Effect of HPV self-collection kits on cervical cancer screening uptake among under-screened women from low-income US backgrounds (MBMT-3): a phase 3, open-label, randomised controlled trial.

BACKGROUND: Most cervical cancer in the USA occurs in under-screened women. The My Body, My Test-3 (MBMT-3) trial sought to assess the efficacy of mailed human papillomavirus (HPV) self-collection kits with appointment-scheduling assistance to increase uptake of cervical cancer screening among under-screened women from low-income backgrounds compared with scheduling assistance alone. METHODS: MBMT-3 is a phase 3, open-label, two-arm, randomised controlled trial. Participants were recruited from 22 counties in North Carolina state, USA, and we partnered with 21 clinics across these counties. Participants were eligible for inclusion if they were aged 25-64 years, had an intact cervix, were uninsured or enrolled in Medicaid or Medicare, had an income of 250% or less of the US Federal Poverty Level, were living within the catchment area of a trial-associated clinic, and were overdue for screening (ie, Papanicolaou test ≥4 years ago or high-risk HPV test ≥6 years ago). Participants were randomly assigned (2:1) to receive a mailed HPV self-collection kit and assistance for scheduling a free screening appointment (intervention group) or to receive scheduling assistance alone (control group). Randomisation was conducted by county using permuted blocks of nine patients and assignment to group was not masked. Participants in the intervention group were mailed HPV self-collection kits to collect a cervical-vaginal sample and return it by mail for testing. Samples were tested with the Aptima HPV assay (Hologic, San Diego, CA, USA), and participants were informed of high-risk HPV results by telephone call. Trial staff made up to three telephone call attempts to provide scheduling assistance for in-clinic screening for all participants. The primary outcome was cervical cancer screening uptake (ie, attending an in-clinic screening appointment or testing negative for high-risk HPV with a returned self-collected sample) within 6 months of enrolment in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02651883, and has been completed. FINDINGS: Recruitment occurred between April 11, 2016, and Dec 16, 2019. 4256 women contacted the trial to participate, of whom 899 (21%) were eligible for inclusion and 697 (78%) returned consent forms. Of those who consented, 461 (66%) women were randomly assigned to the intervention group and 236 (34%) women were randomly assigned to the control group. We excluded 32 ineligible women post-randomisation, leaving 665 for primary analysis. Screening uptake was higher in the intervention group (317 [72%] of 438) than control group (85 [37%] of 227; risk ratio 1·93, 95% CI 1·62-2·31). Among intervention participants, 341 (78%) of 438 returned a self-collection kit. Three participants reported hurt or injury when using the self-collection kit; no participants withdrew due to adverse effects. INTERPRETATION: Among under-screened women from low-income backgrounds, mailed HPV self-collection kits with scheduling assistance led to greater uptake of cervical cancer screening than scheduling assistance alone. At-home HPV self-collection testing has the potential to increase screening uptake among under-screened women. FUNDING: National Cancer Institute.

Cost-effectiveness of Human Papillomavirus Self-collection Intervention on Cervical Cancer Screening Uptake among Underscreened U.S. Persons with a Cervix.

BACKGROUND: We evaluate the cost-effectiveness of human papillomavirus (HPV) self-collection (followed by scheduling assistance for those who were HPV+ or inconclusive) compared with scheduling assistance only and usual care among underscreened persons with a cervix (PWAC). METHODS: A decision tree analysis was used to estimate the incremental cost-effectiveness ratios (ICER), or the cost per additional PWAC screened, from the Medicaid/state and clinic perspectives. A hypothetical cohort represented 90,807 low-income, underscreened individuals. Costs and health outcomes were derived from the MyBodyMyTest-3 randomized trial except the usual care health outcomes were derived from literature. We performed probabilistic sensitivity analyses (PSA) to evaluate model uncertainty. RESULTS: Screening uptake was highest in the self-collection alternative (n = 65,721), followed by the scheduling assistance alternative (n = 34,003) and usual care (n = 18,161). The self-collection alternative costs less and was more effective than the scheduling assistance alternative from the Medicaid/state perspective. Comparing the self-collection alternative with usual care, the ICERs were $284 per additional PWAC screened from the Medicaid/state perspective and $298 per additional PWAC screened from the clinic perspective. PSAs demonstrated that the self-collection alternative was cost-effective compared with usual care at a willingness-to-pay threshold of $300 per additional PWAC screened in 66% of simulations from the Medicaid/state perspective and 58% of simulations from the clinic perspective. CONCLUSIONS: Compared with usual care and scheduling assistance, mailing HPV self-collection kits to underscreened individuals appears to be cost-effective in increasing screening uptake. IMPACT: This is the first analysis to demonstrate the cost-effectiveness of mailed self-collection in the United States.

