Search Grants — Free, No Account Required

NIMH - National Institute of Mental Health

PROJECT SUMMARY / ABSTRACT Despite availability of HIV pre-exposure prophylaxis (PrEP) for over a decade, many persons who could benefit from PrEP have not yet accessed PrEP services. Implementation of pharmacy-based PrEP is a promising strategy that presents opportunity to overcome barriers related to clinic distance and stigma and to increase PrEP access, uptake, and continuity of treatment among individuals who would benefit most. Despite the fact that team member and pharmacist Dr. Elyse Tung started the first pharmacy-based PrEP clinic nearly ten years ago, PrEP still is not widely available through pharmacies without a prescription from a doctor or other licensed clinician. As of 2024, not all states allow pharmacists to prescribe medications independently, and many insurance companies erect barriers to providing compensation to pharmacists for this role. Implementation science projects are needed to develop, refine, and evaluate the training and educational support required by pharmacists to expand their scope of practice. Health economics work is also needed to determine whether there are incremental financial benefits for pharmacies to provide injectable PrEP in addition to oral medications and to evaluate the cost-effectiveness of providing PrEP through telehealth. In response to RFA MH-25-185, we propose three specific aims. Aim 1 will build on a current supplement through the Ending the HIV Epidemic (EHE) initiative that is funding a pilot project to evaluate an online virtual community of practice (VCoP) for pharmacists and pharmacy staff to increase their knowledge, capabilities, and comfort in prescribing PrEP. Aims 2 and 3 will conduct financial analyses to provide information for new pharmacy implementation and use time and motion data to compare the costs and benefits of providing injectable PrEP versus oral PrEP and in-pharmacy visits versus telePrEP. This project addresses the Prevent pillar of the EHE plan with a secondary impact on the Diagnose pillar. This project also addresses the NIH HIV/AIDS Research Priorities (NOT-OD-20-018) to reduce HIV incidence by testing new prevention strategies and training the workforce. It is in synergy with the local EHE plan, the Washington State Department of Health, and the National HIV/AIDS Strategy. The national strategy specifically calls out to leverage pharmacists’ knowledge and accessibility in nearly every urban and rural community as part of a comprehensive HIV prevention and care strategy. Ultimately our goal is to provide more PrEP options and motivate pharmacists and pharmacy owners to expand access points for PrEP care in locations and to populations disproportionately impacted by HIV infection in order to end the HIV epidemic.

NIDA - National Institute on Drug Abuse

PROJECT SUMMARY Substance use disorders are a major cause of death and disease in the United States with the country currently experiencing over 100,000 drug overdose deaths 1 and over 5 million disability adjusted life years (DALY’s: equal to one year of healthy life lost) per year. While overall, overdose deaths are declining, this is not the case in all demographics and communities, suggesting that as we address challenges related to substance use disorders (SUDs), many subpopulations are being left behind. These differences highlight the need to consider the unique circumstances of individuals in different subpopulations. Substance misuse and SUD are highly personalized phenomena, influenced by a complex interplay of psychosocial, environmental, genetic, and other unique factors. Psychosocial factors, such as stress, trauma, and social relationships can either predispose individuals to drug use or protect them from it. Environmental influences, including socioeconomic status and injury can also intersect to shape susceptibility to substance misuse and SUD. Additionally, individual differences in brain chemistry, personality traits, and co-occurring mental health disorders contribute to the variability in addiction vulnerability. Thus, there is a need to train the next generation of researchers to understand and study the influences of individualized factors on susceptibility and treatment responses in substance misuse. We are requesting three predoctoral training slots for a duration of five years (two supported by this award, one supported by the Medical College of Wisconsin Graduate School). The Pharmacology Research on Individualized factors in Substance Misuse (PRISM) Training Program is designed to meet this need by providing trainees with in-depth experiences and a holistic education on the impact of unique factors on addiction liability. In the lab, PRISM scholars will study the influence of personalized factors on substance misuse in one of several themes, including stress, neuroinflammation, circuits/plasticity, chronic pain, brain injury, and/or endocannabinoid signaling. Outside the lab, PRISM scholars will get real-world experiences to begin to understand the bidirectional impact of substance use disorders on individuals and communities. These experiences include shadowing practitioners and harm reduction specialists, learning from people with lived experience, and engaging community partners in Milwaukee to discuss scientific and community aspects of substance misuse. To further promote professional development and a broad exposure to different applications of substance misuse research, PRISM scholars will complete a capstone project in one of five themes: community engagement, policy, industry, teaching/education, or translational research. Completion of the capstone project will be supported by a specific capstone mentor and participation in PRISM scholars Learning Community events. By integrating these comprehensive training components, the PRISM Training Program aims to cultivate a new generation of researchers equipped to address the individual challenges of substance misuse.

