Best Practices for Conducting Clinical Trials With Indigenous Children in the United States.

We provide guidance for conducting clinical trials with Indigenous children in the United States. We drew on extant literature and our experience to describe 3 best practices for the ethical and effective conduct of clinical trials with Indigenous children. Case examples of pediatric research conducted with American Indian, Alaska Native, and Native Hawaiian communities are provided to illustrate these practices. Ethical and effective clinical trials with Indigenous children require early and sustained community engagement, building capacity for Indigenous research, and supporting community oversight and ownership of research. Effective engagement requires equity, trust, shared interests, and mutual benefit among partners over time. Capacity building should prioritize developing Indigenous researchers. Supporting community oversight and ownership of research means that investigators should plan for data-sharing agreements, return or destruction of data, and multiple regulatory approvals. Indigenous children must be included in clinical trials to reduce health disparities and improve health outcomes in these pediatric populations. Establishment of the Environmental Influences on Child Health Outcomes Institutional Development Award States Pediatric Clinical Trials Network (ECHO ISPCTN) in 2016 creates a unique and timely opportunity to increase Indigenous children's participation in state-of-the-art clinical trials.

The institutional development award states pediatric clinical trials network: building research capacity among the rural and medically underserved.

PURPOSE OF REVIEW: The institutional development award (IDeA) program was created to increase the competitiveness of investigators in states with historically low success rates for National Institutes of Health (NIH) research funding applications. IDeA states have high numbers of rural and medically underserved residents with disproportionately high rates of infant mortality, obesity, and poverty. This program supports the development and expansion of research infrastructure and research activities in these states. The IDeA States Pediatric Clinical Trials Network (ISPCTN) is part of the environmental influences on child health outcomes program. Its purpose is to build research capacity within IDeA states and provide opportunities for children in IDeA states to participate in clinical trials. This review describes the current and future activities of the network. RECENT FINDINGS: In its initial year, the ISPCTN created an online series on clinical trials, initiated participation in a study conducted by the pediatric trials network, and proposed two novel clinical trials for obese children. Capacity building and clinical trial implementation will continue in future years. SUMMARY: The ISPCTN is uniquely poised to establish and support new pediatric clinical research programs in underserved populations, producing both short and long-term gains in the understanding of child health.

Access to Care for Children under five in Oklahoma: a Geographic Imputation Application.

OBJECTIVE: Geographic access to primary care can be a barrier to receiving appropriate preventative services. Oklahoma has been identified as having relatively few primary care providers per capita to care for its population compared to the US. The goal of this analysis was to identify the areas in Oklahoma with significant concentrations of children under five, no pediatrician within reasonable driving distance, and whether other primary care providers are present. METHODS: The 2016 American Community Survey was used to estimate the total population of children under five years of age for each Census Block Group in Oklahoma. Access was defined as a thirty-minute drive time radius computed around each child's imputed location. The National Provider Identifier database was used to identify and locate pediatricians, family medicine physicians, and mid-level providers in Oklahoma. Areas of high concentrations of children with no pediatrician access were identified and non-pediatrician provider locations were superimposed. RESULTS: Of the estimated 265,818 children under five in Oklahoma, approximately 7% were outside of a thirty-minute drive from a pediatrician. These children are concentrated in northwestern and southeastern Oklahoma, with several smaller additional groupings. There are multiple non-pediatrician primary care providers operating in many of these areas. CONCLUSION: There are areas in the state where a paucity of pediatricians and high concentrations of young children lend themselves to collaborations using technology and education to improve the care of children.

Community Engagement: Why Oklahoma? Why Now?

IMPORTANCE: Oklahoma ranked 43rd in the 2017 America's Health Rankings largely due to health behaviors such as adult obesity, lack of physical activity and smoking. Oklahoma children also suffer from adverse childhood experiences that contribute to poor health outcomes. Community engagement, a process that involves people affiliated by geographic location and shared interest working together to address issues affecting community wellbeing, is a common model that has had some success in Oklahoma communities addressing child health. OBSERVATIONS: Factors that contribute to poor health in Oklahoma include not only health behaviors such as obesity and smoking, but also lack of access to care created by a lack of health insurance and primary care providers, compounded by the largely rural nature of the state. The National Institutes of Health is committed to funding research aimed at improving the health of rural and disadvantaged populations. Historically, these populations are difficult to reach and may not be interested in the national health research initiatives, but rather want to focus on health issues important to their communities. CONCLUSIONS AND RELEVANCE: In this article we discuss some of Oklahoma's most pressing pediatric health needs, community engagement efforts to address these issues and a newly funded NIH grant at OUHSC aimed at supporting and learning from these efforts.

