRIP Protocol due to practical workflow constraints including their level of engagement across the cancer care continuum. Although there are other staff members who engage in navigation activities, navigation is often viewed solely as the responsibility of the PN. Operationalizing navigation as a person rather than a process creates confusion around the role, and PNs are often seen as a catchall position when other staff do not know how to help a patient. The time that PNs spend on tasks unrelated to core navigation activities described in the TRIP Protocol prevents PNs from navigating patients most at risk for delays in care. A lack of continuity across the care continuum can create role confusion for the PNs. DISCUSSION/SIGNIFICANCE: Patient Navigation can promote health equity; however, any task that pulls PNs away from navigating patients most at risk for delays in care diminishes this potential. PNs abilities to enact the TRIP protocol, which they saw as valuable, is circumscribed by the extent to which navigation is operationalized as a process within the institution.

OBJECTIVES/GOALS: University faculty partner with Community Consultants (CC) to: 1) identify health concerns of Chicagos South Side residents, 2) provide information regarding resources that address community health concerns, and 3) disseminate the model across the Institute for Translational Medicines (ITM) institutional partners. METHODS/STUDY POPULATION: CCs met twice monthly with University faculty and staff to identify CGR topics, delivery format, and audience development strategies. Faculty from the University of Chicago and community experts presented on identified health topics. Traditionally held in a community setting, CGR moved to a virtual format due to the pandemic. Recent topics covered included issues around the impact of COVID-19 on African American and LatinX communities and vaccine hesitancy. Audience members were surveyed at the end of each session and provides information on the quality and impact of the content. Twice during the season, partners debriefed on the effectiveness of the partnership and program. A plan was developed to deploy CGR across the ITM partners. RESULTS/ANTICIPATED RESULTS: Since 2010, there have been 63 CGRs, and over 5370 attendees. To date, 95% of audience members report that the content of CGR is of value and would recommend it to others. Audience members surveyed report knowledge gains about the topics presented, satisfaction with venues and speakers, and support the continuation of the series. Despite having to move to a virtual format due to the COVID-19 pandemic, audience members continue to attend CGR and rate the program as valuable and something that they would recommend to others. CCs report commitment to the partnership and CGR. CGR served as a connector for audience members to COVID-19 resources such as grief support groups and financial assistance. Loyola University, an ITM partner, implemented the CGR model, with more planning to do the same. DISCUSSION/SIGNIFICANCE: CGR is effective at providing health information in a community setting. CGRs success is due to the commitment of its partners and its ability to respond to community needs. During the pandemic, attendance at each virtual CGR remained steady and audience feedback remained positive. CGR continues to serve as a connector to valuable resources.

The last 50 years have seen an increasing dependence on academic institutions to develop and commercialize new biomedical innovations, a responsibility for which many universities are ill-equipped. To address this need, we created LEAP, an asset development and gap fund program at Washington University in St. Louis (WUSTL). Beyond awarding funds to promising projects, this program aimed to promote a culture of academic entrepreneurship, and thus improve WUSTL technology transfer, by providing university inventors with individualized consulting and industry expert feedback. The purpose of this work is to document the structure of the LEAP program and evaluate its impact on the WUSTL entrepreneurial ecosystem. Our analysis utilizes program data, participant surveys, and WUSTL technology transfer office records to demonstrate that LEAP consistently attracted new investigators and that the training provided by the program was both impactful and highly valued by participants. We also show that an increase in annual WUSTL start-up formation during the years after LEAP was established and implicate the program in this increase. Taken together, our results illustrate that programs like LEAP could serve as a model for other institutions that seek to support academic entrepreneurship initiatives.

OBJECTIVES/GOALS: The HIV acquisition rate is higher for cisgender black women in the United States. This population has a much lower use of FDA-approved pre-exposure prophylaxis drug (PrEP) for HIV prevention. This systematic literature review examines factors that hinder PrEP use among cisgender black women. METHODS/STUDY POPULATION: PubMed, CINAHL, and Cochrane were used to conduct a systematic literature search. Inclusion and exclusion criteria were predetermined to narrow down the search and to identify the appropriate studies. The retrieved literature was exported to EndNote for deduplication. The literature was then uploaded into Rayyan for title and abstract screening. The two collaborators were blinded to limit bias. Literature characterized as conflict was resolved by an independent, third collaborator. Full-text screening of the selected studies was done and a PRISMA flow diagram was developed for identification, screening, eligibility, and to detail included literature. RESULTS/ANTICIPATED RESULTS: 185 articles were obtained from the systematic literature search. 172 were excluded and 13 full-text articles were accessed for eligibility. One was removed. 12 studies involving 974 study participants met inclusion criteria for analysis. Despite the disproportionally high risk of HIV infection, black women only represented 29% of the study participants. Top three barriers to low PrEP use were stigma, socio-economic factors, and personal factors. Stigma included concerns about HIV and sexuality. Socio economic barriers were related to homelessness and low income. Personal factors included substance abuse, incarceration, and commercial sex work. The data confirms that these risk factors were not always rigid but changed based on patient characteristics and external factors. DISCUSSION/SIGNIFICANCE: The study outcomes confirmed a multitude of risk factors that serve as impediments in the use of PrEP among cisgender black women. When these risk factors are identified and addressed, the decision to use PrEP among cisgender black women may increase, therefore this warrants further investigation.

OBJECTIVES/GOALS: All IN for Health has initiated social media engagement strategies to create bi-directional communication around improved health and research literacy with the public. In addition, the All IN for Healths community-led advisory board, comprised of diverse individuals and organizations, will provide insight on research design and dissemination. METHODS/STUDY POPULATION: The Indiana Clinical and Translational Sciences Institute (CTSI) has committed to enhancing the publics engagement efforts in the All IN for Health program. This program was established in 2017 to improve the health of Indiana residents through the promotion of health resources and opportunities to participate in research. In 2021, the Indiana CTSI decided to integrate public engagement more formally. An official collaboration with the Indiana CTSIs Community Health Partnerships program was created, a digital engagement specialist was hired, and several new community and population health advisory board members were welcomed for quarterly meetings representing the rural and urban areas of the state, faith-based communities, health departments, and underrepresented groups in research. RESULTS/ANTICIPATED RESULTS: A social media campaign, informed by the All IN for Health advisory board was launched in November 2021, and the advisory board has been meeting on a quarterly basis. All IN for Healths established priority area is currently COVID-19 vaccination uptake, and our prioritized audiences are underserved and under resourced in urban and rural communities, and minoritized populations. All IN for Health has posted approximately 20 times per month on topics including COVID-19, Alzeheimers Disease, Diabetes, fitness, mental health, and research studies with a goal to increase followers and engagements by 20%. The hope is that this engagement will also result in an increase in the monthly e-newsletter subscribers and study volunteer registry participants. DISCUSSION/SIGNIFICANCE: All IN for Health has initiated new public engagement efforts to increase the value of the services offered to Indiana residents. Through consultation and co-design with members of the public and dissemination of research opportunities All IN for Health will be better suited to improve health and research literacy.