NIMH - National Institute of Mental Health

PROJECT SUMMARY Gonadal hormones (testosterone, estrogen, progesterone) cause significant changes in food intake in animals, but until recently, were largely ignored in studies of binge eating (BE). Animal and human data now confirm that ovarian hormones (estrogen, progesterone) are critical risk factors for BE in females, and that natural changes in these hormones across the menstrual cycle substantially increase risk for BE via hormonally induced increases in genetic risk. However, a critical gap in this novel area of research remains - the impact of testosterone on BE risk in women. Testosterone is traditionally associated with male physiology, yet it is also present in females and is highly relevant to BE and women's health. Animal studies show higher testosterone levels have stimulatory effects on food intake and preferences for palatable food (PF). Elevated testosterone is associated with increased cravings for PF, and disorders characterized by elevated testosterone in women (e.g., PCOS) are marked by higher BE. Testosterone also exerts potent effects on gene transcription in systems critical for BE. Remarkably, no large-scale study has examined testosterone effects on BE risk in women. Our Specific Aims are to illuminate the critical and unique role of testosterone in risk for BE in women and identify etiologic mechanisms of individual differences in risk. We will capitalize on the availability of novel archival data from our NIMH-funded study that collected daily BE and ovarian hormones across 45 consecutive days (>100,000 datapoints) in a population-based sample of female twins (N = 520). We will assay archival saliva samples (15,000+) for daily testosterone levels and use our daily data to examine testosterone as a critical phenotypic risk factor for BE in women (Aim 1). We will substantially extend these findings by examining whether daily changes in testosterone impact genetic risk for BE (Aim 2) and serve as mechanisms of individual differences in risk. Finally, we will conduct secondary analyses to probe the interplay between testosterone and ovarian hormones to develop the most comprehensive models of gonadal hormone influences on BE in women to date. There is a compelling and urgent public health need to understand the role of testosterone in BE. Millions of women are prescribed hormonal contraceptives that stimulate testosterone/androgenic activity, and testosterone is used to treat health conditions in women. These treatments have proceeded with very little data on the potential adverse effects of testosterone on BE or other psychiatric symptoms. Our project’s integration of unique archival data with new testosterone measurements is a powerful strategy for studying these effects and addressing NIMH’s focus on isolating mechanisms and analyses that “incorporate genetic markers of risk, and leverage existing large, population-based cohorts… to advance understanding of complex etiologies.” Our findings will substantially advance etiologic models and inform precision medicine approaches that can reduce BE and improve women’s health.

