Boot Camp Translation using Community-Engaged messaging for adolescent Vaccination: A Cluster-Randomized trial.

BACKGROUND: Routine vaccination coverage for adolescents living in the rural US is lower than adolescents living in urban areas. We sought to measure the effect of Boot Camp Translation (BCT), a community-based participatory intervention, on rural adolescent vaccination coverage. METHODS: A cluster randomized controlled trial was performed September 2018-November 2021 involving 16 rural Colorado counties. Intervention county community members engaged in BCT to develop interventions to improve adolescent vaccination locally. Adolescent vaccination coverage was measured using the Colorado Immunization Information System. RESULTS: For 11-12-year-olds, HPV initiation, HPV up-to-date, MenACWY, and Tdap vaccination coverage was lower post- versus pre-intervention in the control and intervention groups. For 11-12-year-olds in the intervention group, there was no significant difference post- versus pre-intervention in the odds of HPV vaccine initiation (adjusted ratio of odds ratios [aROR] = 0.93, 95 %: 0.85-1.02, p = 0.10) or up-to-date HPV vaccination (aROR: 1.10, 95 % CI: 0.98-1.23, p = 0.11) compared with the control group. Among 11-12-year-olds, the decrease in the proportion vaccinated with MenACWY and Tdap in the intervention group was significantly greater than the control group. Among 13-17-year-olds, there were significant increases in HPV initiation, HPV up-to-date, MenACWY, and Tdap vaccination coverage from pre- to post-intervention for both groups, with no significant differences between groups. CONCLUSION: 11-12-year-old vaccination coverage decreased slightly from pre- to post-intervention while 13-17-year-old vaccination coverage increased. We saw no effect from the BCT intervention. Our findings about the effectiveness of BCT for improving vaccine uptake may not be generalizable because the study coincided with the COVID-19 pandemic. CLINICAL TRIAL REGISTRY: This study was registered with ClinicalTrials.gov, NCT03955757.

Communication Interactions, Needs, and Preferences During Clinical Encounters of African American Parent-Child Dyads.

Human papillomavirus (HPV) vaccination rates remain suboptimal among African American adolescents. Although provider recommendations during clinical encounters are believed to be highly effective in increasing uptake and series completion, little has been reported about parent-child perspectives on the counseling received during these encounters. Among African American parent-child dyads, we sought to explore and compare interactions, needs, and preferences during clinical encounters by child's HPV vaccination status. We applied a qualitative, phenomenological study design to conduct semi-structured interviews with African American parent-child dyads representing children who were unvaccinated (n = 10), had initiated but not completed (n = 11), or had completed the HPV vaccine series (n = 9). Using iterative, inductive-deductive thematic analysis, five themes were generated: (1) parents' attitudes varied about the HPV vaccine but were mostly positive for vaccines in general; (2) patient-parent-provider clinical encounters from the parent perspective; (3) patient-parent-provider clinical encounters from the child perspective; (4) methods of distribution of supplemental HPV information; and (5) communication desired on HPV vaccination by parents and children. Parents stating they received a provider's recommendation increased by vaccination status (unvaccinated: 6 out of 10; initiated: 7 out of 11; completed: 9 out of 9). Most parents and children were not satisfied with provider communication on the HPV vaccine and used supplemental materials to inform decision-making. Ongoing communication on the HPV vaccine was requested even post-vaccination of the child. During clinical encounters, children and parental messaging needs are similar yet dissimilar. We offer communication strategies and messaging that can be used for African American parent-child dyads by child HPV vaccination status during a clinical encounter.

Correction: Development of a Tailored Mobile Phone-Based Intervention to Facilitate Parent-Child Communication and Build Human Papillomavirus Vaccine Confidence: Formative Qualitative Study.

[This corrects the article DOI: 10.2196/43041.].

Development of a Tailored Mobile Phone-Based Intervention to Facilitate Parent-Child Communication and Build Human Papillomavirus Vaccine Confidence: Formative Qualitative Study.

