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Novel preventive interventions are needed to address the rising incidence of human papillomavirus (HPV)-mediated oropharyngeal cancer (HPV+ OPC). This pilot study evaluated the feasibility of a stepped, behavioral and biological screening program for oral oncogenic HPV infection, an intermediate HPV+ OPC outcome.This was a cross-sectional, feasibility study. Eligible 45–74 years old adults identified from three clinical research registries were administered a behavioral risk survey (step 1). Participant tobacco use and sexual behavior history were translated into a quantifiable risk of oral oncogenic HPV DNA, according to prior National Health and Nutrition Examination Survey analyses. Females with >2% risk and males with >7% risk were offered biological screening for oral oncogenic HPV DNA (step 2) via an oral rinse and gargle specimen.A total of 292 individuals were contacted, but only 144 (49%) were reached. Among these, 56 individuals (19%) were uninterested and 18 (13%) were ineligible. Seventy individuals began the survey and 66 completed it (step 1), among whom 46 were classified as low-risk. Among the remaining 20 participants classified as high-risk for an oral oncogenic HPV infection, 5% were current smokers and the median participant had performed oral sex on 10 unique partners. During step 2 (biological screening), 45% (9/20) completed testing, all of whom tested negative for oral oncogenic HPV DNA.In this pilot of a stepped, oral oncogenic HPV screening program, enrollment and study completion were suboptimal. These barriers to screening should be characterized and addressed before reevaluating the feasibility of this program.Prevention Relevance:Novel preventive interventions are needed to address the rising incidence of HPV+ OPC. In this feasibility study, we characterized barriers to a two-step, behavioral and biological screening program for oral oncogenic HPV infection, an intermediate outcome for HPV+ OPC.

Potential care gaps in the cervical cancer screening process among women diagnosed with cervical cancer in an era with increased human papillomavirus (HPV) testing have not been extensively evaluated.Women diagnosed with cervical cancer between ages 21 and 65 at four study sites between 2010 and 2014 were included. Screening histories were ascertained from 0.5 to 4 years prior to cervical cancer diagnosis. We identified potential care gaps in the screening history for each woman and classified them into one of three mutually exclusive types: lack of a screening test, screening test failure, and diagnostic/treatment care gap. Distributions of care gaps were tabulated by stage, histology, and study site. Multivariable nominal logistic regression was used to examine the associations between demographic and cancer characteristics and type of care gap.Of 499 women evaluated, 46% lacked a screening test in the time window examined, 31% experienced a screening test failure, and 22% experienced a diagnostic/treatment care gap. More than half of the women with advanced cancer and squamous cell carcinoma lacked a screening test compared to 31% and 24% of women with localized cancer and adenocarcinoma, respectively. Women aged 21-29 at diagnosis were more likely to experience screening test failure and diagnostic/treatment care gap, while those aged 50-65 were more likely to lack a screening test, compared to women aged 30-39.Our findings demonstrate a continuing need to develop interventions targeting unscreened and under-screened women and improve detection and diagnosis of adenocarcinoma in women undergoing cervical cancer screening and diagnostic follow-up.

DOC file, 30K, Definitions for Categories of Process Failures.

PDF file, 64K, Study Population.

A total of 3 vaccines are recommended for U.S. adolescents: tetanus, diphtheria, and acellular pertussis; meningococcal conjugate; and human papillomavirus. To understand the disparities in vaccine availability and hesitancy, adolescent-, household-, and area-level characteristics associated with patterns of vaccine coverage are described.In 2020-2021, the authors generated national estimates among 8 possible combinations of vaccine coverage and identified the associated characteristics using 2015-2017 National Immunization Survey-Teen for male and female adolescents aged 13-17 years (N=63,299) linked to area (ZIP code) characteristics. Next, the factors associated with a missed opportunity for human papillomavirus vaccine (i.e., receipt of tetanus, diphtheria, and acellular pertussis and meningococcal conjugate only compared with coverage of all the 3 vaccines) were identified using logistic regression.Most U.S. adolescents received all the 3 vaccines (42.9%) or tetanus, diphtheria, and acellular pertussis and meningococcal conjugate only (32.1%); fewer received no vaccines (7.7%) or tetanus, diphtheria, and acellular pertussis only (6.6%); and the remainder received some combination of 1-2 vaccines. Missed opportunities for human papillomavirus vaccination were more likely among adolescents who were male, were of White race, were uninsured, were in middle-income households, and were living in rural areas and were less likely among adolescents who were older, who were Medicaid insured, whose parents completed surveys in Spanish, who were in poverty-level households, and who were living in high-poverty areas.A substantial number of U.S. adolescents are not fully vaccinated, and coverage varies by vaccine type, population, and place. Providers should routinely stock all the 3 vaccines and promote simultaneous, same-day vaccination to avoid missed vaccine opportunities. More research and interventions are needed to understand and modify patient, provider, payer, vaccine supply/storage, or other reasons for suboptimal coverage of all the recommended vaccines.

