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Latinx populations have unique barriers to HPV vaccination. In the current study, we assessed the effectiveness of an online intervention to increase HPV vaccination intentions among patients of clinics that principally serve a Latinx population (n = 85%) as part of a randomized control trial (RCT). Participants viewed on an iPad either an individually tailored educational website (CHiCOS) or untailored information derived from the Vaccine Information Sheet (VIS) for HPV. Vaccination intention and related covariates were assessed via survey items administered before (pre-test) and after (post-test) viewing the material. No statistically significant differences were seen in changes of intention to vaccinate between groups (N = 1294). However, 16% of all (tailored and untailored combined) participants increased in their intention to vaccinate, while 7% decreased in intention. Overall 72% of participants had high intentions to vaccinate, yet far fewer actually received a vaccine dose. The current study explores implications of the demonstrated intention-behavior gap. As such, it presents opportunities to improve future interventions-specifically those that employ tailored messaging., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: To increase vaccine acceptance, we created a Web-based the "Vaccines and Your Baby" intervention (VAYB) that provided new parents with vaccine information messages tailored to vaccine beliefs and values. We evaluated the effectiveness of the VAYB by comparing timely uptake of infant vaccines to an untailored version of the intervention (UT) or usual care intervention (UC) only., Methods: Between April 2016 and June 2019, we conducted a randomized clinical trial. Pregnant women and new parents were randomly assigned to the VAYB, UT, or UC arms. In the VAYB and UT arms, participants were exposed to interventions at 4 time points from pregnancy until their child was 15 months of age. The primary outcome was up-to-date status for recommended vaccines from birth to 200 days of age. A modified intent-to-treat analysis was conducted. Data were analyzed with logistic regression to generate odds ratios (ORs) and 95% confidence intervals (CIs)., Results: We enrolled 824 participants (276 VAYB, 274 UT, 274 UC), 143 (17.4%) of whom were lost to follow-up. The up-to-date rates in the VAYB, UT, and UC arms were 91.44%, 92.86%, and 92.31%, respectively. Infants in the VAYB arm were not more likely to be up to date than infants in the UC arm (OR = 0.89; 95% CI, 0.45-1.76) or in the UT arm (OR = 0.82; 95% CI, 0.42-1.63). The odds of being up to date did not differ between UT and UC arms (OR = 1.08; 95% CI, 0.54-2.18)., Conclusions: Delivering Web-based vaccine messages tailored to parents' vaccine attitudes and values did not positively impact the timely uptake of infant vaccines., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2020 by the American Academy of Pediatrics.)

Background: Vaccine hesitancy among parents leads to childhood undervaccination and outbreaks of vaccine-preventable disease. As the reasons for vaccine hesitancy are diverse, there is often not enough time during regular clinical visits for medical providers to adequately address all the concerns that parents have. Providing individually tailored vaccine information via the internet before a clinical visit may be a good mechanism for effectively allaying parents' vaccination concerns while also being time efficient. Including tailoring based on values is a promising, but untested, approach to message creation., Objective: This study aimed to describe the process by which we developed a Web-based intervention that is being used in an ongoing randomized controlled trial aimed at improving the timeliness of infant vaccination by reducing parental vaccine hesitancy., Methods: Development of the intervention incorporated evidence-based health behavior theories. A series of interviews, surveys, and feedback sessions were used to iteratively develop the intervention in collaboration with vaccination experts and potential end users., Results: In all, 41 specific content areas were identified to be included in the intervention. User feedback elucidated preferences for specific design elements to be incorporated throughout the website. The tile-based architecture chosen for the website was perceived as easy to use. Creating messages that were two-sided was generally preferred over other message formats. Quantitative surveys identified associations between specific vaccine values and vaccination beliefs, suggesting that values tailoring should vary, depending on the specific belief being endorsed., Conclusions: Using health behavior theories, qualitative and quantitative data, and significant expert and end user input, we created a novel, Web-based intervention to improve infant vaccination timeliness. The intervention is based on tailoring messages according to each individual's values and beliefs. This intervention is currently being tested in a controlled randomized clinical trial., (©Amanda Frisch Dempsey, Bethany M Kwan, Nicole M Wagner, Jennifer Pyrzanowski, Sarah E Brewer, Carter Sevick, Komal Narwaney, Kenneth Resnicow, Jason Glanz. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 05.03.2020.)

