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NICHD - Eunice Kennedy Shriver National Institute of Child Health and Human Development

ABSTRACT Premature rupture of membranes (PROM) and preterm PROM (pPROM) affect up to 10% and 4% of pregnancies globally, respectively, leading to significant maternal and fetal health risks if not detected and managed promptly. These risks include maternal chorioamnionitis, neonatal sepsis, umbilical cord prolapse, placental abruption, and preterm labor. Current detection methods, such as the Nitrazine test and immunoassays for biomarkers like PAMG-1 and IGFBP-1, are effective but are often costly, invasive, and depend on the mother's ability to identify abnormal vaginal discharge. Such dependency on patient recognition is problematic, especially in persistent low-volume leakage where symptoms are easily mistaken for normal discharge, delaying diagnosis and treatment. These challenges are further compounded in rural or underserved areas, where limited access to healthcare can delay diagnosis and increase risks. Our research aims to develop a novel colorimetric detection system that functions as a vaginal insert for the early identification of premature rupture of membranes (PROM) and preterm PROM (pPROM). This insert is specifically designed to distinguish amniotic fluid from other vaginal discharges, offering an at-home, minimally invasive solution that integrates into a patient’s daily routine. By utilizing a pH-sensitive polymer, the device reacts to the presence of amniotic fluid by releasing a biocompatible dye, causing a visible color change in vaginal discharge. This allows for early detection, even with small leaks, enabling patients to seek timely medical care without frequent clinical visits. The system leverages the design of pessary devices, which are already widely used by pregnant women for long-term use, ensuring comfort and improving patient compliance. Placing the device close to the uterus maximizes contact with amniotic fluid while minimizing interference from other secretions. The device uses FDA-approved materials to ensure biocompatibility and safety for both mother and fetus. In contrast to costly and time-consuming biomarker assays, this solution provides a simple, cost-effective alternative by utilizing the pH difference between amniotic fluid and vaginal discharge. Ultimately, this system offers a user-friendly, accessible, and highly sensitive method to detect PROM and pPROM, improving maternal and fetal health outcomes, especially in low-resource settings. Aim 1: Optimize the formulation of a pH-responsive polymer with additives to ensure stability in an acidic vaginal environment while maintaining high sensitivity to amniotic fluid. Aim 2: Refine device designs, including geometric configurations and material placement, to enhance detection sensitivity and specificity, minimizing false positives and negatives. Aim 3: Assess the biocompatibility, stability, and effectiveness (i.e., sensitivity and selectivity) of the prototype devices for detecting amniotic fluid leakage using a mouse model

NINDS - National Institute of Neurological Disorders and Stroke

PROJECT SUMMARY Chronic pain imposes tremendous burden on society, with disproportionate impact on rural communities. Evidence-based, mind and body interventions for persons with chronic pain involve nonpharmacologic care often provided by physical therapists (PTs). Nonpharmacologic mind-body EBIs are underutilized, and often un- available, in rural communities with profound consequences including greater risk for disability, work loss and opioid use. Social determinants of health create unique challenges for EBI delivery in rural communities. Rural residents tend to have less healthcare access, lower income, less education attainment, etc. Persons of Hispanic/Latino ethnicity are a growing part of rural communities, increasing the need for culturally-congruent care. COVID showed the potential of telehealth to expand access to evidence-based care, while also raising many questions for rural residents. An array of digital health technologies hold promise to increase the reach and impact of telehealth, but have not been developed or studied in partnership with rural communities. The overall goal of the Better Pain Care with Telehealth & Technology (BP-2) trial is to better leverage digital health strategies to improve pain management in rural communities. BP-2 is a hybrid II effectiveness-implemen- tation trial that uses a study-within-a-trial design to efficiently address two research gaps; 1) how to best leverage digital health to provide mind-body pain EBIs using TH; and 2) how to reach persons in rural communities to connect to a mind-body pain EBI. BP-2 is a fully de-centralized trial, a key design consideration for increasing participation of rural healthcare settings and residents. We will partner with Federally Qualified Health Centers and two large health systems to identify persons with chronic musculoskeletal pain via electronic health records and randomize them to different text messaging (TM) strategies to reach and connect them to a PT-led telehealth EBI. Four TM strategies will test factorial combinations of two factors; 1) TM content (personalized or not), and 2) TM cadence (weekly or early density). In the second randomization persons who connect to the telehealth EBI and enroll are randomized to a delivery strategy; 1) TH, or 2) TH with app-based remote monitoring (TH+). The BP-2 study will use this design to test 3 specific aims; 1) determine differences in delivery strategies for telehealth EBI (TH vs/ TH+) for rural residents, 2) determine differences in reach among TM strategies to connect rural residents to a pain EBI, and 3) explore mind-body pain EBI implementation outcomes with rural residents using mixed methods. BP-2 addresses critical research gaps on how to use digital health to reach patients, and optimize the effectiveness evidence-based, nonpharmacologic, mind-body interventions.

NIMH - National Institute of Mental Health

ABSTRACT Suicide is a significant global health issue, contributing to an alarming one million deaths each year. Of particular significance is the heightened risk for suicide observed among homosexual cisgender men (HCM). While innovative suicide prevention strategies, particularly app-based interventions, have been developed, there is limited data on their applicability and real-world implementation in low-resource or rural contexts. Nepal offers an ideal setting to fill this gap, given that nearly all men use smartphones and mental health services are limited. Lessons from Nepal will inform the development of scalable, culturally competent, and adaptable suicide prevention strategies in the United States. Moreover, intervention delivery is not temporally optimized to address the dynamic nature of suicide risk, suggesting the need for an adaptive approach to intervention delivery. Just-in-time adaptive interventions (JITAIs) represent an innovative approach by deploying a tailored intervention when needed. Specifically, apps that incorporate JITAI can be more effective than traditional app-based interventions by addressing the dynamic nature of suicidal thoughts and behaviors (STBs). Although JITAI has been utilized effectively to address addiction, physical inactivity, and obesity, it has not yet been applied to suicide prevention for ho. To address this gap, we propose developing and testing Chissa – an app-based JITAI designed to identify suicide risk and deliver tailored interventions for HCM in Nepal. The proposed research builds on our prior work and a long history of collaboration with local partners in Nepal. Specifically, we will utilize the Discover, Design, Build, and Test (DDBT) model, which incorporates principles of human-centered design, to adapt, refine, and extend features of the existing apps, which will be integrated into the existing clinics providing healthcare services to HCM communities. We have completed the first phase of the DDBT model (Discover), which involved conducting focus groups with HCM and other stakeholders to explore the parameters of the Chissa JITAI. To develop an empirically-informed Chissa JITAI, we will first, conduct at least three co-design sessions with a team of HCM and other stakeholders (N=10) to build consensus around JITAI features/content and develop implementation strategies based on the outputs from the Discover Phase, followed by the development of the Chissa app (Design and Build Phase; Aim 1). Second, we will conduct a 30-day micro-randomized trial (N=30) of the Chissa app to assess its usability and the impact of its JITAI components on STBs to optimize it (Test Phase; Aim 2). Next, we will conduct a type 1 hybrid implementation science trial that involves an assessment of the efficacy of the Chissa app (Aim 3a) while assessing contextual implementation factors to guide its future adoption and scale-up (Aim 3b). If efficacious, the Chissa app, capable of identifying users’ suicidal risk and delivering tailored intervention, could help shape culturally responsive and scalable interventions to help reduce the suicide burden in the United States.