HPV vaccine initiation at 9 or 10 years of age and better series completion by age 13 among privately and publicly insured children in the US.

The US Advisory Committee on Immunization Practice recommends routine human papillomavirus (HPV) vaccination at 11-12 years of age, but states that vaccination may be initiated as early as 9 years. Our primary goal was to assess whether initiating HPV vaccination at 9-10 years of age, compared to 11-12, was associated with a higher rate of series completion by 13 years of age, and to identify factors associated with series completion by age 13. The study used vaccine claims and other data from the IBM MarketScan Commercial Claims and Encounters (privately insured) and IBM MarketScan Multi-State Medicaid (publicly insured) databases. Participants were 9-12 years of age and initiated HPV vaccination between January 2006 and December 2018 (publicly insured) or February 2019 (privately insured). Among 100,117 privately insured individuals, those initiating the HPV vaccination series at 9-10 years of age had a significantly higher series completion rate by 13 years of age than did those initiating at 11-12 years of age (76.2% versus 48.1%; p < .001). The same pattern was observed for 115,863 publicly insured individuals (70.4% versus 40.0%; p < .001). Provider and health care plan type, female sex, race/ethnicity, and wellness checks or non-HPV vaccinations during the baseline period were significantly associated with series completion by 13 years of age. Proactive initiation of HPV vaccination at 9-10 years of age was associated with higher rates of series completion by 13 years of age. These findings can inform provider education and other interventions to encourage timely HPV vaccination series completion.

The Impact of The Real Cost Vaping and Smoking Ads across Tobacco Products.

INTRODUCTION: Little research has examined the spillover effects of tobacco communication campaigns, such as how anti-smoking ads affect vaping. AIMS AND METHODS: Participants were a national sample of 623 U.S. adolescents (ages 13-17 years) from a probability-based panel. In a between-subjects experiment, we randomly assigned adolescents to view one of four videos online: (1) a smoking prevention video ad from the Food and Drug Administration's (FDA) The Real Cost campaign, (2) a neutral control video about smoking, (3) a vaping prevention video ad from The Real Cost campaign, or (4) a neutral control video about vaping. We present effect sizes as Cohen's d, standardized mean differences, with 95% confidence intervals (CIs). RESULTS: Exposure to The Real Cost vaping prevention ads led to more negative attitudes toward vaping compared with control (d = 0.30, 95% CI: 0.07, 0.53), while exposure to The Real Cost smoking prevention ads did not affect smoking-related outcomes compared with control (p-values > .05). Turning to spillover effects, exposure to The Real Cost smoking prevention ads led to less susceptibility to vaping (d = -0.34, 95% CI: -0.56, -0.12), more negative attitudes toward vaping (d = 0.43, 95% CI: 0.20, 0.65) and higher perceived likelihood of harm from vaping (d = 0.26, 95% CI: 0.04, 0.48), compared with control. Exposure to The Real Cost vaping prevention ads did not affect smoking-related outcomes compared with control (p-values > .05). CONCLUSIONS: This experiment found evidence of beneficial spillover effects of smoking prevention ads on vaping outcomes and found no detrimental effects of vaping prevention ads on smoking outcomes. IMPLICATIONS: Little research has examined the spillover effects of tobacco communication campaigns, such as how anti-smoking ads affect vaping. Using a national sample of 623 U.S. adolescents, we found beneficial evidence of spillover effects of smoking prevention ads on vaping outcomes, which is promising since it suggests that smoking prevention campaigns may have the additional benefit of reducing both smoking and vaping among adolescents. Additionally, we found that vaping prevention campaigns did not elicit unintended consequences on smoking-related outcomes, an important finding given concerns that vaping prevention campaigns could drive youth to increase or switch to using combustible cigarettes instead of vaping.

