Humoral Immune Response to Messenger RNA Coronavirus Disease 2019 Vaccination Among Children Aged 5-11 Years in a Multisite Prospective Cohort Study, September 2021-September 2022.

Background: The PROTECT study is a longitudinal cohort study initiated in July 2021 with weekly testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 4 states: Arizona, Florida, exas, and Utah. This study aims to examine vaccine-elicited antibody response against postvaccination SARS-CoV-2 infections. Methods: Children aged 5-11 years had serum collected 14-59 days after their second dose of monovalent Pfizer-BioNTech coronavirus disease 2019 messenger RNA vaccine. Vaccine-elicited antibodies were measured using the area under the curve (AUC) and end-point titer using enzyme-linked immunosorbent assay (receptor-binding domain [RBD] and S2) and surrogate neutralization assays against ancestral (WA1) and Omicron (BA.2). Results: 79 vaccinated participants (33 [41.7%] female; median age, 8.8 years [standard deviation, 1.9 years]), 48 (60.8%) were from Tucson, Arizona; 64 (81.0%) were non-Hispanic white; 63 (80.8%) attended school in person; 68 (86.1%) did not have any chronic conditions; and 47 (59.5%) were infected after vaccination. Uninfected children had higher AUCs against WA1 (P = .009) and Omicron (P = .02). The geometric mean and surrogate neutralization titer above the limit of detection was 346.0 for WA1 and 39.7 for Omicron, an 8.7-fold decrease (P < .001). After adjustment of covariates in the WA1-specific model, we observed a 47% reduction in the odds of postvaccination infection for every standard deviation increase in RBD AUC (aOR, 0.53 [95% confidence interval, .29-.97) and a 69% reduction in the odds of infection for every 3-fold increase in RBD end titer (0.31 [.06-1.57]). Conclusions: Children with higher antibody levels experienced a lower incidence of postvaccination SARS-CoV-2 infection.

Common Data Element Collection in Underserved School Communities: Challenges and Recommendations.

OBJECTIVES: To provide recommendations for future common data element (CDE) development and collection that increases community partnership, harmonizes data interpretation, and continues to reduce barriers of mistrust between researchers and underserved communities. METHODS: We conducted a cross-sectional qualitative and quantitative evaluation of mandatory CDE collection among Rapid Acceleration of Diagnostics-Underserved Populations Return to School project teams with various priority populations and geographic locations in the United States to: (1) compare racial and ethnic representativeness of participants completing CDE questions relative to participants enrolled in project-level testing initiatives and (2) identify the amount of missing CDE data by CDE domain. Additionally, we conducted analyses stratified by aim-level variables characterizing CDE collection strategies. RESULTS: There were 15 study aims reported across the 13 participating Return to School projects, of which 7 (47%) were structured so that CDEs were fully uncoupled from the testing initiative, 4 (27%) were fully coupled, and 4 (27%) were partially coupled. In 9 (60%) study aims, participant incentives were provided in the form of monetary compensation. Most project teams modified CDE questions (8/13; 62%) to fit their population. Across all 13 projects, there was minimal variation in the racial and ethnic distribution of CDE survey participants from those who participated in testing; however, fully uncoupling CDE questions from testing increased the proportion of Black and Hispanic individuals participating in both initiatives. CONCLUSIONS: Collaboration with underrepresented populations from the early study design process may improve interest and participation in CDE collection efforts.

A Multi-Study Synthesis of Facilitators and Barriers to SARS-CoV-2 Testing Enrollment in School Settings.