Vaccination Rates among Adolescents in Minnesota as Compared with the United States: Not "Above Average".

Because adolescents make relatively few visits to clinics for preventive care, their vaccination rates suffer. We examined rates among Minnesota youths to see how they compared with those among teens throughout the United States. We used National Immunization Survey-Teen (NIS-Teen) data to estimate vaccination rates for 13- to 17-year-olds in Minnesota from 2008 through 2013 and compared them to national rates for MCV4, Tdap and HPV vaccines. We also examined rates of provider recommendation for each of the three vaccines and rates of parental intention to vaccinate against HPV. We found rates for all three vaccinations increased between 2008 and 2013, but they continue to be low for both MCV4 (69%) and HPV (38% of females and 9% of males completed the three-dose series in 2013). Fortunately, the percentage of Minnesota clinicians recommending those vaccines is increasing (the percentage recommending HPV vaccination for females increased from 55% in 2008 to 74% in 2013; however, only 44% recommended it for males in 2013). The percentage of parents in Minnesota reporting intent to vaccinate their female children against HPV rose from 52% in 2008 to 58% in 2013; the percentage intending to vaccinate their male children rose from 16% in 2010 to 47% in 2013. Clinicians and public health officials must address how we can improve HPV vaccination rates among adolescents.

Adolescent vaccination in Oklahoma: a work in progress.

BACKGROUND: Nationally, uptake of adolescent vaccines is variable. OBJECTIVE: To compare adolescent immunization rates and clinician recommendation for adolescent vaccines over time in Oklahoma with the U.S. METHODS: We analyzed the 2010-2012 National Immunization Survey of Teens (NIS-Teen). RESULTS: MCV4 and Tdap are consistently lower in Oklahoma compared to the U.S. HPV rates have been comparable. Parents report that health care providers in Oklahoma are less likely to recommend adolescent vaccines compared to the national average. Intention to not receive HPV in the next 12 months is distressingly high both in Oklahoma and across the nation with both improving. CONCLUSION: Over the three years, Oklahoma's immunization rates consistently underperform national estimates for MCV4 and Tdap but not for HPV. We recommend Oklahoma health care providers improve their vaccination rates through making clear their vaccine recommendations to the parent and patient in the clinical encounter.

Rural Family Satisfaction With Telehealth Delivery of an Intervention for Pediatric Obesity and Associated Family Characteristics.

Objective: To describe satisfaction with the telehealth aspect of a pediatric obesity intervention among families from multiple rural communities and assess differences in satisfaction based on sociodemographic factors. Methods: This is a secondary analysis of data from a pilot randomized controlled trial of a 6-month intensive lifestyle intervention (iAmHealthy) delivered through telehealth to children 6-11 years old with BMI ≥85th%ile and their parents from rural communities. Parents completed a sociodemographic survey and a validated survey to assess satisfaction with the telehealth intervention across four domains (technical functioning, comfort of patient and provider with technology and perceived privacy, timely and geographic access to care, and global satisfaction) on a 5-point Likert scale. Kruskal-Wallis nonparametric rank test were used to compare mean satisfaction scores based on parent sociodemographics. Results: Forty-two out of 52 parents (67% White, 29% Black, 5% multiracial, and 50% with household income <$40,000) completed the survey. Mean satisfaction scores ranged from 4.16 to 4.54 (standard deviation 0.44-0.61). Parents without a college degree reported higher satisfaction across all domains compared with parents with a college degree, including global satisfaction (mean 4.64 vs. 4.31, p = 0.03). Parents reporting a household income <$40,000 (mean 4.70) reported higher scores in the comfort with technology and perceived privacy domain compared with parents with higher incomes (mean 4.30-4.45, p = 0.04). Discussion: Parents from rural communities, especially those from lower socioeconomic backgrounds, were highly satisfied with the iAmHealthy telehealth intervention. These findings can be used to inform future telehealth interventions among larger more diverse populations. ClinicalTrials.gov Identifier: NCT04142034.