BACKGROUND: Human papillomavirus (HPV) vaccine hesitancy is on the rise, and provider communication is a first-line strategy to address parental concerns. The use of the presumptive approach and motivational interviewing by providers may not be enough to influence parental decision-making owing to the providers' limited time, self-efficacy, and skills to implement these strategies. Interventions to enhance provider communication and build parental HPV vaccine confidence have been undertested. Delivering tailored patient education to parents via mobile phones before they visit the health care provider may address time constraints during clinic visits and positively affect vaccine uptake. OBJECTIVE: This study aimed to describe the development and evaluate the acceptability of a mobile phone-based, family-focused intervention guided by theory to address concerns of HPV vaccine-hesitant parents before the clinic visit, as well as explore intervention use to facilitate parent-child communication. METHODS: The health belief model and theory of reasoned action guided intervention content development. A multilevel stakeholder engagement process was used to iteratively develop the HPVVaxFacts intervention, including a community advisory board review, a review by an advisory panel comprising HPV vaccine-hesitant parents, a health communications expert review, semistructured qualitative interviews with HPV vaccine-hesitant parents (n=31) and providers (n=15), and a content expert review. Inductive thematic analysis was used to identify themes in the interview data. RESULTS: The qualitative interviews yielded 4 themes: overall views toward mobile device use for health information, acceptability of HPVVaxFacts, facilitators of HPVVaxFacts use, and barriers to HPVVaxFacts use. In parent interviews after reviewing HPVVaxFacts prototypes, almost all parents (29/31, 94%) stated they intended to have their child vaccinated. Most of the parents stated that they liked the added adolescents' corner to engage in optional parent-child communication (ie, choice to share and discuss information with their child; 27/31, 87%) and shared decision-making in some cases (8/31, 26%). After incorporating all input, the final intervention consisted of a 10-item survey to identify the top 3 concerns of parents, followed by tailored education that was mapped to each of the following concerns: evidential messages, images or graphics to enhance comprehension and address low literacy, links to credible websites, a provider video, suggested questions to ask their child's physician, and an optional adolescents' corner to educate the patient and support parent-child communication. CONCLUSIONS: The multilevel stakeholder-engaged process used to iteratively develop this novel intervention for HPV vaccine-hesitant families can be used as a model to develop future mobile health interventions. This intervention is currently being pilot-tested in preparation for a randomized controlled trial aiming to increase HPV vaccination among adolescent children of vaccine-hesitant parents in a clinic setting. Future research can adapt HPVVaxFacts for other vaccines and use in other settings (eg, health departments and pharmacies).

Development of PIVOT with MI: A motivational Interviewing-Based vaccine communication training for pediatric clinicians.

Delay or refusal of childhood vaccines is common and may be increasing. Pediatricians are parents' most trusted source for vaccine information, yet many struggle with how to communicate with parents who resist recommended vaccines. Evidence-based communication strategies for vaccine conversations are lacking. In this manuscript, we describe the development and perceived usefulness of a curriculum to train clinicians on a specific vaccine communication strategy as part of the PIVOT with MI study, a cluster randomized trial testing the effectiveness of this communication strategy on increasing childhood vaccination uptake among 24 pediatric practices in Colorado and Washington. The communication strategy is based on the existing evidence-based communication strategies of a presumptive format for initiating vaccine conversations and use of motivational interviewing if hesitancy persists. Focus groups and semi-structured interviews with pediatric clinicians helped inform the development of the training curriculum, which consisted of an introductory video module followed by 3 training sessions. Between September 2019 and January 2021, 134 pediatric clinicians (92 pediatricians, 42 advanced practice providers) participated in the training as part of the PIVOT with MI study. Of these, 92 % viewed an introductory video module, 93 % attended or viewed a baseline synchronous training, 82 % attended or viewed a 1st refresher training, and 77 % attended or viewed a 2nd refresher training. A follow-up survey was administered August 2020 through March 2021; among respondents (n = 100), >95 % of participants reported that each component of the training program was very or somewhat useful. These data suggest that the PIVOT with MI training intervention is a useful vaccine communication resource with the potential for high engagement among pediatric clinicians.

Promoting HPV vaccination among Latinx: an application of the extended parallel processing model.