OBJECTIVES: Understanding the motivators and barriers to testing enrollment from different stakeholder perspectives is essential to increasing participation in school-based testing programs, particularly among underserved populations. This multistudy analysis aimed to identify facilitators and barriers to enrollment in school-based testing for coronavirus disease 2019 (COVID-19). METHODS: Four independent studies collected and analyzed qualitative data from study participants regarding: (1) motivators, benefits, and/or reasons for enrolling and/or participating in COVID-19 testing in schools; and/or (2) concerns, barriers, and/or negative outcomes related to COVID-19 testing in schools. Study authors conducted a retrospective review of findings from the independent studies to identify themes related to testing motivators and concerns that emerged across the studies. RESULTS: The analysis identified 10 distinct themes regarding the perceived motivators of COVID-19 testing in schools and 15 distinct themes regarding concerns and barriers to COVID-19 testing in schools. Common motivators across multiple studies included convenience of testing in school and the desire to keep self and others safe from COVID-19. Concerns about the implications of receiving a positive test result was a barrier identified by multiple studies. CONCLUSIONS: Themes from 4 independent studies revealed insights about the motivations and barriers to enrolling and participating in COVID-19 testing programs in kindergarten through 12th grade school settings. Study findings can be used to improve enrollment and participation in new and existing school-based testing programs to reduce transmission of COVID-19 and other infectious diseases in schools.

Utilization and Impact of Symptomatic and Exposure SARS-CoV-2 Testing in K-12 Schools.

OBJECTIVES: The Centers for Disease Control and Prevention recommend that schools can offer severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostic (on-demand) testing for students and staff with coronavirus disease 2019 symptoms or exposures. Data related to the uptake, implementation, and effect of school-associated on-demand diagnostic testing have not been described. METHODS: The Rapid Acceleration of Diagnostics Underserved Populations Return to School program provided resources to researchers to implement on-demand SARS-CoV-2 testing in schools. This study describes the strategies used and uptake among the different testing programs. Risk of positivity was compared for symptomatic and exposure testing during the δ and ο variant periods. We estimated the number of school absence days saved with school-based diagnostic testing. RESULTS: Of the 16 eligible programs, 7 provided school-based on-demand testing. The number of persons that participated in these testing programs is 8281, with 4134 (49.9%) receiving >1 test during the school year. Risk of positivity was higher for symptomatic testing compared with exposure testing and higher during the ο variant predominant period compared with the δ variant predominant period. Overall, access to testing saved an estimated 13 806 absent school days. CONCLUSIONS: School-based on-demand SARS-CoV-2 testing was used throughout the school year, and nearly half the participants accessed testing on more than 1 occasion. Future studies should work to understand participant preferences around school-based testing and how these strategies can be used both during and outside of pandemics.

Building School-Academic Partnerships to Implement COVID-19 Testing in Underserved Populations.

OBJECTIVE: In April 2021, the US government made substantial investments in students' safe return to school by providing resources for school-based coronavirus disease 2019 (COVID-19) mitigation strategies, including COVID-19 diagnostic testing. However, testing uptake and access among vulnerable children and children with medical complexities remained unclear. METHODS: The Rapid Acceleration of Diagnostics Underserved Populations program was established by the National Institutes of Health to implement and evaluate COVID-19 testing programs in underserved populations. Researchers partnered with schools to implement COVID-19 testing programs. The authors of this study evaluated COVID-19 testing program implementation and enrollment and sought to determine key implementation strategies. A modified Nominal Group Technique was used to survey program leads to identify and rank testing strategies to provide a consensus of high-priority strategies for infectious disease testing in schools for vulnerable children and children with medical complexities. RESULTS: Among the 11 programs responding to the survey, 4 (36%) included prekindergarten and early care education, 8 (73%) worked with socioeconomically disadvantaged populations, and 4 focused on children with developmental disabilities. A total of 81 916 COVID-19 tests were performed. "Adapting testing strategies to meet the needs, preferences, and changing guidelines," "holding regular meetings with school leadership and staff," and "assessing and responding to community needs" were identified as key implementation strategies by program leads. CONCLUSIONS: School-academic partnerships helped provide COVID-19 testing in vulnerable children and children with medical complexities using approaches that met the needs of these populations. Additional work is needed to develop best practices for in-school infectious disease testing in all children.

eHealth Familias Unidas Mental Health: Protocol for an effectiveness-implementation hybrid Type 1 trial to scale a mental health preventive intervention for Hispanic youth in primary care settings.