Primary Care and Community-Based Partnerships to Enhance HPV Vaccine Delivery.

INTRODUCTION/OBJECTIVES: With growing vaccination misinformation and mistrust, strategies to improve vaccination communication across community-based settings are needed. METHODS: The Rural Adolescent Vaccine Enterprise (RAVE), a 5-year (2018-2022) stepped-wedge cluster randomized study, tested a clinic-based practice facilitation intervention designed to improve HPV vaccination. An exploratory aim sought to explore the use of partnerships between primary care clinics and a community partner of their choosing, to implement a social marketing campaign related to HPV immunization. We assessed perceptions about the value and success of the partnership, and barriers and facilitators to its implementation using a 29-item community partner survey, key informant interviews, and field notes from practice facilitators. RESULTS: Of the initial 45 clinics participating in RAVE, 9 were unable to either start or complete the study, and 36 participants (80.0%) were actively engaged. Of these, 16/36 clinics (44.4%) reported establishing successful partnerships, 10 reported attempting to develop partnerships (27.8%), and another 10 reported not developing a partnership (27.8%), which were often caused by the COVID-19 pandemic. The most common partnership was with public health departments at 27.3%. Other partnerships involved libraries, school districts, and local businesses. More than half (63.7%) reported that creating messages regarding getting HPV vaccination was moderately to very challenging. Just under half reported (45.5%) that messaging was hard because of a lack of understanding about the seriousness of diseases caused by HPV, parents being against vaccines because of safety concerns, and religious values that result in a lack of openness to HPV vaccines. Community partners' health priorities changed as a result of RAVE, with 80% prioritizing childhood immunizations as a result of the RAVE partnership. CONCLUSIONS: Community groups want to partner with primary care organizations to serve their patients and populations. More research is needed on how best to bring these groups together.

Validation of remote anthropometric measurements in a rural randomized pediatric clinical trial in primary care settings.

Rural children are more at risk for childhood obesity but may have difficulty participating in pediatric weight management clinical trials if in-person visits are required. Remote assessment of height and weight observed via videoconferencing may provide a solution by improving the accuracy of self-reported data. This study aims to validate a low-cost, scalable video-assisted protocol for remote height and weight measurements in children and caregivers. Families were provided with low-cost digital scales and tape measures and a standardized protocol for remote measurements. Thirty-three caregiver and child (6-11 years old) dyads completed remote (at home) height and weight measurements while being observed by research staff via videoconferencing, as well as in-person measurements with research staff. We compared the overall and absolute mean differences in child and caregiver weight, height, body mass index (BMI), and child BMI adjusted Z-score (BMIaz) between remote and in-person measurements using paired samples t-tests and one sample t-tests, respectively. Bland-Altman plots were used to estimate the limits of agreement (LOA) and assess systematic bias. Simple regression models were used to examine associations between measurement discrepancies and sociodemographic factors and number of days between measurements. Overall mean differences in child and caregiver weight, height, BMI, and child BMIaz were not significantly different between remote and in-person measurements. LOAs were - 2.1 and 1.7 kg for child weight, - 5.2 and 4.0 cm for child height, - 1.5 and 1.7 kg/m2 for child BMI, - 0.4 and 0.5 SD for child BMIaz, - 3.0 and 2.8 kg for caregiver weight, - 2.9 and 3.9 cm for caregiver height, and - 2.1 and 1.6 kg/m2 for caregiver BMI. Absolute mean differences were significantly different between the two approaches for all measurements. Child and caregiver age were each significantly associated with differences between remote and in-person caregiver height measurements; there were no significant associations with other measurement discrepancies. Remotely observed weight and height measurements using non-research grade equipment may be a feasible and valid approach for pediatric clinical trials in rural communities. However, researchers should carefully evaluate their measurement precision requirements and intervention effect size to determine whether remote height and weight measurements suit their studies.Trial registration: ClinicalTrials.gov NCT04142034 (29/10/2019).

