Community-engaged implementation of a safety bundle for pregnancy-related severe hypertension in the outpatient setting: protocol for a type 3 hybrid study with a multiple baseline design.

BACKGROUND: Hypertensive disorders of pregnancy are among the leading causes of maternal mortality and morbidity in the U.S., with rates highest among birthing people who are Black, rural residents, and/or have low-income. Severe hypertension, in particular, increases risk of stroke and other serious pregnancy complications. To promote early detection and treatment of severe hypertension, the Alliance for Innovation on Maternal Health developed the Severe Hypertension During Pregnancy and Postpartum Period Safety Bundle (HTN Bundle). Multiple studies have demonstrated the HTN Bundle's effectiveness in the inpatient setting. With funding from the National Heart, Lung, and Blood Institute, we engaged community partners to adapt the HTN Bundle for the outpatient setting (i.e., O-HTN Bundle) and planned for its implementation. In this paper, we describe the protocol for a study evaluating O-HTN Bundle implementation in 20 outpatient clinics serving Black, rural, and/or low-income populations. METHODS: This study is a hybrid type 3 effectiveness-implementation trial with a multiple baseline design. We will implement the O-HTN Bundle in three successive cohorts of clinics using a multicomponent implementation strategy to engage community partners (coalition, patient workgroup) and support clinics (training, facilitation, education materials, and simulations of severe hypertension events). To test the strategy, we will compare clinic fidelity to evidence-based guidelines for (a) patient education on hypertension and (b) blood pressure measurement technique, with repeated measures occurring before and after strategy receipt. We will also observe strategy effects on community- and clinic-level intermediate outcomes (community engagement, organizational readiness), implementation outcomes (reach, adoption, fidelity, maintenance), and effectiveness outcomes (receipt of guideline concordant care). Analyses will address whether outcomes are equitable across Black, rural, and/or low-income subgroups. Guided by the Consolidated Framework for Implementation Research 2.0, we will use mixed methods to identify adaptations and other determinants of implementation success. DISCUSSION: This study integrates community engagement and implementation science to promote equitable and timely response to severe HTN in the outpatient setting during pregnancy and postpartum. This is one of the first studies to implement an outpatient HTN Bundle and to use simulation as a strategy to reinforce team-based delivery of guideline concordant care. TRIAL REGISTRATION: This study was registered with ClinicalTrials.gov as "Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle (AC3HIEVE)." Registration number NCT06002165, August 21, 2023: https://clinicaltrials.gov/study/NCT06002165 .

Listening to the community: identifying obesity prevention strategies for rural preschool-aged children.

Multi-level interventions promoting healthy weight in rural preschool children aged 2-5 years are limited. With the goal of developing a community-informed obesity prevention intervention for rural preschool-aged children, the purpose of this descriptive study was to identify: (1) community settings and intervention strategies to prioritize for an intervention; (2) potential implementation challenges and solutions; and (3) immediate interventions the study team and community partners could collaboratively implement. Workshops occurred in two rural communities in Indiana (2 workshops) and North Carolina (2 workshops), with high obesity rates. A guide was developed to moderate discussions and participants voted to rank community settings and intervention strategies. There were 9-15 participants per workshop, including parents, childcare providers, and representatives of community organizations. Community settings identified as priorities for child obesity prevention included the home, educational settings (preschools), food outlets, recreational facilities, and social media. Priority intervention strategies included providing nutrition and physical activity education, increasing access to healthy foods and physical activity in the built environment, and enhancing food security. Potential intervention implementation challenges centered on poor parental engagement; using personalized invitations and providing transportation support to families were proffered solutions. Immediate interventions to collaboratively implement focused on making playgrounds esthetically pleasing for physical activity using game stencils, and nutrition education for families via quarterly newsletters. This participatory approach with community partners provided insight into two rural communities' needs for child obesity prevention, community assets (settings) to leverage, and potential intervention strategies to prioritize. Findings will guide the development of a multi-level community-based intervention.

Intervening in the Cancer Care System: An Analysis of Equity-Focused Nurse Navigation and Patient-Reported Outcomes.