This article focuses on the rationale, design and methods of an effectiveness-implementation hybrid type I randomized trial of eHealth Familias Unidas Mental Health, a family-based, online delivered intervention for Hispanic families to prevent/reduce depressive and anxious symptoms, suicide ideation/behaviors, and drug use in Hispanic youth. Utilizing a rollout design with 18 pediatric primary care clinics and 468 families, this study addresses intervention effectiveness, implementation research questions, and intervention sustainment, to begin bridging the gap between research and practice in eliminating mental health and drug use disparities among Hispanic youth. Further, we will examine whether intervention effects are partially mediated by improved family communication and reduced externalizing behaviors, including drug use, and moderated by parental depression. Finally, we will explore whether the intervention's impact on mental health and drug use, as well as sustainment of the intervention in clinics, varies by quality of implementation at clinic and clinician levels. Trail registration: ClinicalTrials.gov Identifier: NCT05426057, First posted June 21, 2022.

Association of Adverse Childhood Experiences with Heart Conditions in Children: Insight from the 2019-2020 National Survey of Children's Health.

Adverse Childhood Experiences (ACEs) have been associated with a higher risk of developing cardiovascular diseases and premature mortality in adults. OBJECTIVES: We evaluated the associations between ACEs and heart diseases among children in the United States. METHODS: Data on children ages 0 to 17 years reported by parents/guardians to have current heart conditions were analyzed. Using Stata version 17 software, descriptive statistics were generated for the demographic characteristics and the various health outcomes using the chi-square of independence. Multivariate logistic regression models were employed to determine the associations between ACEs and heart conditions, the severity of heart conditions, and overall health status. RESULTS: There were 826 children with current heart conditions from a total of 68,753 surveyed children. This corresponded to an estimated 780,000 (1.13%) children living with heart conditions in the U.S. On multivariate logistic models, several ACEs, including household economic hardship, parental/guardian's alcohol/drug abuse, severe mental health illness of parents/guardians, racial/ethnic discrimination, exposure to neighborhood violence, and accumulation of two or more ACEs, were significantly associated with heart diseases among children. Though the accumulation of two or more ACEs did not have a significant association with the severity of heart condition, it was significantly associated with caregiver reports of undesirable overall health status. CONCLUSIONS: ACEs are significantly associated with heart conditions among children and contribute to unfavorable overall health status among children with heart conditions in the U.S. There is a need for policies and programs that will promptly identify ACEs and mitigate their negative impact on children.

Mapping of Pediatric COVID-19 Cases in Miami-Dade and Broward Counties: an Analysis of Sociodemographic Disparities.

BACKGROUND: Numerous studies have shown a disproportionate impact of COVID-19 infection on Black and Hispanic Americans in the adult patient population. However, few studies have been done with pediatric populations. The aim of this study is to identify the prevalence and distribution of COVID-19 cases among pediatric patients in Miami-Dade and Broward counties and identify any sociodemographic disparities. METHODS: A total of 10,087 children/adolescents ages zero years-old to 20 years-old were tested from July 1, 2020, to December 31, 2020. ArcGIS was used to map cases and obtain sociodemographic data. SPSS software was used to determine significance of data trends and create a predictive model. RESULTS: There were 1,161 pediatric COVID-19 cases detected. White Hispanics and Black Hispanics had statically significantly higher cases when compared to White non-Hispanics and Black non-Hispanics. Percentage of households on food stamps, percentage of households below the poverty line, percentage of minority populations, and percentage of Hispanic population showed a positive correlation with detected pediatric COVID-19 cases. Alternatively, areas with higher median household incomes and higher educational status were negatively correlated with COVID-19. Percentage of Hispanic population and percentage of households below the poverty line were predictive of pediatric COVID-19 cases. CONCLUSION: There was a disproportionate impact of pediatric COVID-19 infection on zip codes of lower socioeconomic status and increased racial/ethnic minority populations. This study demonstrates the need for public health policies that prioritize testing children/adolescents in these communities.