NCI - National Cancer Institute

Project Summary & Abstract Background: Rural residents experience higher colorectal cancer (CRC) incidence and mortality rates than their urban counterparts. Adherence to CRC screening is essential for early detection, timely treatment, and reduced mortality. The fecal immunochemical test (FIT) is a preferred screening method among rural populations due to its non-invasive nature, affordability, and at-home convenience. Patient navigation plays a crucial role in increasing FIT completion rates but faces structural and logistical challenges. While adaptive, stepped-care patient navigation interventions have been developed to improve scalability and cost-effectiveness, they have not been failed to account for individual sociodemographic factors and evolving patient needs in real time, and have not determined the optimal timing or type of person-led navigation. The primary goal of this study is to optimize a novel adaptive patient navigation model using a two-stage Sequential Multiple Assignment Randomized Trial (SMART) to promote FIT screening among rural residents. In Stage 1, this study will evaluate chatbot-based navigation (FITtrack) versus standard SMS reminders as an initial assistive tool and determine the optimal timing for introducing additional person-led support. In Stage 2, this study will assess the optimal type of person-led support, comparing nurse navigators and peer navigators. Specific Aims: 1) Evaluate the feasibility and acceptability of the digital intervention (4-week SMS reminders, 4-week FITtrack chatbot, and 12- week FIT track chatbot), supplemental person-led navigation (nurse vs. peer), and adaptive interventions (digital intervention plus person-led navigation); 2) Evaluate the preliminary effectiveness of these interventions; 3) Understand step-specific challenges and supports needed in completing FIT. Innovation: This study is highly innovative as it tailors to individual sociodemographic factors and real-time needs through the integration of AI- based chatbot technology, utilizes a novel trial design (i.e., SMART) to inform the development of an adaptive model, and directly addresses the unique challenges faced by rural residents. Significance: Aligned with PA- 25-295, this study accelerates priority initiatives by identifying optimal type and timing of digital and person- assisted navigation approaches to improve CRC screening adherence among rural populations. Ultimately, these findings will support the development of a scalable, adaptive, and cost-effective patient navigation intervention, advancing cancer prevention and early detection efforts in populations with high cancer burden.

NIH

Significance to VA: Women Veterans are exposed to interpersonal violence at high rates throughout their lifespans which may escalate risk for psychosocial impairment and suicidal behavior. Facets of social functioning such as connectedness and social support can mitigate suicide risk. Given their risk for suicide and barriers to engaging in Veterans Administration (VHA) healthcare, violence-exposed women Veterans represent a specialized population for which expansion of VHA programming to include opportunities for socialization and community building as a key component of holistic health are needed. Coinciding with a congressional mandate for women-only retreat-based rehabilitation following military service, retreats are increasingly offered by community organizations. Retreats are associated with significant improvements in mental health and quality of life; however, no research to date has examined retreat programming as an upstream suicide prevention strategy for a high priority, high risk population of Veterans. The pilot will examine Growth, Resilience, Insight, and Togetherness (GRIT), a retreat program developed with and for Veteran women who have experienced interpersonal violence, relative to Growth, Resilience, and Insight (GRI), a self- guided version of the program, as an intervention for improving social functioning. Innovation and Impact: In preliminary work conducted by our team, violence-exposed women Veterans expressed a clear preference for a VHA-endorsed retreat program and were drawn to such a program by its use of non-clinical, nature-based environment. A retreat, grounded in Whole Health, provides women Veterans with many benefits such as time to reflect, connect, and access mental health programming that may be challenging to receive in their daily lives. The offering of a retreat in collaboration with an established community partner heeds the call for tailored, trauma-informed, community-based innovative prevention strategies within VHA to address the problem of suicide among women Veterans. Specific Aims: Aim 1: Determine feasibility of study methods and implementation of GRIT and GRI including the use of VHA clinicians. Aim 2: Establish relative acceptability of GRIT and GRI and study methods by assessing credibility, satisfaction, and perceived usefulness and burdensomeness among study clinicians and participants. Aim 3: Collect preliminary data on social functioning before, following, and two months after program completion along with indicators of suicide risk (i.e., overall risk, suicide ideation, posttraumatic stress symptoms, depression, emotional dysregulation, sleep quality). Data on therapeutic processes and social functioning during program participation will be gathered to identify key program components and potential adaptations for a larger multi-site randomized clinical trial. Methodology: Using a selective suicide prevention strategy, we will recruit women Veterans (N = 48) who have experienced interpersonal violence and endorse difficulties in at least two areas of social functioning to be randomly assigned to GRIT or GRI. Feasibility and acceptability will be evaluated using mixed-method data collection and synthesis of research tracking, self-report surveys and/or assessor-administered questionnaires, and semi-structured interviews with participants and VHA clinicians serving as facilitators. Path to Translation/Implementation: The pilot will establish infrastructure and methods, gather preliminary data, and build partnerships that will provide a foundation for expansions of retreat-based programming and a model for use within VHA. The pilot be an opportunity to: a) further engage key interdisciplinary collaborators; b) determine what settings are most ideal for and in need of retreat program implementation (e.g., rural regions, Women's Mental health clinics); and c) ensure that measures and evaluation plans match selective suicide prevention program goals for improving social functioning. Data gathered will be used to inform a multi- site randomized clinical trial.