OBJECTIVE: Optimizing a self-persuasion intervention app for adolescent HPV vaccination requires investigating its hypothesized mechanisms. Guided by the experimental medicine approach, we tested whether (a) self-persuasion intervention components (verbalize vaccination reasons, choose HPV topics) changed putative mechanisms (memory, autonomous motivation) and (b) measures of the putative mechanisms were associated with HPV vaccination. METHODS: These are secondary analyses from a randomized 2 (cognitive processing: verbalize reasons vs. listen) × 2 (choice: choose HPV topics vs. assigned) factorial trial (Tiro et al., 2016). Undecided parents (N = 161) with an unvaccinated child (11–17 years old) used the self-persuasion app, recalled reasons for vaccination (memory measure), and completed an autonomous motivation measure. Adolescent vaccination status was extracted from electronic medical records 12 months post-intervention. RESULTS: The verbalize component resulted in greater recall accuracy of vaccination reasons (p < .001); however, the choose topics component did not increase autonomous motivation scores (p = .74). For associations with HPV vaccination, recall accuracy was not associated (ps > .51), but autonomous motivation scores significantly predicted vaccination (ps < .03), except when controlling for baseline motivation (p = .22). CONCLUSION: The intervention app engages parents in reasons for vaccination; however, memory may not be a viable mechanism of vaccination. Although the intervention did not affect autonomous motivation, associations with vaccination status suggest it is a viable intervention target for HPV vaccination but alternative strategies to change it are needed. Future testing of a refined app should examine implementation strategies to optimize delivery in clinical or community settings.

In 2018, the US Preventive Services Task Force endorsed primary human papillomavirus testing (pHPV) for cervical cancer screening. We aimed to describe providers’ beliefs about pHPV testing effectiveness and which screening approach they regularly recommend. We invited providers who performed 10 or more cervical cancer screens in 2019 in 3 healthcare systems that had not adopted pHPV testing: Kaiser Permanente Washington, Mass General Brigham, and Parkland Health; 53.7% (501/933) completed the survey between October and December 2020. Response distributions varied across modalities (P

Background Tobacco dependence, alcohol abuse, depression, distress, and other adverse patient-level influences are common in head and neck cancer (HNC) survivors. Their interrelatedness and precise burden in comparison with survivors of other cancers are poorly understood. Methods National Health Interview Survey data from 1997 to 2016 were pooled. The prevalence of adverse patient-level influences among HNC survivors and matched survivors of other cancers were compared using descriptive statistics. Multivariable logistic regressions evaluating covariate associations with the primary study outcomes were performed. These included 1) current cigarette smoking and/or heavy alcohol use (>14 drinks per week) and 2) high mental health burden (severe psychological distress [Kessler Index ≥ 13] and/or frequent depressive/anxiety symptoms). Results In all, 918 HNC survivors and 3672 matched survivors of other cancers were identified. Compared with other cancer survivors, more HNC survivors were current smokers and/or heavy drinkers (24.6% [95% CI, 21.5%-27.7%] vs 18.0% [95% CI, 16.6%-19.4%]) and exhibited a high mental health burden (18.6% [95% CI, 15.7%-21.5%] vs 13.0% [95% CI, 11.7%-14.3%]). In multivariable analyses, 1) a high mental health burden predicted for smoking and/or heavy drinking (odds ratio [OR], 1.4; 95% CI, 1.0-1.9), and 2) current cigarette smoking predicted for a high mental health burden (OR, 1.7; 95% CI, 1.2-2.3). Furthermore, nonpartnered marital status and uninsured/Medicaid insurance status were significantly associated with both cigarette smoking and/or heavy alcohol use (ORs, 1.9 [95% CI, 1.4-2.5] and 1.5 [95% CI, 1.0-2.1], respectively) and a high mental health burden (ORs, 1.4 [95% CI, 1.1 -1.8] and 3.0 [95% CI, 2.2-4.2], respectively). Conclusions Stakeholders should allocate greater supportive care resources to HNC survivors. The interdependence of substance abuse, adverse mental health symptoms, and other adverse patient-level influences requires development of novel, multimodal survivorship care interventions.

This cross-sectional study compares human papillomavirus vaccinations by age and season before and during the COVID-19 pandemic.