Community voices on factors influencing COVID-19 concerns and health decisions among racial and ethnic minorities in the school setting.

Racial and ethnic minority communities have been disproportionately affected by COVID-19, but the uptake of COVID-19 mitigation strategies like vaccination and testing have been slower in these populations. With the continued spread of COVID-19 while in-person learning is a priority, school-aged youth and their caregivers must make health-related decisions daily to ensure health at school. It is critical to understand factors associated with COVID-related health decisions such as vaccination, testing, and other health behaviors (e.g., wearing masks, hand washing). Community-engaged campaigns are necessary to overcome barriers to these health behaviors and promote health equity. The aim of this study was to examine COVID-19-related concerns and influences on health decisions in middle and high schools serving primarily racial and ethnic minority, low-income families. Seven focus groups were conducted with school staff, parents, and students (aged 16 years and older). Qualitative data were analyzed using a general inductive approach. Factors related to COVID-19 concerns and health decisions centered on (1) vaccine hesitancy, (2) testing hesitancy, (3) developmental stage (i.e., ability to engage in health behaviors based on developmental factors like age), (4) cultural and family traditions and beliefs, (5) compatibility of policies and places with recommended health behaviors, (6) reliability of information, and (7) perceived risk. We explore sub-themes in further detail. It is important to understand the community's level of concern and identify factors that influence COVID-19 medical decision making to better address disparities in COVID-19 testing and vaccination uptake.

Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT): Protocol for a Multisite Longitudinal Cohort Study.

BACKGROUND: Assessing the real-world effectiveness of COVID-19 vaccines and understanding the incidence and severity of SARS-CoV-2 illness in children are essential to inform policy and guide health care professionals in advising parents and caregivers of children who test positive for SARS-CoV-2. OBJECTIVE: This report describes the objectives and methods for conducting the Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT) study. PROTECT is a longitudinal prospective pediatric cohort study designed to estimate SARS-CoV-2 incidence and COVID-19 vaccine effectiveness (VE) against infection among children aged 6 months to 17 years, as well as differences in SARS-CoV-2 infection and vaccine response between children and adolescents. METHODS: The PROTECT multisite network was initiated in July 2021, which aims to enroll approximately 2305 children across four US locations and collect data over a 2-year surveillance period. The enrollment target was based on prospective power calculations and accounts for expected attrition and nonresponse. Study sites recruit parents and legal guardians of age-eligible children participating in the existing Arizona Healthcare, Emergency Response, and Other Essential Workers Surveillance (HEROES)-Research on the Epidemiology of SARS-CoV-2 in Essential Response Personnel (RECOVER) network as well as from surrounding communities. Child demographics, medical history, COVID-19 exposure, vaccination history, and parents/legal guardians' knowledge and attitudes about COVID-19 are collected at baseline and throughout the study. Mid-turbinate nasal specimens are self-collected or collected by parents/legal guardians weekly, regardless of symptoms, for SARS-CoV-2 and influenza testing via reverse transcription-polymerase chain reaction (RT-PCR) assay, and the presence of COVID-like illness (CLI) is reported. Children who test positive for SARS-CoV-2 or influenza, or report CLI are monitored weekly by online surveys to report exposure and medical utilization until no longer ill. Children, with permission of their parents/legal guardians, may elect to contribute blood at enrollment, following SARS-CoV-2 infection, following COVID-19 vaccination, and at the end of the study period. PROTECT uses electronic medical record (EMR) linkages where available, and verifies COVID-19 and influenza vaccinations through EMR or state vaccine registries. RESULTS: Data collection began in July 2021 and is expected to continue through the spring of 2023. As of April 13, 2022, 2371 children are enrolled in PROTECT. Enrollment is ongoing at all study sites. CONCLUSIONS: As COVID-19 vaccine products are authorized for use in pediatric populations, PROTECT study data will provide real-world estimates of VE in preventing infection. In addition, this prospective cohort provides a unique opportunity to further understand SARS-CoV-2 incidence, clinical course, and key knowledge gaps that may inform public health. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/37929.