NIAID - National Institute of Allergy and Infectious Diseases

Abstract This developmental research grant award (R21) requests funds to characterize the social and transmission networks of Rosebud Sioux Tribe (RST) (Sicangu Lakota Oyate) community members to mitigate ongoing and future syphilis epidemics among American Indian/Alaska Native (AI/AN) populations and move towards elimination of congenital syphilis: A Sicangu-driven social network strategy for syphilis prevention (S4). In addition to classic transmission networks, we include social networks that confer influence, social support, diffuse information/innovation and can lead to syphilis prevention interventions that the team has experience implementing. AI/AN individuals in South Dakota (SD) are one of the most syphilis impacted communities and are at increased risk of syphilis transmission, including congenital syphilis. In 2020, 3% of all AI/AN babies born in South Dakota had congenital syphilis. AI/AN individuals are more likely to live in rural areas with limited access to prenatal care and hospital obstetric units, creating barriers to timely identification and treatment of syphilis. Earlier this year, The Great Plains Tribes requested emergency assistance from the federal government to declare a public health emergency and address the syphilis epidemic. Critical to public health is improving syphilis prevention among AI/AN communities and their larger social networks. Network analysis traditionally focuses on transmission dynamics and potential for future epidemics. Contact tracing and other strategies do not, however, fully include the larger social network and data can be limited due to the stigma associated with providing names, as well as mistrust in government and healthcare providers, particularly for AI/AN individuals. Social network analysis that this team has expertise in, can illuminate multiple networks and develop metrics tied not only to disease transmission but to diffusion of information, and among highly marginalized groups such as people who use substances. The PI has a track record of collaborative work implementing participant network recruitment protocols such as the Social Network Strategy to be used in S4. The PI and site-PI are joined by additional experts in AI/AN Health, Indigenous community leaders and local community members engaging in Talking Circles in these contexts. Accordingly, we aim to: Characterize the social networks of RST community members and measure features of their network structure— assortativity, density and bridging – most relevant to syphilis transmission and network intervention; Explore individual (ie. age, education), contextual (ie employment type), network and structural (stigma, health care access) factors associated with syphilis seropositivity. We will collect survey data and biologic samples to model potential factors associated with historic and recent syphilis transmission and; Determine individual and social network level factors associated with syphilis prevention behaviors (ie. condom use, drug treatment, doxyPEP) and network intervention (ie. information sharing, proportion approving of syphilis prevention), which could lead to future network interventions.

NIMH - National Institute of Mental Health

Overall Study Abstract Comprehensive specialty care programs for young people in the initial phases of psychotic disorders, such as Coordinated Specialty Care (CSC), deliver superior clinical outcomes compared to usual care. However, CSC programs face challenges to utilize health care data to continually improve clinical decision-making and services delivery, and to develop innovative interventions that improve key outcomes. The Academic- Community EPINET (AC-EPINET): Enhancing outcomes through improved stress tolerance in early psychosis will address these challenges through a network of six early intervention (“spoke”) sites connected through advanced informatics to a central hub. Our network will implement and embed a Learning Healthcare System (LHS) in the everyday workflow of spoke clinics to identify performance gaps, drive continuous quality improvement and enable practice-based research. In Aim 1, the LHS will utilize the EPINET common assessment battery (CAB), and CSC-HONE will serve as the informatics platform. It consolidates data from electronic health records, minimizing dual entry and supporting a culture of measurement and continuous improvement. Dashboard displays of outcomes permit real-time comparisons within and across spoke clinics, driving patient outcomes towards international best practice standards, while maintaining critical privacy standards. In Aim 2, we will improve our LHS by expanding stakeholder involvement, integrating community partners with lived experience in the formation of a quality improvement incubator to improve care outcomes. Our six clinical spoke sites share the following: 1) established early psychosis programs following the CSC model; 2) deep expertise in data collection, assessments, and clinical trial research to enhance the conduct of the pilot research study; 3) community-based, “real-world” early psychosis clinics enrolling underserved populations, including urban poor and rural populations; and 4) strong interests in and experience with real world research. The Administrative Core will provide study governance, oversight, data management, training, adherence to timelines and milestones, and secure, de-identified data transfer to the NDCC. The leadership team has deep expertise in stress research, behavioral treatments, clinical trials and large data set outcomes analytics. Thus, the AC-EPINET is well positioned to achieve data-driven, improved clinical services through the use of the CAB. For Aim 3, we will conduct two research projects focused on increased stress sensitivity in early psychosis and treatment to improve stress tolerance. Using data from the CAB, the Clinical Practice Data Research Project will develop an analytic model of how stress sensitivity affects functional outcomes. The Prospective Practice-Oriented Research Project will examine the preliminary effectiveness of mindfulness-based stress reduction treatment on stress sensitivity in EP. This research will inform the identification of at-risk participants with high stress sensitivity and related functional deficits who may be good candidates for targeted interventions.

