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Abstract Background COVID-19 inequities are abundant in low-income communities of color. Addressing COVID-19 vaccine hesitancy to promote equitable and sustained vaccination for underserved communities requires a multi-level, scalable, and sustainable approach. It is also essential that efforts acknowledge the broader healthcare needs of these communities including engagement in preventive services. Methods This is a hybrid type 3 effectiveness-implementation study that will include a multi-level, longitudinal, mixed-methods data collection approach designed to assess the sustained impact of a co-created multicomponent strategy relying on bidirectional learning, shared decision-making, and expertise by all team members. The study capitalizes on a combination of implementation strategies including mHealth outreach with culturally appropriate messaging, care coordination to increase engagement in high priority preventive services, and the co-design of these strategies using community advisory boards led by Community Weavers. Community Weavers are individuals with lived experience as members of an underserved community serving as cultural brokers between communities, public health systems, and researchers to co-create community-driven, culturally sensitive public health solutions. The study will use an adaptive implementation approach operationalized in a sequential multiple assignment randomized trial design of 300 participants from three sites in a Federally Qualified Health Center in Southern California. This design will allow examining the impact of various implementation strategy components and deliver more intensive support to those who benefit from it most. The primary effectiveness outcomes are COVID-19 vaccine completion, engagement in preventive services, and vaccine confidence. The primary implementation outcomes are reach, adoption, implementation, and maintenance of the multicomponent strategy over a 12-month follow-up period. Mixed-effects logistic regression models will be used to examine program impacts and will be triangulated with qualitative data from participants and implementers. Discussion This study capitalizes on community engagement, implementation science, health equity and communication, infectious disease, and public health perspectives to co-create a multicomponent strategy to promote the uptake of COVID-19 vaccination and preventive services for underserved communities in San Diego. The study design emphasizes broad engagement of our community and clinic partners leading to culturally sensitive and acceptable strategies to produce lasting and sustainable increases in vaccine equity and preventive services engagement. Trial registration ClinicalTrials.gov Identifier: NCT05841810 May 3, 2023

The worldwide elimination of measles and rubella is feasible, but not without overcoming the substantial challenge of vaccine hesitancy. This challenge is complicated by the spread of misinformation and disinformation fueled by rapidly progressing technologies and evolving forms of online communication. The recent COVID-19 pandemic has only added further complexity to this challenge. However, considerable progress has been made in understanding the scope of the problem and the complex factors that influence vaccine hesitancy. Our understanding of evidence-based strategies for addressing vaccine hesitancy has grown significantly, including evidence for effective communication and behavioral interventions. In this article, we review measles and rubella vaccines and vaccine hesitancy. We then provide an overview of evidence-based strategies for addressing vaccine hesitancy, including communication strategies and behavioral interventions. This article is relevant to healthcare professionals, health system leaders, public health professionals, policymakers, community leaders, and any individuals who have a role in addressing vaccine hesitancy in their communities. Finally, we review future directions and major areas of research need.