Effectiveness of 2-Dose BNT162b2 (Pfizer BioNTech) mRNA Vaccine in Preventing SARS-CoV-2 Infection Among Children Aged 5-11 Years and Adolescents Aged 12-15 Years - PROTECT Cohort, July 2021-February 2022.

The BNT162b2 (Pfizer-BioNTech) mRNA COVID-19 vaccine was recommended by CDC's Advisory Committee on Immunization Practices for persons aged 12-15 years (referred to as adolescents in this report) on May 12, 2021, and for children aged 5-11 years on November 2, 2021 (1-4). Real-world data on vaccine effectiveness (VE) in these age groups are needed, especially because when the B.1.1.529 (Omicron) variant became predominant in the United States in December 2021, early investigations of VE demonstrated a decline in protection against symptomatic infection for adolescents aged 12-15 years and adults* (5). The PROTECT† prospective cohort of 1,364 children and adolescents aged 5-15 years was tested weekly for SARS-CoV-2, irrespective of symptoms, and upon COVID-19-associated illness during July 25, 2021-February 12, 2022. Among unvaccinated participants (i.e., those who had received no COVID-19 vaccine doses) with any laboratory-confirmed SARS-CoV-2 infection, those with B.1.617.2 (Delta) variant infections were more likely to report COVID-19 symptoms (66%) than were those with Omicron infections (49%). Among fully vaccinated children aged 5-11 years, VE against any symptomatic and asymptomatic Omicron infection 14-82 days (the longest interval after dose 2 in this age group) after receipt of dose 2 of the Pfizer-BioNTech vaccine was 31% (95% CI = 9%-48%), adjusted for sociodemographic characteristics, health information, frequency of social contact, mask use, location, and local virus circulation. Among adolescents aged 12-15 years, adjusted VE 14-149 days after dose 2 was 87% (95% CI = 49%-97%) against symptomatic and asymptomatic Delta infection and 59% (95% CI = 22%-79%) against Omicron infection. Fully vaccinated participants with Omicron infection spent an average of one half day less sick in bed than did unvaccinated participants with Omicron infection. All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations.

Connecting Primary Care Providers in Free Clinics with Specialists Via Telehealth: A Pilot Program with Three Miami Clinics.

The Medical Alumni Volunteer Expert Network (MAVEN) Project (MP) in Miami, Florida piloted primary care provider (PCP)-specialist telehealth consults in three clinics for the uninsured. Preliminary findings suggest telehealth consults may improve quality of care, provider knowledge, and confidence, and may represent innovative health care delivery for the uninsured.

A Retrospective Analysis of Blood Lead Levels in Newly Arrived Immigrant Children, Miami-Dade County, Florida, 2013-2016.

