Participation In Clinical Trials Research Articles

Exploring the Strategic Use of TikTok for Clinical Trial Recruitment: How audiences’ Prior Short-Form Video Usage Influences Persuasive Effects

Guided by the elaboration likelihood model and framing theory, this study explores the potential of short-form video platforms (e.g. TikTok), for targeted clinical trial recruitment. An online experiment compared doctor vs. peer-led videos addressing logistical or psychological barriers to participation, mimicking common TikTok communication tactics. Results indicate that high (vs. low) TikTok users are more persuaded by recruitment messages, and they exhibit stronger intentions to participate in clinical trials. Although doctor-sourced messages generate greater credibility and a more favorable message attitude, peer-sourced messages may be more effective in increasing participation intention. Lastly, doctor-sourced videos that address logistical barriers and peer-sourced videos that discuss psychological barriers result in higher self-efficacy for clinical trial participation. This study contributes to the growing body of research on new media’s role in health communication and provides insights into how to strategically utilize TikTok and other short-form video platforms for clinical trial recruitment.

Current status of inclusion of older groups in evaluations of new medications: Gaps and implementation needs to fill them.

Under-representation of subgroups of the population in clinical trials has been and continues to be a problem despite goals of academia, industry, and government. Older adults are among the groups that are under-represented in trials of medications that they are likely to receive once marketing approval has been received. Recent legislation that mandates that clinical trial participants be representative of patient population has been passed and creates hope that greater numbers of older adults will be enrolled in clinical trials and that they will be representative of "typical" geriatric patients. However, there is the need for collection of current data on disease prevalences with granularity as to age, gender, and race as well as geriatric co-morbidities to assess the representativeness of clinical trial participants relative to patient populations. Consensus on definitions and collection of data relevant to geriatric patient populations are needed to evaluate effects of comorbidities, frailty, cognitive and physical function. There will also be a need for expansion of the geriatric research workforce, facilities for research both in academic centers but also in the community and long-term care facilities, and for engagement with and involvement of communities that have been traditionally under-represented to conduct clinical trials that enroll truly representative patient populations.

Comorbid Pathology in Clinical Trial Participants: Autopsy Findings and Clinical Features (P4-9.014)

Comorbid Pathology in Clinical Trial Participants: Autopsy Findings and Clinical Features (P4-9.014)

More than Just a Number: Perspectives from Black Male Participants on Community-Based Interventions and Clinical Trials to Address Cardiovascular Health Disparities

Background: Black Americans remain significantly underrepresented and understudied in research. Community-based interventions have been increasingly recognized as an effective model for reckoning with clinical trial participation challenges amongst underrepresented groups, yet a paucity of studies implement this approach. The present study sought to gain insight into Black male participants’ perception of clinical trials before and after participating in a community-based team lifestyle intervention in the United States. Methods: Black Impact, a 24-week community-based lifestyle intervention, applied the American Heart Association’s Life’s Simple 7 (LS7) framework to assess changes in the cardiovascular health of seventy-four Black male participants partaking in weekly team-based physical activities and LS7-themed education and having their social needs addressed. A subset of twenty participants completed an exit survey via one of three semi-structured focus groups aimed at understanding the feasibility of interventions, including their perceptions of participating in clinical trials. Data were transcribed verbatim and analyzed using a content analysis, which involved systematically identifying, coding, categorizing, and interpreting the primary patterns of the data. Results: The participants reported a positive change in their perceptions of clinical trials based on their experience with a community-based lifestyle intervention. Three prominent themes regarding their perceptions of clinical trials prior to the intervention were as follows: (1) History of medical abuse; (2) Lack of diversity amongst research teams and participants; and (3) A positive experience with racially concordant research teams. Three themes noted to influence changes in their perception of clinical trials based on their participation in Black Impact were as follows: (1) Building trust with the research team; (2) Increasing awareness about clinical trials; and (3) Motivating participation through community engagement efforts. Conclusions: Improved perceptions of participating in clinical trials were achieved after participation in a community-based intervention. This intervention may provide a framework by which to facilitate clinical trial participation among Black men, which must be made a priority so that Black men are “more than just a number” and no longer “receiving the short end of the stick”.