Abstract Background Many pregnant women and parents have concerns about vaccines. This analysis examined the impact of MomsTalkShots, an individually tailored educational application, on vaccine attitudes of pregnant women and mothers. Methods MomsTalkShots was the patient-level component of a multi-level intervention to improve maternal and infant vaccine uptake that also included provider- and practice-level interventions. The impact of these interventions was studied using a two-by-two factorial design, randomizing at both the patient- and the practice-level. Study staff recruited pregnant women from a diverse set of prenatal care practices in Colorado and Georgia between June 2017 and July 2018. All participants (n = 2087) received a baseline survey of maternal and infant vaccine intentions and attitudes, and two follow-up surveys at least 1 month and 1 year after their infant’s birth, respectively. Half of participants (n = 1041) were randomly assigned to receive educational videos through MomsTalkShots, algorithmically tailored to their vaccine intentions, attitudes, and demographics. Since the practice/provider intervention did not appear impactful, this analysis focused on MomsTalkShots regardless of the practice/provider intervention. Results By 1 month post-birth, MomsTalkShots increased perceived risk of maternal influenza disease (61% among MomsTalkShots recipients vs 55% among controls; Odds Ratio: 1.61, 95% Confidence Interval: 1.23–2.09), confidence in influenza vaccine efficacy (73% vs 63%; OR: 1.97, 95%CI: 1.47–2.65), and perceived vaccine knowledge (55% vs 48%; OR: 1.39, 95%CI: 1.13–1.72). Among those intending not to vaccinate at baseline, MomsTalkShots increased perceived risk of maternal influenza disease (38% vs 32%; OR: 2.07, 95%CI: 1.15–3.71) and confidence in influenza vaccine efficacy (44% vs 28%; OR: 2.62, 95%CI: 1.46–4.69). By 1 year post-birth, MomsTalkShots increased perceived vaccine knowledge (62% vs 50%; OR: 1.74, 95%CI: 1.36–2.24) and trust in vaccine information from obstetricians and pediatricians (64% vs 55%; OR: 1.53, 95%CI: 1.17–2.00). Among those uncertain about vaccinating at baseline, MomsTalkShots increased perceived vaccine knowledge (47% vs 12%; OR: 6.89, 95%CI: 1.52–31.25) and reduced infant vaccine safety concerns (71% vs 91%; OR: 0.24, 95%CI: 0.06–0.98). Conclusions MomsTalkShots improved pregnant women’s and mothers’ knowledge and perceptions of maternal and infant vaccines and the diseases they prevent, and offers a scalable tool to address vaccine hesitancy. Trial registration Registered at Clinicaltrials.gov on 13/09/2016 (registration number: NCT02898688).

The American Academy of Pediatrics (AAP) recommends starting the human papillomavirus (HPV) vaccine series between 9 and 12 years, at an age that the provider deems optimal for acceptance and completion of the vaccination series. This recommendation differs from the Advisory Committee on Immunization Practices (ACIP), which recommends HPV vaccination be initiated at age 11 or 12 years, stating the series can be started at age 9 years. This commentary discusses the reasoning behind AAP’s decision to differ from ACIP, as the AAP and ACIP schedules are essentially harmonized for all other vaccines. Reasons include recognition that (1) vaccination uptake is suboptimal; (2) offering vaccination earlier offers provider’s flexibility in introducing the vaccine; (3) initiating the vaccine at age 9 or 10 may be preferable for parents or adolescents who do not want to receive ≥3 concomitant vaccines at age 11 or 12; (4) earlier initiation may disentangle HPV recommendations from discussions of sexuality; (5) earlier recommendation might alleviate HPV vaccine hesitancy “fatigue;” (6) the immune response is robust at younger ages with no evidence of waning protection; and (7) there is a dearth of evidence supporting starting the recommendation at age 11 or 12 within the “adolescent immunization platform.”

Abstract Background Respiratory conditions are the leading cause of hospitalization and death in children with Trisomy 21 (T21). Diffuse alveolar hemorrhage (DAH) occurs at higher frequency in children with T21; yet, it is not widely studied nor is there a standardized approach to diagnosis or management. The objective of this study was to identify children with T21 and DAH in order to understand contributing factors and identify opportunities to improve outcomes. We identified 5 children with T21 at a single institution with histology-proven DAH over 10 years and discuss their presentation, evaluation, management, and outcomes. We also reviewed the cases in the literature. Case presentation Patient 1 died at age seven due to secondary hemophagocytic lymphohistiocytosis. DAH was seen on autopsy. Patient 2 was a three-year-old with systemic-onset juvenile idiopathic arthritis diagnosed with DAH after presenting for hypoxia. Patient 3 was diagnosed with DAH at age nine after presenting with recurrent suspected pneumonia and aspiration. Patient 4 was diagnosed with DAH at age eight after presenting with pallor and fatigue. She had additional ICU admissions for DAH with infections. Patient 5 developed hemoptysis at age three and had recurrent DAH for 10 years. Four patients responded positively to immune-modulation such as intravenous immunoglobulin, glucocorticoids, and rituximab. Of the 19 patients identified in the literature, only one was from the United States. The majority had anemia, respiratory distress, autoantibodies, and recurrences. Very few patients had hemoptysis. Idiopathic pulmonary hemosiderosis was the most common diagnosis. Almost all received glucocorticoids with or without additional immunosuppression. The majority of our patients and those in the literature had positive auto-antibodies such as anti-neutrophil cytoplasmic antibodies and anti-nuclear antigen antibodies. Diagnostic clues included respiratory distress, hypoxia, anemia, recurrent pneumonia, and/or ground glass opacities on imaging. We identified four contributors to DAH: structural lung abnormalities, pulmonary arterial hypertension, infection/aspiration, and autoimmune disease/immune dysregulation. Conclusion These cases demonstrate the need for an increased index of suspicion for DAH in children with T21, particularly given the low frequency of hemoptysis at presentation, enrich the understanding of risk factors, and highlight the favorable response to immunosuppressive therapies in this vulnerable population.