BACKGROUND: Nurse navigation can improve quality of cancer care and reduce racial disparities in care outcomes. Addressing persistent structurally-rooted disparities requires research on strategies that support patients by prompting structural changes to systems of care. We applied a novel conceptualization of social support to an analysis of racial equity-focused navigation and patient-reported outcomes. METHOD: We applied an antiracism lens to create a theory-informed definition of system-facing social support: intervening in a care system on a patient's behalf. Participants were adults with early-stage breast or lung cancer, who racially identified as Black or White, and received specialized nurse navigation (n = 155). We coded navigators' clinical notes (n = 3,251) to identify instances of system-facing support. We then estimated models to examine system-facing support in relation to race, perceived racism in health care settings, and mental health. RESULTS: Twelve percent of navigators' clinical notes documented system-facing support. Black participants received more system-facing support than White participants, on average (b = 0.78, 95% confidence interval [CI]: [0.25, 1.31]). The interaction of race*system-facing support was significant in a model predicting perceived racism in health care settings at the end of the study controlling for baseline scores (b = 0.05, 95% CI [0.01, 0.09]). Trends in simple slopes indicated that among Black participants, more system-facing support was associated with slightly more perceived racism; no association among White participants. DISCUSSION: The term system-facing support highlights navigators' role in advocating for patients within the care system. More research is needed to validate the construct system-facing support and examine its utility in interventions to advance health care equity.

"We grew up in the church": A critical discourse analysis of Black and White rural residents' perceptions of mental health.

RATIONALE: Known as the "Black-White mental health paradox," Black Americans typically report better mental health than White Americans, despite chronic exposure to the psychologically harmful effects of racism and discrimination. Yet, researchers rarely examine how mental health is experienced across racial groups in economically distressed rural regions where all residents have disproportionately less access to mental healthcare resources. OBJECTIVE: The purpose of this study was to explore how the racialized social system potentially contributes to the mental health beliefs and attitudes of racially majoritized and minoritized rural residents. METHODS: We conducted a secondary analysis of 29 health-focused oral history interviews from Black American (n = 16) and White American (n = 13) adults in rural North Carolina. Through critical discourse analysis, we found nuanced discourses linked to three mental-health-related topics: mental illness, stressors, and coping. RESULTS: White rural residents' condemning discourses illustrated how their beliefs about mental illnesses were rooted in meritocratic notions of individual choice and personal responsibility. Conversely, Black rural residents offered compassionate discourses toward those who experience mental illness, and they described how macro-level mechanisms can affect individual well-being. Stressors also differed along racial lines, such that White residents were primarily concerned about perceived social changes, and Black residents referenced experiences of interpersonal and structural racism. Related to coping, Black and White rural residents characterized the mental health benefits of social support from involvement in their respective religious organizations. Only Black residents signified that a personal relationship with a higher power was an essential positive coping mechanism. CONCLUSIONS: Our findings suggest that belief (or disbelief) in meritocratic ideology and specific religious components could be important factors to probe with Black-White patterning in mental health outcomes. This research also suggests that sociocultural factors can disparately contribute to mental health beliefs and attitudes among diverse rural populations.

Mechanisms to enhance racial equity in health care: Developing a model to facilitate translation of the ACCURE intervention.

Background: As medical and public health professional organizations call on researchers and policy makers to address structural racism in health care, guidance on evidence-based interventions to enhance health care equity is needed. The most promising organizational change interventions to reduce racial health disparities use multilevel approaches and are tailored to specific settings. This study examines the Accountability for Cancer Care through Undoing Racism and Equity (ACCURE) intervention, which changed systems of care at two U.S. cancer centers and eliminated the Black-White racial disparity in treatment completion among patients with early-stage breast and lung cancer. Purpose: We aimed to document key characteristics of ACCURE to facilitate translation of the intervention in other care settings. Methods: We conducted semi-structured interviews with participants who were involved in the design and implementation of ACCURE and analyzed their responses to identify the intervention's mechanisms of change and key components. Results: Study participants (n = 18) described transparency and accountability as mechanisms of change that were operationalized through ACCURE's key components. Intervention components were designed to enhance either institutional transparency (e.g., a data system that facilitated real-time reporting of quality metrics disaggregated by patient race) or accountability of the care system to community values and patient needs for minimally biased, tailored communication and support (e.g., nurse navigators with training in antiracism and proactive care protocols). Conclusions: The antiracism principles transparency and accountability may be effective change mechanisms in equity-focused health services interventions. The model presented in this study can guide future research aiming to adapt ACCURE and evaluate the intervention's implementation and effectiveness in new settings and patient populations.