Vaccine hesitancy is a substantial barrier to increasing HPV vaccination rates among Latinx in the US who experience disproportional rates of HPV-related cancers. The current research tests the effectiveness of culturally-targeted, fear-appeal messages designed using the Extended Parallel Processing Model (EPPM). We compared differences among Latinx young adults and parents of adolescents of the effectiveness of messages that highlight HPV-related cancers, genital warts, or a control condition to promote online information seeking about the HPV vaccine-a known precursor to vaccination intention. Results found messages containing EPPM messaging elements produced significantly higher self-reported intention to seek information about HPV vaccines in comparison to a control message group. However, participants who received control messages had the highest percentage of hyperlink clicks to more information about HPV (a novel measure of information seeking). Findings suggest that fear appeals may be effective for promoting information seeking about HPV vaccination, which in turn could increase vaccine utilization, among Latinx participants. Clinical trial registration number (NCT05206669) retrospectively registered January 25, 2022.

Is tailored messaging more effective? An analysis of a digital health intervention to promote HPV vaccination intent among Latinx.

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.

Healthcare providers' practice protocols, strategies, and needed tools to address parental HPV vaccine hesitancy: An exploratory study.

Parental hesitancy related to human papillomavirus (HPV) vaccines has increased during the pandemic, and there is a call to action by the National HPV Vaccination Roundtable to improve vaccination rates. While there are evidence-based strategies available to address parental hesitancy, there are few clear guidelines on how to engage parents to build confidence in the HPV vaccine within the clinical settings. The purpose of this investigation is to explore practice protocols, individual provider strategies, and perceived tools needed to address HPV vaccine hesitant parents from the perspective of providers during the COVID-19 pandemic in the United States. Fifteen healthcare providers participated in qualitative, semi-structured interviews between May 2021 and March 2022. An inductive, qualitative content analysis approach was used to analyze the data. Five themes were described: 1) Provider experiences engaging with HPV vaccine hesitant parents; 2) Existing protocols in the clinics to address HPV vaccine hesitant parents; 3) Strategies used by providers to address parental HPV vaccine hesitancy; 4) Sample message content used by providers to address parental HPV vaccine concerns; and 5) Perceived strategies and tools needed to address parental vaccine hesitancy. Recommendations to address parental hesitancy include recommending HPV vaccinationat 9 years, using a strong recommendation and continued discussion, applying evidence-based approaches and/or promising strategies, linking parents to credible outside sources, and ongoing follow-up if delayed or declined. These findings can be used by researchers and clinicians to improve strategies and messages to inform the development of a protocol to standardize encounters and communication for patient-parent-provider encounters that can influence parental decision-making around HPV vaccine uptake.

Pre-implementation evaluation for an HPV vaccine provider communication intervention among primary care clinics.

OBJECTIVES: Interventions to improve health care provider communication about HPV vaccination can increase vaccine acceptance. Our objectives were to (1) identify clinics in locations with high HPV-associated cancer and low HPV-vaccination rates that would potentially benefit from dissemination of a proposed HPV Provider Communication intervention and (2) use qualitative interviews and a dissemination and implementation framework to assess readiness for change and fit of the HPV Provider Communication intervention to the context of these clinics. METHODS: Local HPV-associated cancer and HPV vaccination rates were assigned to Practice-Based Research Network clinics using data from the Colorado Central Cancer Registry, the Colorado Immunization Information System, and the American Community Survey. Staff from 38 clinics located in areas with high numbers of adolescents not up-to-date for HPV vaccine and high rates of HPV-associated cancers were recruited for qualitative interviews. Interview questions used the Promoting Action on Research Implementation in Health Services (PARIHS) conceptual framework and addressed the proposed intervention, current vaccination practices and prior quality improvement (QI) experience. RESULTS: Twenty-seven interviews were completed with clinicians, clinic managers, and other staff across 17 clinics (9 pediatric, 5 family medicine, 3 public/school-based health). Most clinics had some prior QI experience and there were few thematic differences between sites with more or less foundation for QI/immunization work. Participants were motivated to improve the health of their patients and valued both guidelines and local experience as important evidence to consider adopting an intervention. Interviewees were more interested in implementing the proposed intervention if it aligned with existing priorities and fit within clinic workflows. Facilitation needs included adequate time and external facilitation support for data tracking and analysis. CONCLUSIONS: Qualitative interviews to understand clinic context and fit of an HPV Provider Communication intervention can inform implementation in settings with the highest potential for clinical impact.