Objective: Evidence-based strategies to address vaccine hesitancy are lacking. Personal values are a measurable psychological construct that could be used to deliver personalized messages to influence vaccine hesitancy and behavior. Our objectives were to develop a valid, reliable self-report survey instrument to measure vaccine values based on the Schwartz theory of basic human values, and to test the hypothesis that vaccine values are distinct from vaccine attitudes and are related to vaccine hesitancy and behavior., Methods: Parental Vaccine Values (PVV) scale items were generated using formative qualitative research and expert input, yielding 24 items for testing. 295 parents of children aged 14-30 months completed a self-report survey with measures of Schwartz's global values, the PVV, vaccine attitudes, and vaccine hesitancy. Factor analysis was used to determine vaccine values factor structure. Associations between vaccine values, vaccine attitudes, vaccine hesitancy, and vaccination behavior were assessed using linear and logistic regression models. Late vaccination was assessed from electronic medical records., Results: A six-factor structure for vaccine values was determined with good fit (RMSEA = 0.07, Bentler's CFI = 0.91) with subscales for Conformity, Universalism, Tradition, Self-Direction, Security- Disease Prevention, and Security- Vaccine Risk. Vaccine values were moderately associated with Schwartz global values and vaccine attitudes, indicating discriminant validity from these constructs. Multivariable linear regression showed vaccine hesitancy was associated with vaccine values Conformity (partial R 2  = 0.10) and Universalism (0.04) and vaccine attitudes Vaccine Safety (0.52) and Vaccine Benefit (0.16). Multivariable logistic regression showed that late vaccination was associated with vaccine value Self-direction (OR = 1.80, 95% CI: 1.26-2.65) and vaccine attitude of Vaccine Benefit (OR = 0.44, 95% CI: 0.32-0.60)., Conclusions: The PVV scale had good psychometric properties and appears related to but distinct from Schwartz global values and vaccine attitudes. Vaccine values are associated with vaccine hesitancy and late vaccination and may be useful in tailoring future interventions., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Objective: To test the effectiveness of a multimodal intervention in obstetrics/gynecology (ob-gyn) clinics to increase uptake of influenza and tetanus-diphtheria-acellular pertussis (Tdap) vaccines in pregnant women and these vaccines plus human papillomavirus (HPV) vaccine in non-pregnant women., Methods: A cluster randomized controlled trial among 9 private ob-gyn practices in Colorado from 9/2011 to 5/2014. The intervention consisted of: designation of immunization champions, staff/provider trainings, assistance with vaccine purchasing/management, identification of eligible patients, standing order implementation, chart review/feedback, and patient education materials. Control practices continued usual care. Primary outcomes were receipt of influenza and Tdap vaccines among pregnant women and these vaccines plus HPV vaccine among non-pregnant women, comparing a Baseline period (Year 0/Year 1) to Year 2, intervention versus control. With an estimated sample size of 32,590 per arm, there would be >80% power to detect a 10% difference between groups., Results: In the Baseline period, 27% of pregnant women in both intervention and control practices received influenza vaccine. In Year 2, 29% of pregnant women in intervention practices received influenza vaccine versus 41% in control practices. In the Baseline period, 18% of pregnant women in intervention practices received Tdap vaccine versus 22% in control practices. Both intervention and control practices increased to 51% in Year 2, representing an increase of 33% for intervention practices and 29% for control practices, consistent with a change in Tdap recommendations. Relatively few HPV, influenza or Tdap vaccines (≤6% of eligible patients) were given to non-pregnant patients in either intervention or control practices at any time during the study., Conclusion: In this cluster randomized trial designed to increase vaccination uptake, both intervention and control practices showed improved vaccination of pregnant but not non-pregnant patients. Future work should focus on tailoring evidence-based immunization practices or developing new approaches to specifically fit busy ob-gyn offices., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Objectives: To assess among pregnant and recently delivered women the timing of thinking about and seeking information about childhood vaccines and the preferred modes of vaccine education., Study Design: An e-mail survey among women in 9 urban and rural obstetrics practices in Colorado was conducted from February to April 2014, timed so that approximately one-half had delivered and one-half were still pregnant, designed to assess the frequency of thinking about and seeking information about vaccines in relation to estimated or actual delivery date. A shortened version of the Parental Attitudes About Childhood Vaccines scale was used to assess vaccine hesitancy., Results: The response rate was 54% (230 of 425); 56% were pregnant, 44% had delivered, and 18% were vaccine-hesitant. Compared with pregnant women, women who had delivered more often reported thinking about vaccines for their infant (pregnant: 19% often, 42% sometimes; delivered: 29% often, 51% sometimes; P < .05) and looking for information about vaccines (pregnant: 6% often, 22% sometimes; delivered: 16% often, 34% sometimes; P < .01). Women most frequently reported seeking information about vaccines 2-4 weeks after delivery, followed by 4-6 weeks after delivery. The most preferred method for vaccine education was their child's doctor (95% acceptable; 92% likely to use) followed by their obstetrician (79% acceptable; 64% likely to use)., Conclusions: Within 6 weeks postdelivery appears to be when the most women seek vaccine information. A child's doctor remains the most acceptable source of vaccine education., (Copyright © 2018. Published by Elsevier Inc.)