Background: Recent outbreaks of vaccine-preventable diseases have affected members of religious communities. While major religions support vaccines, the views of individual clergy who practice and propagate major faith traditions are unclear. Our objective was to explore clergy attitudes toward vaccines and vaccine advocacy. Methods: In 2018–2019, we conducted qualitative interviews with clergy in Colorado and North Carolina. We inductively analyzed transcripts using a grounded theory approach, developing codes iteratively, resolving disagreements by consensus, and identifying themes. Results: We interviewed 16 clergy (1 Buddhist, 3 Catholic, 2 Jewish, 1 Hindu, 1 Islamic, 7 Protestant, and 1 Unity). Analyses yielded seven themes: attitudes toward vaccines, congregational needs, public health climate, perceived responsibility, comfort and competing interests, reported advocacy efforts, and clergy health advocacy goals. Most clergy had positive vaccination attitudes and were open to vaccine advocacy, although discomfort with medical concepts and competing interests in their congregations influenced whether many had chosen to advocate for vaccines. Over half reported promoting vaccination in various contexts. Conclusions: In our sample, U.S. clergy held complex attitudes toward vaccines, informed by experience and social norms as much as religious beliefs or Scriptures. Clergy may be open to vaccine advocacy, but a perceived lack of relevance in their faith communities or a lack of medical expertise may limit their advocacy efforts in diverse contexts. Amidst growing vaccine hesitancy, pediatricians could partner with clergy in their communities, answer questions about vaccines, raise awareness of recent outbreaks, and empower clergy in joint educational events.

Childhood vaccination is one of the greatest public health achievements of the 20th century, yet increasingly, parents question the safety of and need for vaccines. This has led to increased rates of vaccine delay and refusal and outbreaks of vaccine-preventable diseases. Physicians struggle with how to respond to families who refuse vaccines, as there are few known effective interventions to convince a family to vaccinate. In the United States, the practice of dismissing families for vaccine refusal appears to be increasing as a strategy for dealing with vaccine refusal. In this review, we review the literature surrounding this controversial practice, starting with the impact that vaccine-refusing families have on medical practices, followed by a review of dismissal policies of US physicians, and ending with a discussion of the ethics of this practice.

Vaccine coverage for maternal vaccines is suboptimal; only about half of pregnant women received influenza and Tdap vaccines in 2018. We explored knowledge, attitudes, beliefs, intentions, and trust regarding maternal and infant vaccines among pregnant women. Between June 2017 and July 2018, we surveyed 2196 pregnant women recruited from geographically and socio-demographically diverse prenatal care practices in Georgia and Colorado (56% response rate). Fifty-six percent of pregnant women intended to receive both influenza and Tdap vaccines during pregnancy and 68% intended to vaccinate their baby with all recommended vaccines on time. Attitudinal constructs associated with intention to vaccinate include confidence in vaccine safety (ORs: 16–38) and efficacy (ORs: 4–19), perceived risk of vaccine-preventable diseases (ORs: 2–6), social norms (ORs: 4–10), and trust in sources of vaccine information. Women pregnant with their first child were less likely than women who had prior children to intend to vaccinate themselves and their children, more likely to be unsure about their intentions to receive both maternal and infant vaccines, and less likely to report feeling they had enough knowledge or information about vaccines and vaccine safety (p < .01). This demonstrates an opportunity for vaccine education to increase vaccine confidence and informed decision-making, especially among first-time pregnant women.

