Jacobson, Robert M.

Abstract Background: Human papillomavirus (HPV) vaccination rates in the United States remain low and lag behind other recommended adolescent vaccines. Studies evaluating the association of geographic and area-level characteristics with HPV vaccination rates provide a valuable resource for public health planning. Method: We used the Rochester Epidemiology Project data linkage system to ascertain HPV vaccination rates between 2010 and 2015 in a 7-county region of southern Minnesota. Geocoded individual patient data were spatially linked to socioeconomic data from the American Community Survey at the census block group level. Bayesian hierarchical logistic regression was used to model incident vaccination rates, adjusting for individual- and area-level sociodemographic characteristics, and geolocation. Geolocation was modeled as an approximated Gaussian field using a Stochastic Partial Differential Equations approach. All models were estimated using Integrated Nested Laplace Approximations. Results: In adjusted models, increasing age and female sex were associated with increased HPV vaccination. Lower socioeconomic status was associated with decreased rates of initiation [adjusted odds ratio (AOR); 95% confidence interval = 0.90 (0.86–0.95)], completion of the second dose [AOR = 0.88 (0.83–0.93)], and completion of the third dose [AOR = 0.85 (0.80–0.92)]. Geographic spatial analysis demonstrated increased odds of vaccination for the eastern region and in the greater Rochester metropolitan area, showing significant spatial variation not explained by individual level characteristics and ACS block group-level data. Conclusions: HPV vaccination rates varied geographically and by individual and geographically indexed sociodemographic characteristics. Impact: Identifying geographic regions with low HPV vaccination rates can help target clinical and community efforts to improve vaccination rates. Cancer Epidemiol Biomarkers Prev; 26(4); 533–40. ©2017 AACR. See all the articles in this CEBP Focus section, “Geospatial Approaches to Cancer Control and Population Sciences.”

Objectives. We assessed whether extra-immunization can serve as a clinical indicator for fragmentation of care. Methods. Using public-use files of the 1999–2003 National Immunization Survey, we classified children 19–35 months of age by their vaccination providers for the degree of fragmentation of care as ordered from lowest with one vaccine provider, to increasing fragmentation with multiple providers in one facility type, to multiple providers in more than one facility type. Extra-immunization was defined conservatively based on the year-specific recommendations of the Advisory Committee on Immunization Practices (ACIP) for immunizations due before 18 months of age. Of note, 1999–2003 transitioned from oral to inactivated poliovirus vaccines. Results. The rate for extra-immunization was 9.4% (95% confidence interval [CI] 9.2, 9.7). Of single vaccines, the rate for polio vaccine was highest (5.7%, 95% CI 5.5, 6.0). Extra-immunization was lowest for the 69% of children with only one vaccination provider (6.4%, 95% CI 6.1, 6.7), was higher in children who had more than one vaccination provider with one vaccination facility type (13.9%, 95% CI 13.2, 14.6), and highest with more than one facility type (24.1%, 95% CI 22.5, 25.6). Logistic regression (including race/ethnicity, language, provider type, survey year, and a parent-held immunization record) confirmed that multiple providers (adjusted odds ratio [AOR] = 2.30), multiple facility types (AOR=4.67), Spanish language (AOR=1.29), and race/ethnicity (black AOR=1.16, Hispanic AOR=1.31) were each associated with extra-immunization. Excluding poliovirus vaccine from the analysis, AORs for multiple providers and multiple facility types increased to 3.64 and 8.95, respectively. Conclusions. Extra-immunization is associated with receiving immunizations from multiple providers and multiple facility types.