Background: Vaccination is the preferred preventive strategy against influenza. Though health behaviors are known to affect immunity and vaccine delivery modes utilize different immune processes, data regarding the preferred influenza vaccine type among adults endorsing specific health-related behaviors (alcohol use, tobacco use, and exercise level) are limited., Methods: The relative effectiveness of two currently available influenza vaccines were compared for prevention of influenza-like illness during 2 well-matched influenza seasons (2006/2007, 2008/2009) among US military personnel aged 18-49 years. Relative vaccine effectiveness was compared between those self-reporting and not reporting recent smoking history and potential alcohol problem, and by exercise level using Cox proportional hazard modeling adjusted for sociodemographic and military factors, geographic area, and other health behaviors., Results: 28,929 vaccination events and 3936 influenza-like illness events over both influenza seasons were studied. Of subjects, 27.5% were smokers, 7.7% had a potential alcohol-related problem, 10.5% reported minimal exercise, and 4.4% reported high exercise levels. Overall, the risk of influenza-like illness did not significantly differ between live attenuated and trivalent inactivated influenza vaccine recipients (hazard ratio, 0.98; 95% confidence interval, 0.90-1.06). In the final adjusted model, the relative effectiveness of the 2 vaccine types did not differ by smoking status (p = 0.10), alcohol status (p = 0.21), or activity level (p = 0.11)., Conclusions: Live attenuated and trivalent inactivated influenza vaccines were similarly effective in preventing influenza-like illness among young adults and did not differ by health-related behavior status. Influenza vaccine efforts should continue to focus simply on delivering vaccine.

In response to bioterrorism threats, anthrax vaccine has been used by the US military and considered for civilian use. Concerns exist about the potential for adverse reproductive health effects among vaccine recipients. This retrospective cohort evaluated birth defects, in relation to maternal anthrax vaccination, among all infants born to US military service women between 1998 and 2004. Department of Defense databases defined maternal vaccination and infant diagnoses; multivariable regression models described potential associations between anthrax vaccination and birth defects in liveborn infants. Among 115,169 infants born to military women during this period, 37,140 were born to women ever vaccinated against anthrax, and 3,465 were born to women vaccinated in the first trimester of pregnancy. Birth defects were slightly more common in first trimester-exposed infants (odds ratio = 1.18, 95% confidence interval: 0.997, 1.41) when compared with infants of women vaccinated outside of the first trimester, but this association was statistically significant only when alternative referent groups were used. Although the small observed association may be unlikely to represent a causal relation between vaccination in early pregnancy and birth defects, this information should be considered when making decisions about administering anthrax vaccine to pregnant women.

Background: Women serving in the US military have some unique occupational exposures, including exposure to vaccinations that are rarely required in civilian professions. When vaccinations are inadvertently given during pregnancy, such exposures raise special concerns. These analyses address health outcomes, particularly preterm births and birth defects, among infants who appear to have been exposed to maternal smallpox vaccination in pregnancy., Methods: This retrospective cohort study included 31,420 infants born to active-duty military women during 2003-2004. We used Department of Defense databases to define maternal vaccination and infant health outcomes. Multivariable regression models were developed to describe associations between maternal smallpox vaccination and preterm births and birth defects in liveborn infants., Results: There were 7,735 infants identified as born to women ever vaccinated against smallpox, and 672 infants born to women vaccinated in the first trimester of pregnancy. In multivariable modeling, maternal smallpox vaccination in pregnancy was not associated with preterm or extreme preterm delivery. Maternal smallpox vaccination in the first trimester of pregnancy was not significantly associated with overall birth defects (OR 1.40; 95% CI: 0.94, 2.07), or any of seven specific defects individually modeled., Conclusions: Results may be reassuring that smallpox vaccine, when inadvertently administered to pregnant women, is not associated with preterm delivery or birth defects in liveborn infants., ((c) 2008 Wiley-Liss, Inc.)