Drivers of COVID-19 policy stringency in 175 countries and territories: COVID-19 cases and deaths, gross domestic products per capita, and health expenditures.

Background: New data on COVID-19 may influence the stringency of containment policies, but these potential effect are not understood. We aimed to understand the associations of new COVID-19 cases and deaths with policy stringency globally and regionally. Methods: We modelled the marginal effects of new COVID-19 cases and deaths on policy stringency (scored 0-100) in 175 countries and territories, adjusting for gross domestic product (GDP) per capita and health expenditure (% of GDP), and public expenditure on health. The time periods examined were March to August 2020, September 2020 to February 2021, and March to August 2021. Results: Policy response to new cases and deaths was faster and more stringent early in the COVID-19 pandemic (March to August 2020) compared to subsequent periods. New deaths were more strongly associated with stringent policies than new cases. In an average week, one new death per 100 000 people was associated with a stringency increase of 2.1 units in the March to August 2020 period, 1.3 units in the September 2020 to February 2021 period, and 0.7 units in the March to August 2021 period. New deaths in Africa and the Western Pacific were associated with more stringency than in other regions. Higher health expenditure as a percentage of GDP was associated with less stringent policies. Similarly, higher public expenditure on health by governments was mostly associated with less stringency across all three periods. GDP per capita did not have consistent patterns of associations with stringency. Conclusions: The stringency of COVID-19 policies was more strongly associated with new deaths than new cases. Our findings demonstrate the need for enhanced mortality surveillance to ensure policy alignment during health emergencies. Countries that invest less in health or have a lower public expenditure on health may be inclined to enact more stringent policies. This new empirical understanding of COVID-19 policy drivers can help public health officials anticipate and shape policy responses in future health emergencies.

Reducing Poverty-Related Disparities in Cervical Cancer: The Role of HPV Vaccination.

BACKGROUND: Near elimination of cervical cancer in the United States is possible in coming decades, yet inequities will delay this achievement for some populations. We sought to explore the effects of human papillomavirus (HPV) vaccination on disparities in cervical cancer incidence between high- and low-poverty U.S. counties. METHODS: We calibrated a dynamic simulation model of HPV infection to reflect average counties in the highest and lowest quartile of poverty (percent of population below federal poverty level), incorporating data on HPV prevalence, cervical cancer screening, and HPV vaccination. We projected cervical cancer incidence through 2070, estimated absolute and relative disparities in incident cervical cancer for high- versus low-poverty counties, and compared incidence with the near-elimination target (4 cases/100,000 women annually). RESULTS: We estimated that, on average, low-poverty counties will achieve near-elimination targets 14 years earlier than high-poverty counties (2029 vs. 2043). Absolute disparities by county poverty will decrease, but relative differences are estimated to increase. We estimate 21,604 cumulative excess cervical cancer cases in high-poverty counties over the next 50 years. Increasing HPV vaccine coverage nationally to the Healthy People 2020 goal (80%) would reduce excess cancer cases, but not alter estimated time to reach the near-elimination threshold. CONCLUSIONS: High-poverty U.S. counties will likely be delayed in achieving near-elimination targets for cervical cancer and as a result will experience thousands of potentially preventable cancers. IMPACT: Alongside vaccination efforts, it is important to address the role of social determinants and health care access in driving persistent inequities by area poverty.

Perceived Financial Barriers to Cervical Cancer Screening and Associated Cost Burden Among Low-Income, Under-Screened Women.