Characteristics of Oklahoma Pediatricians Who Dismiss Families for Refusing Vaccines.

Vaccine refusal is increasing. Objectives were to assess frequency of declining or dismissing patients who refuse vaccines, which vaccine(s) prompt pediatricians to decline/dismiss patients, and demographics of pediatricians who decline/dismiss patients. Active members of the Oklahoma American Academy of Pediatricians (AAP) were surveyed. Chi-square tests with non-overlapping 95% confidence intervals compared proportions of providers across various metrics. In all, 47% (48/103) versus 35% (34/98) reported declining versus dismissing patients for refusing vaccines, respectively. Pediatricians were unlikely to decline/dismiss patients if they refused influenza, human papilloma virus (HPV), or MenB vaccines. Pediatricians with more years in practice were less likely to decline 15% (9/62) versus 44% (16/36), P = 0.002 and dismiss 8% (5/62) versus 33% (12/36), P = 0.002 patients. Rural pediatricians were less likely than urban to decline 12% (2/17) versus 29% (26/89), P = NS and dismiss patients 0% (0/17) versus 21% (19/89), P = 0.04. Dismissing/declining patients for vaccine refusal is more common among Oklahoma pediatricians than nationally reported. Patterns differ by practice setting, years in practice, and specific vaccine refused.

Clinic-level differences in human papillomavirus vaccination rates among rural and urban Oregon primary care clinics.

PURPOSE: Human papillomavirus (HPV) infection contributes to vaccine-preventable malignancies. Rural populations experience lower HPV vaccination rates despite similar rates of other childhood vaccinations. Individual- and clinic-level characteristics likely contribute to this disparity, but little is known about the separate roles of each. We compared clinic-level HPV vaccination rates among rural versus urban primary care clinics, identified factors associated with HPV vaccination, and separately assessed the impact of individual- and clinic-level characteristics on rural disparities in HPV vaccination. METHODS: This cross-sectional study included 537 Oregon primary care clinics participating in the Vaccines for Children (VFC) program during 2019. Vaccination status was assessed using Oregon's ALERT Immunization Information System and included HPV vaccine ≥ 1 dose for ages 11 and 12; HPV vaccination up to date (UTD) for ages 13-17, and coadministration with tetanus, diphtheria, and acellular pertussis (Tdap). Rural versus urban clinic-level outcomes were assessed using negative binomial regression. FINDINGS: Participating clinics were 24.5% rural and 75.6% urban. Family medicine clinics comprised 71.1%; pediatrics, 16.9%; and mixed, 12.1%. Across clinics, the average proportion of patients qualifying for VFC was 43%, and non-White patients were 14.1%. The mean rate of HPV vaccine ≥1 dose was lower among rural clinics (46.9% vs 51.1%, P = .039), as was vaccination UTD (40.5% vs 49.9%, P < .001). Adjusting for differences in individual- and clinic-level characteristics, rural disparities were no longer statistically significant. CONCLUSIONS: Both individual- and clinic-level characteristics play a role in rural disparities in HPV vaccination, and modifiable clinic-level differences may be opportune targets to address these disparities.

A comparison of electronic health records and the Oregon state immunization registry for human papilloma virus vaccine delivery (2005-2022).

INTRODUCTION: Immunization Information Systems (IIS) play an important information-sharing role at the point of care, and provide vital vaccination data for research studies and policy-makers. Previous validation studies comparing the accuracy of state registry data to health records have had mixed results. METHODS: We conducted a retrospective review of EHR vaccination data for 9-17 year-old patients from 10 Oregon primary care clinics who had at least one ambulatory care visit in the past 3 years from the date of validation data collection. Data on 100 age eligible youth were captured per clinic. We compared HPV and Tdap vaccinations captured in the EHR to the Oregon ALERT IIS. All clinics were located in rural areas with both family medicine (n = 7) and pediatric (n = 3) primary care clinics. RESULTS: Overall agreement for HPV vaccination between EHR and ALERT IIS was 89.4 % (k = 0.83; p < 0.05). For Tdap vaccination overall agreement was 80.8 % (k = 0.60; p < 0.05). Pediatric clinics showed a higher overall vaccine agreement for both HPV at 93.3 % (k = 0.89; p < 0.05) and Tdap at 95.3 % (k = 0.90; p < 0.05). Among clinics that used bidirectional data exchange (only family medicine clinics), HPV agreement was higher at 91 % (k = 0.85) versus 88 % (k = 0.81; p < 0.05) and was lower for Tdap 75 % with bidirectional data exchange (k = 0.50) versus 86 % without bidirectional data exchange (k = 0.70; p < 0.05). When the EHR and ALERT IIS disagreed, ALERT ISS usually had additional vaccines. CONCLUSIONS: ALERT IIS data provides more accurate data than EHRs can provide when measuring vaccine delivery among adolescents in rural Oregon.