OD - NIH Office of the Director

Project Abstract Degenerative spinal conditions are a major public health burden contributing to the United States (US) having the highest rate of lumbar spine surgery in the world. Despite surgical advances, up to 40% of patients report chronic pain and disability after surgery. Physical activity is an important determinant of recovery after spine surgery. Our own data demonstrate that patients who walk early after spine surgery are more likely to achieve meaningful improvement in pain, disability, and opioid use. To address physical inactivity and improve long- term outcomes, our research team recently completed a pilot trial of a Physical Activity intervention to improve Surgical Spine outcomes. PASS is a mind-body physical activity intervention based on a Brief Action Planning (BAP) framework that integrates behavioral strategies with pain coping skills and individualized feedback from wearable technology (Fitbit). BAP involves self-management support through motivational interviewing, SMART goals, and problem-solving to build self-efficacy and promote behavior change. Pilot work has shown the benefits of PASS for improving physical activity and long-term pain-related and functional outcomes after lumbar spine surgery. Therefore, we propose a fully remote two-group randomized controlled trial at three high volume medical centers in the Southeast, Northeast, and Pacific Northwest regions of the US. We plan to recruit 220 adults with a degenerative lumbar spine condition undergoing spine surgery. Eligible patients will be randomized after surgery to (1) 8-session PASS intervention or (2) standard of care physical activity education. The 8-session PASS intervention is delivered weekly by a physical therapist using a web-based platform. Remote assessments will be conducted by an evaluator unaware of randomization assignment before surgery and at 6 and 12 months after surgery. We hypothesize that participants in a remotely delivered mind-body physical activity intervention will have higher objective physical activity at 6 months (primary outcome) and better pain, disability, physical function, mental health, and opioid use at 12 months (secondary outcomes) compared to standard of care physical activity education. Physical activity will be assessed through a triaxial accelerometer (ActiGraph) and secondary outcomes through validated questionnaires and electronic health record data on opioid prescriptions. Exploratory data will be collected on depression (8-item Patient Health Questionnaire), sleep (ActiGraph), and heart rate variability (heart rate monitor) to assess overlapping mechanisms related to physical activity and pain-related outcomes. This study will be the first to investigate a mind-body postoperative rehabilitation program that targets multiple pathways for enhancing physical activity in order to achieve long-term impact after spine surgery. The results of our randomized trial will serve to broadly disseminate integrative physical and psychosocial strategies to physical therapists managing patients at-risk for poor surgical outcomes. There is an urgent need for older adults to have readily accessible mind-body treatments that allow them to take an active role in their care.

NIMH - National Institute of Mental Health

PROJECT SUMMARY Decision making has a profound impact on how we interact with the world. For instance, adults with posttraumatic stress disorder (PTSD) often form inaccurate beliefs about their environment leading to flawed decision-making and missed opportunities (e.g., the world is a dangerous place and therefore I should not leave my house to attend a social gathering). In fact, a major goal of cognitive processing therapy (CPT) in PTSD involves identifying and modifying traumatic beliefs and cognitive biases that impair decision-making. This process typically involves promoting more complex learning in which individuals form an abstract representation of the environment which allows them to make prospective predictions about likely outcomes based on different choices (termed model- based learning). Greater engagement in model-based learning is thought to provide individuals with more flexibility and allow more adaptive learning and decision-making – which overlaps with major treatment targets in CPT. As such, manipulations that can boost model-based learning may prove to play an important role in enhancing important cognitive processes of CPT – an efficacious treatment with room for improvement (~50- 60% remission rate). We recently demonstrated that an acute 30-minute bout of moderate-vigorous intensity aerobic exercise promoted model-based over model-free learning during decision making in adults with and without PTSD. However, it remains unknown whether habitual physical activity levels (as opposed to a single laboratory exercise session) also influence model-based decision-making and whether such a relationship between physical activity and model-based decision-making may also be mediated by candidate biomarkers that are sensitive to physical activity and involved in reward-based learning and decision-making (e.g., endocannabinoids). As such, the purpose of this study is to determine whether and how engagement in regular physical activity is associated with model-based decision-making (under threat and non-threat conditions). In line with this R03 mechanism, we propose a self-contained study that will utilize computational modeling and assess physical activity behaviors, candidate biomarkers, and performance on a commonly administered lab- based decision-making task (i.e., two-stage Markov task) capable of discriminating model-free from model-based decision-making in adult men and women with and without PTSD (N=90) over a 3-week period. The results from this study may have significant clinical implications and improve our understanding of the potential for incorporating physical activity into the treatment of PTSD and will be instrumental for the design and development of subsequent randomized-controlled trials. This study will be executed by a multi-disciplinary team that has an extensive history of conducting studies aimed at improving our understanding of the psychobiological mechanisms responsible for the effects of physical activity on cognitive processes in adults with and without PTSD.

National Institutes of Health

<p>The National Institute on Drug Abuse seeks to support pilot and feasibility studies in preparation for efficacy, effectiveness and/or services research trials. Topics may include:1) developing interventions to prevent substance use, misuse or progression to disorder, 2) substance use prevention, treatment or recovery services research, including comorbid pain, medical and mental health disorders, 3) HIV eradication research, including implementation science, prevention, treatment and recovery in substance use settings/populations.</p><p>Projects may address information gaps, strengthen stakeholder partnerships, or pilot test interventions. Activities might include intervention development/adaptation; assessing intervention or service model acceptability and feasibility; and development of measures, materials, or methods for the future trial. Preliminary data is not required. A well-defined theory of change or logic model is expected. Applicants must engage relevant end users in study design, execution, and interpretation (e.g., policymakers, state and local decision makers, practitioners, individuals with lived/living experience, families, youth, and community members).</p><p>Applications are not being solicited at this time. This notice is to allow applicants time to develop collaborations and responsive projects. Grant authorities that allow this forecast are 42 U.S.C. §§ 241 and 284.</p><p>&nbsp;</p>