Background: Despite screening's effectiveness in reducing cervical cancer incidence and mortality, disparities in cervical cancer screening uptake remain, with lower rates documented among uninsured and low-income individuals. We examined perceived financial barriers to, and the perceived cost burden of, cervical cancer screening. Materials and Methods: We surveyed 702 low-income, uninsured or publicly insured women ages 25-64 years in North Carolina, U.S., who were not up to date on cervical cancer screening according to national guidelines. Participants were asked about perceived financial barriers to screening and how much they perceived screening would cost. We used multivariable logistic regression to assess the sociodemographic predictors of perceived financial barriers. Results: Seventy-two percent of participants perceived financial barriers to screening. Screening appointment costs (71%) and follow-up/future treatment costs (44%) were most commonly reported, followed by lost pay due to time missed from work (6%) and transportation costs (5%). In multivariable analysis, being uninsured (vs. publicly insured), younger (25-34 vs. 50-64 years), White (vs. Black), and not reporting income data were associated with perceiving screening costs and future treatment costs as barriers to screening. Participants reported wide-ranging estimates of the perceived out-of-pocket cost of screening ($0-$1300), with a median expected cost of $245. Conclusions: The majority of our sample of low-income women perceived substantial financial barriers to screening, particularly related to screening appointment costs and potential follow-up/future treatment costs. Providing greater cost transparency and access to financial assistance may reduce perceived financial barriers to screening, potentially increasing screening uptake among this underserved population. Clinicaltrials.gov registration number NCT02651883.

Cost-effectiveness of Interventions to Increase HPV Vaccine Uptake.

OBJECTIVES: We sought to prioritize interventions for increasing human papillomavirus (HPV) vaccination coverage based on cost-effectiveness from a US state perspective to inform decisions by policy makers. METHODS: We developed a dynamic simulation model of HPV transmission and progression scaled to a medium-sized US state (5 million individuals). We modeled outcomes over 50 years comparing no intervention to a one-year implementation of centralized reminder and recall for HPV vaccination, school-located HPV vaccination, or quality improvement (QI) visits to primary care clinics. We used probabilistic sensitivity analysis to assess a range of plausible outcomes associated with each intervention. Cost-effectiveness was evaluated relative to a conservative willingness-to-pay threshold; $50 000 per quality-adjusted life-year (QALY) . RESULTS: All interventions were cost-effective, relative to no intervention. QI visits had the lowest cost and cost per QALY gained ($1538 versus no intervention). Statewide implementation of centralized reminder and recall cost $28 289 per QALY gained versus QI visits. School-located vaccination had the highest cost but was cost-effective at $18 337 per QALY gained versus QI visits. Scaling to the US population, interventions could avert 3000 to 14 000 future HPV cancers. When varying intervention cost and impact over feasible ranges, interventions were typically preferred to no intervention, but cost-effectiveness varied between intervention strategies. CONCLUSIONS: Three interventions for increasing HPV vaccine coverage were cost-effective and offered substantial health benefits. Policy makers seeking to increase HPV vaccination should, at minimum, dedicate additional funding for QI visits, which are consistently effective at low cost and may additionally consider more resource-intensive interventions (reminder and recall or school-located vaccination).

Overcoming barriers to adolescent vaccination: perspectives from vaccine providers in North Carolina.