Background: Cancer screening is a complex process involving multiple steps and levels of influence (e.g., patient, provider, facility, health care system, community, or neighborhood). We describe the design, methods, and research agenda of the Population-based Research to Optimize the Screening Process (PROSPR II) consortium. PROSPR II Research Centers (PRC), and the Coordinating Center aim to identify opportunities to improve screening processes and reduce disparities through investigation of factors affecting cervical, colorectal, and lung cancer screening in U.S. community health care settings. Methods: We collected multilevel, longitudinal cervical, colorectal, and lung cancer screening process data from clinical and administrative sources on >9 million racially and ethnically diverse individuals across 10 heterogeneous health care systems with cohorts beginning January 1, 2010. To facilitate comparisons across organ types and highlight data breadth, we calculated frequencies of multilevel characteristics and volumes of screening and diagnostic tests/procedures and abnormalities. Results: Variations in patient, provider, and facility characteristics reflected the PROSPR II health care systems and differing target populations. PRCs identified incident diagnoses of invasive cancers, in situ cancers, and precancers (invasive: 372 cervical, 24,131 colorectal, 11,205 lung; in situ: 911 colorectal, 32 lung; precancers: 13,838 cervical, 554,499 colorectal). Conclusions: PROSPR II's research agenda aims to advance: (i) conceptualization and measurement of the cancer screening process, its multilevel factors, and quality; (ii) knowledge of cancer disparities; and (iii) evaluation of the COVID-19 pandemic's initial impacts on cancer screening. We invite researchers to collaborate with PROSPR II investigators. Impact: PROSPR II is a valuable data resource for cancer screening researchers.

Mailing HPV self-sampling kits to overdue individuals increases cervical cancer screening adherence; offering self-sampling to previously adherent individuals has not been evaluated in the U.S. Given heterogeneity of the U.S. health system and population, data are needed to optimize how HPV self-sampling is offered to individuals who are overdue, due after successful past screening, or have an unknown screening history.STEP is a pragmatic randomized controlled trial set within a U.S. integrated healthcare delivery system, designed to compare different outreach approaches for offering HPV self-sampling in populations defined by prior screening behavior (previously-adherent, overdue, or unknown screening history). Over 14 months, eligible individuals were identified through electronic medical record (EMR) data and randomized to Usual Care (UC), Education (UC + educational materials about cervical cancer screening), Direct-Mail (UC + Education + a mailed self-sampling kit) or Opt-In (UC + Education + option to request a kit), depending on screening history. The primary objective is to compare screening completion by outreach approach and screening history. Secondary objectives include evaluating incremental cost-effectiveness of outreach approaches, and identifying patient preference for, and satisfaction with, HPV self-screening, and barriers to abnormal results follow-up (measured through interviews and focus groups).The trial was designed to generate data that U.S. health systems can use to inform primary HPV screening implementation strategies that incorporate HPV self-sampling options to improve screening access, adherence, and patient satisfaction. The objective of this report is to describe the rationale and design of this pragmatic trial.

Objectives: To qualitatively characterize pretreatment head and neck cancer (HNC) patients’ supportive care (SC) needs, attitudes toward SC, and barriers to SC utilization. Materials and Methods: A prospective, nested, bi-institutional, cross-sectional pilot study design was employed. Participants were sub-selected from a representative sample of 50 patients newly diagnosed with mucosal or salivary gland HNC or sarcoma of the head and neck. Eligibility criteria included reporting ≥2 unmet needs (according to the Supportive Care Needs Survey—Short Form 34) or clinically-significant distress (National Comprehensive Cancer Network Distress Thermometer score ≥4). Semi-structured interviews were performed prior to initiation of oncologic treatment. Audio-recorded interviews were transcribed and thematically analyzed using NVivo 12.0 (QSR Australia). Thematic findings and representative quotes were interpreted by the entire research team. Results: Twenty-seven patients were interviewed. One-third were treated at the county safety-net hospital and the remainder were treated at the university health system. An equal proportion of patients presented with oral cavity, oropharyngeal, and laryngeal or other tumors. Two significant findings were identified on semi-structured interviews. First, patients did not perceive the relevance of SC prior to treatment. Second, anxiety surrounding the HNC diagnosis and impending treatment dominated in the pretreatment phase. Conclusion: Improved HNC patient education about the relevance and importance of SC in the pretreatment setting is needed. Integration of social work or psychological services in HNC clinics is warranted to address patients’ cancer-related worry—a discrete, dominant pretreatment SC need.