NIDDK - National Institute of Diabetes and Digestive and Kidney Diseases

PROJECT SUMMARY/ABSTRACT Acute kidney injury (AKI) is an abrupt loss of kidney function that affects 1 in 5 hospitalized patients. AKI survivors experience a 1.5-2.5-fold higher risk of chronic kidney disease (CKD), a 1.4-fold higher risk of cardiovascular disease, and 50% of affected individuals are readmitted within 1 year. Despite these grave sequelae, the care of non-dialysis-dependent AKI survivors is inadequate. One-third of patients fail to receive basic kidney health follow-up (i.e., laboratory assessment of kidney function and a visit with a clinician). 87% of AKI survivors use nephrotoxic medications in the 3 years after discharge, which independently increases the risk for CKD. These gaps are especially prominent in the 20% of AKI survivors from rural settings who experience health disparities including transportation barriers, a higher comorbidity burden, decreased health literacy, and reduced access to nephrology specialist care. Addressing these gaps in care facilitates prognostication, decision making, medication reconciliation and supportive care which can limit AKI complications. We therefore developed the AKI in Care Transitions (ACT) program, a multidisciplinary bundled care delivery model tailored to individual prognosis. AKI survivors are risk-stratified according to post-discharge prognosis. Those at the lowest risk are provided access to informational resources about AKI. Patients at moderate risk receive kidney health education before discharge from nurses and coordinated follow-up in primary care with a provider and a pharmacist in the 7-14 days after discharge. The highest-risk patients are provided with home monitoring technology (e.g., blood pressure cuff, tablet for symptom assessments) and followed remotely by nephrology specialists for up to 90 days. Pilot testing in an academic medical center demonstrated feasibility, a significant increase in timely and complete follow-up, improved medication reconciliation, and a decreased incidence of kidney disease progression. This proposal extends ACT to rural settings to address the overall goal of creating effective, patient-centered, scalable care delivery models that improve health outcomes for all AKI survivors. We will test the impact of ACT on health outcomes and processes of care (e.g., kidney disease progression, excess days in acute care, adverse drug events, guideline-concordant care) in rural patients using a pragmatic cluster randomized trial conducted in the Mayo Clinic Health System (MCHS; Aim 1). We will then richly characterize the rural AKI survivor experience including illness burden, treatment burden, and patient capacity (Aim 2a) and assess the impact of ACT (Aim 2b) using qualitative data gathered from rural patients at MCHS and the University of Maryland Medical System. This innovative proposal leverages digital health and the multidisciplinary team to improve outcomes and reduce health disparities for AKI survivors in rural settings.

NICHD - Eunice Kennedy Shriver National Institute of Child Health and Human Development

PROJECT SUMMARY (See instructions): Perinatal depression (PND) affects approximately 25% of women in India, with rates as high as 60% antenatally in preliminary data from the Vadu Health and Demographic Surveillance System (HDSS) — a population-based surveillance platform covering 220,000 individuals across 22 villages in Pune district, Maharashtra. Untreated PND has cascading consequences for the entire family unit, including diminished mother-infant bonding, low birth weight, and long-term child developmental impairments. In India, where marital and family dynamics are primary determinants of women’s mental health and health-seeking, couples-based approaches that engage husbands as active treatment partners are theoretically compelling yet entirely absent from South Asia. This R00 will adapt and pilot test JODI (Joint Outreach for Depression and gender Inequity), the first couples-based PND treatment intervention designed for lay counselor delivery in an LMIC, developed during the K99 phase through a global systematic review, formative qualitative research with perinatal couples in rural Rajasthan, and series of stakeholder intervention development steps. JODI integrates the Communal Coping Model and Bodenmann’s Systemic Transactional Model with a Gender Transformative Framework to address the structural and relational drivers of PND through dyadic coping skill-building and gender norm examination across weekly sessions delivered by trained female lay counselors. In Aim 1, JODI will be adapted for the Maharashtra context through stakeholder consultations and theater testing in KEM Hospital Research Centre (KEMRC), Pune. In Aim 2, a hybrid type 1 implementation-effectiveness pilot RCT (N=100 couples) at the Vadu HDSS will assess feasibility, acceptability, and preliminary efficacy of JODI versus enhanced usual care, guided by Proctor’s framework. Findings will directly inform a future R01 full-scale multisite efficacy trial and, if effective, position JODI as a scalable, low-cost model for addressing PND across South Asia and similar resource-limited settings.

NICHD - Eunice Kennedy Shriver National Institute of Child Health and Human Development

PROJECT SUMMARY (See instructions): Perinatal depression (PND) affects approximately 25% of women in India, with rates as high as 60% antenatally in preliminary data from the Vadu Health and Demographic Surveillance System (HDSS) — a population-based surveillance platform covering 220,000 individuals across 22 villages in Pune district, Maharashtra. Untreated PND has cascading consequences for the entire family unit, including diminished mother-infant bonding, low birth weight, and long-term child developmental impairments. In India, where marital and family dynamics are primary determinants of women’s mental health and health-seeking, couples-based approaches that engage husbands as active treatment partners are theoretically compelling yet entirely absent from South Asia. This R00 will adapt and pilot test JODI (Joint Outreach for Depression and gender Inequity), the first couples-based PND treatment intervention designed for lay counselor delivery in an LMIC, developed during the K99 phase through a global systematic review, formative qualitative research with perinatal couples in rural Rajasthan, and series of stakeholder intervention development steps. JODI integrates the Communal Coping Model and Bodenmann’s Systemic Transactional Model with a Gender Transformative Framework to address the structural and relational drivers of PND through dyadic coping skill-building and gender norm examination across weekly sessions delivered by trained female lay counselors. In Aim 1, JODI will be adapted for the Maharashtra context through stakeholder consultations and theater testing in KEM Hospital Research Centre (KEMRC), Pune. In Aim 2, a hybrid type 1 implementation-effectiveness pilot RCT (N=100 couples) at the Vadu HDSS will assess feasibility, acceptability, and preliminary efficacy of JODI versus enhanced usual care, guided by Proctor’s framework. Findings will directly inform a future R01 full-scale multisite efficacy trial and, if effective, position JODI as a scalable, low-cost model for addressing PND across South Asia and similar resource-limited settings.