AbstractHuman papillomavirus (HPV) vaccines offer primary prevention of cervical cancer and protection against other HPV‐associated cancers. HPV vaccine coverage in the United States (U.S.) remains low, particularly among older adolescents/young adults, and the uninsured. We assessed awareness and knowledge of HPV disease, HPV‐related cancers, and HPV vaccines among working, uninsured adults. Data from the 2014 Health Information National Trends Survey (HINTS 4, Cycle 4) were used as a benchmark. Patients were surveyed in late 2014 at the Volunteers in Medicine free clinic in Duval County, Florida. Surveys contained validated measures of HPV disease and vaccine knowledge; HPV‐related cancer knowledge was also assessed. Two‐hundred and ninety‐six surveys were analyzable with an 84% participation rate. Half (50.3%) of participants had heard of HPV, and 32.1% had heard of the HPV vaccine; in HINTS, these estimates were 63.6% and 62.7%, respectively (both P < 0.0001). In adjusted models, high HPV disease knowledge was associated with white race and increased education; high vaccine knowledge was associated with white race, increased education, and female sex. Recognition of HPV as a causative agent was 43.9% for cervical, 9.1% for anal, and 11.1% for throat cancers. For all HPV‐associated cancers, participants had lower knowledge/recognition relative to HINTS. The uninsured, socioeconomically disadvantaged adults we surveyed were unaware of a ubiquitous virus that can cause cancer and the existence of a vaccine to protect against it. These findings point to settings and populations in which initiatives to promote HPV vaccination as a cancer prevention tool remain critical.

Abstract Background: Human papillomavirus (HPV) is a causative agent in cervical cancer as well as anal, oropharyngeal, penile, and vaginal/vulvar cancers. Licensed, effective HPV vaccines have been available in the U.S. since mid-2006 for females and late 2011 for males and are recommended up to age 26. Despite this, in 2014, only 39.7% of U.S. girls and 21.6% of boys 13 to 17 years of age completed the three-dose vaccine series. ‘Lack of knowledge’ was a primary reason cited among parents for not vaccinating their children. HPV vaccination rates are lower still among 19-26 year olds, particularly among the uninsured. We assessed awareness and knowledge of HPV disease, HPV-related cancers, and HPV vaccines among working, uninsured adults and used 2014 data from the Health Information National Trends Survey (HINTS cycle 4) as a national benchmark against which to compare our data. Methods: Self-administered surveys were offered to patients attending appointments at the Volunteers in Medicine (VIM) clinic in Jacksonville, FL between September 10, 2014 and October 24, 2014. VIM provides free primary care for working individuals without insurance living and/or working in Duval County. Patients were eligible to participate if they were at least 18 years of age, not in acute distress, and had not completed a survey during pilot-testing. Surveys were available in English and Spanish and contained a validated HPV knowledge measure assessing disease knowledge and vaccine knowledge. Additionally, HPV-related cancer knowledge was assessed: 5 HPV-related (cervical, anal, throat, penile, vaginal/vulvar) and 4 not currently known to be HPV-related (lung, breast, prostate, skin). High knowledge was defined as having a knowledge score in the upper quartile of positive values. Odds ratios (OR) and 95% confidence intervals (CI) were estimated using logistic regression to assess the association of demographic characteristics with having high knowledge of HPV, HPV vaccines, and HPV-related cancer. Additional models assessed individual cancers. During the study period 356 patients were eligible to participate; of these, 55 declined (84% participation rate). Of the 301 surveys, 5 surveys were excluded from analysis due to excessive missing data; a total of 296 surveys were analyzed. Results: 50.3% of participants (n=149) had heard of HPV, 37.2% (n=110) correctly indicated that HPV is sexually transmitted, and 32.1% (n=95) had heard of the HPV vaccine. In HINTS 4, these estimates were 63.6%, 44.0%, and 62.7%, respectively. In adjusted models, high HPV disease knowledge was associated with race (OR non-white = 0.39 (0.19, 0.78)) and education (OR &gt;high school = 2.34 (1.14, 4.84)) while high HPV vaccine knowledge was associated with race (OR non-white = 0.42 (0.21, 0.82)), education (OR &gt;high school = 5.04 (2.30, 11.06)), and sex (OR male = 0.34 (0.12, 0.94)). Of the HPV-related cancers, 43.9% answered correctly for cervical, 9.1% for anal, 11.1% for mouth/throat, 11.5% for penile, and 30.7% for vaginal/vulvar cancer. Males were less likely than females to know that HPV is a causative agent for cervical (OR=0.41 (0.22, 0.75)) and vaginal/vulvar cancers (OR=0.43 (0.22, 0.86)). Conclusion: Using estimates obtained in HINTS 4 as a benchmark, awareness and knowledge of HPV, HPV-related cancers, and HPV vaccines were low among working, uninsured adult patients. In addition to improving access to HPV vaccination (e.g. volunteer clinics), the findings demonstrate a need for strategies to educate medically underserved adults about HPV. Maximizing access to HPV vaccination, including catch-up vaccination for adults up to age 26 are consistent with the recommendations of the President's Cancer Panel, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Advisory Committee on Immunization Practices. Citation Format: Carmen Radecki Breitkopf, Lila Finney Rutten, Debra Jacobson, Patrick Wilson, Monica Albertie, Robert M. Jacobson, Gerardo Colon-Otero. Awareness and knowledge of HPV, HPV-related cancers, and HPV vaccines in a working, uninsured clinic population. [abstract]. In: Proceedings of the Eighth AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 13-16, 2015; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2016;25(3 Suppl):Abstract nr B91.