National Institutes of Health

The National Institute on Drug Abuse seeks to support pilot and feasibility studies in preparation for efficacy, effectiveness and/or services research trials. Topics may include:1) developing interventions to prevent substance use, misuse or progression to disorder, 2) substance use prevention, treatment or recovery services research, including comorbid pain, medical and mental health disorders, 3) HIV eradication research, including implementation science, prevention, treatment and recovery in substance use settings/populations.Projects may address information gaps, strengthen stakeholder partnerships, or pilot test interventions. Activities might include intervention development/adaptation; assessing intervention or service model acceptability and feasibility; and development of measures, materials, or methods for the future trial. Preliminary data is not required. A well-defined theory of change or logic model is expected. Applicants must engage relevant end users in study design, execution, and interpretation (e.g., policymakers, state and local decision makers, practitioners, individuals with lived/living experience, families, youth, and community members).Applications are not being solicited at this time. This notice is to allow applicants time to develop collaborations and responsive projects. Grant authorities that allow this forecast are 42 U.S.C. 241 and 284.

National Institutes of Health

NIMH seeks applications for pilot effectiveness projects to evaluate the preliminary effectiveness of therapeutic and service delivery interventions for the post-acute management of mental health conditions that are matched to the stage of illness in terms of both their focus (e.g., consolidating and maintaining gains from initial treatment, managing residual symptoms/impairment, preventing relapse, promoting adherence and appropriate service use) and intensity/burden. In this pilot phase of effectiveness research, the trial should be designed to evaluate the feasibility, tolerability, acceptability, safety, and potential effectiveness of the approach; to address whether the intervention engages the target(s)/mechanisms(s) that is/are presumed to underlie the intervention effects; and to obtain preliminary data needed as a pre-requisite to a larger-scale effectiveness trial (e.g., comparative effectiveness study, practical trial) designed to definitely test the effectiveness of interventions to improve post-acute outcomes. This Notice of Funding Opportunity (NOFO) supports pilot effectiveness research to evaluate the feasibility, tolerability, acceptability, safety and preliminary indications of effectiveness of post-acute phase intervention approaches and inform the design of definitive effectiveness trials. Support for fully-powered, definitive effectiveness studies focused on post-acute phase interventions is provided via the R01 currently TEMP-24813.

National Institutes of Health

NIMH seeks applications for pilot effectiveness projects to evaluate the preliminary effectiveness of therapeutic and service delivery interventions for the post-acute management of mental health conditions that are matched to the stage of illness in terms of both their focus (e.g., consolidating and maintaining gains from initial treatment, managing residual symptoms/impairment, preventing relapse, promoting adherence and appropriate service use) and intensity/burden. In this pilot phase of effectiveness research, the trial should be designed to evaluate the feasibility, tolerability, acceptability, safety, and potential effectiveness of the approach; to address whether the intervention engages the target(s)/mechanisms(s) that is/are presumed to underlie the intervention effects; and to obtain preliminary data needed as a pre-requisite to a larger-scale effectiveness trial (e.g., comparative effectiveness study, practical trial) designed to definitely test the effectiveness of interventions to improve post-acute outcomes. This Notice of Funding Opportunity (NOFO) supports pilot effectiveness research to evaluate the feasibility, tolerability, acceptability, safety and preliminary indications of effectiveness of post-acute phase intervention approaches and inform the design of definitive effectiveness trials. Support for fully-powered, definitive effectiveness studies focused on post-acute phase interventions is provided via the R01 currently TEMP-24813.

National Institutes of Health

This Notice of Funding Opportunity (NOFO) encourages pilot and preliminary research in preparation for larger-scale services research effectiveness trials. Relevant trials may test a wide range of approaches, including interventions, practices, and policies designed to optimize access to, and the quality, effectiveness, affordability and utilization of drug, tobacco, or alcohol use disorder treatments and related services, as well as services for comorbid medical and mental disorder conditions. Relevant approaches may include both those that are novel, and those that are commonly used in practice but lack an evidence base. This NOFO provides resources for assessing the feasibility, acceptability, and utility of these approaches, in addition to usual trial preparation activities.

