Transferring care to enhance access to early-phase cancer clinical trials: Protocol to evaluate a novel program.

Involving diverse populations in early-phase (phase I and II) cancer clinical trials is critical to informed therapeutic development. However, given the growing costs and complexities of early-phase trials, trial activation and enrollment barriers may be greatest for these studies at healthcare facilities that provide care to the most diverse patient groups, including those in historically underserved communities (e.g., safety-net healthcare systems). To promote diverse and equitable access to early-phase cancer clinical trials, we are implementing a novel program for the transfer of care to enhance access to early-phase cancer clinical trials. We will then perform a mixed-methods study to determine perceptions and impact of the program. Specifically, we will screen, recruit, and enroll diverse patients from an urban, integrated safety-net healthcare system to open and active early-phase clinical trials being conducted in a university-based cancer center. To evaluate this novel program, we will: (1) determine program impact and efficiency; and (2) determine stakeholder experience with and perceptions of the program. To achieve these goals, we will conduct preliminary cost analyses of the program. We will also conduct surveys and interviews with patients and caregivers to elucidate program impact, challenges, and areas for improvement. We hypothesize that broadening access to early-phase cancer trials conducted at experienced centers may improve equity and diversity. In turn, such efforts may enhance the efficiency and generalizability of cancer clinical research.

Barriers to human papillomavirus (HPV) vaccination among young adults, aged 18-35.

In the United States (US), an estimated 35,900 human papillomavirus (HPV)-related cancers are diagnosed annually. HPV vaccines are projected to eliminate âˆ¼90% of these cancers. Routine vaccination is recommended at age 11-12 with "catch-up" vaccination through age 26 and shared clinical decision making for ages 27-45. However, vaccine uptake has been slow with many young adults remaining unvaccinated. This study examined barriers to HPV vaccination among individuals aged 18-35 years and assessed likelihood of future HPV vaccination. Age-eligible participants (n = 499) recruited through Facebook advertisements, Facebook posts, and clinics (6/2019-3/2020) completed an online survey. Descriptive statistics and bivariate analysis examined HPV vaccine barriers and intent. Logistic regression models examined predictors of HPV vaccine intent. Most (57.1%) reported they were not at all likely to get vaccinated for HPV in the future. Lower intent was associated with belief that the vaccine is not necessary (aOR: 0.134, 95% CI: 0.073, 0.246) and not safe (aOR: 0.312, 95% CI: 0.126, 0.773). Intent was positively associated with the belief that health insurance would not cover vaccination (aOR: 2.226, 95% CI: 1.070, 4.631). Provider recommendation was not significantly associated with vaccine intention. This study highlights challenges to HPV vaccine uptake for young adults. Though several successful interventions exist, most target adolescents and their parents or providers. Future steps should use this evidence to inform development of targeted interventions to increase HPV vaccine intention and uptake in adults, ultimately reducing the burden of HPV-related cancers.

Patients' self-reported barriers to colon cancer screening in federally qualified health center settings.

Colorectal cancer (CRC) is a leading cause of cancer-related death in the United States. Despite evidence that screening reduces CRC incidence and mortality, only about 60% of age-eligible adults are up-to-date on CRC screening. This analysis aims to identify self-reported barriers to CRC screening among patients in a safety-net healthcare setting. Participants were recruited from safety-net primary care sites that were participating in a trial to increase CRC screening. At baseline, patients (n = 483) completed self-report surveys that assessed demographics, healthcare and CRC screening. Barriers to CRC screening were assessed through an open-ended question. Using a basic text analysis, data were coded and organized into key topics. Overall, 65.2% ever had CRC screening; 46.4% were up-to-date. Of those who described barriers (n = 198), 22.9% said they were not due for screening or their provider had not recommended it. Other common barriers included fear or worry about the procedure or outcome, financial challenges such as lack of insurance or cost of testing, and logistic challenges such as transportation and time. Fewer said that screening was of low importance or mentioned discomfort with the procedure or colonoscopy preparation. In this safety-net setting, CRC screening rates were lower than national rates. These qualitative results are similar to quantitative findings reported in the literature but the qualitative data add to our understanding of patient-reported concerns and challenges faced by safety-net patients. These results may be applied to developing targeting communication or intervention strategies to improve CRC screening rates within safety-net health centers.

Correlates of human papillomavirus (HPV) vaccination initiation and completion among 18-26 year olds in the United States.

PURPOSE: To examine correlates of HPV vaccination uptake in a nationally representative sample of 18-26-year-old adults. METHODS: Young adults aged 18-26 years were identified from the 2014 and 2015 National Health Interview Survey (n = 7588). Survey-weighted multivariable logistic regression models estimated sociodemographic factors associated with HPV vaccine initiation (≥1 dose) and completion (≥3 doses). RESULTS: Approximately 27% of study participants had initiated the HPV vaccine and 16% had completed the HPV vaccine. Participants were less likely to initiate the vaccine if they were men [(adjusted odds ratio) 0.19; (95% confidence interval) 0.16-0.23], had a high school diploma (0.40; 0.31-0.52) or less (0.46; 0.32-0.64) vs. college graduates, and were born outside the United States (0.52; 0.40-0.69). But, participants were more likely to initiate the HPV vaccine if they visited the doctor's office 1-5 times (2.09; 1.56-2.81), or ≥ 6 times (1.86; 1.48-2.34) within the last 12 months vs. no visits. Odds of completing HPV vaccine uptake followed the same pattern as initiation. And after stratifying the study population by gender and foreign-born status, these variables remained statistically significant. CONCLUSIONS: In our nationally representative study, only one out of six 18-26 year olds completed the required vaccine doses. Men, individuals with high school or less education, and those born outside the United States were less likely to initiate and complete the HPV vaccination. Our findings suggest that it may be useful to develop targeted interventions to promote HPV vaccination among those in the catch-up age range.

Conducting a randomized trial in rural and urban safety-net health centers: Added value of community-based participatory research.

BACKGROUND: Colorectal cancer (CRC) is the second most common cancer in the US. Despite evidence that screening reduces CRC incidence and mortality, screening rates are sub-optimal with disparities by race/ethnicity, income, and geography. Rural-urban differences in CRC screening are understudied even though approximately one-fifth of the US population lives in rural areas. This focus on urban populations limits the generalizability and dissemination potential of screening interventions. METHODS: Using community-based participatory research (CBPR) principles, we designed a cluster-randomized trial, adaptable to a range of settings, including rural and urban health centers. We enrolled 483 participants across 11 health centers representing 2 separate networks. Both networks serve medically-underserved communities; however one is primarily rural and one primarily urban. RESULTS: Our goal in this analysis is to describe baseline characteristics of participants and examine setting-level differences. CBPR was a critical for recruiting networks to the trial. Patient respondents were predominately female (61.3%), African-American (66.5%), and earned <$1200 per month (87.1%). The rural network sample was older; more likely to be female, white, disabled or retired, and have a higher income, but fewer years of education. CONCLUSIONS: Variation in the samples partly reflects the CBPR process and partly reflects inherent differences in the communities. This confirmed the importance of using CBPR when planning for eventual dissemination, as it enhanced our ability to work within diverse settings. These baseline findings indicate that using a uniform approach to implementing a trial or intervention across diverse settings might not be effective or efficient.