National Estimates of the Participation of Patients With Cancer in Clinical Research Studies Based on Commission on Cancer Accreditation Data.

National estimates of cancer clinical trial participation are nearly two decades old and have focused solely on enrollment to treatment trials, which does not reflect the willingness of patients to contribute to other elements of clinical research. We determined inclusive, contemporary estimates of clinical trial participation for adults with cancer using a national sample of data from the Commission on Cancer (CoC). The data were obtained from accreditation information submitted by the 1,200 CoC programs, which represent more than 70% of all cancer cases diagnosed in the United States each year. Deidentified, institution-level aggregate counts of annual enrollment to treatment, biorepository, diagnostic, economic, genetic, prevention, quality-of-life (QOL), and registry studies were examined. Overall, study-type estimates for the period 2013-2017 were estimated. Multiple imputation by chained equations was used to account for missing data, with summary estimates calculated separately by type of program (eg, National Cancer Institute [NCI]-designated cancer centers) and pooled. The overall estimated patient participation rate to cancer treatment trials was 7.1%. Patients with cancer participated in a wide variety of other studies, including biorepository (12.9%), registry (7.3%), genetic (3.6%), QOL (2.8%), diagnostic (2.5%), and economic (2.4%) studies. Treatment trial enrollment was 21.6% at NCI-designated comprehensive cancer centers, 5.4% at academic (non-NCI-designated) comprehensive cancer programs, 5.7% at integrated network cancer programs, and 4.1% at community programs. One in five patients (21.9%) participated in one or more cancer clinical research studies. In a first-time use of national accreditation information from the CoC, enrollment to cancer treatment trials was 7.1%, higher than historical estimates of <5%. Patients participated in a diverse set of other study types. Contributions of adult patients with cancer to clinical research is more common than previously understood.

220 The Unheard Voices of Clinical Trials: Fostering Inclusivity for People Experiencing Homelessness in Clinical Trials

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

506 Examining Participant Representation in Atopic Dermatitis Clinical Trials from 2011-2022

OBJECTIVES/GOALS: This study seeks to comprehensively evaluate the extent to which participants in clinical trials (CT) for Atopic Dermatitis (AD) accurately mirror the demographics and characteristics of the broader AD-affected populations. We will achieve this objective by analyzing data from AD CTs spanning the years 2011 to 2022. METHODS/STUDY POPULATION: We examined completed trials for 10 FDA approved treatments for AD, utilizing data sourced fromclinicaltrials.gov [http://clinicaltrials.gov]. In light of the increased number of AD clinical trials over the past decade, we tailored our search parameters to encampass all trials related to approved treatments from 2011-2022. To assess the characteristics of the participant population in these trials, information including inclusion and exclusion criteria, age, location, sex, and disease severity were collected for each trial. Furthermore, race and ethnicity data were also extracted and analyzed. Additionally, comparisons were drawn between trials completed before and after April 2017, when the FDA began requiring that researchers publish race and ethnicity data toclinicaltrials.gov [http://clinicaltrials.gov]. RESULTS/ANTICIPATED RESULTS: Across 67 CTs examined, 45% of trials were restricted to adult patients, 28% were restricted to pediatric patients, and 27% included both. 77% of CTs occurred in urban settings and 23% occurred in rural settings according to the The Economic Research Service definition. 36% of CTs included mild-to-moderate AD patients, and 64% of CTs included moderate-to-severe AD patients. Race distribution of CTs revealed 67% White, 14% Black/African American, 16% Asian, and 3% others. 13% of participants identified as Hispanic or Latino. With further analysis, we will determine whether there is a difference in ethnic distribution between trials completed before and after April 2017, when the FDA started requiring race/ethnicity data to be submitted. DISCUSSION/SIGNIFICANCE: The findings highlight a significant concern in AD CTs: the insufficient representation of Black and Asian populations. The findings emphasize the need for a more inclusive selection process that accurately reflects the diversity of patients. Failing to do so could undermine the assessment of treatment effectiveness in such populations.