Women living with HIV (WLWH) are at increased risk of anal cancer compared to women without HIV, often due to persistent human papillomavirus (HPV) infections. This paper describes current practices and challenges conducting anal cancer screening for WLWH at an urban integrated safety-net system and a non-profit community-based HIV clinic. We conducted 25 semi-structured interviews with clinical and administrative stakeholders to assess knowledge, clinic practices and procedures, and experiences with anal cancer screening. Interview transcripts and fieldnotes were thematically analyzed using an iterative deductive and inductive coding scheme. Findings were organized by the Consolidated Framework for Implementation Research (CFIR) domains and constructs. Provider-level barriers to conducting anal cancer screening included limited knowledge of guidelines. System-level barriers included: structural characteristics such as lack of coordination between clinics to discern provider roles and responsibilities; and limitations in available resources such as configuration of electronic health records and infrastructure to manage referrals of abnormal anal Pap results. We conclude that anal cancer screening and follow-up for WLWH requires organization and coordination between multiple care teams, updated clinical information systems to facilitate communication and support anal Pap ordering and result documentation, and infrastructure that includes policies and protocols for management of abnormal results. Trial registration: ClinicalTrials.gov identifier: NCT02135419.

Background Accrual to cancer clinical trials is suboptimal. Few data exist regarding whether financial reimbursement might increase accruals. Objective The objective of this study was to assess perceptions about reimbursement to overcome barriers to trial accrual. Research design This was a cross-sectional survey. Subjects Oncologists identified from the American Medical Association Physician Masterfile. Measures We report descriptive statistics, associations of physician characteristics with perceptions of reimbursement, domains, and subthemes of free-text comments. Results Respondents (n=1030) were mostly medical oncologists (59.4%), ages 35-54 (67%), and male (75%). Overall, 30% reported discussing trials with >25% of patients. Barriers perceived were administrative/regulatory, physician/staff time, and eligibility criteria. National Cancer Institute cooperative group participants and practice owners were more likely to endorse higher reimbursement. Respondents indicated targeted reimbursement would help improve infrastructure, but also noted potential ethical problems with reimbursement for discussion (40.7%) and accrual (85.9%). Free-text comments addressed reimbursement sources, recipients, and concerns about the real and apparent conflict of interest. Conclusions Though concerns about a potential conflict of interest remain paramount and must be addressed in any new system of reimbursement, oncologists believe reimbursement to enhance infrastructure could help overcome barriers to trial accrual.

Successful cervical cancer prevention requires screening and appropriate management of abnormal test results. Management includes diagnostic evaluation and treatment, if indicated, based on cervical cancer risk after most abnormal test results. There is little guidance on the optimal timing of diagnostic evaluation, and few data exist on factors associated with timely management. We quantified time-to-colposcopy within 12 months of an abnormal cervical cancer screening or surveillance test result from 2010 to 2018 across three diverse healthcare systems and described factors associated with timely colposcopy. Among 21-65 year-old patients with an abnormal test result for which colposcopy was indicated (n = 28,706), we calculated the proportion who received a colposcopy within 12 months of the abnormal test and used Kaplan-Meier methods to estimate the probability of colposcopy within 12 months. Across all systems, 75.3% of patients received a colposcopy within 12 months, with site-specific estimates ranging from 70.0 to 83.0%. We fit mixed-effects multivariable logistic regression models to identify factors associated with receipt of colposcopy within 12 months. The healthcare system and cytology result severity were the most important factors associated with of timely colposcopy. We observed that sites with more centralized processes had higher proportions of colposcopy completion, and patients with high-grade results were more consistently evaluated earlier than patients with low-grade results. Patient age also affected receipt of timely colposcopy, though this association differed by healthcare system and result severity. These data suggest opportunities for system-level interventions to improve management of abnormal cervical cancer test results.

Characterize prevalence of intimate partner violence (IPV) among breast and cervical survivors receiving care in an urban safety-net healthcare system; Examine the relationship between IPV and clinical characteristics, receipt of cancer treatment, and guideline-recommended survivorship care. From 2010 to 2017, breast and cervical cancer survivors were identified and recruited from a large, integrated, safety-net hospital system. Electronic health records (EHR; to measure survivorship care), cancer registry (to measure clinical characteristics), and patient telephone surveys (to measure IPV) were triangulated among 312 survivors. Bivariate and multivariable models assessed the relationship between victimization and clinical characteristics, cancer treatment, and guideline-recommended survivorship care. Among the 312 participants, 54% identified as IPV+. Among breast cancer, IPV+ cancer participants were twice more likely to develop estrogen receptor negative ER- and/or progesterone receptor negative PR- tumor receptors compared with IPV- cancer participants (AOR = 2.31; 95% CI, 1.20, 4.44). IPV+ breast cancer participants were less likely to have surgery and less likely to have hormone therapy as a first course of treatment compared with IPV- participants. There was no relationship between IPV and adherence to guideline-recommended cancer survivorship care. This study expands our current knowledge on how victimization, and specifically IPV, impact health among specialty care. Future research should determine the feasibility of implementing Trauma-Informed Care in oncology practices to better optimize care. At integrated hospital systems, IPV+ cancer participants should utilize social workers, within their oncology clinics, to connect to victim services.