Institutional Reform to Promote Antiracism: A Tool for Developing an Organizational Equity Action and Accountability Plan.

Racism is a public health problem. Systems, structures, policies, and practices perpetuate a culture built on racism. Institutional reform is needed to promote antiracism. This article describes 1) a tool used to develop an equity action and accountability plan (EAAP) that promotes antiracism in the Department of Health Behavior at the University of North Carolina at Chapel Hill's Gillings School of Global Public Health, 2) strategies that were developed, and 3) short-term outcomes and lessons learned. A study coordinator, not affiliated with the Department of Health Behavior, was hired to collect qualitative data that documented the lived experiences of students and alumni of color (ie, racial and ethnic minority students) over time in the department. Seeking action from faculty and departmental leadership, students engaged in collective organizing covered the department chair's office door with notes describing microaggressions, and visited faculty one-on-one to demand action. In response, 6 faculty members volunteered to form the Equity Task Force (ETF) to explicitly address students' concerns. The ETF identified priority areas for action based on 2 student-led reports, gathered resources from other institutions and the public health literature, and examined departmental policies and procedures. The ETF drafted the EAAP, solicited feedback, and revised it according to 6 priority strategies with actionable steps: 1) transform culture and climate, 2) enhance teaching, mentoring, and training, 3) revisit performance and evaluation of faculty and staff, 4) strengthen recruitment and retention of faculty of color, 5) increase transparency in student hiring practices and financial resources, and 6) improve equity-oriented research practices. This planning tool and process can be used by other institutions to achieve antiracist reform.

Photovoice Reveals Residents' Concerns for Air and Water Quality in Industry-Impacted Rural Community.

Rural communities of color in the southeastern U.S. experience a high burden of environmental hazards from concentrated industry placement. Community-engaged research and qualitative methods can improve our understanding of meaning-making in a community impacted by polluting facilities. This study applies the photovoice method to assess how a predominantly African American community in rural North Carolina, impacted by a landfill and confined animal feeding operations (CAFOs), perceives their health-related quality of life (HRQoL). Two research questions were developed with community-based partners: (a) How do environmental health concerns in this community influence residents' perceptions of their HRQoL? and (b) How do community and county factors facilitate or inhibit community organizing around these concerns? Three photo assignment sessions were held to engage participants in discussions related to the research questions. Researchers analyzed discussion audio recordings and identified themes related to concerns about the following issues: health and quality of life, the landfill industry's influence on community cohesion and self-determination, and actions to address environmental injustice in Sampson County. Photovoice benefits community-engaged researchers by providing a process for assessing the research interests of a community. Photovoice also serves community organizers by providing residents with a structured way to discuss their lived experiences and strategize ways to reduce hazard exposure.

Examining ACCURE's Nurse Navigation Through an Antiracist Lens: Transparency and Accountability in Cancer Care.