110 Answering the Call for Greater LGBTQ+ Research Inclusivity by Co-Developing A Workshop for Researchers

OBJECTIVES/GOALS: The objectives of this workshop were to: (1) provide learners with a space to become aware of and discuss the history of the LGBTQ+ community in medical and public health research; (2) apply frameworks for LGBTQ+ inclusivity in research, inspired by lived experience and multimedia; and (3) assess LGBTQ+ research inclusivity best practices. METHODS/STUDY POPULATION: The CTSC provided the LGBT Community Center of Greater Cleveland (Center) with access to academic resources via an affiliate account and insights on the clinical and translational science research process. Members of the CTSC Research Equity, Accessibility, Diversity, and Inclusion team met regularly with the education and programming team at the Center to review research findings for workshop segments, ideate and provide feedback on activities, and strategize to ensure a psychologically safe virtual environment for learners. Zoom registration was used for workshop registration. An evaluation survey, created by the LGBT Community Center of Greater Cleveland (Center), was deployed by the CTSC to learners after the workshop. Respondents reported that the LGBTQ+ terminology focus was most valuable. RESULTS/ANTICIPATED RESULTS: To maximize investment in and scale theLGBTQ+ Inclusivity For Researchers workshop, the LGBT Community Center of Greater Cleveland offered a shortened version to their Youth Participatory Action Research group and will continue to offer the workshop in their suite of program/educational offerings. The CTSC plans to offer opportunities to co-host the workshop at its hospital system partner institutions, with room to tailor content based on internal LGBT resources (e.g., gender care offered at the institution). We hope to see a remarkable increase in LGBTQ+ identifying researchers, LGBTQ+ participation in research studies and clinical trials, and LGBTQ+ research topics/ideas/questions in response to CTSC pilots, local, national, and global funding opportunities. DISCUSSION/SIGNIFICANCE: LGBTQ+ people are less likely to have a regular health care provider—impeding screening, diagnosis, and treatment. This is reflected in health research where clinical research participation may follow a diagnosis. By providing tools for LGBTQ+ research inclusion, we will catalyze more research with LGBTQ+ people—as researchers and participants.

Recruitment and retention of clinical trial participants: understanding motivations of patients with chronic pain and other populations.

This paper aims to present and discuss the issues, challenges, and strategies related to recruitment and retention in clinical trials involving participants with chronic pain. The randomized controlled clinical trial (RCT) is widely regarded as the gold standard for evaluating clinical interventions. However, it is crucial to acknowledge and address the challenges associated with recruiting and retaining participants. To prioritize the experience of the study population, targeted outreach strategies and a patient-centric approach are necessary. Researchers should consider incorporating recruitment and retention strategies during the study design phase. Implementing multi-pronged recruitment methods, leveraging relationships with community providers, and involving representatives of the patient population are helpful approaches. Effective communication and maintaining a professional environment are vital for optimizing engagement and supporting the successful execution of clinical trials involving participants with chronic pain.

Conscientious enrolment in clinical trials during the COVID-19 pandemic: right patient, right trial

This article describes our efforts to screen and enrol clinical trial participants conscientiously in the COVID-19 pandemic setting. We present the standard screening and enrolment process prior to, and our process of adapting to, the pandemic. Our goal was to develop a way to screen and enrol people for clinical trials that was both equitable and effective. In addition, we outline the steps our research department took to ensure that ethical, clinical and logistical factors were considered when matching a patient to a clinical trial.

Patient experience of medication administration and development of a Patient Experience and Preference Questionnaire (PEPQ) for patients with advanced or metastatic cancer.