COVID-19 Vaccine Hesitancy Among Parents: A Qualitative Study.

OBJECTIVES: Addressing parental/caregivers' coronavirus disease 2019 (COVID-19) vaccine hesitancy is critical to improving vaccine uptake in children. Common concerns have been previously reported through online surveys, but qualitative data from KII and focus groups may add much-needed context. Our objective was to examine factors impacting pediatric COVID-19 vaccine decision-making in Black, Spanish-speaking, and rural white parents/caregivers to inform the content design of a mobile application to improve pediatric COVID-19 vaccine uptake. METHODS: Parents/caregivers of children aged 2 to 17 years from groups disproportionately affected by COVID-19-related vaccine hesitancy (rural-dwelling persons of any race/ethnicity, urban Black persons, and Spanish-speaking persons) were included on the basis of their self-reported vaccine hesitancy and stratified by race/ethnicity. Those expressing vaccine acceptance or refusal participated in KII, and those expressing hesitancy in focus groups. Deidentified transcripts underwent discourse analysis and thematic analysis, both individually and as a collection. Themes were revised until coders reached consensus. RESULTS: Overall, 36 participants completed the study: 4 vaccine acceptors and 4 refusers via KIIs, and the remaining 28 participated in focus groups. Participants from all focus groups expressed that they would listen to their doctor for information about COVID-19 vaccines. Infertility was a common concern, along with general concerns about vaccines. Vaccine decision-making was informed by the amount of information available to parents/caregivers, including scientific research; possible positive and negative long-term effects; and potential impacts of vaccination on preexisting medical conditions. CONCLUSIONS: Parents/caregivers report numerous addressable vaccine concerns. Our results will inform specific, targeted interventions for improving COVID-19 vaccine confidence.

The interface between U.S. primary care clinics and pharmacies for HPV vaccination delivery: A scoping literature review.

Completion of the Human Papilloma Virus (HPV) vaccine series remains low. Partnerships between primary care (PC) clinics and local pharmacies could boost vaccination rates. We conducted a scoping literature review to address what is known and what gaps exist on the interface between U.S. primary care clinics and pharmacies for HPV vaccination. We searched Ovid MEDLINE ALL file and Cumulative Index to Allied Health Literature for articles published between 1/1/2010 and 12/31/2020. Search subjects included: 1) Pharmacy HPV Vaccination, 2) Pharmacy/PC Collaboration, and 3) Pharmacy/PC Collaboration vaccination. We developed an abstraction form to collect information on research methods, settings, strengths, weaknesses and findings. We screened 407 articles for inclusion; 17 met inclusion criteria: 13 (76.5%) reported on observational/descriptive studies; 4 articles (23.5%) reported on intervention studies, none of which were conducted in rural areas. Observational studies focused on willingness to be vaccinated for HPV and facilitators and barriers for vaccination, especially at pharmacies. Many studies concluded that knowledge about and comfort with HPV vaccine administration were needed for all vaccination stakeholders (clinicians, pharmacists, parents, and patients). Intervention studies were small with weak study designs, many of which revealed that pharmacists were not successful in integrating services into broader primary care systems. Challenges included getting physicians to sign standing order protocols, poor service delivery due to engagement barriers, and low parental demand for pharmacists to administer the vaccine. In conclusion, larger more discerning studies are needed to fully understand the potential of primary care and pharmacy interactions for HPV vaccination.

Improving pediatric COVID-19 vaccine uptake using an mHealth tool (MoVeUP): a randomized, controlled trial.