There are persistent disparities in the delivery of cancer treatment, with Black patients receiving fewer of the recommended cancer treatment cycles than their White counterparts on average. To enhance racial equity in cancer care, innovative methods that apply antiracist principles to health promotion interventions are needed. The parent study for the current analysis, the Accountability for Cancer Care through Undoing Racism and Equity (ACCURE) intervention, was a system-change intervention that successfully eliminated the Black-White disparity in cancer treatment completion among patients with early-stage breast and lung cancer. The intervention included specially trained nurse navigators who leveraged real-time data to follow-up with patients during their treatment journeys. Community and academic research partners conducted thematic analysis on all clinical notes (n = 3,251) written by ACCURE navigators after each contact with patients in the specialized navigation arm (n = 162). Analysis was informed by transparency and accountability, principles adapted from the antiracist resource Undoing Racism and determined as barriers to treatment completion through prior research that informed ACCURE. We identified six themes in the navigator notes that demonstrated enhanced accountability of the care system to patient needs. Underlying these themes was a process of enhanced data transparency that allowed navigators to provide tailored patient support. Themes include (1) patient-centered advocacy, (2) addressing system barriers to care, (3) connection to resources, (4) re-engaging patients after lapsed treatment, (5) addressing symptoms and side effects, and (6) emotional support. Future interventions should incorporate transparency and accountability mechanisms and examine the impact on racial equity in cancer care.

Lessons Learned in Centering Youth Voices in HIV Prevention: The Adolescent Health Working Group.

BACKGROUND: There remains critical need for community-based approaches to HIV prevention which center youth voices and needs. OBJECTIVES: We established an adolescent health working group (AHWG) to convene youth, parents, providers, and advocates in agenda-setting for interventions to increase pre-exposure prophylaxis uptake in Durham. METHODS: Our three study phases included six AHWG meetings from 2019 to 2020, youth-only meetings guided by a participatory engagement framework (Youth Generate and Organize), and interviews (n=13) and surveys with youth in the community (N=87). We also developed materials such as an AHWG mission statement, a list of themes and informational needs, and documented strategies about pivoting the project during the onset of the COVID-19 global pandemic.Lessons Learned/Conclusions: Engaging adults in youth-focused HIV prevention differs greatly to engaging youth themselves. Creating spaces to promote adolescent sexual Health requires trust building, breaking down sensitivities and stigma to, and flexibility to navigate both virtual and in-person spaces to do so.

Youth Empowered Advocating for Health (YEAH): Facilitating Partnerships Between Prevention Scientists and Black Youth to Promote Health Equity.

Structural racism inflicts a disproportionate burden of stress and trauma within Black communities, resulting in physical and mental health inequities that impact Black youth. Yet few multilevel interventions exist to address these deeply rooted inequities from a preventive standpoint, and even fewer are informed by the participatory input of the impacted communities. To bridge these gaps, we developed a community-based prevention strategy that promotes agency and active resistance to structural racism, Youth Empowered Advocating for Health (YEAH), and implemented it across various settings. We outline the development, implementation, and expansion of YEAH as a tool for promoting optimal health among Black communities. Lastly, we discuss lessons learned and offer a framework outlining key principles for prevention scientists to partner with Black youth and engage them in translational science to address structural racism. This framework is aimed at driving policies, practices, and procedures that promote equitable and sustainable change for and with Black communities.

Structural Barriers to HIV Prevention and Services: Perspectives of African American Women in Low-Income Communities.

BACKGROUND: African American women are at a disproportionate HIV risk compared with other U.S. women. Studies show that complex structural and social determinants, rather than individual behaviors, place African American women at greater risk of HIV infection; however, little is known about women's views of what puts them at risk. AIMS: This study sought to comprehend the perceptions of African American women living in low-income housing regarding the factors that influence both their personal sexual health behaviors and use of HIV prevention services. METHODS: We conducted seven focus groups with 48 African American women from 10 public housing communities in a small city in the southeastern United States. We analyzed the focus group transcripts using thematic data analysis to identify salient themes and points of interest related to the study aim. RESULTS: Women identified factors related to the health care system (trustworthiness of the health care system), the external environment (racism, classism, patriarchal structures, and violence/crime), as well as predisposing (health beliefs, stigma, and gender norms), enabling (agency to negotiate gendered power), and need (perceived HIV risk and perceptions of partner characteristics) features of individuals in the population. CONCLUSION: African American women living in public housing are especially vulnerable to HIV infection due to intersectional discrimination based on racism, classism, gender power dynamics, and community conditions. Our findings confirm the need to develop HIV intervention programming addressing intersectional identities of those making up the communities they plan to address, and being informed by those living in the communities they plan to act on.