Introduction: A better understanding of patient experience of intravenous (IV) or subcutaneous (SC) routes of administration is fundamental to providing optimal administration of medical therapies to oncology patients. The objective of this study was to examine patient experiences of IV and SC treatment with nivolumab and confirm the relevance of item concepts in the Patient Experience and Preference Questionnaire (PEPQ). The PEPQ is a clinical outcomes' assessment instrument developed to obtain patient-centric data and understand the experience with IV and SC treatment administration. Methods: Embedded qualitative interviews were conducted with a subset of participants from three treatment cohorts with metastatic non-small-cell lung cancer (NSCLC), renal cell carcinoma (RCC), unresectable or advanced metastatic melanoma, hepatocellular carcinoma (HCC), or colorectal cancer (CRC) from the CA209-8KX clinical trial. Concept elicitation interviews were conducted within 14days of the initial treatment cycle and patient experiences with IV and SC treatment administration were assessed. Concepts from interviews were mapped to the PEPQ version 1.0 questions to assess relevance and convergence of concepts. Results: Interviews were conducted with 43 trial participants from clinical sites opting to participate from six countries (Argentina, France, the Netherlands, Poland, Spain, and New Zealand). The mean age of sub-study participants was 66 ± 11.3years (range 24-80years), and 67.4% (N = 29) were male. Sub-study participants with experience of SC most frequently reported symptoms or signs of injection-related redness (27.9%), itching (14.0%), and pain (of needle), and described the pain as pricking, stinging, or tingling (11.0% each). The amount of pain and time burden were widely endorsed as important factors for satisfaction and related to the route of medication administration. For 11 sub-study participants with experience with both IV and SC treatments, 10 (90.9%) preferred SC over IV treatment administration. Conclusion: This study summarizes the experience and satisfaction of receiving IV or SC treatment and confirms the relevance of the PEPQ in a subgroup of CA209-8KX clinical trial participants with metastatic NSCLC, RCC, melanoma, HCC, and CRC. Participant treatment experience and satisfaction with the route of medication mapped to the PEPQ question content support the relevance of PEPQ v2.0 in clinical trials as a self-report measure.

Designing mHealth Apps to Incorporate Evidence-Based Techniques for Prolonging User Engagement.

Maintaining user engagement with mobile health (mHealth) apps can be a challenge. Previously, we developed a conceptual model to optimize patient engagement in mHealth apps by incorporating multiple evidence-based methods, including increasing health literacy, enhancing technical competence, and improving feelings about participation in clinical trials. This viewpoint aims to report on a series of exploratory mini-experiments demonstrating the feasibility of testing our previously published engagement conceptual model. We collected data from 6 participants using an app that showed a series of educational videos and obtained additional data via questionnaires to illustrate and pilot the approach. The videos addressed 3 elements shown to relate to engagement in health care app use: increasing health literacy, enhancing technical competence, and improving positive feelings about participation in clinical trials. We measured changes in participants' knowledge and feelings, collected feedback on the videos and content, made revisions based on this feedback, and conducted participant reassessments. The findings support the feasibility of an iterative approach to creating and refining engagement enhancements in mHealth apps. Systematically identifying the key evidence-based elements intended to be included in an app's design and then systematically testing the implantation of each element separately until a satisfactory level of positive impact is achieved is feasible and should be incorporated into standard app design. While mHealth apps have shown promise, participants are more likely to drop out than to be retained. This viewpoint highlights the potential for mHealth researchers to test and refine mHealth apps using approaches to better engage users.

Beyond community engagement: perspectives on the meaningful involvement of people with HIV and affected communities (MIPA) in HIV cure research in The Netherlands

Background Meaningful involvement of people with HIV and affected communities in HIV cure research is essential to ensuring that cure research efforts are conducted transparently, socially justly, and ethically. This study set out to investigate how people with HIV and affected communities are involved in cure research in the Netherlands and explore what can be done to optimize involvement and engagement. Methods Eighty-five semi-structured online, telephone, and face-to-face interviews were conducted with people with HIV (N = 30), key populations (N = 35), and key informants (KI; N = 20) in the field of HIV. The interviews were analyzed using reflexive thematic analysis. Results Awareness of the meaningful involvement of people with HIV (MIPA) efforts was low among people with HIV and key populations, which contrasted with KI, who exhibited greater awareness. People with HIV and KI emphasized the importance of MIPA in ensuring the representation of lived experiences in HIV cure research and fostering trust between communities and researchers. Practical implementations of MIPA were unclear, ultimately resulting in difficulties defining MIPA beyond clinical trial participation. People with HIV and key populations also doubted their skills and self-efficacy to make meaningful contributions when confronted with involvement beyond participating in research and clinical trials. Conclusions MIPA is crucial for improving the quality, transparency, and ethical conduct of HIV cure research. It emphasizes the need for increased awareness and funding, standardized guidelines to ensure meaningful involvement, and combat tokenism and misconceptions.