NIA - National Institute on Aging

Project Abstract Dementia prevalence in Sub-Saharan Africa is projected to increase by over 300% within the next 25 years as the population aged 60 years and older triples to more than 235 million. Beyond the demographic transition and population growth, a major driver of these increases is the growing burden of communicable and non- communicable diseases, which contributes to disability and adverse brain health outcomes. Currently, there are limited data on Alzheimer's Disease and related dementias to inform healthcare and research policies within resource-strained health systems in SSA. This gap is especially evident in French-speaking African countries (30-40% of SSA), which are critically underrepresented in ADRD research. Indeed, our recent review highlights the cultural, ethnic, linguistic, and socioeconomical challenges to dementia research in this setting. In Cameroon, ADRD mortality has increased by over 130% in 20 years and ADRD represents 12.4% of outpatient neurology consultations. Our prior work highlights the urgent need to develop and validate scalable and accessible assessment tools for ADRD to establish a robust infrastructure to support dementia diagnosis, care, and research nationwide. The growing field of digital cognitive tools offers an innovative opportunity for developing easily accessible and highly accurate neuropsychological tools for cost- and time-efficient case identification. Standardized administration, automated scoring/interpretation, and cross platform integration features can address several challenges and support the development of dementia registries – a valuable resource for dementia research and care. The main objectives of this proposal are to culturally adapt and validate a brief multi-domain digital cognitive assessment tool in Cameroon and to develop and pilot the infrastructure needed for improved dementia care and research. Specifically, we plan to culturally adapt TabCAT-BHA digital cognitive assessment in Cameroon, evaluate demographic effects on performance and generate regression-based norms in a community representative sample of healthy adults in rural and urban areas (Aim 1). Concurrently, we will examine TabCAT-BHA’s diagnostic accuracy to detect mild cognitive impairment (MCI) and dementia in the existing BRAIN Cohort and examine its neuroanatomical validity to domain specific regional patterns of brain atrophy on MRI (Aim 2). Finally, as an exploratory aim, we will determine implementation barriers to cognitive testing and dementia diagnosis in a clinical setting in Cameroon to develop the infrastructure needed for improved dementia care and research (Aim 3). These proposed studies will begin to fill the data gap on dementia research in French-Speaking Sub-Saharan Africa (FS-SSA) and provide the first ever neuroimaging data in people living with dementia in Cameroon and set the stage for more comprehensive dementia studies in FS-SSA. For future research following this proposal, we anticipate that valid digital neuropsychological tools coupled with blood biomarkers that still need validation in this setting, could be a scalable and sustainable path for ADRD research, diagnosis and care (R01 proposal)

NHLBI - National Heart Lung and Blood Institute

Project Summary/Abstract Mississippi (MS) is the poorest U.S. state with the lowest life expectancy and highest prevalence of hypertension (HTN). Rural individuals in MS additionally experience geographic and contextual factors that exacerbate chronic disease severity and their accompanying medical and social costs. The objective of this program is to conduct essential preparatory activities for a type 1 hybrid effectiveness-implementation trial to address and improve HTN in rural MS. We have developed and validated a program that includes theory- informed chronic disease self-management (CDSM) and incorporates: (1) longitudinal home blood pressure monitoring (HBPM), recognized as highly effective for patient engagement to improve self-efficacy and HTN management; and (2) a virtual agent, delivered by smartphone to provide an empathic, personalized CDSM curriculum. Our preliminary data demonstrate that the agent has high acceptability, enhances HBPM adherence, and contributes to 6-month reduction in systolic blood pressure (SBP). We have developed a Community Engagement Collaborative (CEC) to participate in the adaptation and evaluation of our CDSM program for HTN with the following aims: Aim 1. Modify the virtual agent intervention for application in rural MS. We will retain the agent’s primary objective to promote CDSM for HTN with routine HBPM and the secondary objectives to address health literacy, medication adherence, and non-pharmacologic approaches to HTN control. We will engage in an iterative, user-centered process that prioritizes the expertise and perspective of the target user. We will apply the results to rapid cycle adaptation of the agent to enhance its accessibility and usability and to evaluate novel gamification elements to support HBPM and agent use. Aim 2. Conduct a pilot evaluation to assess the effect of the intervention on SBP and HBPM adherence. We will enroll individuals with poorly controlled HTN (n=80) to receive a BP cuff and standardized instruction accompanied by 1:1 randomization with or without the virtual agent. As our primary outcome we will evaluate the effect of the HTN virtual agent on SBP at 6 months. As secondary outcomes we will evaluate (1) adherence to HBPM at 6 months and (2) the effect of the HTN virtual agent on SBP at 12 months. Aim 3. Evaluate the implementation process of the program with qualitative assessments of participants and primary care providers as guided by the Consolidated Framework for Implementation Research 2.0. We will conduct an explanatory sequential mixed methods design to identify potential mechanisms of effect of the program and its barriers, facilitators, and context. Expected results: Our multidisciplinary team in concert with our CEC has expertise in HBPM delivery, interventions for HTN, community engagement, and implementation. The proposed activities will adapt and evaluate a validated intervention to improve HTN control in individuals in rural MS. The results will enhance rigor, infrastructure, community engagement, and capacity to successfully conduct the proposed trial.

NIMH - National Institute of Mental Health

Globally, alcohol use disorders (AUD) cause 3.3 million deaths each year and account for nearly 100 million disability-adjusted life years (DALYs). Alcohol use is also one of the most prominent risk factors for death by suicide, as people with AUD have a lifetime risk of suicide more than 7 times higher than the general population. Efforts to prevent suicide can reduce disruptions and fragility of the U.S. health system and serve as a public health good to benefit Americans. We are developing innovative approaches to bridge mental health and substance use treatment gaps, including telehealth and nurse-led counseling interventions with clear potential to reduce suicide in the United States and other settings. In our preliminary study, 7% of patients with AUD were experiencing suicidal thoughts or behavior. Despite this high comorbidity, routine screening and treatment for both suicide risk and alcohol use disorder are extremely rare in emergency care settings. Thus, there is a critical need for innovative, resource-efficient treatments for suicide prevention among people with AUD. In an earlier NIMH-funded study, our team adapted an evidence-based Motivational Interviewing intervention, MI-SafeCope, to develop IDEAS for Hope, a telehealth intervention for suicide prevention in HIV care. In the current grant, we will revisit this process by adapting MI-SafeCope to reduce suicide risk among people with AUD who are presenting for care in a Tanzanian Emergency Department. The resulting intervention, IDEAS-AUD, will address suicide risk with a four-pillared approach: reducing alcohol-related harm, building social support, enhancing emotional health, and meeting basic needs. The pillars are integrated with Motivational Interviewing-enhanced safety planning and referral for psychiatric care as appropriate. Intervention refinement in a low-cost, high-burden global setting has great potential for adaptation and implementation in the rural U.S., where mental health needs are high. The aims of this grant are to: 1) adapt IDEAS-AUD for the AUD population; 2) rigorously evaluate the acceptability and feasibility of IDEAS-AUD; and 3) develop our intervention package for a future implementation evaluation and a clinical trial in the rural U.S. In Aim 1 of the current study, we will identify drivers of suicide risk and desired intervention characteristics to prevent suicide in the AUD population. In Aim 2, we will adapt an evidence-based suicide prevention intervention to existing AUD care, guided by a community coalition. In Aim 3, we will pilot test the telehealth intervention to assess its feasibility and acceptability for reducing suicide risk in the AUD population. By the end of this proposed project, we will have a framework-guided, resource-adapted, piloted protocol for IDEAS-AUD, including screening tools, programmatic, and implementation components. The research is innovative, yet fundamentally essential, and supports NIH Strategic Objectives to prevent suicide across the lifespan, address mental health comorbidities such as AUD, and develop interventions that can be rapidly implemented to strengthen mental health outcomes in the U.S. and improve the health of Americans.