Background Human Papillomavirus (HPV) vaccination is recommended for children aged 11-12 years in the United States. One factor that may contribute to low national HPV vaccine uptake is parental exposure to misinformation on social media. Objective This study aimed to examine the association between parents’ perceptions of the HPV vaccine information on social media and internet verification strategies used with the HPV vaccine decision-making stage for their child. Methods Parents of children and adolescents aged 9-17 years were recruited for a cross-sectional survey in North Texas (n=1192) and classified into 3 groups: children and adolescents who (1) were vaccinated, (2) unvaccinated and did not want the vaccine, and (3) unvaccinated and wanted the vaccine. Multinomial logistic regression models were estimated to identify factors associated with the HPV vaccine decision-making stage with children and adolescents who were vaccinated as the referent group. Results Of the 1192 respondents, 44.7% (n=533) had an HPV-vaccinated child, 38.8% (n=463) had an unvaccinated child and did not want the vaccine, and 16.4% (n=196) had an unvaccinated child and wanted the vaccine. Respondents were less likely to be “undecided/not wanting the vaccine” if they agreed that HPV information on social media is credible (adjusted odds ratio [aOR] 0.40, 95% CI 0.26-0.60; P=.001), disagreed that social media makes them question the HPV vaccine (aOR 0.22, 95% CI 0.15-0.33; P Conclusions Interventions that promote web-based health literacy skills are needed so parents can protect their families from misinformation and make informed health care decisions.

As clinical trials have become more complex, with increasing numbers of required procedures and clinic visits, gaining access to promising new treatments has become even more challenging for many individuals. To address these barriers, we implemented a financial reimbursement and outreach program designed to increase the number and diversity of participants in cancer clinical trials at centers in Dallas, Houston, and Philadelphia. As endorsed by U.S. Food and Drug Administration (FDA) and the Texas and Pennsylvania State Legislatures, the program provides financial reimbursement for non-clinical costs (e.g., travel, lodging) to patients on cancer clinical trials with household income up to 700% the Federal poverty rate. The research study described here, centered at the Dallas site, evaluates program impact by assessing (1) numbers and diversity of patients enrolled to cancer clinical trials before and after program implementation; (2) characteristics of patients offered participation in the program who do versus do not enroll; (3) characteristics of patients enrolled in the program who do versus do not complete the reimbursement process. To evaluate perceived barriers and facilitators of program participation, we will conduct semi-structured interviews and administer the Comprehensive Score for Financial Toxicity Patient Reported Outcome Measure (COST PROM) and the Short Assessment of Health Literacy (SAHL). This program will examine how reimbursement of non-clinical costs can improve access to cancer clinical trials, with the eventual goal of increasing trial enrollment, diversity, representativeness, and generalizability.

The effectiveness and efficiency of cancer screening in real-world settings depend on many factors, including test sensitivity and specificity. Outside of select experimental studies, not everyone receives a gold standard test that can serve as a comparator in estimating screening test accuracy. Thus, many studies of screening test accuracy use the passage of time to infer whether or not cancer was present at the time of the screening test, particularly for patients with a negative screening test. We define the accuracy assessment interval as the period of time after a screening test that is used to estimate the test's accuracy. We describe how the length of this interval may bias sensitivity and specificity estimates. We call for future research to quantify bias and uncertainty in accuracy estimates and to provide guidance on setting accuracy assessment interval lengths for different cancers and screening modalities.

BACKGROUND: In 1971, the National Cancer Act created a process to recognize the leadership, facilities, and research efforts at cancer centers throughout the United States. Toward this goal, each National Cancer Institute (NCI)-designated Cancer Center defines and describes a catchment area to which they tailor specific scientific and community engagement activities. METHODS: The geographically defined catchment areas of 63 NCI-designated comprehensive and clinical Cancer Centers are collated and presented visually. Additionally, the NCI-designated Cancer Centers catchment areas are geographically linked with publicly available data sources to aggregate sociodemographic and epidemiologic characteristics across the NCI Cancer Centers Program. RESULTS: The national map portrays the size, shape, and locations for 63 catchment areas of the 71 NCI-designated Cancer Centers. The findings illustrate the geographic extent of the NCI Cancer Centers Program during the 50(th) anniversary of the National Cancer Act. CONCLUSIONS: NCI-designated Cancer Centers occupy a prominent role in the cancer control ecosystem and continue to perform research to address the burden of cancer among their local communities. The strength of the NCI Cancer Centers Program is partly defined by the scope, quality, and impact of community outreach and engagement activities in the catchment areas. IMPACT: The collation and geographic presentation of the distinct, but complementary, NCI-designated Cancer Center catchment areas are intended to support future research and community outreach activities among NCI-designated Cancer Centers.