The coronavirus disease 2019 (COVID-19) first came to the Unites States in January 2020. Though adult and pediatric vaccines became available to the public, vaccine uptake among youth and particularly younger children has been gradual. This explanatory study aimed to better understand parents’ attitudes and beliefs of the pediatric COVID-19 vaccine and the barriers and facilitators to vaccine uptake in a rural community through a brief, online demographic survey, and in-depth qualitative interviews. Forty-one in depth interviews were conducted with parents (31-English and 10-Spanish-speaking) residing in rural and frontier counties in Colorado between September 2021 and February 2022. Six emergent themes related to COVID-19 pediatric vaccine uptake were identified among the population. These themes spanned the three levels of influence in the Social Ecological Model (individual, interpersonal, and community levels). The six themes were identified as such; 1) Vaccine accessibility was associated with pediatric COVID vaccine uptake in rural communities, 2) Previous pediatric vaccine behaviors were not associated with COVID-19 pediatric vaccine uptake, 3) Perceived health status of a child or family member influenced pediatric COVID-19 vaccine uptake, 4) COVID-19 health seeking behaviors, like COVID pediatric vaccine uptake, are influenced by an individual’s prosocial or individualistic perspectives, 5) Child autonomy and “age of consent” frames vaccine decision making behaviors in parents, and lastly 6) Social networks impacted COVID-19 pediatric vaccine decision making. These findings inform next steps for COVID-19 pediatric vaccine uptake including targeted and tailored messaging for communities (cues to actions), engaging youth stakeholders, and identifying trusted sources to build rapport and trust between health professionals and community members. The growing vaccine hesitancy among parents has serious implications for disease eradication and future viral outbreaks. Understanding the perceived barriers and facilitators to pediatric vaccine uptake is important to maintain the health of our youth and communities.

Introduction: Religious vaccine exemptions are widely available and increasing despite decreases in American religiosity. We tested associations between religion, religiosity, and caregiver vaccine hesitancy in a sample of caregivers of 2-year-olds. Methods: We analyzed data from a 2020 survey in three pediatric clinics, estimating distinct multivariable logistic regression models to examine associations. Results: Our sample included 255 predominantly poor, Latino, Christian, and English-speaking caregivers (response rate: 90%); 13% were vaccine hesitant. Caregivers identifying with major faith traditions were not more likely to be hesitant than those without a tradition (adjusted odds ratio 1.46; 95% CI 0.29, 7.26). There were no significant associations between caregiver vaccine hesitancy and three religiosity domains. Conclusions: We found no associations between parental vaccine hesitancy, religiosity, or adherence to a major faith tradition in a sample of mostly poor, Latino, Christian mothers. Additional work is needed to inform exemption policies and public health and faith leaders.

There is a critical need for campaigns and interventions to increase rates of human papillomavirus (HPV) vaccination among U.S. adolescents. Healthcare providers are key stakeholders in parents’ HPV vaccine decision-making. The current study presents the evaluation of secondary outcomes in a multi-component communication-based intervention to improve healthcare providers’ communication about HPV vaccination. Evaluation was conducted via surveys of providers participating in a 12-month randomized controlled trial. Findings suggest use of communication components (combined use of the presumptive approach [PA] with all patients, and motivational interviewing and a fact sheet with vaccine hesitant parents) contributed to providers in the intervention group reporting higher perceived levels of parental HPV vaccine acceptance than control providers, as well as increased vaccination rates in the intervention arm in the main RCT.

We conducted a qualitative study from 2018 to 2019 to update the reasons why US parents’ refuse or delay vaccines. Four focus groups and 4 semi-structured interviews involving 33 primary care pediatric providers were conducted in Washington and Colorado. A thematic analysis was conducted to identify themes related to reasons for parental refusal or delay. Five predominant themes were identified: (1) vaccine safety, (2) relative influence of information sources, decision-makers, and timing, (3) low perceived risk of contracting vaccine-preventable disease, (4) lack of trust, and (5) religious objection. Vaccine safety was the theme mentioned most frequently by providers (N = 45 times by 26 providers) and religious objection to vaccination was referred to the least (N = 6 times by 6 providers). Provider-reported reasons for parental refusal or delay of childhood vaccines in 2018 to 2019 remain similar to those reported in previous studies.