Association between early childhood lower respiratory tract infections and subsequent asthma.

OBJECTIVE: We examined the relationship between recurrent lower respiratory tract infections (LRTI) in young children and subsequent childhood asthma outcomes. METHODS: Retrospective cohort study using 2009-2017 Colorado All Payer Claims Database to assess 0- to 2-year-old children with visits due to LRTI and acute gastroenteritis (AGE). The primary exposure was number of LRTI visits prior to 2 years of age. Children with AGE served as the no LRTI comparator group. The primary outcome was incident asthma, defined by ICD-9 (490.XX) or ICD-10 (J45.9XX) codes, in the same children between 3 and 9 years of age. Multivariable accelerated failure time (AFT) models were used to estimate the effect of LRTI visits on median time to asthma diagnosis. Sensitivity analyses were performed using more conservative asthma diagnostic criteria and with hospitalized children only. RESULTS: Of 38,441 eligible subjects, 32,729 had ≥1 LRTI and 5,712 had AGE (no LRTI) between 0 and 2 years of age. Children with ≥3 LRTI visits had an 80% decrease in median time to asthma diagnosis relative to those with AGE visits only (time ratio [TR] 0.2; 95% CI 0.16, 0.24). Children with ≥3 LRTI hospitalizations had a 98% reduction in median time to asthma diagnosis relative to those with AGE hospitalizations only (TR 0.02; 95% CI 0.01, 0.07). History of atopy, wheezing, and family history of asthma documented prior to 2 years of age were also associated with earlier asthma diagnosis. CONCLUSIONS: Recurrent LRTIs, especially LRTI hospitalizations, before 2 years of age are associated with earlier diagnosis of pediatric asthma.

Exploring mechanisms of a web-based values-tailored childhood vaccine promotion intervention trial: Effects on parental vaccination values, attitudes, and intentions.

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.

Testing Messages on Facebook to Promote Use of an HPV Educational Web-Intervention.

In the US, the human papillomavirus (HPV) vaccine remains underutilized leading to disparities in HPV-related diseases. Latinx have some of the highest rates of cancer caused by HPV. In a previous study, we developed a tailored-messaging based online educational intervention (CHICOS) that was found to increase HPV vaccination intention among Latinx participants. The current research uses Facebook Advertising to test the comparative effectiveness of messages designed using the Extended Parallel Processing Model (EPPM) to promote the use of CHICOS among Latinx young adults and parents of adolescents. We also looked at differences in the effectiveness of messages that highlighted HPV-related cancers, genital warts, or a control condition as well as differences in Spanish vs. English messages. Results found Latinx young adults and parents, were more likely to click on Facebook Advertisements containing messages in Spanish and those that mention cancer risks pertinent to this population compared to those in English or messages that discuss genital warts. Thus, findings suggest that Facebook Advertising has the potential to be a useful tool for motivating information seeking online about HPV vaccination.

"It's Like 1998 Again": Why Parents Still Refuse and Delay Vaccines.

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.

Rural Adolescent Immunization: Delivery Practices and Barriers to Uptake.

BACKGROUND: Rural adolescent vaccination rates lag behind urban. We sought to assess rural-urban differences in barriers to adolescent vaccination, perceived parental vaccine attitudes, and immunization delivery practices among public health nursing (PHN), pediatric (Peds), and family medicine (FM) clinicians. METHODS: Internet and mail survey of Colorado PHN, Peds, and FM clinicians from June-August 2019. Study population was recruited from local health plans and the American Medical Association Physician Masterfile. Rural and urban responses were compared using Cochran Armitage trend, Fisher's exact, and chi-square tests. RESULTS: Response rate was 38% (163/433; 91 rural, 72 urban). Rural respondents were less likely than urban to agree most patients have insurance that covers vaccination (86% vs 97%; P = .02). Rural respondents were less likely than urban to indicate most parents in their practice would agree with statements about vaccine benefits (P = .02) and trust in medical providers (P = .05). Rural respondents were more likely than urban to report adolescents were somewhat/very likely to receive vaccines at public health departments (65% vs 28%; P < .0001) and less likely to report adolescents were somewhat/very likely to receive vaccines at pharmacies (26% vs 45%; P = .02). Fewer providers strongly recommended HPV vaccine (81% for females, 80% for males 11 to 12 years) than other adolescent immunizations (Tdap: 97%, MenACWY at 11 to 12 years: 87%; influenza at 11 to 17 years: 87%; each P < .005, rural-urban responses did not differ). CONCLUSIONS: Rural barriers to adolescent vaccination include logistic issues and parental vaccine attitudes. Efforts to improve rural adolescent vaccination should include public health departments and address vaccine confidence and access barriers.