ImportanceHuman papillomavirus (HPV) self-sampling addresses barriers to cervical cancer screening, and mailed self-sampling kits have been reported to increase screening uptake. International research suggests mailed kits are cost-effective in certain settings. However, the cost-effectiveness of mailing HPV self-sampling kits for increasing screening uptake has not been evaluated in the US.ObjectiveTo conduct an economic evaluation of a mailed HPV self-sampling intervention among underscreened women enrolled in an integrated US health care system.Design, Setting, and ParticipantsThis economic evaluation involved a cost-effectiveness analysis of results from a randomized clinical trial of 19 851 women aged 30 to 64 years enrolled in a health plan from Kaiser Permanente Washington (KPWA), a US-based integrated health care system. Women were identified through electronic medical records, and eligible participants were enrolled in a health plan for at least 3 years and 5 months, had a primary care clinician, had not received a Papanicolaou test for at least 3 years and 5 months, and had not received a hysterectomy. Enrollment occurred from February 25, 2014, to August 29, 2016, with follow-up through February 25, 2018. The current economic evaluation was conducted between August 2, 2021, and July 30, 2022. Intervention delivery costs were calculated from both the KPWA and Medicare perspectives and were based on either wellness visit or Papanicolaou test–only visit costs.InterventionParticipants in the control group received usual care, which comprised patient reminders and ad hoc outreach for screening. Participants in the intervention group received usual care plus a mailed HPV self-sampling kit.Main Outcome and MeasuresThe primary economic outcome was the incremental cost-effectiveness ratio (ICER) for increased screening uptake, defined as the incremental difference in cost (intervention group minus control group) divided by the difference in the number of participants completing screening (intervention group minus control group) within 6 months of randomization.ResultsAmong 19 851 women (mean [SD] age, 50.1 [9.5] years; 76.7% White), 9960 were randomized to the intervention group, and 9891 were randomized to the control group. Baseline ICERs ranged from $85.84 (95% CI, $85.68-$85.99) using KPWA wellness visits as the cost basis to $146.29 (95% CI, $146.20-$146.38) using Medicare Papanicolaou test–only visits as the cost source. Subgroups of participants aged 50 to 64 years and participants most recently overdue for screening achieved cost-effectiveness at lower levels of willingness to pay for an additional completed screening than other subgroups.Conclusions and RelevanceIn this economic evaluation, mailing HPV self-sampling kits to women overdue for cervical cancer screening was cost-effective for increased screening uptake relative to usual care. These results support mailing HPV kits as an efficient outreach strategy for increasing screening rates among eligible women in US health care systems.

Background: Over 14,000 cervical cancers are diagnosed annually in the U.S. In 2019, ~30% of individuals with a cervix were under-screened based on current guidelines. Previous studies established feasibility of mailed self-sampling high-risk HPV test kits to improve screening adherence. Qualitative findings from our HOME trial found unmet information needs and anxiety among patients with a positive kit result. We designed the STEP trial to test optimized implementation strategies for educating patients about screening when offering the kit to patients due/overdue for screening, and when reporting results. Purpose: To evaluate acceptability of the implementation strategies, we interviewed individuals after receiving a positive kit result about the result communication processes and their information needs. Methods: The STEP trial added a centralized licensed practical nurse to communicate about and arrange scheduling for all patients with positive kit results, and provided an educational pamphlet to explain the purpose of HPV testing (especially difference to Pap testing) and how latent infections can reactivate. Telephone interviews were conducted from December 2021 to March 2022 with 29 patients (56% of invited) who had a positive kit result. Interview guide asked about reaction to the kit, results communication, patient-provider interactions, and follow-up visit experiences; and included a survey regarding attitudes toward the kit. Five coders analyzed interview transcripts using iterative content analysis; 12 transcripts were double-coded. Codes were organized into node reports to identify overarching themes. Results: Of 29 participants, most (65.5%) were non-Hispanic White and the average age was 47.5 years (SD=11.2). Participants appreciated the convenience of the kit, though a few worried about the accuracy of self-sampling test results, especially compared to screening performed by a provider. While surprised by the positive kit result, all reported feeling reassured after talking with the nurse and understood next steps in the diagnosis and management process, although some reported still wanting to check with their primary care provider about the test findings. Though an educational pamphlet was provided with the home HPV kit, most participants did not recall receiving it or using it to understand their kit results. After reflecting on home kit versus in-clinic screening, most (69%) preferred using the kit on their own to provider-collected screening. All (100%) agreed that the kit instructions were easy to understand, however 90% were sure that they had sampled the right place, and 86% believed that the home test results were correct. Discussion: Unlike the prior HOME trial, there was less negative affect expressed by patients after receiving results. This suggests patients received the information needed to continue with the screening process and supports the value of a centralized nurse. Providing educational materials at multiple timepoints may further improve results communication in the future. Citation Format: Meera Muthukrishnan, Jasmin A. Tiro, Kris Hansen, John Lin, Caitlin Dorsey, Hongyuan Gao, Catherine Troja, Melissa Anderson, Richard Meenan, Beverly B. Green, Diana S.M. Buist, Rachel Winer. Improving communication and management following a positive home HPV self-sampling kit result [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr A108.