Introduction Vaccination against influenza and pertussis in pregnancy offers a ‘two-for-one’ opportunity to protect mother and child. Pregnant patients have increased risk of severe disease from influenza and newborns have increased risk of severe disease from both influenza and pertussis. Obstetricians need communication tools to support their self-efficacy and effectiveness in communicating the importance of immunisation during pregnancy and ultimately improving maternal vaccination rates.Methods and analysis We describe the protocol for a pragmatic study testing the feasibility and potential impact of a clinician communication strategy on maternal vaccination uptake. This study will be conducted in five prenatal care settings in Colorado, USA. The Motivational Interviewing for Maternal Immunisation strategy involves training prenatal care providers to use motivational interviewing in the vaccine conversation with pregnant patients. Our primary outcomes will be the adoption and implementation of the intervention measured using the Enhanced RE-AIM/Practical Robust Implementation and Sustainability Model for dissemination and implementation. Secondary outcomes will include provider time spent, fidelity to Motivational Interviewing and self-efficacy measured through audio recorded visits and provider surveys, patients’ visit experience based on audio recorded visits and follow-up interviews, and maternal vaccine uptake as measured through chart reviews.Ethics and dissemination This study is approved by the following institutional review boards: Colorado Multiple Institutional Review Board. Results will be disseminated through peer-reviewed manuscripts and conference presentations.Trial registration number NCT04302675.

Introduction: Influenza vaccination during pregnancy can offer many benefits to both mother and infant. Despite recommendations from the Advisory Committee on Immunization Practices, vaccine coverage rates among pregnant women during pregnancy are below 40% in the United States. There is a need for a greater understanding of what interventions can improve vaccine uptake among pregnant women. Areas covered: This review synthesizes the existing evidence on the effectiveness of interventions to improve maternal influenza vaccine uptake. These interventions are examined within the framework of the three psychological propositions: thoughts and feelings, social processes and changing behavior directly. Expert commentary: A number of promising and effective interventions were identified in this review. Nudge-based interventions that build on favorable intentions to vaccinate such as provider prompts and standing orders have demonstrated significant success in improving influenza vaccine uptake. However, substantial gaps in the literature still exist. Provider recommendations are the most important predictor of vaccine receipt among pregnant women, yet few studies evaluated intervening to improve the dialogue between patient and provider. With the potential for even more vaccines to be added to the maternal immunization schedule, it is vitally important to understand how to improve uptake.

Pregnancy is an ideal time to communicate with women about vaccines for themselves and their infants, yet maternal immunization rates remain suboptimal. This study aimed to identify clinic, provider, and staff-related attributes and facilitators to be utilized for a comprehensive vaccine intervention in ob-gyn clinical settings. We conducted in-depth interviews with 24 providers, both healthcare providers (e.g., physicians, nurse practitioners, midwives) and practice managers, from urban and suburban ob-gyn practices in Georgia and Colorado about their immunization attitudes, practices, and patient experiences. Qualitative analyses included Pearson correlation tests to evaluate patterns and relationships within the data to determine themes. Six major themes emerged: 1) strong provider “buy in” for maternal immunization; 2) the supporting role of clinical/interpersonal cues for vaccine promotion; 3) varying provider-patient communication approaches and its influence on maternal and pediatric uptake; 4) an urgent need for a designated office immunization champion; 5) reimbursement and practice implementation challenges; and 6) region differences in attitudes and values toward maternal immunization. Although providers expressed strong support for maternal immunization practices and offered environmental cues for vaccine promotion, practices often lacked a designated, structured role for an immunization champion equipped to manage delicate conversations with patients. The findings reflect needs for immunization champion identification, training, and support, along with best practices guidelines to improve coordination of vaccine promotion and delivery efforts in ob-gyn provider offices. Additionally, provider training on communication approaches to enhance acceptance and uptake of maternal vaccines is warranted.

