Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) was initiated by the US government to rapidly develop and test vaccines and therapeutics against COVID-19 in 2020. The ACTIV Therapeutics-Clinical Working Group selected ACTIV trial teams and clinical networks to expeditiously develop and launch master protocols based on therapeutic targets and patient populations. The suite of clinical trials was designed to collectively inform therapeutic care for COVID-19 outpatient, inpatient, and intensive care populations globally. In this report, we highlight challenges, strategies, and solutions around clinical protocol development and regulatory approval to document our experience and propose plans for future similar healthcare emergencies.

OBJECTIVES/GOALS: Research emphasizes the importance of play in early childhood to support social, emotional, and physical development. This study explores how the Prescription for Play (P4P) is executed in clinical contexts by analyzing implementation fidelity and contextualizing the adaptations, challenges, and facilitators to the program’s functionality. METHODS/STUDY POPULATION: This project is an ongoing multi-site case study. At the time of study completion in December of 2023, there will be over 40 clinical observations of pediatric well-child check (WCC) visits completed across 7 Federally Qualified Health Centers (FQHC) participating P4P, a play promotion program wherein providers discuss the importance of play in WCC visits and provide a free play kit. All visits are with children 18-36 months old, with a broad demographic spread across sites. Observations are recorded through a guided observation protocol informed by a standard implementation fidelity framework, conducted by 5 researchers. Through inductive thematic analysis, this study will analyze observations of WCC visits to understand the ways providers engage with P4P across sociocultural contexts within FQHCs. RESULTS/ANTICIPATED RESULTS: Preliminary analysis of clinic observations (N = 30) indicates the degree of implementation fidelity varies across sites, with particular variances between WCC visits conducted in English versus non-English languages (NEL). In NEL visits, there were discrepancies among indicators of quality of delivery and participant responsiveness. NEL visits were less likely to have the provider model play with the caregiver and far less likely to open the play kit given to the family. Providers in NEL visits were also less likely to discuss certain benefits of play like brain development and reduced screen time. Across all observations, providers “prescribed play” approximately half the time. As more observations are conducted, researchers anticipate seeing continued differences between English and NEL visits. DISCUSSION/SIGNIFICANCE: From preliminary analysis, discrepancies in implementation fidelity indicate the P4P intervention may require adaptation and additional training related to how to prescribe and discuss play in WCC visits conducted in NEL visits. Additionally, this study elucidates the impact language can have on the fidelity of clinical interventions.

The United States Government (USG) public-private partnership “Accelerating COVID-19 Treatment Interventions and Vaccines” (ACTIV) was launched to identify safe, effective therapeutics to treat patients with Coronavirus Disease 2019 (COVID-19) and prevent hospitalization, progression of disease, and death. Eleven original master protocols were developed by ACTIV, and thirty-seven therapeutic agents entered evaluation for treatment benefit. Challenges encountered during trial implementation led to innovations enabling initiation and enrollment of over 26,000 participants in the trials. While only two ACTIV trials continue to enroll, the recommendations here reflect information from all the trials as of May 2023. We review clinical trial implementation challenges and corresponding lessons learned to inform future therapeutic clinical trials implemented in response to a public health emergency and the conduct of complex clinical trials during “peacetime,” as well.

OBJECTIVES/GOALS: The Translational Science Benefits Model offers an approach for evaluating the downstream health and social impact of research. Using the new Translating for Impact Toolkit of nine web-based tools, researchers can create free, secure accounts to plan, track, and demonstrate the impact of their work. METHODS/STUDY POPULATION: Development of the online toolkit includes 6 phases: 1) Review of existing tools, 2) Development of fillable PDF tool prototypes, 3) Pilot testing, 4) Development of web-based tools, 5) Usability testing, and 6) Refinement of web-based tools. First, we reviewed existing tools for measuring research impact. We then created prototypes of nine tools, published on the TSBM website, and pilot tested with researchers. Based on feedback and testing, we developed and launched web-based versions of the tools. We are currently conducting usability testing with researchers, which we will use to evaluate the ease-of-use and quality of the tools, identify areas for improvement, and refine the tools. RESULTS/ANTICIPATED RESULTS: Researchers can sign up for user accounts, create projects, invite collaborators and program administrators, and save progress as the complete the nine tools in the Translating for Impact Toolkit. The tools are divided into three steps: Plan (Roadmap to Impact, Benefits 2x2, Partner Mapper, and Team Manager), Track (Impact Tracker), and Demonstrate (Product Navigator, Case Study Builder, Impact Profile, and Dissemination Planner). The toolkit also includes a dashboard that provides a quick snapshot of translational impact for each project. The toolkit will help both individual translational scientists demonstrate the impact of their work and CTSA hubs evaluate impact of their projects. DISCUSSION/SIGNIFICANCE: The TSBM online toolkit is a free, secure, easy-to-use platform researchers can use to plan for, track, and demonstrate the impacts of their work. The toolkit provides a structured process that will help the next generation of scientists prioritize and promote translational impact in their work.