To capture strategies for achieving high adolescent coverage of tetanus-diphtheria-acellular pertussis (Tdap), meningococcal conjugate (MenACWY), and human papillomavirus (HPV) vaccination, we surveyed employees of 20 North Carolina (N.C.) clinics that achieved adolescent vaccination coverage higher than the state average. One employee per clinic completed a surveysummarizing clinic practices regarding adolescent vaccination; perceived barriers and facilitators to Tdap/MenACWY/HPV vaccination; and the role of "champions" who made special efforts to promote adolescent vaccination. Common perceived barriers for all vaccinations were parental opposition and logistical barriers to receiving vaccination. For HPV vaccination, employees cited parental concerns about sexual behavior and injection site pain; no school vaccination requirement; and low-perceived benefit in boys. Most clinics (80%) implemented successful changes to increase adolescent vaccination: consistently offering vaccination, tracking vaccination status using existing data, providing appointment reminders, updating providers on vaccination recommendations, and expanding vaccination hours. Strategies to improve HPV vaccination included co-administration with Tdap and MenACWY, and providing reminders to complete the vaccination series. Vaccine champions strongly recommended vaccination to parents (55%) and educated parents on vaccination recommendations (36%). Clinics in N.C.and similar settings can implement these and other low-resource strategies to overcome adolescent vaccination barriers. ABBREVIATIONS: CDC=Centers for Disease Control and Prevention; EHR=Electronic health record; HPV=Human papillomavirus; Tdap=Tetanus-diphtheria-acellular pertussis vaccine; MenACWY=Meningococcal Conjugate Vaccine; NCIB=North Carolina Immunization Branch; NCIR=North Carolina Immunization Registry; ACIP=Advisory Committee on Immunization Practices.

Health Warnings on Sugar-Sweetened Beverages: Simulation of Impacts on Diet and Obesity Among U.S. Adults.

INTRODUCTION: Overconsumption of sugar-sweetened beverage (SSB) is a significant contributor to obesity. Policymakers have proposed requiring health warnings on SSBs to reduce SSB consumption. Randomized trials indicate that SSB warnings reduce SSB purchases, but uncertainty remains about how warnings affect population-level dietary and health outcomes. METHODS: This study developed a stochastic microsimulation model of dietary behaviors and body weight using the 2005-2014 National Health and Nutrition Examination Surveys, research on SSB health warnings, and a validated model of weight change. In 2019, the model simulated a national SSB health warning policy's impact on SSB intake, total energy intake, BMI, and obesity among U.S. adults over 5 years. Sensitivity analyses varied assumptions about: (1) how warning efficacy changes over time, (2) the magnitude of warnings' impact on SSB intake, and (3) caloric compensation. RESULTS: A national SSB health warning policy would reduce average SSB intake by 25.3 calories/day (95% uncertainty interval [UI]= -27.0, -23.6) and total energy intake by 31.2 calories/day (95% UI= -32.2, -30.1). These dietary changes would reduce average BMI by 0.64 kg/m2 (95% UI= -0.67, -0.62) and obesity prevalence by 3.1 percentage points (95% UI= -3.3%, -2.8%). Obesity reductions persisted when assuming warning efficacy wanes over time and when using conservative estimates of warning impact and caloric compensation. Benefits were larger for black and Hispanic adults than for white adults, and for adults with lower SES than for those with higher SES. CONCLUSIONS: A national SSB health warning policy could reduce adults' SSB consumption and obesity prevalence. Warnings could also narrow sociodemographic disparities in these outcomes.

Predictors of Cervical Cancer Screening Among Infrequently Screened Women Completing Human Papillomavirus Self-Collection: My Body My Test-1.

Background: Approximately one-half of cervical cancer cases in the United States occur in underscreened or never-screened women. We examined predictors to completing Papanicolaou (Pap) testing and whether a positive human papillomavirus (HPV) self-collection result affects Pap testing adherence among underscreened women. Materials and Methods: Low-income women aged 30-65 years who reported no Pap testing in ≥4 years were recruited in North Carolina. Knowledge, attitudes, and barriers regarding cervical cancer and Pap testing were assessed by telephone questionnaires. We mailed self-collection kits for HPV testing and provided information regarding where to obtain affordable Pap testing. Participants received $45 for completing all activities. We used multivariable logistic regression to assess the predictors of longer reported time since last Pap (≥10 vs. 4-9 years) and of completion of Pap testing following study enrollment (follow-up Pap). Results: Participants (n = 230) were primarily black (55%), uninsured (64%), and with ≤high school education (59%). Cost and finding an affordable clinic were the most commonly reported barriers to screening. White women and those with ≤high school education reported longer intervals since last Pap test. Half of the participants reported completing a follow-up Pap test (55%). Women with a positive HPV self-collection were five times more likely to report completing a follow-up Pap test than those with negative self-collection (odds ratio = 5.1, 95% confidence interval 1.4-25.7). Conclusions: Improving awareness of resources for affordable screening could increase cervical cancer screening in underserved women. Home-based HPV self-collection represents an opportunity to re-engage infrequently screened women into preventive screening services.