Highlights • Providers (29%) experience HPV-specific vaccine hesitancy from parents. • Providers feel least confident in responding to families’ religious beliefs. • Some providers (25%) agree with dismissal policies for families refusing vaccines., Parental vaccine hesitancy is a growing concern. Less is known about provider or practice characteristics that encounter HPV-specific vaccine-hesitant parents, the providers’ confidence in responding to HPV vaccine concerns, and the attitudes and use of vaccine dismissal policies (i.e., removing patients from the practice). North Texas providers completed an online survey. Dependent variables assessed: (1) percentage of HPV vaccine-hesitant parents encountered in practice defined as substantive, or high (≥11%, or among more than one out of ten adolescent patient encounters) versus low (≤10%) levels; (2) confidence in responding to 11 HPV vaccine concerns; (3) attitudes and use of vaccine dismissal policies. Chi-square and Fisher’s exact tests were conducted. Among 156 providers, 29% reported high HPV vaccine hesitancy (≥11% of patient population). Overall, providers reported being “very confident” in addressing vaccine concerns (mean: 3.37 out of 4, SD: 0.57). Mean confidence scores were significantly higher for white (vs. non-white) providers and for pediatricians (vs. family practitioners). Providers were least confident in responding to parents’ religious/personal beliefs (69%). Some providers (25%) agreed with policies that dismissed vaccine-hesitant parents after repeated counseling attempts. More providers used dismissal policies for childhood (19%) than adolescent (10%) immunizations. Provider communication training should include parental religious/personal beliefs to effectively address HPV vaccine hesitancy. Other regions should examine their HPV-specific vaccine hesitancy levels to understand how the use of dismissal policies might vary between adolescent and childhood immunizations.

Since 2012, cervical cancer screening guidelines allow for choice of screening test for women age 30–65 years (i.e., Pap every 3 years or Pap with human papillomavirus co-testing every 5 years). Intended to give patients and providers options, this flexibility reflects a trend in the growing complexity of screening guidelines. Our objective was to characterize variation in cervical screening at the individual, provider, clinic/facility, and healthcare system levels. The analysis included 296,924 individuals receiving screening from 3626 providers at 136 clinics/facilities in three healthcare systems, 2010 to 2017. Main outcome was receipt of co-testing vs. Pap alone. Co-testing was more common in one healthcare system before the 2012 guidelines (adjusted odds ratio (AOR) of co-testing at the other systems relative to this system 0.00 and 0.50) but was increasingly implemented over time in a second with declining uptake in the third (2017: AORs shifted to 7.32 and 0.01). Despite system-level differences, there was greater heterogeneity in receipt of co-testing associated with providers than clinics/facilities. In the three healthcare systems, providers in the highest quartile of co-testing use had an 8.35, 8.81, and 25.05-times greater odds of providing a co-test to women with the same characteristics relative to the lowest quartile. Similarly, clinics/ facilities in the highest quartile of co-testing use had a 4.20, 3.14, and 6.56-times greater odds of providing a co-test relative to the lowest quartile. Variation in screening test use is associated with health system, provider, and clinic/facility levels even after accounting for patient characteristics.