OBJECTIVE: The Centers for Disease Control and Prevention's (CDC's) recommendation for blood lead level (BLL) screening of refugee children is to test new arrivals aged 6 months to 16 years. No such recommendations exist for testing immigrant children. Our objective was to provide evidence in support of creating lower age-specific guidelines for BLL screening for newly arrived immigrant populations to reduce the burden of unnecessary BLL testing. METHODS: We conducted a 3-year (2013-2016) retrospective analysis of BLLs of 1349 newly arrived immigrant children, adolescents, and young adults aged 3-19 who visited the University of Miami Pediatric Mobile Clinic in Miami, Florida. We obtained capillary samples and confirmed values >5 µg/dL via venous sample. The primary outcome was BLL in µg/dL. The main predictor variable was age. We further adjusted regression models by poverty level, sex, and ethnicity. RESULTS: Of 15 patients with a BLL that warranted further workup and a lead level of concern, 9 were aged 3-5 and 6 were aged 6-11. None of the adolescent and young adult patients aged 12-19 had a lead level of concern. Nearly half of the patients (n = 658, 48.8%) lived in zip codes of middle to high levels of poverty. CONCLUSION: This study provides evidence to support the creation of lower age-specific guidelines for BLL screening among newly arrived immigrant children and adolescents. Future studies should elucidate appropriate age ranges for BLL testing based on epidemiologic evidence, such as age and country of origin.

Evidence to Support Universal Blood Pressure Screening in School-Based Clinical Settings.

BACKGROUND: Most pediatric elevated blood pressure (BP) remains undiagnosed. The American Academy of Pediatrics states "there is limited evidence to support school-based measurement of children's BP." We explored the utility school-based BP screening. METHODS: A cross-sectional sample of 4096 students ages 6 to 17 from Title 1 Miami-Dade Public Schools (50% female, 71% non-Hispanic black, 26% Hispanic) had their systolic/diastolic BP (SBP/DBP) and body mass index (BMI) collected over the 2016 to 2017 or 2017 to 2018 school years. Relative risks (RRs) ratios were calculated to estimate normal/elevated SBP/DBP by BMI percentile, ethnicity, and sex. RESULTS: Overall, 26.4% had at least one elevated BP measurement, of which 59% were not obese. RR for obese status was significant for all categories of elevated BP (RRs > 1.88, p < .0001). Being either female (RR = 1.34, p = .009) or Hispanic (RR = 1.31, p = .014) was significantly associated with elevated DBP. BMI accounted for <10% of the variation in BP (SBP: F(1, 4095) = 367.6, adjusted R2  = .08, p < .0001; DBP: F(1, 4095) = 93.3, adjusted R2  = .02, p < .0001). CONCLUSION: These findings support providing BP screenings in school settings. Low-income and minority students often have limited access to health care, higher obesity rates, and unhealthy behaviors. Our findings support universal school-based BP screening regardless of weight status, particularly among ethnically diverse populations.

Rationale and design for eHealth Familias Unidas Primary Care: A drug use, sexual risk behavior, and STI preventive intervention for hispanic youth in pediatric primary care clinics.

Family-based behavioral interventions are efficacious and effective in preventing drug use and sexual risk behaviors; unfortunately, they have not been evaluated and disseminated in pediatric primary care practice, where they can have a significant impact. There is an increased focus on integrating parenting interventions into primary care to reduce health disparities among ethnic minorities such as Hispanics. Although Hispanic youth demonstrate higher levels of drug use and sexual risk behaviors than their non-Hispanic counterparts, few parenting interventions are available for Hispanic youth, and none have been delivered specifically to Hispanic adolescents in primary care. Therefore, this manuscript describes the rationale and design of an Internet-based, family-centered, Hispanic-specific, evidence-based prevention intervention, eHealth Familias Unidas Primary Care. Hispanic adolescents (n = 456) and their care givers will be recruited from pediatric primary care clinics in South Florida and randomized to: eHealth Familias Unidas Primary Care or prevention as usual. The intervention will be delivered by trained interns, clinic volunteers, social workers, mental health counselors, students, and nurses. Outcomes will be measured at baseline and 6, 12, 24, and 36 months post-baseline. This study will determine whether the intervention, compared to prevention as usual, is effective in reducing drug use, unprotected sex, and STI incidence in Hispanic youth through the improvement of family functioning. Additionally, we will determine the cost effectiveness of delivering eHealth Familias Unidas within primary care settings. The effectiveness of eHealth Familias Unidas Primary Care will further inform the need to integrate effective behavioral health interventions into primary care settings.