National Institutes of Health

This Notice of Funding Opportunity (NOFO) encourages pilot and preliminary research in preparation for larger-scale services research effectiveness trials. Relevant trials may test a wide range of approaches, including interventions, practices, and policies designed to optimize access to, and the quality, effectiveness, affordability and utilization of drug, tobacco, or alcohol use disorder treatments and related services, as well as services for comorbid medical and mental disorder conditions. Relevant approaches may include both those that are novel, and those that are commonly used in practice but lack an evidence base. This NOFO provides resources for assessing the feasibility, acceptability, and utility of these approaches, in addition to usual trial preparation activities.

NIMH - National Institute of Mental Health

Project Summary/Abstract Despite their impact, postpartum intrusive thoughts -- unwanted, distressing thoughts, images, and urges often about harming one’s infant -- are common yet overlooked. This can lead to distress, shame, impairment, and for some, diagnoses of depression, anxiety, or OCD; postpartum OCD affects up to 11% of mothers, and postpartum anxiety up to 18%. These diagnoses often arise from interpretation bias - the misinterpretation of one’s intrusive thoughts as dangerous, unacceptable, or predictive of harm. Postpartum mental health referrals, typically at the six-week obstetric appointment, are often ineffective since many miss this visit, non-birthing parents are left out, referral options are scarce, and by this point, most parents with intrusive thoughts have been struggling for weeks, missing a key intervention window. Even when symptoms are identified, parents face treatment barriers including time constraints, lack of childcare, and stigma. Psychoeducation has shown promise for perinatal populations and has potential for targeting interpretation bias by reducing threatening misinterpretations of the thoughts through normalization, increasing disclosure, and reducing shame. Digital Single Session Interventions (SSIs) provide an innovative dissemination strategy; they are self-guided programs delivered in one encounter. There is a critical need for scalable, sustainable interventions that target cognitive vulnerabilities driving postpartum intrusive thoughts. Interventions developed by the study team are compelling but require adaptation to optimize scalability, sustainability, and relevance for new parents at risk. We propose a type 1 hybrid effectiveness-implementation trial to adapt and test an SSI targeting misinterpretation of postpartum intrusive thoughts, and to explore implementation and sustainability. Our central hypothesis is the SSI will reduce interpretation bias and improve outcomes for clinically significant postpartum intrusive thoughts, parent anxiety, parent-infant relationships, and psychosocial functioning. We will also assess preliminary implementation outcomes (e.g., reach, acceptability) to inform long-term sustainability. First, we will develop a personalized digital SSI by adapting existing evidence-based interventions to address postpartum interpretation bias, in collaboration with an Advisory Board of patients and expert clinicians. We will then test this SSI in an open trial with an iterative case series design (N = 24) for new parents with distressing intrusive thoughts, evaluating feasibility and acceptability with continuous refinement. Second, we will conduct a pilot RCT (target N = 80) for a preliminary effectiveness test comparing the SSI vs. waitlist in reducing intrusive thoughts severity. Third, we will explore key implementation outcomes to inform sustainability, interviewing stakeholders and collecting surveys from users to identify barriers and facilitators to sustainable implementation across the digital resources that will deliver this SSI to new parents. Achievement of these aims will support a future fully-powered hybrid type 1 trial. This multidisciplinary team led by an Early Stage Investigator will deliver a brief, sustainable intervention to improve public health for new parents.

National Institutes of Health

Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R01 Clinical Trial Required). As part of NIMH's clinical trials pipeline NOFOs, this announcement encourages pilot effectiveness studies focused on 1) optimizing the effectiveness of preventive and therapeutic interventions with previously demonstrated efficacy, for use with broader target populations or for use in community practice settings, and 2) developing and preliminary testing innovative services interventions. Consistent with the NIMH experimental therapeutics approach, this NOFO is intended to support pilot studies of intervention effectiveness or service delivery approaches that explicitly address whether the intervention engages the target(s)/mechanism(s) presumed to underlie the intervention effects (i.e., the mechanism(s) that accounts for changes in clinical/functional outcomes, changes in provider behavior, improved access or continuity of services, etc.).