Background: Coronavirus disease 2019 (COVID-19) vaccines demonstrate excellent effectiveness against infection, severe disease, and death. However, pediatric COVID-19 vaccination rates lag among individuals from rural and other medically underserved communities. The research objective of the current protocol is to determine the effectiveness of a vaccine communication mobile health (mHealth) application (app) on parental decisions to vaccinate their children against COVID-19. Methods: Custodial parents/caregivers with ≥1 child eligible for COVID-19 vaccination who have not yet received the vaccine will be randomized to download one of two mHealth apps. The intervention app will address logistical and motivational barriers to pediatric COVID-19 vaccination. Participants will receive eight weekly push notifications followed by two monthly push notifications (cues to action) regarding vaccinating their child. Through branching logic, users will access customized content based on their locality, degree of rurality-urbanicity, primary language (English/Spanish), race/ethnicity, and child's age to address COVID-19 vaccine knowledge and confidence gaps. The control app will provide push notifications and information on general pediatric health and infection prevention and mitigation strategies based on recommendations from the American Academy of Pediatrics (AAP) and the Centers for Disease Control and Prevention (CDC). The primary outcome is the proportion of children who complete COVID-19 vaccination series. Secondary outcomes include the proportion of children who receive ≥1 dose of COVID-19 vaccine and changes in parent/caregiver scores from baseline to immediately post-intervention on the modified WHO SAGE Vaccine Hesitancy Scale adapted for the COVID-19 vaccine. Discussion: The COVID-19 pandemic inflicts disproportionate harm on individuals from underserved communities, including those in rural settings. Maximizing vaccine uptake in these communities will decrease infection rates, severe illness, and death. Given that most US families from these communities use smart phones, mHealth interventions hold the promise of broad uptake. Bundling multiple mHealth vaccine-uptake interventions into a single app may maximize the impact of deploying such a tool to increase COVID-19 vaccination. The new knowledge to be gained from this study will directly inform future efforts to increase COVID-19 vaccination rates across diverse settings and provide an evidentiary base for app-based vaccine communication tools that can be adapted to future vaccine-deployment efforts. Clinical Trials Registration: Name of the registry: clinicaltrials.gov Trial registration number: NCT05386355 Date of registration: May 23, 2022 URL of trial registry record: https://clinicaltrials.gov/ct2/show/NCT05386355.

Conducting a pediatric randomized clinical trial during a pandemic: A shift to virtual procedures.

Background/Objective: Prior to the COVID-19 pandemic, our research group initiated a pediatric practice-based randomized trial for the treatment of childhood obesity in rural communities. Approximately 6 weeks into the originally planned 10-week enrollment period, the trial was forced to pause all study activity due to the COVID-19 pandemic. This pause necessitated a substantial revision in recruitment, enrollment, and other study methods in order to complete the trial using virtual procedures. This descriptive paper outlines methods used to recruit, enroll, and manage clinical trial participants with technology to obtain informed consent, obtain height and weight measurements by video, and maintain participant engagement throughout the duration of the trial. Methods: The study team reviewed the IRB records, protocol team meeting minutes and records, and surveyed the site teams to document the impact of the COVID-19 shift to virtual procedures on the study. The IRB approved study changes allowed for flexibility between clinical sites given variations in site resources, which was key to success of the implementation. Results: All study sites faced a variety of logistical challenges unique to their location yet successfully recruited the required number of patients for the trial. Ultimately, virtual procedures enhanced our ability to establish relationships with participants who were previously beyond our reach, but presented several challenges and required additional resources. Conclusion: Lessons learned from this study can assist other study groups in navigating challenges, especially when recruiting and implementing studies with rural and underserved populations or during challenging events like the pandemic.

Improving pediatric COVID-19 vaccine uptake using an mHealth tool (MoVeUp): study protocol for a randomized, controlled trial.