Concerns exist regarding reproductive health, including potential infertility, among young adults with military-related occupational exposures. This study evaluated infertility diagnoses in a large population of healthy young adults in relation to prior smallpox vaccination. Using a retrospective cohort design, the population consisted of United States military members eligible for smallpox vaccination in 2003-2004 who had electronic health care utilization records available through at least December 2005. Multivariable logistic regression models were applied to evaluate infertility among male and female populations separately. Among 253,973 men and 44,332 women included in these analyses, the adjusted odds of infertility diagnoses in those with prior smallpox vaccination were 0.94 [95% confidence interval (CI), 0.83-1.06] and 1.10 (95% CI, 0.94-1.28), respectively. Therefore, no association was found between smallpox vaccination and subsequent infertility diagnoses in either men or women. This study represents the first large epidemiologic investigation of infertility after the smallpox vaccine.

A recent childhood vaccine promotion intervention trial showed no effects on vaccination outcomes relative to usual care. The purpose of this paper was to test assumptions and theory‐based relationships underlying hypothesised mechanisms for two vaccine promotion educational websites (one tailored to parental values, beliefs, and intentions; one untailored) compared with usual care. This is a secondary analysis of a three‐arm randomized controlled trial. Parental vaccine values, hesitancy, attitudes, and intention to vaccinate surveys were administered at baseline (≤2 months) and at 4–6 and 10–12 months of age. Vaccination was assessed using electronic health records. Analyses included random coefficient models and risk differences with exact confidence limits. Parental vaccine values were mostly stable over time. Vaccine attitudes were generally positive, with no differences among study arms. Both tailored and untailored website arms showed similar increases in intention to vaccinate more than usual care. Positive changes in intentions were associated with lower rates of late vaccination. Although attitudes and intentions predicted vaccination behavior and the intervention increased intention to vaccinate all on time, the web‐based education and values‐tailored messaging approaches were not effective at increasing vaccination rates. Intentions are necessary but insufficient targets for vaccine promotion interventions. [ABSTRACT FROM AUTHOR]

Objective: To determine the costs and reimbursement associated with running a vaccine program in 5 obstetrics/gynecology practices in Colorado that had participated in a 3-year randomized, controlled trial focused on increasing vaccination in this setting.Materials and Methods: This was a secondary analysis on costs from 5 clinics participating in a cluster-randomized controlled trial that assessed the effectiveness of a multimodal intervention to improve vaccination rates in outpatient obstetrics/gynecology clinics in central Colorado. The intervention included designation of an immunization champion within the practice, purchasing recommended vaccines for the practice, guidance on storage and management, implementing practices for routine identification of eligible patients for vaccination using the medical record, implementation of standing orders for vaccination, and vaccine administration to patients. Data on costs were gathered from office invoices, claims data, surveys and in-person observations during the course of the trial. These data incorporated supply and personnel costs for administering vaccines to individual patients that were derived from a combination of time-motion studies of staff and provider clinical activity, and practice reports, as well as costs related to maintaining the vaccination program at the practice level, which were derived from practice reports and invoices. Cost data for personnel time during visits in which vaccination was assessed and/or discussed, but no vaccine was given to the patient were also included in the main analysis. Data on practice revenue were derived from practice reimbursement records. All costs were described in 2014 dollars. The primary analysis was the proportion of costs for the program that were reimbursed, aggregated over all years of the study and combining all vaccines and practices, separated by obstetrics vs gynecology patients.Results: Collectively the 5 clinics served >40,000 patient during the study period and served a population that was 16% Medicaid. Over the 3-year observation period, there were 6573 vaccination claims made collectively by the practices (4657 for obstetric patients, 1916 for gynecology patients). The most expensive component of the program was the material costs of the vaccines themselves, which ranged from a low of $9.67 for influenza vaccines, to a high of $141.40 for human papillomavirus vaccine. Staff costs for assessing and delivering vaccines during patient visits were minimal ($0.09-$1.24 per patient visit depending on the practice and whether an obstetrics or gynecology visit was being assessed) compared with staff costs for maintaining the program at a practice level (ie, assessing inventory, ordering and stocking vaccines; $0.89-$105.89 per vaccine dose given). When assessing all costs compared with all reimbursement, we found that vaccines for obstetrics patients were reimbursed at 159% of the costs over the study period, and for gynecology patients at 97% of the costs. Overall, the vaccination program was financially favorable across the practices, averaging 125% reimbursement of costs across the three study years.Conclusion: Providing routine vaccines to patients in the ambulatory obstetrics/gynecology setting is generally not financially prohibitive for practices, and may even be financially beneficial, though there is variability between practices that can affect the overall reimbursement margin. [ABSTRACT FROM AUTHOR]