Effective interventions to increase representation of under-served groups in randomised trials in UK and Ireland: a scoping literature review

Background Participants in clinical trials often do not reflect the populations that could benefit from the treatments being investigated. There are known barriers to trial participation for under-served groups, but limited evidence on strategies to alleviate these barriers to improve representation. This scoping review aimed to identify effective interventions and design features that improve the representation `of under-served groups in trials, focusing on the UK and Ireland. Methods We included methodological research studies that reported interventions to improve representation of ethnic minority groups, socioeconomically disadvantaged groups, older people, or those with impaired capacity to consent to randomised controlled trials, conducted in the UK and Ireland, published between 2000–2021. Systematic searches were conducted in November 2021 and data were independently extracted by two authors and narratively synthesised. Results Seven studies were included: one randomised controlled study embedded in five trials, one mixed-methods study, and five studies reporting ‘lessons learnt’ from one trial. We categorised the 47 reported interventions or strategies into nine broad themes: Recruitment sites, recruitment settings, community engagement, and communication with participants, incentives, inclusion criteria, flexibility, patient documentation, and the consent process. Only 28/47 interventions were evaluated, 23 of which were comparison of recruitment pathways. The randomised study found that a £100 incentive mentioned in the invitation letter increased positive responses overall across drug trials in cardiovascular disease and hypertension, but not for older people or those living in the most deprived areas. Invitation letters via GPs and working with communities were reported as successful recruitment pathways in recruiting different under-served populations. Conclusions Interventions aiming to improve the recruitment of under-served groups in the UK and Ireland were reported across seven papers, but their effectiveness was rarely rigorously evaluated. Included studies were context specific. Using a variety of recruitment methods is likely to help achieve a more diverse cohort.

Impact of patient demographics and neighborhood socioeconomic variables on clinical trial participation patterns for non-Hodgkin lymphoma

AbstractPrior studies have demonstrated that certain populations including older patients, racial/ethnic minority groups, and women are underrepresented in clinical trials. We performed a retrospective analysis of patients with non-Hodgkin lymphoma (NHL) seen at MD Anderson Cancer Center (MDACC) to investigate the association between trial participation, race/ethnicity, travel distance, and neighborhood socioeconomic status (nSES). Using patient addresses, we ascertained nSES variables on educational attainment, income, poverty, racial composition, and housing at the census tract (CT) level. We also performed geospatial analysis to determine the geographic distribution of clinical trial participants and distance from patient residence to MDACC. We examined 3146 consecutive adult patients with NHL seen between January 2017 and December 2020. The study cohort was predominantly male and non-Hispanic White (NHW). The most common insurance types were private insurance and Medicare; only 1.1% of patients had Medicaid. There was a high overall participation rate of 30.5%, with 20.9% enrolled in therapeutic trials. In univariate analyses, lower participation rates were associated with lower nSES including higher poverty rates and living in crowded households. Racial composition of CT was not associated with differences in trial participation. In multivariable analysis, trial participation varied significantly by histology, and participation declined nonlinearly with age in the overall, follicular lymphoma, and diffuse large B-cell lymphoma (DLBCL) models. In the DLBCL subset, Hispanic patients had lower odds of participation than White patients (odds ratio, 0.36; 95% confidence interval, 0.21-0.62; P = .001). In our large academic cohort, race, gender, insurance type, and nSES were not associated with trial participation, whereas age and diagnosis were.