OBJECTIVES/GOALS: This study examined youth tobacco use, disaggregated by sexual and gender minority (SGM) identity and race, in Massachusetts before and after the state implemented a flavored tobacco restriction. We assessed if the policy differentially impacted groups that have had higher rates of flavored tobacco use (i.e., SGM and African Americans [AAs]). METHODS/STUDY POPULATION: Data for this analysis came from the 2019 and 2021 Massachusetts Youth Risk Behavior Survey (YRBS), a biennial, national survey conducted among high school students, provided by the Massachusetts Department of Elementary and Secondary Education. Changes in current use of cigarettes and e-cigarettes between 2019 and 2021 were examined for the entire sample and by SGM identity and race/ethnicity. Current cigarette use and current e-cigarette use were defined as reporting any use of the product in the past 30 days. We received confirmation from the IRB that because the data are de-identified and available to the public, this research is considered Not Human Subjects Research. RESULTS/ANTICIPATED RESULTS: Between 2019 and 2021, current cigarette use and current e-cigarette use decreased for the entire sample (3.78% to 2.79% and 27.69% to 15.74%, respectively). Decreases were also observed after disaggregating results, but smaller changes were observed among minoritized groups (i.e., SGM and AAs), particularly for e-cigarettes. Current e-cigarette use decreased 25.56% among individuals identifying as SGM (28.14% to 20.95%) compared to a 49.33% decrease among non-SGM individuals (27.63% to 14.0%). Among all races, AAs had the lowest prevalence of current e-cigarette use in 2019 (15.10%), but also saw the lowest percentage decrease (17.68%). Among whites, current e-cigarette use decreased 45.75% from 32.33% in 2019 to 17.54% in 2021. DISCUSSION/SIGNIFICANCE: After implementation of Massachusetts’ flavored tobacco restriction, current cigarette and e-cigarette use declined among Massachusetts youth overall and among groups that have been most affected by flavored tobacco. However, minoritized groups (i.e., SGMs, AAs) had lower percentage decreases compared to non-minoritized groups.

OBJECTIVES/GOALS: This study examines health provider andcaregiver influences on adolescent dual prevention strategies, or the use of condoms and another form of contraception, to informa clinically focused triadic intervention, involving caregivers, adolescents aged 15-17, and health providers. METHODS/STUDY POPULATION: Data for the 2021 Teen and Parent Surveywere two online, cross-sectional surveys, a national sample of adolescents aged 15-19, and a survey of caregivers of 15–17-year-old adolescents. Data were matched to create a dyadic dataset (n=273). Drawing from the Actor-Partner-Dependance Model we will conduct a secondary retrospective analysis, specifically cross-sectional univariate, bivariate, and multivariate logistic regression analyses on sets of influences around contraception and sexual health: communication with parents and health providers, information delivery of sexual health, condom attitudes and self-efficacy around preventative behaviors. RESULTS/ANTICIPATED RESULTS: In preliminary unadjusted analyses, 91% of the sample were cis-gender females (n=249), of which 32% (n=87) had sexual contact with someone who could get them pregnant. In the past, 35% (n=86) discussed birth control pills and 9% (n=24) discussed long-acting contraception with a health provider. In the last health visit, 29% (n=72) discussed STI prevention. Caregivers discussed sexual decision-making (49%, n=144), how to prevent pregnancy (62%, n=169), and how to prevent STIs (55%, 151) at least once in the past year. At last sex (n=49) most used condoms (47%, n=23), followed by birth control pills (33%, n=16), and withdrawal (14%, n=7). Additional predictors and adjusted analyses will be further examined. DISCUSSION/SIGNIFICANCE: Dual prevention strategies can be influenced by caregivers and health providers, but they are contingent on communication. Triadic interventions may consider involving both caregiver and health provider communication around sexual health prevention.