"Organic," "Natural," and "Additive-Free" Cigarettes: Comparing the Effects of Advertising Claims and Disclaimers on Perceptions of Harm.

INTRODUCTION: The US Tobacco Control Act restricts advertising or labeling that suggests one tobacco product is less harmful than another. We sought to examine how "organic," "natural," and "additive-free" advertising claims and corresponding disclaimers affect perceptions of cigarettes' harm. METHODS: Participants were a national probability sample of adults in the United States (n = 1114, including 344 smokers). We conducted a 5 (claim) × 2 (disclaimer) between-subjects factorial experiment. Participants viewed a Natural American Spirit cigarettes ad claiming they were "organic," "natural," "additive-free," "light," or "regular;" and with or without a corresponding disclaimer. The outcome was perceived harm of the advertised cigarettes. Among smokers, we also assessed interest in switching within their current brand to cigarettes with this characteristic (eg, "additive-free"). RESULTS: Claims in the ad had a large effect on perceived harm (Cohen's d = 0.87, 95% CI = 0.47 to 1.29). Claims of cigarettes being "organic," "natural," or "additive-free" reduced perceived harm from the advertised cigarettes, as compared with "regular" and "light" claims. Disclaimers had a small effect, increasing perceived harm (d = 0.25, 95% CI = 0.08 to 0.41). The problematic claims also increased smokers' interest in switching. Disclaimers had no effect on smokers' interest in switching. CONCLUSIONS: "Organic," "natural," and "additive-free" claims may mislead people into thinking that the advertised cigarettes are less harmful than other cigarettes. Disclaimers did not offset misperceptions of harm created by false claims. The US Food and Drug Administration should restrict the use of these misleading claims in tobacco advertising. IMPLICATIONS: "Organic," "natural," and "additive-free" cigarette advertising claims decrease perceptions of harm among the public and increase interest in switching to such cigarettes among smokers. Disclaimers do not counteract the reduced perceptions of harm or increased interest in switching to these cigarettes. The US Food and Drug Administration should restrict the use of "organic," "natural," and "additive-free" claims in tobacco marketing.

Coaching primary care clinics for HPV vaccination quality improvement: Comparing in-person and webinar implementation.

State health departments commonly use quality improvement coaching as an implementation strategy for improving low human papillomavirus (HPV) vaccination coverage, but such coaching can be resource intensive. To explore opportunities for improving efficiency, we compared in-person and webinar delivery of coaching sessions on implementation outcomes, including reach, acceptability, and delivery cost. In 2015, we randomly assigned 148 high-volume primary care clinics in Illinois, Michigan, and Washington State to receive either in-person or webinar coaching. Coaching sessions lasted about 1 hr and used our Immunization Report Card to facilitate assessment and feedback. Clinics served over 213,000 patients ages 11-17. We used provider surveys and delivery cost assessment to collect implementation data. This report is focused exclusively on the implementation aspects of the intervention. More providers attended in-person than webinar coaching sessions (mean 9 vs. 5 providers per clinic, respectively, p = .004). More providers shared the Immunization Report Card at clinic staff meetings in the in-person than webinar arm (49% vs. 20%; p = .029). In both arms, providers' belief that their clinics' HPV vaccination coverage was too low increased, as did their self-efficacy to help their clinics improve (p < .05). Providers rated coaching sessions in the two arms equally highly on acceptability. Delivery cost per clinic was $733 for in-person coaching versus $461 for webinar coaching. In-person and webinar coaching were well received and yielded improvements in provider beliefs and self-efficacy regarding HPV vaccine quality improvement. In summary, in-person coaching cost more than webinar coaching per clinic reached, but reached more providers. Further implementation research is needed to understand how and for whom webinar coaching may be appropriate.