Noble gas constraints on the fate of arsenic in groundwater.

Groundwater contamination of geogenic arsenic (As) remains a global health threat, particularly in south-east Asia. The prominent correlation often observed between high As concentrations and methane (CH4) stimulated the analysis of the gas dynamics in an As contaminated aquifer, whereby noble and reactive gases were analysed. Results show a progressive depletion of atmospheric gases (Ar, Kr and N2) alongside highly increasing CH4, implying that a free gas phase comprised mainly of CH4 is formed within the aquifer. In contrast, Helium (He) concentrations are high within the CH4 (gas) producing zone, suggesting longer (groundwater) residence times. We hypothesized that the observed free (CH4) gas phase severely detracts local groundwater (flow) and significantly reduces water renewal within the gas producing zone. Results are in-line with this hypothesis, however, a second hypothesis has been developed, which focuses on the potential transport of He from an adjacent aquitard into the (CH4) gas producing zone. This second hypothesis was formulated as it resolves the particularly high He concentrations observed, and since external solute input from the overlying heterogeneous aquitard cannot be excluded. The proposed feedback between the gas phase and hydraulics provides a plausible explanation of the anti-intuitive correlation between high As and CH4, and the spatially highly patchy distribution of dissolved As concentrations in contaminated aquifers. Furthermore, the increased groundwater residence time would allow for the dissolution of more crystalline As-hosting iron(Fe)-oxide phases in conjunction with the formation of more stable secondary Fe minerals in the hydraulically-slowed (i.e., gas producing) zone; a subject which calls for further investigation.

Lessons Learned From Conducting Community-Based Research on HIV Prevention With Youth During COVID-19.

Mitigating HIV burden among Black youth requires true community engagement. This brief report identifies challenges, strategies, and lessons learned from transitioning our three-phased, community-engaged HIV prevention project with Black youth to a remote format during COVID-19. The project involved (1) building a community-academic partnership on youth sexual health, (2) participatory youth workshops, and (3) youth surveys and interviews about HIV prevention. Feedback from community-academic partnership, pile sorting themes, and preliminary qualitative analyses guided this report. Challenges included a disruption to in-person engagement while strategies included relying heavily on pre-existing partnerships to recruit youth for interviews. We learned that pre-existing community engagement was essential for completing phase three remotely. More education is needed to support Pre-Exposure Prophylaxis (PrEP) awareness for HIV prevention and there is a need to address structural barriers to healthcare engagement such as community violence and mental illness. Community-engaged HIV research focused on youth can adapt if anchored in community relationships. Future studies must work to more fully center youth's voices and address the structural issues that may inhibit them from engaging in HIV prevention.

Using Participatory Methods to Assess PrEP Interest and Uptake Among Young People Living in the Southeastern US: A Mixed Methods Assessment.

Adolescents and young adults (AYA; 13-24 years-old) comprise 22% of new HIV infections in the United States (US), most of whom live in the South. We used the situated-Information, Motivation, Behavioral skills (sIMB) model to identify priorities for intervention on multi-level factors that influence HIV preventive care among Black AYA in Durham, North Carolina. We conducted two participatory workshops (ages 13-17, N = 6; ages 18-24, N = 7) to engage youth about how to discuss HIV. We also assessed sIMB constructs from a separate quantitative sample of youth to contextualize the workshop findings (N = 80). HIV knowledge was low overall, but lower among younger Black AYA, suggesting a need for comprehensive sexual education. Trusted adults provided sexual health information, motivation for health maintenance, and behavioral skills support. HIV prevention interventions should provide comprehensive sexual health education to Black AYA, be age-specific, and include social supporters like parents, teachers, and community members.

Did the 2015 USPSTF Abnormal Blood Glucose Recommendations Change Clinician Attitudes or Behaviors? A Mixed-Method Assessment.