The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Cross-Trial Statistics Group gathered lessons learned from statisticians responsible for the design and analysis of the 11 ACTIV therapeutic master protocols to inform contemporary trial design as well as preparation for a future pandemic. The ACTIV master protocols were designed to rapidly assess what treatments might save lives, keep people out of the hospital, and help them feel better faster. Study teams initially worked without knowledge of the natural history of disease and thus without key information for design decisions. Moreover, the science of platform trial design was in its infancy. Here, we discuss the statistical design choices made and the adaptations forced by the changing pandemic context. Lessons around critical aspects of trial design are summarized, and recommendations are made for the organization of master protocols in the future.

OBJECTIVES/GOALS: This study engaged Black adults who reside in a rural area of Kentucky to explore their beliefs, norms, knowledge, attitudes, and health-related behaviors about Alzheimer’s disease (AD) (RQ1) and what message elements are most relevant for designing a health message aimed at encouraging them to get screened for AD (RQ2). METHODS/STUDY POPULATION: This qualitative study was guided bythe Integrative Model of Behavior. Participants were recruited from a faith-based institution in rural Kentucky. Black adults aged 50+ years were invited to participate in the study, which consisted of two focus groups. Group 1 gained information about behavioral determinants (RQ1) and examined which message design elements were important to Black adults by asking for feedback on a handout from the Alzheimer’s Association that encouraged AD screening (RQ2). The handout was redesigned based on feedback from Group 1. Group 2 was involved in a discussion of the redesigned handout, asking for further feedback. Focus groups were audio recorded and transcribed verbatim. Data analysis included thematic analysis of transcripts of the focus groups and quantitative analysis. RESULTS/ANTICIPATED RESULTS: Participants (N=18) were all female and Black with a mean age of sixty-two years. For RQ1, Results revealed that 1) limited knowledge of AD led to feelings of not being able to do anything about the disease, whereas awareness and education led to hope; 2) past healthcare experiences informed subsequent beliefs and behaviors, and 3) culture impacted beliefs, with a cultural norm of “what happens in our house, stays in our house” being prominent. For RQ2, results revealed the importance of regionally specific messaging for AD. Generic statements that applied broadly did not appeal to participants. Message delivery, layout, and format for low literacy individuals are key for maximizing audience impact. Pictures give hints about the message and aid in understanding. DISCUSSION/SIGNIFICANCE: Barriers such as past experiences, lack of knowledge, and cultural norms negatively impact the likelihood that Black adults will get screened for AD, resulting in delayed healthcare or healthcare avoidance. Regionally specific health messaging for AD has the potential to encourage modifications in health-related behaviors.

This manuscript addresses a critical topic: navigating complexities of conducting clinical trials during a pandemic. Central to this discussion is engaging communities to ensure diverse participation. The manuscript elucidates deliberate strategies employed to recruit minority communities with poor social drivers of health for participation in COVID-19 trials. The paper adopts a descriptive approach, eschewing analysis of data-driven efficacy of these efforts, and instead provides a comprehensive account of strategies utilized. The Accelerate COVID-19 Treatment Interventions and Vaccines (ACTIV) public–private partnership launched early in the COVID-19 pandemic to develop clinical trials to advance SARS-CoV-2 treatments. In this paper, ACTIV investigators share challenges in conducting research during an evolving pandemic and approaches selected to engage communities when traditional strategies were infeasible. Lessons from this experience include importance of community representatives’ involvement early in study design and implementation and integration of well-developed public outreach and communication strategies with trial launch. Centralization and coordination of outreach will allow for efficient use of resources and the sharing of best practices. Insights gleaned from the ACTIV program, as outlined in this paper, shed light on effective strategies for involving communities in treatment trials amidst rapidly evolving public health emergencies. This underscores critical importance of community engagement initiatives well in advance of the pandemic.

OBJECTIVES/GOALS: Sexual minority men (SMM) of color are at greater dementia risk than their White and non-SMM counterparts. The purpose of this study is to examine the relative effects of ethnoracial minority status, sexual minority status, and the intersection of both on dementia risk for men in the U.S. using subjective cognitive decline (SCD) as a proxy for dementia. METHODS/STUDY POPULATION: Data will be weighed to represent population estimates from 35 states’ 2019-2022 Behavioral Risk Factor Surveillance System Survey to describe SCD among 4 study groups consisting of SMM and non-SMM who are from minoritized ethnoracial groups (i.e., minoritized ethnoracial gay and bisexual men, minoritized ethnoracial heterosexual men), and White SMM and White non-SMM (i.e., White gay and bisexual men, White heterosexual men) aged ≥45 years. Logistic regressions and adjusted odds ratios will determine SCD prevalences and test for differences between prevalence and demographic characteristics (i.e., education, employment, income, marital status, health coverage, and depression). RESULTS/ANTICIPATED RESULTS: Due to excess chronic stress from belonging to multiple intersecting marginalized identities, we expect that SMM from minoritized ethnoracial groups will have a greater prevalence and higher odds of SCD after accounting for demographic factors when compared to groups that benefit from both “White Privilege” and heterosexism (White non-SMM, White SMM, and minoritized ethnoracial non-SMM). We also expect the odds of SCD to be higher in minoritized ethnoracial SMM when compared to White non-SMM and minoritized ethnoracial non-SMM. The odds of SCD are expected to be higher in White SMM compared to White non-SMM. DISCUSSION/SIGNIFICANCE: This is the first population-based study to apply an intersectional lens to examine dementia risk across the axes of race, sexual orientation, and gender identity. Findings from this study can inform targeted interventions to address the needs and experiences of LGBTQ+ subgroups at risk or living with dementia.