The article discusses research on the efficacy of pandemic H1N1 influenza vaccine on pregnant women and their newborn babies. The retrospective cohort study conducted among active-duty military pregnant women compared effects of vaccination with pandemic H1N1 vaccine with seasonal influenza vaccine. It discusses effects on rates of pregnancy loss, reclaims or eclampsia, and preterm labor with a consequent study on newborns on preterm birth, birth defects and fetal growth issues.

Objective To update a previous assessment of birth defects among infants born to active duty U.S. military mothers who received the 2009–2010 pandemic H1N1 vaccine, in comparison to the 2008–2009 seasonal influenza vaccine, during pregnancy. Here, we updated the previous comparative analyses with a more refined definition for birth defects using an additional year of follow-up data from both inpatient and outpatient medical encounters. Methods The study population included 15,510 live born infants born to active duty mothers vaccinated during pregnancy with either the 2009–2010 pandemic H1N1 vaccine (n = 9033) or the 2008–2009 seasonal influenza vaccine (n = 6477). Birth defect cases were defined as those infants who received a birth defect diagnosis on one inpatient record or two outpatient records on different days within the first year of life. Multivariable logistic regression models were conducted to estimate the odds ratios (ORs) and 95% confidence intervals (CIs) for the association between birth defects and maternal vaccination during pregnancy with pandemic H1N1 vaccine versus seasonal influenza vaccine. Results Infants born to mothers vaccinated during pregnancy with the pandemic H1N1 vaccine, versus the seasonal influenza vaccine, were not at increased odds of birth defects in univariable (OR: 1.13, 95% CI: 0.95–1.34) or multivariable (OR: 1.14, 95% CI: 0.96–1.35) models. Findings were not significant when further limited to first trimester exposure. Multivariable models were adjusted for infant sex and plurality; maternal age, race/ethnicity, marital status, service branch, military rank, and occupation; timing of vaccination; and receipt of vaccination(s) not routinely recommended during pregnancy. Conclusion Comparable to our previous analyses assessing birth defects diagnosed at birth, no significant association was found between the pandemic H1N1 vaccination during pregnancy and birth defects, versus the seasonal influenza vaccine. These findings are reassuring and provide additional support for H1N1-containing seasonal influenza vaccination during pregnancy. [ABSTRACT FROM AUTHOR]

Background Anthrax vaccine adsorbed (AVA) vaccination is compulsory for United States military servicemembers with operational indicators. As the number of female military servicemembers has increased, so has the chance of inadvertent AVA vaccination during pregnancy. Building upon past analyses assessing AVA vaccination during pregnancy and birth defects risk, this study sought to determine if inadvertent AVA vaccination during pregnancy is significantly associated with risk of birth defects after adjusting for other potential risk factors. Methods The study population included 126,839 liveborn infants in the Department of Defense Birth and Infant Health Registry (2003–2010). Mothers were categorized by AVA vaccination exposure timing in relation to pregnancy. Infant medical records were assessed for birth defect diagnoses within the first year of life. Multivariable logistic regression was used to calculate odds ratios (ORs) and 95% confidence intervals (CIs). Results Infants of first trimester AVA vaccinated mothers versus receipt at any other time point (OR, 1.10; 95% CI, 0.93–1.29) were not at higher odds of birth defects in adjusted models. Infants of mothers vaccinated prepregnancy versus postpregnancy had a 1.11 (95% CI, 1.01–1.22) higher odds of having a birth defect. Vaccination postpregnancy versus never vaccinated revealed a 10% lower odds of birth defects (OR, 0.90; 95% CI, 0.83–0.99). Conclusions No strong associations between inadvertent AVA vaccination during pregnancy and birth defects risk were observed. Marginal associations between prepregnancy vaccination or never vaccinated women and birth defects risk was observed when compared to postpregnancy vaccination. These findings may be due to self-selection and/or reverse causation bias when assessing comparisons with postpregnancy vaccination, and a “healthy worker” effect when assessing comparisons with women never vaccinated. [ABSTRACT FROM AUTHOR]