Abstract 2242: Clinical trials knowledge among Hispanic/Latino gastrointestinal cancer survivors in Puerto Rico

Abstract The discovery of innovative cancer prevention and treatment approaches relies on voluntary participation in clinical trials (CTs); however, participation remains low among minorities/ethnic groups. Knowledge of CTs has been reported as a barrier to CT participation. Yet, there is limited understanding regarding CTs knowledge and participation among gastrointestinal (GI) cancer survivors in Puerto Rico (PR). Colorectal cancer is the second leading cause of death in PR, accounting for 13% among men and women. We aimed to describe the knowledge and factors associated with cancer-related CTs among Hispanic/Latino GI cancer survivors in PR. We analyzed preliminary data from an ongoing cross-sectional study targeting Hispanic/Latino GI cancer survivors aged 21+ years in PR. The study employed an interviewer-administered questionnaire to assess participants' awareness, knowledge, and participation in cancer-related CTs, and the social determinants of health (SDoH) associated with CT participation. Descriptive statistics were used to describe the population. Pearson chi-square test or Fisher's exact test were used accordingly to assess significance. A generalized linear model was used to estimate the odds ratios and 95% confidence intervals (CI) for significant variables. As of November 9, 2023, 59 Hispanic/Latino GI cancer survivors had completed the questionnaire. Women accounted for 56% of the sample, and the median age of study participants was 65 years (IQR: 19). Racial identity among participants was primarily white (63%), followed by other races (18%) and African-American (18%). Most participants were in complete or partial remission from cancer (83%). A significant proportion of the respondents reported having at least 12th grade (81%) and an annual income of $20,000 or higher (67%). Most participants (76%) accurately identified the correct definition of a CT. Participants with 12th grade or more had 1.5 (95% CI:1.1-1.9) times the possibility to correctly identify the CT definition compared to to those with less than 12th grade. Similarly, respondents with an annual income equal or higher than $20,000 had 1.4 (95% CI:1.1-1.8) times the possibility to correctly identify the CT definition compared to their counterpart. Furthermore, 93.2% of respondents had a score of at least 80% of correct responses regarding their knowledge of CTs. Although nearly 100% of the respondents knew about CTs, only 20% had participated. Despite a high level of knowledge regarding CTs in PR, a significant gap remains between knowledge and participation. Factors such as education and income might play a role in understanding the CT definition. However, the barriers preventing participation, including SDoH need further exploration. Enhancing participation among Hispanic/Latino GI cancer survivors in PR is essential for advancing cancer research and improving outcomes for this at-risk population. Citation Format: Hilmaris Centeno-Girona, Marievelisse Soto-Salgado, Mariela Bournigal-Feliciano, Sofia F. Contreras-Fernández, Karina Torres-Mojica, Victoria Williams, Arnethea L. Sutton, Katherine Tossas, Robert Winn, Marcia R. Cruz-Correa. Clinical trials knowledge among Hispanic/Latino gastrointestinal cancer survivors in Puerto Rico [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 2242.

Abstract 810: Assessing human papillomavirus (HPV) awareness and intentions to participate in HPV vaccination and clinical trials (CT) among Latinos/as in Los Angeles (LA) County: A multicomponent intervention

Abstract Background: The incidence of HPV-related cancers continues to disproportionately affect women and men of Latino origin. In LA, a total of 20,868 individuals have been diagnosed with HPV-related cancers from 2009 to 2019. HPV infection knowledge and interpersonal barriers contribute to HPV vaccine delay and refusal. Similarly, Latinos/as continue to also have low participation in clinical trials research. To address the low knowledge, attitudes, and intentions towards HPV vaccination and participation in clinical trials (CT), we have adopted the NCI National Outreach Network framework and have used community health educators to deliver bilingual-culturally appropriate workshops on HPV and CT. Methods: Individuals, 18 and over and parents with eligible age children (in respect to the HPV initiative) were recruited through community outreach and local community partnerships to participate in the bilingual (English and Spanish) health education workshops. A baseline assessment was administered before each educational workshop and a follow-up assessment was administered after to evaluate change in HPV and CT knowledge, intentions to vaccinate, and likelihood to participate in CT. Descriptive statistics were calculated to assess distribution of demographic variables of interest and a paired T-test was used to explore matched pre-post differences in knowledge scores and intentions. Results: 290 (HPV) 272 (CT) individuals participated in the workshops. The mean age of participants was 41.13yrs with a (SD=11.63). More than half of participants were women 453 (81.7%), men 94 (16.9%) and other 7 (1.26%). Comparing HPV knowledge scores of matched pre-and post-surveys, showed that for baseline (n=182) (M=72.9%, SD=13.3) was statistically different from post-scores (n=182) (M=81%, SD=9.85) where p&amp;lt;0.05. Intentions were measured using a Likert scale, baseline (M=4.1), agree to get HPV vaccine, post (M=4.5) strongly agree to get HPV vaccine. In respect to CT baseline knowledge (n=174) (M=75.3%, SD=0.15), following a Likert scale response of (M=3.4), unsure to join a clinic trial. In assessing post-CT scores (N=174) (M=78%, SD:0.14), mean scores were significant where p&amp;lt;0.05 and an increase to (M=3.7) agree to join a clinical trial. After workshops attendance, not only was knowledge increased, but intentions to vaccinate against HPV and to participate in a clinical trial was strengthen. Conclusions: Strengthening community-based education and providing the necessary tools, can help reframe misconceptions about HPV and HPV vaccination and promote willingness to vaccinate and participate in clinical trials. Citation Format: Alejandra Ramos, Carolina Aristizabal, Lourdes A. Baezconde-Garbanati. Assessing human papillomavirus (HPV) awareness and intentions to participate in HPV vaccination and clinical trials (CT) among Latinos/as in Los Angeles (LA) County: A multicomponent intervention [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 810.