National Institutes of Health

Pilot Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 Clinical Trial Required)

National Institutes of Health

Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R01 Clinical Trial Required). As part of NIMH's clinical trials pipeline NOFOs, this announcement encourages pilot effectiveness studies focused on 1) optimizing the effectiveness of preventive and therapeutic interventions with previously demonstrated efficacy, for use with broader target populations or for use in community practice settings, and 2) developing and preliminary testing innovative services interventions. Consistent with the NIMH experimental therapeutics approach, this NOFO is intended to support pilot studies of intervention effectiveness or service delivery approaches that explicitly address whether the intervention engages the target(s)/mechanism(s) presumed to underlie the intervention effects (i.e., the mechanism(s) that accounts for changes in clinical/functional outcomes, changes in provider behavior, improved access or continuity of services, etc.).

NIMH - National Institute of Mental Health

Project Summary/Abstract This proposal addresses the significant public health concern of destructive interparental conflict (IPC), which is strongly associated with a range of adverse outcomes for children, including mental health disorders, substance use, academic challenges, risky behaviors, and suicidality. These effects are particularly pronounced in the context of parental separation and divorce, which impacts over half of U.S. children by age 15. Family courts frequently interact with families experiencing high levels of IPC, making them critical settings for implementing interventions aimed at reducing these negative outcomes. However, most parenting programs mandated or referred by family courts are not evidence-based, leaving a critical gap in effective support for families experiencing high IPC. This pilot study aims to address this gap by evaluating the feasibility, acceptability, and preliminary impact of intervention components designed to mitigate the effects of IPC on children’s mental health. Using the Multiphase Optimization Strategy (MOST) framework, we will pilot a highly efficient experimental trial design (N = 96) to gather preliminary data on five candidate intervention components: high- versus low-intensity delivery of IPC reduction approaches, inclusion of constructive IPC skills, inclusion of IPC resolution skills, inclusion of skills for repairing parent-child relationships after IPC events, and high- versus low-intensity home practice support. These components were selected based on empirical support for their potential to reduce child mental health problems. The findings from this pilot study will inform the design of a future fully powered trial to identify the most effective and scalable combination of components that can be delivered within the practical constraints of family courts. In Aim 1, we will assess the feasibility of recruitment, randomization, and trial procedures, and the acceptability of intervention components among parents and family courts. Quantitative and qualitative feedback will guide refinements to the components and trial design. In Aim 2, we will explore the components’ preliminary impact on children’s mental health using validated measures and explore hypothesized mechanisms of action, including quality of parents’ home practice and children’s emotional security. These findings will help refine the intervention’s conceptual model. In Aim 3, we will identify potential implementation barriers and facilitators by conducting qualitative interviews with judges and court administrators from three family courts of varying resources and sizes. Using the Consolidated Framework for Implementation Research (CFIR) and the Expert Recommendations for Implementing Change (ERIC), we will develop an Implementation Research Logic Model (IRLM) to guide scale-up planning for the fully powered trial. This pilot study will lay the foundation for a scalable and effective intervention addressing IPC, leveraging family courts as a key implementation context. The future fully powered trial will advance the development of effective, evidence-based parenting programs that improve children’s mental health outcomes in the aftermath of parental separation/divorce.

Administration for Children and Families - ORR

This NOFO is modified. Changes are made to Step 1: Review the Opportunity and Step 2: Get Ready to Apply. The disqualifying factors section has been updated to clarify that applications from organizations currently funded by ORR to support Program of Initial Resettlement services will be disqualified, including organizations receiving PIR funding through subaward. The webinar description has been updated to include instructions on submitting questions in advance of the webinar. The Office of Refugee Resettlement (ORR) within the Administration for Children and Families (ACF), invites eligible applicants to submit applications to administer the Placement and Coordination (PC) program. ORR will provide funding to diversify providers of PC services through awards to eligible organizations not currently implementing the Program of Initial Resettlement (PIR). New providers will strengthen the national resettlement framework by contributing unique innovations and perspectives.PC providers will be responsible for administering services including the Program of Initial Resettlement (PIR) and Intensive Case Management (ICM) through one or more local service providers. Through PIR, PC providers will review refugee case profiles assigned by ORR, conduct outreach to identified U.S. ties, and confirm case placement locations. PC providers will either serve cases directly or place them with local resettlement providers (LRPs) in their network. After the refugee arrives, the LRP will assume responsibility for providing PIR services for 30 to 90 days after arrival in the United States, based on self-sufficiency needs of the case. Examples of services include airport pickup upon initial arrival, securing and furnishing housing, benefits applications, referrals, provision of cultural orientation, and provision of direct assistance. Through ICM, providers will serve individuals with significant vulnerabilities that create barriers to assimilation and self-sufficiency for a service period of six to 12 months, or 12 to 24 months for individuals with long-term physical or mental health conditions or disabilities. Examples of services include regular case management discussions, psychosocial support, and connections to external sources of assistance.