The emergence of the COVID-19 pandemic required an immediate global clinical research response. The ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines)-3 trials and the ACTIV-associated Outpatient Treatment with Anti-Coronavirus Immunoglobulin trial used Good Participatory Practices (GPP) to develop materials for study implementation from a global network perspective. GPP guidelines offer a framework for engaging stakeholders throughout the research process. This paper provides an overview of the materials developed and their applicability in various settings, reports results from a survey of study site personnel on the materials’ usefulness, summarizes important lessons learned, and serves as a reference for networks eager to apply GPP. Survey results showed that flipbooks and overview videos were highly ranked. Stakeholder input was valuable in developing easily understandable participant-facing materials with culturally appropriate images. Materials should be available to submit with the initial protocol submissions to ethics committees, and in formats that accommodate a wide range of institutional resources, policies, and infection-control practices. This article emphasizes the importance of GPP, including stakeholder consultation, in developing materials that support clinical research and address language, cultural, and sociopolitical barriers during a pandemic. The findings will be used to optimize efforts and resource allocation for new and ongoing studies.

OBJECTIVES/GOALS: The project goal was to conduct formative work using community-based participatory research (CBPR) to inform the development of a laundromat-based reproductive health literacy intervention (LI)informed by Passhe-Orlow and Wolf’s Conceptual Model. We provide insights to support the development of similar health literacy interventions. METHODS/STUDY POPULATION: In Phase I, we recruited female patrons over the age of 18 living in DC from 4 community laundromats. Participants completed a survey with validated measures to assess reproductive health knowledge, self-efficacy, and intentions to seek care. Open-ended questions assessed participants’ experiences accessing care, communication with health providers, and laundromat use. Data informed the development of a 2-3 minute reproductive health literacy intervention (LI) storyboard. In Phase II, in-depth interviews were conducted with reproductive health providers (midwives, obstetricians-gynecologists, women’s health registered nurses, women’s health nurse practitioners) working in the communities where the laundromats are located. LI acceptability and appropriateness were explored. RESULTS/ANTICIPATED RESULTS: For Phase I, we recruited 60 patrons. Participants (68.3%) expressed interest in a laundromat-based reproductive health literacy intervention (LI). Identified reproductive knowledge gaps included: unaware of fertile days (50.0%); believe prenatal care should begin after 2nd trimester of pregnancy (50.0%); unclear about pregnancy spacing (85.0%); unable to identify use for folic acid (91.7%); believe once a cesarean always a cesarean (53.3%). In Phase II, all 14 providers supported increasing community accessibility to health information: “we have to move beyond doing public health education in a provider’s office. That’s very outdated.” Providers identified the LI as an approachable, informative, and accessible way to disseminate health information. DISCUSSION/SIGNIFICANCE: Patron and provider input informed our choice of content, style, and delivery of the reproductive health literacy intervention. An essential aspect of our CBPR approach, this research will inform effective, appropriate reproductive health education despite barriers presented by access, transportation, and work schedules.