NIMH - National Institute of Mental Health

Globally, alcohol use disorders (AUD) cause 3.3 million deaths each year and account for nearly 100 million disability-adjusted life years (DALYs). Alcohol use is also one of the most prominent risk factors for death by suicide, as people with AUD have a lifetime risk of suicide more than 7 times higher than the general population. Efforts to prevent suicide can reduce disruptions and fragility of the U.S. health system and serve as a public health good to benefit Americans. We are developing innovative approaches to bridge mental health and substance use treatment gaps, including telehealth and nurse-led counseling interventions with clear potential to reduce suicide in the United States and other settings. In our preliminary study, 7% of patients with AUD were experiencing suicidal thoughts or behavior. Despite this high comorbidity, routine screening and treatment for both suicide risk and alcohol use disorder are extremely rare in emergency care settings. Thus, there is a critical need for innovative, resource-efficient treatments for suicide prevention among people with AUD. In an earlier NIMH-funded study, our team adapted an evidence-based Motivational Interviewing intervention, MI-SafeCope, to develop IDEAS for Hope, a telehealth intervention for suicide prevention in HIV care. In the current grant, we will revisit this process by adapting MI-SafeCope to reduce suicide risk among people with AUD who are presenting for care in a Tanzanian Emergency Department. The resulting intervention, IDEAS-AUD, will address suicide risk with a four-pillared approach: reducing alcohol-related harm, building social support, enhancing emotional health, and meeting basic needs. The pillars are integrated with Motivational Interviewing-enhanced safety planning and referral for psychiatric care as appropriate. Intervention refinement in a low-cost, high-burden global setting has great potential for adaptation and implementation in the rural U.S., where mental health needs are high. The aims of this grant are to: 1) adapt IDEAS-AUD for the AUD population; 2) rigorously evaluate the acceptability and feasibility of IDEAS-AUD; and 3) develop our intervention package for a future implementation evaluation and a clinical trial in the rural U.S. In Aim 1 of the current study, we will identify drivers of suicide risk and desired intervention characteristics to prevent suicide in the AUD population. In Aim 2, we will adapt an evidence-based suicide prevention intervention to existing AUD care, guided by a community coalition. In Aim 3, we will pilot test the telehealth intervention to assess its feasibility and acceptability for reducing suicide risk in the AUD population. By the end of this proposed project, we will have a framework-guided, resource-adapted, piloted protocol for IDEAS-AUD, including screening tools, programmatic, and implementation components. The research is innovative, yet fundamentally essential, and supports NIH Strategic Objectives to prevent suicide across the lifespan, address mental health comorbidities such as AUD, and develop interventions that can be rapidly implemented to strengthen mental health outcomes in the U.S. and improve the health of Americans.

NIDA - National Institute on Drug Abuse

SUMMARY/ABSTRACT BACKGROUND. The candidate Dr. Judith Tsui an Addiction Medicine trained physician-scientist who is a leader and expert in patient-oriented research on innovative models of care delivery to improve access to medications for treating opioid use disorder (OUD) and treating and preventing viral co-morbidities such as hepatitis C. Her research, clinical work, and efforts to educate and mentor trainees are aligned: her clinical work informs her research questions and her research allows her to teach and practice the most “up-to-date” evidence-based care. She is currently a Professor at the University of Washington, in the Department of Medicine, recently promoted in 2022. She has an established track record of productivity, publishing over 180 scientific papers in peer-reviewed journals with most recent publications led or co-authored by mentees, and she has been an investigator on 36 NIH grants, 12 of them as PI. Her most recent patient-oriented research has focused on developing and testing interventions (including collaborative care models and mHealth adherence support tools) for patients with substance use disorders to improve health outcomes. MENTORING EXPERIENCE AND PLANNED MENTORING. Dr. Tsui mentors trainees along the spectrum of the clinician- scientist pipeline including through 2 NIDA-funded research training programs (R25 and T32) for which she is PI/MPI. She has mentored >20 early-stage clinician investigators, and currently mentors 4 individuals on NIH K awards. Through this K24 she will expand her mentoring to include more medical residents and fellows. CAREER DEVELOPMENT. The K24 award will support Dr. Tsui in attaining 3 career objectives: 1) to provide tailored, trainee-centered mentoring to individuals at all stages of the physician scientist pipeline; 2) to build her research leadership experience and skills, and support her mentees to pursue leadership opportunities; and 3) to create opportunities and resources for mentorship training to support mentors (“mentor the mentor”) and guide trainees to become effective mentors. These will be accomplished through a combination of formal training, attending conferences and maintaining 1-1 meeting with longstanding and new collaborators and mentors. RESEARCH. The research proposed builds upon a recently funded R01 to investigate how to adapt and scale interventions to achieve broader impact. Aim #1 will apply the “Framework for Reporting Adaptations and Modifications Enhanced” (FRAME) to describe adaptations to the Pharmacist, Physician, Patient Navigator Collaborative Care Model (PPP-CCM) intervention that occur during the R01 study. Aim #2 will conduct landscape analysis to evaluate how to scale PPP-CCM model on a state-level to provide hepatitis C cure to people who use drugs, particularly in rural areas with provider shortages. IMPACT. This K24 will enable Dr. Tsui to broaden her experience as an implementation researcher, expand mentoring, and extend knowledge of how to adapt and scale collaborative care models to improve care for people who use drugs.