ABSTRACT Protective antigen (PA)-specific antibody and cell-mediated immune (CMI) responses to annual and alternate booster schedules of anthrax vaccine adsorbed (AVA; BioThrax) were characterized in humans over 43 months. Study participants received 1 of 6 vaccination schedules: a 3-dose intramuscular (IM) priming series (0, 1, and 6 months) with a single booster at 42 months (4-IM); 3-dose IM priming with boosters at 18 and 42 months (5-IM); 3-dose IM priming with boosters at 12, 18, 30, and 42 months (7-IM); the 1970 licensed priming series of 6 doses (0, 0.5, 1, 6, 12, and 18 months) and two annual boosters (30 and 42 months) administered either subcutaneously (SQ) (8-SQ) or IM (8-IM); or saline placebo control at all eight time points. Antibody response profiles included serum anti-PA IgG levels, subclass distributions, avidity, and lethal toxin neutralization activity (TNA). CMI profiles included frequencies of gamma interferon (IFN-γ)- and interleukin 4 (IL-4)-secreting cells and memory B cells (MBCs), lymphocyte stimulation indices (SI), and induction of IFN-γ, IL-2, IL-4, IL-6, IL-1β, and tumor necrosis factor alpha (TNF-α) mRNA. All active schedules elicited high-avidity PA-specific IgG, TNA, MBCs, and T cell responses with a mixed Th1-Th2 profile and Th2 dominance. Anti-PA IgG and TNA were highly correlated (e.g., month 7, r 2 = 0.86, P < 0.0001, log 10 transformed) and declined in the absence of boosters. Boosters administered IM generated the highest antibody responses. Increasing time intervals between boosters generated antibody responses that were faster than and superior to those obtained with the final month 42 vaccination. CMI responses to the 3-dose IM priming remained elevated up to 43 months. (This study has been registered at ClinicalTrials.gov under registration no. NCT00119067.)

AbstractEach year 610,000 cases of anogenital and oropharyngeal cancers caused by human papillomavirus (HPV) occur worldwide. HPV vaccination represents a promising opportunity to prevent cancer on a global scale. The vaccine's story dates back to discoveries in chickens at the beginning of the 20th century with evidence that a cell‐free filtrate could transmit the propensity to grow cancers. Later, studies with similarly derived filtrates from mammalian tumors showed that hosts could develop immunity to subsequent exposures. Epidemiologic studies linked cervical cancer to members of a family of viruses that cause papillomatosis and common warts. This led to work with DNA hybridization demonstrating a causal relationship. The formation of virus‐like particles from viral capsid proteins led to the development of models for safe and effective vaccines. While much work remains with the acceptance of universal vaccination, the HPV vaccines Gardasil and Cervarix thus represent a century of successful translational research.

Abstract Cohen’s kappa coefficient, which was introduced in 1960, serves as the most widely employed coefficient to assess inter-observer agreement for categorical outcomes. However, the original kappa can only be applied to cross-sectional binary measurements and, therefore, cannot be applied in the practical situation when the observers evaluate the same subjects at repeated time intervals. This study summarizes six methods of assessing agreement of repeated binary outcomes under different assumptions and discusses under which condition we should use the most appropriate method in practice. These approaches are illustrated using data from the CDC anthrax vaccine adsorbed (AVA) human clinical trial comparing the agreement for two solicited adverse events after AVA between the 1–3 day in-clinic medical record and the patient’s diary on the same day. We hope this article can inspire researchers to choose the most appropriate method to assess agreement for their own study with longitudinal binary data.