False-positive results have been rarely investigated among uninsured minority women who undergo 3-D screening mammography. Here, we analyzed data from 21,022 women participating in the Breast Screening and Patient Navigation (BSPAN) program of North Texas with an aim to report prevalence and correlates of false-positive results after 3-D screening mammography, stratified by age. False-positives were defined as a negative diagnostic mammogram or a negative biopsy within 1 year of a positive screen. We used multivariable logistic regression to assess associations of demographic and clinical covariates and false positive results for age groups 40-49 and 50-64 years. Prevalence of false-positive results was 11.8% and 9.6% in the 40-49 and 50-64 age groups, respectively. Multivariable logistic regression demonstrated that, in the 40-49 age group, women who were non-menopausal, did not use hormone replacement therapy (HRT), and had self-reported prior mammograms had higher odds of false-positive results than those who were menopausal, used HRT and had no self-reported prior mammograms, respectively. In the 50-64 age group, women with a prior self-reported diagnostic mammogram had higher odds of false-positive results than those without a prior self-reported diagnostic mammogram. This study establishes contemporary evidence regarding prevalence and correlates of false-positive results after 3-D mammography in the unique BSPAN population, and demonstrate that use of 3-D mammography is not enough to reduce false-positive rates among uninsured women served through community outreach programs. Further research is needed to explore improved techniques to reduce false-positive rates, and ensure optimal use of scarce resources in outreach programs.

The effectiveness of hepatocellular carcinoma (HCC) surveillance is mitigated by underuse in clinical practice, highlighting a need for interventions. We evaluated the effectiveness of mailed HCC surveillance outreach to promote HCC surveillance in patients with cirrhosis.We conducted a multicenter pragmatic randomized clinical trial comparing mailed outreach for surveillance ultrasound (n = 1436) and usual care with visit-based surveillance (n = 1436) among patients with cirrhosis at 3 health systems (tertiary care referral center, safety net health system, and Veterans Affairs medical center) from April 2018 to December 2019. The primary outcome of this interim analysis was guideline concordant semiannual HCC surveillance over a 12-month period and a secondary outcome was proportion time covered by surveillance. All patients were included in intention-to-screen analyses.Compared with usual care, the outreach arm had significantly higher semiannual surveillance (35.1% vs 21.9%) and lower no-surveillance (29.8% vs 43.5%) (P.001), resulting in significant increases in the proportion of time covered by surveillance (41.3% vs 31.0%; P.001). The intervention increased HCC surveillance across most predefined subgroups; however, there were site-level differences in the intervention effect, with significant increases in semiannual surveillance at the Veterans Affairs and safety net health systems but not at the tertiary care referral center.Mailed outreach significantly increased semiannual HCC surveillance vs usual care in patients with cirrhosis, with a consistent intervention effect across most examined subgroups. Continued follow-up is ongoing to determine if these increases in surveillance translate into improved downstream outcomes includi.ng early HCC detection and curative treatment receipt. (ClinicalTrials.gov, Numbers: NCT02582918 and NCT03756051).

ImportanceMailing human papillomavirus (HPV) self-sampling kits increases cervical cancer screening participation, but effects may differ across subpopulations. Subpopulation data can inform US health care system implementation.ObjectiveTo identify patient characteristics that modify effectiveness of a mailed kit intervention at increasing screening.Design, Setting, and ParticipantsThis was a secondary analysis of data from the Home-Based Options to Make Cervical Cancer Screening Easy (HOME) randomized clinical trial conducted from 2014 to 2018 at Kaiser Permanente Washington. Data analysis was performed from March 2018 to May 2022. Individuals aged 30 to 64 years with female sex, health plan enrollment longer than 3 years and 5 months, a current primary care clinician, and no Papanicolaou test within the prior 3 years and 5 months were identified through electronic medical records and randomized (1:1) to the control or intervention group.InterventionsThe control group received usual care Papanicolaou screening reminders and outreach. The intervention group received usual care plus an unsolicited mailed HPV self-sampling kit.Main Outcomes and MeasuresScreening uptake was captured within 6 months after randomization. Baseline patient characteristics (age, race, ethnicity, travel time to clinic, income, body mass index, tobacco use, health plan enrollment duration, time since last Papanicolaou test, mammography, comorbidities, and colorectal cancer screening adherence) were extracted from the electronic medical record.ResultsOf 19 734 individuals (mean [SD] age, 50.1 [9.5] years; 14 129 [71.6%] White), 9843 were randomized to the intervention group, and 9891 were randomized to the control group. Screening uptake was 26.3% (2592 of 9843 individuals) in the intervention group vs 17.4% (1719 of 9891 individuals) in the control group (relative risk [RR], 1.51; 95% CI, 1.43-1.60). Although absolute differences in uptake by group varied little by screening history, relative effects were greater with longer vs shorter time since last Papanicolaou test (no prior Papanicolaou test: RRs, 1.85-3.25; ≥10 years: RR, 2.78; 5-10 years: RRs, 1.69-1.86; Conclusions and RelevanceIn this secondary analysis of a randomized clinical trial, clinically important improvements in screening uptake were observed for all subgroups. Differences in magnitude of intervention effect and kit use highlighted opportunities to optimize HPV self-sampling for priority groups.Trial RegistrationClinicalTrials.gov Identifier: NCT02005510