BACKGROUND: In 2015, the US Preventive Services Task Force (USPSTF) revised clinical recommendations to more broadly recommend abnormal blood glucose screening and more clearly recommend referral to behavioral interventions for adults with prediabetes. OBJECTIVE: To assess the effects of the 2015 USPSTF recommendation changes on abnormal blood glucose screening and referral to behavioral interventions, and to examine physicians' perceptions of the revised recommendation. DESIGN: We utilized a sequential, dependent mixed-methods triangulation design. PARTICIPANTS: A total of 33,444 patients meeting USPSTF abnormal blood glucose screening criteria within 15 health system-affiliated primary care practices and 20 primary care physicians in North Carolina. MAIN MEASURES: We assessed monthly abnormal blood glucose screening rate and monthly referral rate to behavioral interventions. To estimate trend changes in outcomes, we used segmented linear regression analysis of interrupted time-series data. We gathered physicians' perspectives on the 2015 USPSTF abnormal blood glucose recommendation including awareness of, agreement with, adoption of, and adherence to the recommendation. To analyze qualitative data, we used directed content analysis. KEY RESULTS: There was a slight significant change in trend in abnormal blood glucose screening rates post-recommendation. There was a slight, statistically significant decrease in referral rates to behavioral interventions post-recommendation. Physicians were generally unaware of the revisions to the 2015 USPSTF abnormal blood glucose recommendation; however, once the recommendations were described, physicians agreed with the screening recommendation but felt that the behavioral intervention referral recommendation was hard to implement. CONCLUSION: The 2015 USPSTF abnormal blood glucose guideline had little to no effect on abnormal blood glucose screening or referral to behavioral interventions in North Carolina practices. Potential interventions to improve these rates could include clinical decision tools embedded in the electronic health record and better referral systems for community-based diabetes prevention programs.

Expanding the Reach of an Evidence-Based, System-Level, Racial Equity Intervention: Translating ACCURE to the Maternal Healthcare and Education Systems.

The abundance of literature documenting the impact of racism on health disparities requires additional theoretical, statistical, and conceptual contributions to illustrate how anti-racist interventions can be an important strategy to reduce racial inequities and improve population health. Accountability for Cancer Care through Undoing Racism and Equity (ACCURE) was an NIH-funded intervention that utilized an antiracism lens and community-based participatory research (CBPR) approaches to address Black-White disparities in cancer treatment completion. ACCURE emphasized change at the institutional level of healthcare systems through two primary principles of antiracism organizing: transparency and accountability. ACCURE was successful in eliminating the treatment completion disparity and improved completion rates for breast and lung cancer for all participants in the study. The structural nature of the ACCURE intervention creates an opportunity for applications in other health outcomes, as well as within educational institutions that represent social determinants of health. We are focusing on the maternal healthcare and K-12 education systems in particular because of the dire racial inequities faced by pregnant people and school-aged children. In this article, we hypothesize cross-systems translation of a system-level intervention exploring how key characteristics of ACCURE can be implemented in different institutions. Using core elements of ACCURE (i.e., community partners, milestone tracker, navigator, champion, and racial equity training), we present a framework that extends ACCURE's approach to the maternal healthcare and K-12 school systems. This framework provides practical, evidence-based antiracism strategies that can be applied and evaluated in other systems to address widespread structural inequities.

The MI-PHOTOS Project: Understanding the Health and Wellbeing of Rural Historically Marginalized Mothers Through Photovoice.

Despite the persistent health inequities faced by rural women in the United States, few researchers have partnered with women in rural communities to co-create sustainable change. To fill this gap, Mothers Improving Pregnancy and Postpartum Health Outcomes Through stOry Sharing (MI-PHOTOS) employed a community-based participatory research (CBPR) approach by partnering with mothers, community leaders, and community-based organizations in Robeson County, North Carolina, a rural, racially diverse county. The project's aims were (a) to promote maternal health by listening to mothers' stories of having and raising children in their community and (b) to develop a shared understanding of these mothers' strengths and challenges. MI-PHOTOS utilized photovoice, an exploratory and qualitative CBPR methodology. Grounded theory guided data analysis. During photovoice discussions, conversation focused on maternal experiences and evoked strengths, facilitators, and barriers impacting maternal health. Themes focused on (a) MI-PHOTOS serving as a social support group for the community and family stressors that mothers faced and (b) the necessity of professional support programs. Three overarching findings emerged during this process: (a) MI-PHOTOS as an informal support group, (b) mental health stigmatization, and (c) the need to bridge home visiting programs with peer and confidential therapeutic services. Future work should incorporate mothers' and communities' strengths into program development by drawing on existing home visiting programs, identifying opportunities for peer-support, and creating referral networks for individual, confidential therapeutic services. Through continued community partnership, we can generate fuller understandings of mothers' experiences of having and raising children and ultimately promote health equity among rural mothers.