Abstract 4840: Creating a culturally sensitive manual to increase clinical trial participation among African Americans and African Nationals

Abstract Background: Racial and ethnic minorities are immensely underrepresented in clinical trial studies in the United States. Black/African Americans, Latinos/as, Asians, American Indians, and Pacific Islanders make up roughly 30% of all clinical trials (CT) participation across all race groups. Being inclusive of all populations in CT ensures that everyone has access to modern medicines and treatments, but also, that these latest treatments work and react well to all people. Methods: We developed a manual on clinical trials with a target focus to African Americans and African Nationals. We hosted two focus groups with Blacks/African Americans in which we found they are more comfortable getting cancer related information through trusted community services, such as coming from churches. We have connected with over 80 Pastors who agreed to collaborate in clinical trials education. Results: Through outreach and engagement to African American churches in Los Angeles County, we have distributed a copy of this clinical trials educational manual to 90 churches to be disseminated during their services. Our office of Community Outreach and Engagement (COE) regularly attend community health and resource events and provide hard copies of the clinical trials manual at tables/booths designated for our participation. We have attended 50 community events and have disseminated about 1,900 copies of the CT manual so far this year 2023. This manual is also available for free download on our cancer center’s website, in which over 100 toolkits have been downloaded within the last year. Conclusions: By creating a culturally sensitive and adapted educational manual and partnering with trusted services in the community such as faith-based organizations, we can begin to break down barriers to clinical trials participation among all race and ethnic minority groups. Citation Format: Carolina Aristizabal, Eduardo Ibarra, Lourdes A. Baezconde-Garbanati. Creating a culturally sensitive manual to increase clinical trial participation among African Americans and African Nationals [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 4840.

Abstract 2245: Awareness and participation in cancer-related clinical trials among gastrointestinal cancer survivors