Impact of Pharmacists on Access to Vaccine Providers: A Geospatial Analysis.

Policy Points: Policymakers in the United States should consider expanding pharmacy practice laws to allow pharmacists to vaccinate adolescents as a way to improve geographic access to adolescent vaccines, particularly for human papillomavirus (HPV) vaccine, which has low uptake. Our state-level analysis showed that pharmacists are more geographically dispersed than primary care physicians in the US state of Texas. Including pharmacists among available adolescent vaccine providers would improve the geographic distribution of vaccine providers, especially in areas with an inadequate number of primary care physicians. CONTEXT: The largest disparities in human papillomavirus (HPV) vaccination in the United States are due to geography. One potential way of addressing these disparities is by improving geographic access to HPV vaccination. Two federal panels have recommended including community pharmacists as HPV vaccine providers as a strategy to improve opportunities for HPV vaccination for adolescents. We sought to evaluate whether community pharmacists can improve the number of vaccine providers in areas with primary care physician shortages in the US state of Texas. METHODS: We gathered publicly available physician and pharmacist 2016 workforce data from the Texas Medical Board and Board of Pharmacy. We conducted geospatial analysis of census tracts to analyze the distribution of physicians and pharmacists and how pharmacists change vaccine provider coverage across the state. FINDINGS: Census tracts with high numbers of physicians per capita tended to be located near one another, in 5 of 5 analyses of Moran's I (median = .04). In contrast, pharmacist rates were not spatially dependent on census tract in any of our analyses. If pharmacists were added to primary care physicians as vaccine providers, 35% of urban census tracts that previously had inadequate coverage would be adequately covered, while 18% of inadequately covered rural census tracts would become adequately covered. Overall, when pharmacists were included with primary care physicians as vaccine providers, vaccine providers per capita increased in 2,413 of the 4,508 urban census tracts (54%), while the rate increased in 223 of 746 rural census tracts (30%). CONCLUSIONS: Pharmacists are more geographically dispersed across census tracts than primary care physicians. As a result, adding pharmacists to the workforce would increase the availability of vaccine providers in areas with inadequate primary care provider coverage.

Placing Health Warnings on E-Cigarettes: A Standardized Protocol.

Health warnings for e-cigarettes are a promising and novel tobacco control intervention for reducing e-cigarette use. We developed a new protocol for evaluating e-cigarette warnings by placing them on users' own devices to reflect real-world exposure. Study 1 participants were a national convenience sample of 606 U.S. adult e-cigarette users surveyed online in March 2017. Most Study 1 participants were willing to have their e-cigarette devices (87%) and refills (83%) labeled. Study 2 participants were a convenience sample of 22 adult e-cigarette users recruited in California, United States in April 2017. We applied the U.S. Food and Drug Administration's proposed e-cigarette warning to users' own devices and refills. Most Study 2 participants (81%) reported using e-cigarette devices with our warning labels at least 90% of the time during the study. Nearly all (95%) said they would participate in the study again, and 100% would recommend the study to a friend. Conversations about e-cigarette harms, conversations about quitting e-cigarettes, and intentions to quit using e-cigarettes increased during the study (all p < 0.05). These studies show that our naturalistic labeling protocol was feasible, acceptable to participants, and had high retention over three weeks. Using the protocol can yield important evidence on the impact of e-cigarette warnings to inform tobacco warning policies.

Predictors of Human Papillomavirus Vaccine Follow-Through Among Privately Insured US Patients.