Evaluating the clinical utility of early exome sequencing in diverse pediatric outpatient populations in the North Carolina Clinical Genomic Evaluation of Next-generation Exome Sequencing (NCGENES) 2 study: a randomized controlled trial.

BACKGROUND: Exome sequencing (ES) has probable utility for shortening the diagnostic odyssey of children with suspected genetic disorders. This report describes the design and methods of a study evaluating the potential of ES as a routine clinical tool for pediatric patients who have suspected genetic conditions and who are in the early stages of the diagnostic odyssey. METHODS: The North Carolina Clinical Genomic Evaluation by Next-generation Exome Sequencing (NCGENES) 2 study is an interdisciplinary, multi-site Phase III randomized controlled trial of two interventions: educational pre-visit preparation (PVP) and offer of first-line ES. In this full-factorial design, parent-child dyads are randomly assigned to one of four study arms (PVP + usual care, ES + usual care, PVP + ES + usual care, or usual care alone) in equal proportions. Participants are recruited from Pediatric Genetics or Neurology outpatient clinics in three North Carolina healthcare facilities. Eligible pediatric participants are < 16 years old and have a first visit to a participating clinic, a suspected genetic condition, and an eligible parent/guardian to attend the clinic visit and complete study measures. The study oversamples participants from underserved and under-represented populations. Participants assigned to the PVP arms receive an educational booklet and question prompt list before clinical interactions. Randomization to offer of first-line ES is revealed after a child's clinic visit. Parents complete measures at baseline, pre-clinic, post-clinic, and two follow-up timepoints. Study clinicians provide phenotypic data and complete measures after the clinic visit and after returning results. Reportable study-related research ES results are confirmed in a CLIA-certified clinical laboratory. Results are disclosed to the parent by the clinical team. A community consultation team contributed to the development of study materials and study implementation methods and remains engaged in the project. DISCUSSION: NCGENES 2 will contribute valuable knowledge concerning technical, clinical, psychosocial, and health economic issues associated with using early diagnostic ES to shorten the diagnostic odyssey of pediatric patients with likely genetic conditions. Results will inform efforts to engage diverse populations in genomic medicine research and generate evidence that can inform policy, practice, and future research related to the utility of first-line diagnostic ES in health care. TRIAL REGISTRATION: ClinicalTrials.gov NCT03548779 . Registered on June 07, 2018.

Carbon and methane cycling in arsenic-contaminated aquifers.

Geogenic arsenic (As) contamination of groundwater is a health threat to millions of people worldwide, particularly in alluvial regions of South and Southeast Asia. Mitigation measures are often hindered by high heterogeneities in As concentrations, the cause(s) of which are elusive. Here we used a comprehensive suite of stable isotope analyses and hydrogeochemical parameters to shed light on the mechanisms in a typical high-As Holocene aquifer near Hanoi where groundwater is advected to a low-As Pleistocene aquifer. Carbon isotope signatures (δ13C-CH4, δ13C-DOC, δ13C-DIC) provided evidence that fermentation, methanogenesis and methanotrophy are actively contributing to the As heterogeneity. Methanogenesis occurred concurrently where As levels are high (>200 µg/L) and DOC-enriched aquitard pore water infiltrates into the aquifer. Along the flowpath to the Holocene/Pleistocene aquifer transition, methane oxidation causes a strong shift in δ13C-CH4 from -87‰ to +47‰, indicating high reactivity. These findings demonstrate a previously overlooked role of methane cycling and DOC infiltration in high-As aquifers.