Abstract Despite significant advances in cancer prevention, early detection, and treatment, there is a persistent disparity in cancer outcomes between diverse racial/ethnic groups and medically underserved populations in the United States (US). The underrepresentation of non-white racial/ethnic groups in clinical trials (CTs) poses a critical challenge to cancer research and effective care delivery. The Hispanic/Latino population is one of the fastest-growing ethnic groups in the US and has a high rate of gastrointestinal (GI) cancer. Although Hispanics/Latinos comprise 18.5% of the US population, they have participation rates of only 1% in CTs. We aimed to describe the awareness and participation of Hispanic/Latino GI cancer survivors in cancer-related CTs. We analyzed preliminary data from an ongoing cross-sectional study that examines the social determinants of health (SDOH) associated with participation in cancer-related CTs among GI cancer survivors. As of November 7, 2023, 57 individuals aged ≥ 21 years responded to a survey assessing their awareness and participation in CTs, and other SDOH domains. Descriptive statistics were used to describe the population, including frequencies, percentages, mean, and standard deviation. The participants’ mean age was 62.5 ± 12.3 years, and 56.1% were women. Most had more than a high school education (80.6%). Moreover, 59.7% of the participants had state-sponsored health insurance or Medicaid. Twenty-nine (50.9%) of the participants reported having heard about cancer-related CTs; however, only nine (31.0%) indicated that they knew how to participate in a cancer-related CT. Most of the participants had heard about cancer-related CTs from their doctor, nurse, or other health professionals (41.4%), their family/friends (20.7%), or social media/newspapers (20.7%). Furthermore, 13 (44.8%) had been invited to participate and 11 (84.6%) were eligible and participated in cancer-related CTs. Most of the participants who were eligible and participated in cancer-related CTs (90.9%) indicated that they participated because they knew CTs are important for the development of effective cancer treatments. Our preliminary findings show high levels of awareness among Hispanics/Latinos GI cancer survivors towards CTs; however, it is concerning that only a minority of those who were aware of CTs knew how to participate in them. More efforts are needed to assess the factors and SDOH that impact participation in cancer-related CTs among this population. Additionally, we will continue to recruit participants to assess the relationship between adverse SDOH and their willingness to participate in cancer-related CTs. Citation Format: Mariela Bournigal-Feliciano, Marievelisse Soto-Salgado, Hilmaris Centeno-Girona, Sofía Contreras-Fernández, Karina Torres-Mojica, Virginia Williams, Arnethea L. Sutton, Katherine Tossas, Robert Winn, Marcia Cruz-Correa. Awareness and participation in cancer-related clinical trials among gastrointestinal cancer survivors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 2245.

Abstract 2159: Testing of an educational tool kit for the Community Genetic Navigation Engagement Specialists, COGENES, Training Program

Abstract Introduction: There is a lack of culturally sensitive materials to educate the Hispanic/Latino/a/x (H/L) community on colorectal cancer (CRC), which is the second and third leading cause of cancer deaths among H/L men and women in the United States, respectively. For these reasons, an Educational Tool Kit was created for the Community Genetic Navigation Specialists (CoGENEs) program at the Center for Optimizing Engagement of Hispanic Colorectal Cancer Patients in Cancer Genomic Characterization Studies (COPECC) at the University of Southern California (USC). CoGENES is a train the trainer program geared towards the development of a local workforce of trained community engagement specialists, promotores de salud (community health workers) that will act as liaison agents to increase knowledge and create community awareness on genetic research, clinical genetic testing, counseling, biospecimen donation and participation in clinical trials for H/Ls CRC patients, and community at large. Methods: The Tool Kit consisted of a newly developed educational handbook focused on CRC prevention, genetics, counseling, tumor testing, and patient navigation, as well as existing materials with resources for CRC and counseling. To test the handbook, five focus groups in Spanish/English were conducted with 44 participants, recruited via community agencies/clinics serving Los Angeles. Optimization probes focused on readability, knowledge, acceptability, barriers, and recommended changes. Content analysis was conducted with focus group transcripts to inform how to optimize the handbook. A Materials Review Optimization Scorecard was developed to evaluate materials on content, literacy, graphics, layout and typography, learning, stimulation and motivation, and cultural and language appropriateness. Fifteen pieces in the handbook were each rated by three community health workers. A final suitability score was calculated for each piece. Results: Overall, the materials were well received, and participants understood the overall main message of the materials. Feedback included refining terminology, providing additional headings and subtitles, and clarifying images to optimize the illustration of mutations. Final suitability scores from community health educators ranged from 80 to 99% for all materials, translating into “superior materials.” Conclusion: Overall materials were well received, and they were rated as “superior materials.” Participants’ feedback from CoGENES is shared with the Engagement Optimization Unit (EOU) and Patient Engagement Unit (PEU) to optimize ongoing education and research at COPECC. The MR-OS tool will be shared with other PEU’s at other center’s to encourage it use when developing educational materials. Citation Format: Yaneth L. Rodriguez, Janet Rodriguez, Charité Ricker, Julie Culver, Daisy Hernandez, Natalia Guierrez, Yvonne Cardona, Rosa Barahona, Bianca Rosales, Mariana Stern, Lourdes A. Baezconde-Garbanati. Testing of an educational tool kit for the Community Genetic Navigation Engagement Specialists, COGENES, Training Program [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 2159.