NINR - National Institute of Nursing Research

Dating violence (DV) is common among U.S. high school age adolescents and has significant and lifelong negative health consequences, including suicide behaviors. Native American (NA) adolescents are at increased risk for violence victimization and/or perpetration in their dating violence, given their high rates of violence exposure in their homes and communities. Key challenges for dating violence prevention are the lack of services, fear of stigma and discrimination, and limited trust in and access to skilled professionals. The Fort Peck Reservation is home to the Assiniboine and Sioux Tribes in rural Montana. The reservation community reports high rates of violence and suicide behavior with underfunded and limited health and social service, especially for adolescents. The wide range of negative health and social outcomes associated with violence experienced by reservation-based NA adolescents underscores the call for innovative and targeted behavioral health interventions using appropriate technology. myPlan Teen, is an evidence-based healthy relationship and dating violence prevention intervention for adolescents and is delivered through a secure and confidential web based and mobile app. myPlan Teen provides adolescents with immediate access to information about healthy and unhealthy behaviors, safety strategies tailored to their situation with links to youth friendly resources, to reduce confusion, feelings of isolation and stigma associated with unhealthy relationships. In our CDC funded randomized control trial (RCT) with a national sample of 609 adolescents aged 15-17, we found adolescents randomized to myPlan Teen had a significant increase in use and helpfulness of safety behaviors compared to control group (adolescent health website). Further adolescents who used myPlan Teen reported a significant reduction in physical/sexual violence perpetration and suicide behaviors compared to control group. To advance the relevance and use of myPlan Teen with NA adolescents, our interdisciplinary team in partnership with Tribal Health leaders and Youth Advisory Board (YAB) will adapt myPlan Teen by integrating culturally relevant content, including tribal identity and communal mastery for NA adolescents to build healthy relationships, develop safety skills and access culturally relevant resources. Following the adaptation process, the team will evaluate the effectiveness of the culturally adapted myPlan Teen app on health and safety outcomes with 550 NA adolescents. In addition, we will examine the mechanisms by which myPlan Teen improves health and safety outcomes. The study will advance violence prevention interventions with NA adolescents and inform future processes to adapt and disseminate a digital intervention with adolescents nationally.

NIMH - National Institute of Mental Health

Project Summary Adolescents face significant structural, cultural, and economic barriers to accessing mental health care for depression. These discrepancies are deeply pronounced in rural communities, where adolescents report higher rates of internalizing problems compared to their urban peers, yet providers and treatment options are especially scarce. Rural adolescents that do access treatment are overwhelmingly likely to do so in school settings. However, even in schools, treatment options are limited due to a shortage of school mental health providers and funding making it difficult to implement resource-intensive interventions delivered by teachers or other school staff. Thus, when expanding the reach of evidence-based services in rural-area schools, school mental health professionals (SMHP) will be essential for sustainable implementation. Single-session interventions (SSIs) represent one promising approach to offering scalable, effective mental health support in school settings for youth with internalizing symptoms. SSIs offered within school settings can greatly improve rural youths’ access to mental health services – overcoming several of the system-level barriers often faced by their population. Due to difficulty accessing reliable internet services and youth preferences for self-guided treatment versus human-delivered, providing multiple modalities (e.g., digital self- guided treatment, human- delivered) for accessing mental health support can help to alleviate youth internalizing problems. Task sharing has the potential to accelerate the dissemination and implementation of mental health supports for rural youth as a Tier 2 support and provide alternative sources of mental health support for rural teens. In line with NIMH strategic plan goals 3 and 4, which focus on tailoring existing interventions to optimize outcomes and meet the needs of populations in resource constrained settings (e.g., rural adolescents), testing interventions for effectiveness in community settings, and improving the efficiency, effectiveness, and reach of interventions in different communities and populations. The goal of my proposal is to improve access to mental health care for rural youth through the development and evaluation of human-delivered SSIs as a Tier 2 support within school settings by SMHP. I will be in an ideal training environment at Northwestern University to conduct this study and learn how to develop a general research pipeline. Training and mentorship will be received from Dr. Jessica Schleider will provide training in the implementation of SSIs within rural school systems, Dr. Eric J. Bruns on community- engaged research with rural school systems, Dr. Sara Becker on user-centered design (UCD) and dissemination science, Dr. Miya Barnett on UCD and the development of the SMHP toolkit/human- delivered SSI, Dr. Andrew Berry on UCD methods and facilitation of asynchronous remote communities/semi- structured interviews, Dr. Ijeoma Opara on community-engaged research and design with resource- constrained communities. Lastly, Dr. Eric Arzubi will provide mentorship and on-the-ground support in rural communities through his expertise working in rural Montana school districts.

NIMHD - National Institute on Minority Health and Health Disparities

Modified Project Summary/Abstract Section Spina bifida (SB) is one of the most common birth defects in the United States. It is well-documented that children with complex neurodevelopmental conditions, such as SB, experience reduced healthcare access and quality. Indeed, almost 50% of primary care physicians report not feeling knowledgeable about SB. Such challenges are amplified for families from low-income and rural backgrounds. Inadequate healthcare and developmental support during early childhood can then widen the cognitive, social-emotional, and behavioral developmental gap for young children with SB. This is especially concerning given the already lower prenatal spinal closure rates for families of children with SB who have Medicaid and live in less-resourced zip codes, a surgery that is linked to more optimal developmental outcomes in early childhood. Digital health interventions (DHI) that target caregiver distress and positive parenting skills are one promising tool to optimize early development. Thus, the proposed research project will use a community-engaged approach to partner with caregiver and healthcare provider advisory boards from the national Spina Bifida Association to co-design a novel parenting DHI for caregivers of young children (ages 2:6-6 years old) with SB, particularly those from low-income and rural backgrounds (Aim 1). To refine the intervention and implementation plan, rapid-cycle testing will then be conducted with 10 families to examine usability, feasibility, acceptability, and proof-of-concept in improving caregiver distress, positive parenting skills, and child developmental outcomes immediately post-intervention and three months post-intervention (Aim 2). Finally, a randomized feasibility trial will be conducted by enrolling families into the DHI group (n=15) or an internet resource comparison group (n=15) to determine protocol feasibility and retention (Aim 3). In alignment with the Accelerated Creation to Sustainment model, the DHI implementation plan will be designed and refined throughout all aims to minimize the research-to-practice gap. To successfully complete the proposed project and transition into an independent clinician-scientist, Dr. Winning will receive additional training and mentorship in the following key areas: (1) early childhood intervention strategies that promote resilience in children with neurodevelopmental disabilities and their caregivers, (2) DHI co-design with low-income and rural populations, (3) design, conduct, and analysis of behavioral trials, and (4) dissemination and implementation science. This project will leave Dr. Winning well-positioned to conduct a full-scale randomized controlled trial and become a leader in developing DHIs to advance health outcomes for families of children with SB.