OBJECTIVES: To assess predictors of timely human papillomavirus (HPV) vaccine follow-through among privately insured individuals initiating the 3-dose series. METHODS: Using MarketScan Commercial claims data, we identified 1 332 217 privately insured US individuals aged 9 to 26 years who initiated the bivalent or quadrivalent HPV vaccine series from 2006 to 2014, with follow-up data extending through 2015. The study outcome was receipt of third HPV dose within 12 months of the first, compared by year of initiation. Control variables were age, region, insurance plan type, provider type, and seasonal influenza vaccination. RESULTS: Timely HPV vaccine follow-through fell over time. The trend was especially pronounced for females (from 67% in 2006 to 38% in 2014), but was also present for males (from 36% in 2011 to 33% in 2014). Similar patterns were present when we controlled for patient and provider characteristics or used alternative definitions of follow-through. Other positive predictors of timely follow-through included receipt of flu vaccine in the prior year and receipt of first HPV vaccine dose from an obstetrician/gynecologist. CONCLUSIONS: HPV vaccine follow-through is low and has declined over time.

Pharmacies versus doctors' offices for adolescent vaccination.

PURPOSE: We sought to understand the relative advantage of pharmacies compared to doctors' offices for delivering HPV vaccination to adolescents. METHODS: Participants were a national sample of 1500 U.S. parents of adolescents ages 11-17 recruited in 2014-15. In an online survey, items informed by Diffusion of Innovation Theory assessed parents' perceptions of the relative advantages of HPV vaccine delivery in pharmacies and doctors' offices. PRINCIPLE FINDINGS: Many parents believed doctor's offices offered a better health care environment than pharmacies, with more privacy (77%) and a safer place for vaccination (70%). However, many parents also believed pharmacies were more accessible than doctors' offices, requiring less time for vaccinations (71%) and offering more convenient hours (59%). Parents were more willing to get their children HPV vaccine from pharmacists if they indicated more relative advantages in vaccine delivery in pharmacies (ß = .29; p < .001) and believed patient accessibility more important than health care environment (ß = .20; p < .001). CONCLUSIONS: To be more appealing to parents as HPV vaccine providers, pharmacy providers within community and hospital settings should build on their relative advantage with respect to accessibility and enhance their appeal of their healthcare environment.

Design of a randomized clinical trial of a colorectal cancer screening decision aid to promote appropriate screening in community-dwelling older adults.

BACKGROUND: Appropriate colorectal cancer screening in older adults should be aligned with the likelihood of net benefit. In general, patient decision aids improve knowledge and values clarity, but in older adults, they may also help patients identify their individual likelihood of benefit and foster individualized decision-making. We report on the design of a randomized clinical trial to understand the effects of a patient decision aid on appropriate colorectal cancer screening. This report includes a description of the baseline characteristics of participants. METHODS: English-speaking primary care patients aged 70-84 years who were not currently up to date with screening were recruited into a randomized clinical trial comparing a tailored colorectal cancer screening decision aid with an attention control. The intervention group received a decision aid that included a values clarification exercise and individualized decision-making worksheet, while the control group received an educational pamphlet on safe driving behaviors. The primary outcome was appropriate screening at 6 months based on chart review. We used a composite measure to define appropriate screening as screening for participants in good health, a discussion about screening for patients in intermediate health, and no screening for patients in poor health. Health state was objectively determined using patients' Charlson Comorbidity Index score and age. RESULTS: A total of 14 practices in central North Carolina participated as part of a practice-based research network. In total, 424 patients were recruited to participate and completed a baseline visit. Overall, 79% of participants were White and 58% female, with a mean age of 76.8 years. Patient characteristics between groups were similar by age, gender, race, education, insurance coverage, or work status. Overall, 70% had some college education or more, 57% were married, and virtually all had Medicare insurance (90%). The three primary medical conditions among the cohort were a history of diabetes, pneumonia, and cancer (28%, 26%, and 21%, respectively). CONCLUSION: We designed a randomized clinical trial to test a novel use of a patient decision aid to promote appropriate colorectal cancer screening and have recruited a diverse study population that seems similar between the intervention and control groups. The study should be able to determine the ability of a patient decision aid to increase individualized and appropriate colorectal cancer screening.