Historically, partnerships with community leaders (e.g., religious leaders, teachers) have been critical to building vaccination confidence, but leaders may be increasingly vaccine hesitant. In rural Guatemala, the extent of vaccine hesitancy among community leaders is unclear, as are their perceptions of advocacy for childhood vaccines. We sought to: (i) compare Guatemalan religious leaders' and community leaders' attitudes toward childhood vaccines, (ii) describe leaders' experiences and comfort with vaccination advocacy, and (iii) describe community members' trust in them as vaccination advocates. In 2019, we surveyed religious leaders, other community leaders, and parents of children under five in rural Guatemala. We recorded participant demographic information and assessed participant vaccine hesitancy regarding childhood vaccines. We analyzed data descriptively and via adjusted regression modeling. Our sample included 50 religious leaders, 50 community leaders, and 150 community members (response rate: 99%); 14% of religious leaders and community leaders were vaccine hesitant, similar to community members (P = 0.71). In the prior year, 47% of leaders had spoken about vaccines in their formal role; 85% felt responsible to do so. Only 28% of parents trusted politicians "a lot" for vaccine advice, versus doctors (72%; P < 0.01), nurses (62%; P < 0.01), religious leaders (49%; P < 0.01), and teachers (48%; P < 0.01). In this study, religious leaders and community leaders were willing but incompletely engaged vaccination advocates. Most community members trusted doctors and nurses a lot for vaccination advice; half trusted teachers and religious leaders similarly. Public health officials in rural Guatemala can complement efforts by doctors and nurses through partnerships with teachers and religious leaders to increase vaccination confidence and delivery.

The coronavirus disease 2019 (COVID-19) first came to the Unites States in January 2020. Though adult and pediatric vaccines became available to the public, vaccine uptake among youth and particularly younger children has been gradual. This explanatory study aimed to better understand parents' attitudes and beliefs of the pediatric COVID-19 vaccine and the barriers and facilitators to vaccine uptake in a rural community through a brief, online demographic survey, and in-depth qualitative interviews. Forty-one in depth interviews were conducted with parents (31-English and 10-Spanish-speaking) residing in rural and frontier counties in Colorado between September 2021 and February 2022. Six emergent themes related to COVID-19 pediatric vaccine uptake were identified among the population. These themes spanned the three levels of influence in the Social Ecological Model (individual, interpersonal, and community levels). The six themes were identified as such; 1) Vaccine accessibility was associated with pediatric COVID vaccine uptake in rural communities, 2) Previous pediatric vaccine behaviors were not associated with COVID-19 pediatric vaccine uptake, 3) Perceived health status of a child or family member influenced pediatric COVID-19 vaccine uptake, 4) COVID-19 health seeking behaviors, like COVID pediatric vaccine uptake, are influenced by an individual's prosocial or individualistic perspectives, 5) Child autonomy and "age of consent" frames vaccine decision making behaviors in parents, and lastly 6) Social networks impacted COVID-19 pediatric vaccine decision making. These findings inform next steps for COVID-19 pediatric vaccine uptake including targeted and tailored messaging for communities (cues to actions), engaging youth stakeholders, and identifying trusted sources to build rapport and trust between health professionals and community members. The growing vaccine hesitancy among parents has serious implications for disease eradication and future viral outbreaks. Understanding the perceived barriers and facilitators to pediatric vaccine uptake is important to maintain the health of our youth and communities.

Introduction The Healthy People 2020 report states a goal of 80% uptake of recommended vaccines among adolescents, including the human papillomavirus (HPV) vaccine. However, the rate of uptake of the HPV vaccine is estimated at 51% in 2018, which leaves young people vulnerable to morbidity and mortality from preventable, HPV-related cancers. Reasons for this are multifactorial and include factors at the level of the provider, primary care practice, patient and family, and community. The development of interventions that are responsive to these multifactorial barriers in real-world settings is a priority. Boot Camp Translation (BCT) is a community-engaged approach to message development for translating evidence-based practices into clinics and communities. This project aims to (1) Engage practices and communities in the development of interventions to promote HPV vaccine uptake and (2) Evaluate the impact of the BCT-designed intervention on practice-level HPV vaccine initiation rates. We hypothesise that the BCT-designed intervention will increase the rate of HPV vaccine initiation in the practices.Methods and analysis This study will implement HPV-focused BCT in three counties in Colorado with a below average county-level vaccination rate. Each BCT group will design a multipronged intervention targeted at patients, parents, providers and the general community to then be disseminated in the participating practices and communities over the subsequent 6-month period. The long-term goal is to develop a replicable approach and low-cost method of increasing HPV vaccine uptake that is easily adaptable to different settings and sociodemographic contexts.Ethics and dissemination This study is approved by the Colorado Multiple Institutional Review Board. Results will be disseminated through peer-reviewed manuscripts and conference presentations, as well as within Colorado practice-based research networks.Trial registration number NCT04279964