Addressing logistical barriers to childhood vaccination using an automated reminder system and online resource intervention: A randomized controlled trial.

BACKGROUND: As the rates of vaccination decline in children with logistical barriers to vaccination, new strategies to increase vaccination are needed. The goal of this study was to develop and evaluate the effectiveness of the Vaccines For Babies (VFB) intervention, an automated reminder system with online resources to address logistical barriers to vaccination in caregivers of children enrolled in an integrated healthcare system. Effectiveness was evaluated in a randomized controlled trial. METHODS: Qualitative interviews were conducted with parents of children less than two years old to identify logistical barriers to vaccination that were used to develop the VFB intervention. VFB included automated reminders to schedule the 6- and 12-month vaccine visit linking caregivers to resources to address logistic barriers, sent to the preferred mode of outreach (text, email, and/or phone). Parents of children between 3 and 10 months of age with indicators of logistical barriers to vaccination were randomized to receive VFB or usual well child care (UC). The primary outcome was percentage of days undervaccinated at 2 years of life. A difference in differences analysis was conducted. RESULTS: Qualitative interviews with 6 parents of children less than 2 years of age identified transportation, scheduling challenges, and knowledge of vaccine timing as logistical barriers to vaccination. We enrolled 250 participants in the trial, 45% were loss to follow-up. There were no significant differences in vaccination uptake between those enrolled in UC or the VFB intervention (0.51%, p = 0.86). In Medicaid enrolled participants, there was a modest decrease in percentage of days undervaccinated in the VFB intervention compared to UC (6.3%, p = 0.07). CONCLUSION: Automated Reminders and with links to heath system resources was not shown to increase infant vaccination uptake demonstrating additional resources are needed to address the needs of caregivers experiencing logistical barriers to vaccination.

Characteristics of Pediatric Rapid Response Systems: Results From a Survey of PRIS Hospitals.

BACKGROUND: Many hospitals use rapid response systems (RRSs) to identify and intervene on hospitalized children at risk for deterioration. OBJECTIVES: To describe RRS characteristics across hospitals in the Pediatric Research in Inpatient Settings (PRIS) network. METHODS: We developed the survey through a series of prospective respondent, expert, and cognitive interviews. One institutional expert per PRIS hospital (n = 109) was asked to complete the web survey. We summarized responses using descriptive statistics with a secondary analysis of univariate associations between RRS characteristics and perceived effectiveness. RESULTS: The response rate was 72% (79 of 109). Respondents represented diverse hospital types and were primarily physicians (97%) with leadership roles in care escalation. Many hospitals used an early warning score (77%) for identification with variable characteristics (46% automated versus 54% full or partially manual calculation; inputs included vital signs [98%], physical examination findings [88%], diagnoses [23%], medications [19%], and diagnostic tests [14%]). Few incorporated a validated prediction model (9%). Similarly, many RRSs used a rapid response team for intervention (93%) with variable team composition (respiratory therapists [94%], ICU nurses [93%], ICU providers [67%], and pharmacists [27%]). Some used the early warning score to trigger the rapid response team (50%). Only a few staffed a clinician to proactively surveil hospitalized children for risk of deterioration (18%), and these tended to be larger hospitals (annual admissions 12 000 vs 6000, P = .007). Most responding experts stated their RRSs improved patient outcomes (92%). CONCLUSIONS: RRS characteristics varied across PRIS hospitals.

Web-Based Tailored Messaging to Increase Vaccination: A Randomized Clinical Trial.

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.

'Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing' (PIVOT with MI) trial: a protocol for a cluster randomised controlled trial of a clinician vaccine communication intervention.

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.