BACKGROUND: Coronavirus disease 2019 (COVID-19) vaccines demonstrate excellent effectiveness against infection, severe disease, and death. However, pediatric COVID-19 vaccination rates lag among individuals from rural and other medically underserved communities. The research objective of the current protocol is to determine the effectiveness of a vaccine communication mobile health (mHealth) application (app) on parental decisions to vaccinate their children against COVID-19. METHODS: Custodial parents/caregivers with ≥ 1 child eligible for COVID-19 vaccination who have not yet received the vaccine will be randomized to download one of two mHealth apps. The intervention app will address logistical and motivational barriers to pediatric COVID-19 vaccination. Participants will receive eight weekly push notifications followed by two monthly push notifications (cues to action) regarding vaccinating their child. Through branching logic, users will access customized content based on their locality, degree of rurality-urbanicity, primary language (English/Spanish), race/ethnicity, and child's age to address COVID-19 vaccine knowledge and confidence gaps. The control app will provide push notifications and information on general pediatric health and infection prevention and mitigation strategies based on recommendations from the American Academy of Pediatrics (AAP) and the Centers for Disease Control and Prevention (CDC). The primary outcome is the proportion of children who complete COVID-19 vaccination series. Secondary outcomes include the proportion of children who receive ≥ 1 dose of COVID-19 vaccine and changes in parent/caregiver scores from baseline to immediately post-intervention on the modified WHO SAGE Vaccine Hesitancy Scale adapted for the COVID-19 vaccine. DISCUSSION: The COVID-19 pandemic inflicts disproportionate harm on individuals from underserved communities, including those in rural settings. Maximizing vaccine uptake in these communities will decrease infection rates, severe illness, and death. Given that most US families from these communities use smart phones, mHealth interventions hold the promise of broad uptake. Bundling multiple mHealth vaccine uptake interventions into a single app may maximize the impact of deploying such a tool to increase COVID-19 vaccination. The new knowledge to be gained from this study will directly inform future efforts to increase COVID-19 vaccination rates across diverse settings and provide an evidentiary base for app-based vaccine communication tools that can be adapted to future vaccine-deployment efforts. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov NCT05386355 . Registered on May 23, 2022.

Active vs Traditional Methods of Recruiting Children for a Clinical Trial in Rural Primary Care Clinics: A Cluster-Randomized Clinical Trial.

Importance: To our knowledge, there are no published randomized clinical trials of recruitment strategies. Rigorously evaluated successful recruitment strategies for children are needed. Objective: To evaluate the feasibility of 2 recruitment methods for enrolling rural children through primary care clinics to assess whether either or both methods are sufficiently effective for enrolling participants into a clinical trial of a behavioral telehealth intervention for children with overweight or obesity. Design, Setting, and Participants: This cluster-randomized clinical trial of 2 recruitment methods was conducted at 4 primary care clinics in 4 separate states. Each clinic used both recruitment methods in random order. Clinic eligibility criteria included at least 40% pediatric patients with Medicaid coverage and at least 100 potential participants. Eligibility criteria for children included a rural home address, age 6 to 11 years, and body mass index at or above the 85th percentile. Recruitment began February 3, 2020, and randomization of participants occurred on August 17, 2020. Data were analyzed from October 3, 2021, to April 21, 2022. Interventions: Two recruitment methods were assessed: the active method, for which a list of potential participants seen within the past year at each clinic was generated through the electronic health record and consecutively approached by research staff based on visit date to the clinic, and the traditional method, for which recruitment included posters, flyers, social media, and press release. Clinics were randomized to the order in which the 2 methods were implemented in 4-week periods, followed by a 4-week catch-up period using the method found most effective in previous periods. Main Outcomes and Measures: For each recruitment method, the number and proportion of randomized children among those who were approached was calculated. Results: A total of 104 participants were randomized (58 girls [55.8%]; mean age, 9.3 [95% CI, 9.0-9.6] years). Using the active method, 535 child-parent dyads were approached and 99 (18.5% [95% CI, 15.3%-22.1%]) were randomized. Using the traditional method, 23 caregivers expressed interest, and 5 (21.7% [95% CI, 7.5%-43.7%]) were randomized. All sites reached full enrollment using the active method and no sites achieved full enrollment using the traditional method. Mean time to full enrollment was 26.3 (range, 21.0-31.0) days. Conclusions and Relevance: This study supports the use of the active approach with local primary care clinics to recruit children with overweight and obesity from rural communities into clinical trials. Trial Registration: ClinicalTrials.gov Identifier: NCT04142034.

Extra-immunization as a clinical indicator for fragmentation of care.

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