Introduction A key contributor to underimmunisation is parental refusal or delay of vaccines due to vaccine concerns. Many clinicians lack confidence in communicating with vaccine-hesitant parents (VHP) and perceive that their discussions will do little to change parents’ minds. Improving clinician communication with VHPs is critical to increasing childhood vaccine uptake.Methods and analysis We describe the protocol for a cluster randomised controlled trial to test the impact of a novel, multifaceted clinician vaccine communication strategy on child immunisation status. The trial will be conducted in 24 primary care practices in two US states (Washington and Colorado). The strategy is called Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT with MI), and involves clinicians initiating the vaccine conversation with all parents of young children using the presumptive format, and among those parents who resist vaccines, pivoting to using MI. Our primary outcome is the immunisation status of children of VHPs at 19 months, 0 day of age expressed as the percentage of days underimmunised from birth to 19 months for 22 doses of eight vaccines recommended during this interval. Secondary outcomes include clinician experience communicating with VHPs, parent visit experience and clinician adherence to the PIVOT with MI communication strategy.Ethics and dissemination This study is approved by the following institutional review boards: Colorado Multiple Institutional Review Board, Washington State Institutional Review Board and Swedish Health Services Institutional Review Board. Results will be disseminated through peer-reviewed manuscripts and conference presentations.Trial registration number NCT03885232.

BackgroundNorovirus is a leading cause of acute gastroenteritis (AGE) across the age spectrum; candidate vaccines are in clinical trials. While norovirus diagnostic testing is increasingly available, stool testing may not be performed routinely, which can hamper surveillance and burden of disease estimates. Additionally, lack of knowledge of the burden of disease may inhibit provider vaccine recommendations, which could affect coverage rates and ultimately the impact of the vaccine. Our objectives were to understand physicians' stool testing practices in outpatients with AGE, and physician knowledge of norovirus, in order to improve surveillance and prepare for vaccine introduction.MethodsInternet and mail survey on AGE, norovirus, and future norovirus vaccines conducted January to March 2018 among national networks of primary care pediatricians, family practice and general internal medicine physicians.ResultsThe response rate was 59% (820/1383). During peak AGE season, physicians estimated they ordered stool tests for a median of 15% (interquartile range: 5-33%) of their outpatients with AGE. Stool tests were reported as more often available for ova and parasites, Clostridioides difficile, and bacterial culture (>95% for all specialties) than for norovirus (6-33% across specialties); even when available, norovirus-specific tests were infrequently ordered. Most providers were unaware that norovirus is a leading cause of AGE across all age groups (Pediatricians 80%, Family Practice 86%, General Internal Medicine 89%) or that alcohol-based hand sanitizers are ineffective against norovirus (Pediatricians 51%, Family Practice 66%, General Internal Medicine 62%). Concerns cited as major barriers to implementing a future norovirus vaccine included if the vaccine is not covered by insurance (General Internal Medicine 64%, Pediatricians 67%, Family Practice 74%) and lack of adequate reimbursement for vaccination (Pediatricians 43%, General Internal Medicine 46%, Family Practice 50%). Factors that providers believed were 'not at all a barrier' or 'minor barrier' to new vaccine introduction included the belief that "my patients won't need this vaccine" (General Internal Medicine 78%, Family Practice 86%, Pediatricians 90%) and "my patients already get too many vaccines" (Family Practice 89%, General Internal Medicine 92%, Pediatricians 95%).ConclusionsPrimary care physicians had few concerns regarding future norovirus vaccine introduction, but have knowledge gaps on norovirus prevalence and hand hygiene for prevention. Also, physicians infrequently order stool tests for outpatients with AGE, which limits surveillance estimates that rely on physician-ordered stool diagnostics. Closing physician knowledge gaps on norovirus burden and transmission can help support norovirus vaccine introduction.