NIA - National Institute on Aging

Project Summary/Abstract For many older adults in rural America, the enduring presence of chronic pain, compounded by comorbid medical conditions, geographic constraints, and limited resources, poses significant challenges. Three key obstacles hinder effective pain management for this vulnerable population: 1). the complexity of treating multiple chronic conditions alongside pain, 2). the scarcity of specialized care in pain and related comorbidity in rural areas leading to delayed or absent comprehensive pain management, and 3). the limitations of existing pain assessment tools that often neglect the nuanced qualitative aspects of pain, especially in older adults. Additionally, the timely and accurate assessment of conditions comorbid with pain, like depression, is hampered by various clinical and patient-related factors. Our proposal aims to address these challenges through two primary objectives. The first objective is to revolutionize pain measurement by adopting a more comprehensive approach that leverages natural language processing and machine learning. This innovative strategy aims to develop tools capable of capturing the multidimensional nature of pain, including its physical, psychological, and functional aspects. The second objective is to utilize data-driven predictive models to identify individuals at high risk of developing depression related to chronic pain. By analyzing extensive datasets that include pain assessments, treatment histories, medical records, and demographic information, we aim to enable early intervention for these comorbid conditions. By automating the measurement of pain and identifying patients at risk of depression, we can offer invaluable support, particularly in rural settings where medical resources are limited. These advanced tools will not only streamline access to clinical insights but also facilitate timely interventions, improving the capacity of both pain specialists and primary care physicians to make informed decisions. Ultimately, this approach aims to improve the quality of life for older adults in rural areas, addressing the unique challenges they face in managing chronic pain and its associated conditions.

Health and Human Services Department

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

Alaska Department of Commerce, Community, and Economic Development (DCCED)

The Village Safe Water program funds design, construction, and improvement of water and sewer systems in rural Alaska communities, addressing critical sanitation infrastructure needs for Alaska Native villages.

Alaska Department of Education and Early Development (DEED)

DEED provides grants to Rural Education Attendance Areas and school districts for school improvement initiatives, teacher retention programs, and educational technology in Alaska's most remote communities.

Alaska Division of Economic Development

The Division of Economic Development supports small business growth in Alaska through grants for business planning, market development, export promotion, and rural economic diversification projects.

NIH

Background: Early goals of care (GoC) communication regarding prognosis, values, and care preferences improves patient mood and reduces the likelihood of intensive, unwanted care at the end-of-life for Veterans with cancer. In 2017, the VA National Center for Ethics in Health Care (NCEHC) launched the Life-Sustaining Treatment Decisions Initiative (LSTDI), a national program to promote GoC communication between clinicians and their patients. Despite LSTDI, 60% of Veterans with cancer still have no GoC communication or an LST documented note before death. Major barriers include reliance on oncology clinicians to identify appropriate Veterans and initiate these conversations in clinic. In response, we developed the Engagement of Patients with Advanced Cancer (EPAC) intervention – a 6-month telephone-based intervention in which trained lay health workers (LHWs) educate and empower Veterans with cancer to engage in GoC with their oncology clinical teams. To facilitate scale, we propose Algorithm-Enabled EPAC (A-EPAC), which uses the VA Care Assessment Needs (CAN) score to automatically identify patients with cancer who could benefit from EPAC. Significance: Connecting Veterans to the soonest/best care and promoting a culture of safety, learning, and knowledge translation are central to VA priorities. This proposals’ objective for early and equitable GoC communication is strongly aligned with VA’s strategic plan (Goal 2.1) and VHA Directive 1004.03, Advance Care Planning. The research addresses HSR priority topic areas of health care system organization and delivery through access, virtual care, and rural health (remote delivery); behavioral, social, and cultural determinants of health (tailored interventions to address equity); and, strategic methodology areas, including data science (algorithm-based eligibility) and implementation science (type 1 hybrid trial design). Innovation and Impact: Integrating high-tech automated algorithms with high-touch LHW interventions can overcome persistent barriers to GoC communication. Innovative methodologic aspects of this proposal, include: (1) recruitment of oncology sites, including the National Teleoncology Program (NTO), that serve racial and ethnic minorities, women, and Veterans in rural settings; (2) longitudinal assessment of patient mood and care preferences; and (3) decentralized clinical trial with remote recruitment and intervention activities. Specific Aims: 1) Determine whether A-EPAC improves LST documentation within 12 weeks more than usual care alone; 2) Determine whether A-EPAC reduces patient anxiety and depression more than usual care from baseline to 12 weeks; 3) Identify Veteran, clinician, and organizational factors associated with feasibility, adoption, acceptability, and A-EPAC fidelity using the Consolidated Framework for Implementation Research. Methodology: Our intent-to-treat randomized trial is conducted in collaboration with the NTO and the National VA Oncology Program (NOP). We will randomize 200 Veterans with cancer receiving care across 7 VA facilities that serve primarily Black, Latino or Hispanic, and/or rural-dwelling Veterans to either the A-EPAC intervention (algorithm-based identification and referral to EPAC for 6-months) or usual cancer care alone (cancer care provided by oncology teams at the local site). Participants will be followed for 12-months post-enrollment. Our primary outcome is LST documentation within 12 weeks post-enrollment. Secondary outcomes are patient anxiety and depression at 12 weeks measured by PROMIS® short forms. Exploratory outcomes include intensive end-of-life care, advance directive documentation, and acute care use. Using a quant-qual framework, we will conduct validated surveys with 60 Veterans with cancer and Veteran and clinician interviews at 6 months to identify factors associated with feasibility, adoption, acceptability, and A-EPAC fidelity. Next Steps/Implementation: Our collaboration with operational partners including the NTO, NOP, NCEHC, the Veterans Experience Center, and the VA Proactive Patient Centered Care Program founded and directed by MPI Patel, will support widespread dissemination across VA oncology settings.