OBJECTIVES/GOALS: The use of assistive technology (AT) devices is known to improve older adults’ independence in daily activities. However, little is known about the impact of using an AT web app in older Latinos’ life. This study aims to evaluate the value and usefulness of the My Assistive Technology Guide web app among older Latinos with physical function disabilities. METHODS/STUDY POPULATION: We employed a convergent parallel mixed-method design with 12 community-living older Latinos from Puerto Rico. Researchers provided training in the use of My Assistive Technology Guide, a Spanish evidence-based web app with detailed information on 97 AT devices and videos of older people using them. Participants were encouraged to use it for 30 days. Afterward, we collected quantitative data using the subjective quality domain of the User Mobile Application Rating Scale (uMARS), followed by qualitative data through individual interviews. Quantitative data were analyzed with descriptive statistics and qualitative data with thematic content analysis. RESULTS/ANTICIPATED RESULTS: My Assistive Technology Guide web app received high ratings in the uMARS subjective quality domain (mean 4.5 [SD 0.5] out of 5), indicating that participants highly valued the usefulness of the web app. Qualitative data fell into four main categories: functional health, meaningful participation, autonomy, and personal growth. DISCUSSION/SIGNIFICANCE: The findings suggest that the AT knowledge provided by the My Assistive Technology Guide web app has the potential to enhance the quality of life of older Latinos in the face of the challenges posed by physical function disabilities as people age.

OBJECTIVES/GOALS: The CDC-funded Program to Alleviate National Disparities in Ethnic and Minority Immunizations in the Community intersects two national networks that transform building trust in communities: Cooperative Extension Systems and Clinical and Translational Science Awardees, with the goal of reducing vaccine hesitancy and increasing vaccine uptake. METHODS/STUDY POPULATION: PANDEMIC included North Central Florida; Greater Sacramento, California; Bronx, New York; St. Louis and the Ozarks, Missouri; rural Kentucky; and Minnesota. Our 10 Promising Practices (PPs) focus on the equitable distribution of COVID-19 vaccines and health information, with two detailing collaborative efforts to better achieve health equity: PP3) Bringing Services and Vaccines to People Where They Are & PP5) Creating Coalitions with Trusted Neighborhood Partners. CHWs and Extension Educators, trusted community members, work together to deliver culturally/linguistically diverse health messages in plain language in areas of high vaccine hesitancy and bring vaccines to people where they are. All outreach activities are tracked and categorized by PP affiliation. RESULTS/ANTICIPATED RESULTS: From November 2021 – August 2023, PANDEMIC has administered nearly 11,000 COVID-19 vaccines at over 2,500 outreach events. At events, Community Health Workers (CHWs) listen to community members to assess vaccine perceptions and health needs/concerns. We adapt messaging and outreach initiatives to promote vaccination through data analyses that help us understand perceptions. Responses are calculated for the populations of focus (PoF)–Latino/Hispanic, African American/Black, American Indian/Alaskan Native, Asian, Native Hawaiian/Other Pacific Islander) compared to others (Non-Latino/Hispanic White or unspecified race). Over 16,000 surveys were collected from November 2021 – August 2023 with 60% coming from the PoF. Key differences in perceptions will be shown along with other cross-site metrics. DISCUSSION/SIGNIFICANCE: PANDEMIC offers an innovative model for collaboration among CTSAs and Cooperative Extension Systems to better understand community perceptions and support vaccination efforts and overall health promotion in communities of greatest need, with a focus on racial and ethnic minority communities and underinsured/uninsured populations.

OBJECTIVES/GOALS: Low birth weight and preterm birth are significant contributors to infant mortality in the United States that disproportionally impact Black pregnant persons and their offspring. Although these outcomes are linked to chronic stress, the contribution of race-related stress remains largely understudied. METHODS/STUDY POPULATION: We investigated the effect of race-related stress on weight and gestational age at birth in a prospective cohort of 115 pregnant Black persons recruited at Grady Memorial Hospital in Atlanta, Georgia. The Index of Race-Related Stress Brief (IRRS-Brief), Perceived Stress Scale (PSS), and Stressful Events Questionnaire (SEQ) were collected at study enrollment during pregnancy. Neonatal birth weights and gestational age were collected via standardized medical record abstraction. We conducted linear regressions to determine whether greater race-related stress was associated with lower weight and gestational age at birth, while controlling for sources of prenatal stress. RESULTS/ANTICIPATED RESULTS: Global racism (total IRRS score) was significantly associated with birth weight when controlling for prenatal perceived stress and stressful life events within the last six months since study enrollment (beta=−16.7, p=.035). Neonatal gestational age was associated with both global racism (beta=-0.03, p=.028) and individual racism (IRRS’Individual’ subscale score) (beta=-0.09, p=.032) when controlling for prenatal perceived stress and stressful life events within the last six months since study enrollment. These results suggest that greater race-related stress contributes to lower weight and gestational age at birth in pregnant Black persons. DISCUSSION/SIGNIFICANCE: Future studies are necessary to determine the mechanisms by which race-related stress contributes to these adverse birth outcomes and to inform the development risk-assessment tools and interventions to mitigate the threat of race-related stress on adverse birth outcomes in high-risk populations.