Administration for Children and Families - ORR

The Office of Refugee Resettlement (ORR) within the Administration for Children and Families (ACF), invites eligible applicants to submit applications to administer the Placement and Coordination (PC) program. ORR will provide funding to diversify providers of PC services through awards to eligible organizations not currently implementing the Program of Initial Resettlement (PIR). New providers will strengthen the national resettlement framework by contributing unique innovations and perspectives.PC providers will be responsible for administering services including the Program of Initial Resettlement (PIR) and Intensive Case Management (ICM) through one or more local service providers. Through PIR, PC providers will review refugee case profiles assigned by ORR, conduct outreach to identified U.S. ties, and confirm case placement locations. PC providers will either serve cases directly or place them with local resettlement providers (LRPs) in their network. After the refugee arrives, the LRP will assume responsibility for providing PIR services for 30 to 90 days after arrival in the United States, based on self-sufficiency needs of the case. Examples of services include airport pickup upon initial arrival, securing and furnishing housing, benefits applications, referrals, provision of cultural orientation, and provision of direct assistance. Through ICM, providers will serve individuals with significant vulnerabilities that create barriers to assimilation and self-sufficiency for a service period of six to 12 months, or 12 to 24 months for individuals with long-term physical or mental health conditions or disabilities. Examples of services include regular case management discussions, psychosocial support, and connections to external sources of assistance.

NIMH - National Institute of Mental Health

Long-acting injectable HIV antiretroviral medications (LAIs) are a breakthrough in HIV treatment and prevention, alleviate daily medication challenges, and are extremely efficacious. While LAIs have the potential to transform and improve health outcomes for people living with HIV or with vulnerability to HIV infection, clinical implementation of LAIs has been suboptimal, including for populations most impacted by HIV. Without evidence-based implementation models that address systems level determinants, the potential for LAIs to help end the HIV epidemic is unlikely to be realized. One approach to meaningfully address health system barriers is by leveraging existing, organically developed efforts designed by system insiders: pharmacists and providers in federally qualified health centers (FQHCs) in the Bronx, NY (a high-priority jurisdiction with >2% HIV prevalence). Currently, clinical pharmacists have organically developed ad hoc implementation efforts where they play an integral role in LAI delivery, including patient counseling, coordination, procurement, cost coverage, delivery, with similar workflows for HIV prevention and treatment using LAIs (i.e., a status-neutral (SN) model). These efforts show promise and warrant systematic study and protocolization to guide potential replication and scale-up. Using rigorous implementation science methods and leveraging expertise from committed multidisciplinary stakeholders (including pharmacists, patients, providers, nurses, administrators, and researchers), this R21 study will develop, formalize, and pilot an embedded SN-LAI implementation model: “Planning for implementation of Long-Acting iNjectables in Status-neutral HIV primary care FQHCs (the PLANS study)”. We will first identify context-specific determinants of SN-LAI implementation and systematically identify existing or perceived barriers and facilitators (Aim1a) using innovative systems journey mapping interviews with patients and key informants. We will use these data to systematically develop, protocolize, and refine a package of SN-LAI implementation strategies with stakeholders (Aim 1b). In a test of concept, we will then pilot strategies for acceptability, feasibility, appropriateness, fidelity, and explore indicators of strategy effectiveness (Aim 2) in a Bronx FQHC to understand the potential of this organically- driven, multidisciplinary approach to overcome system-level barriers and enhance status-neutral LAI implementation.

NIMH - National Institute of Mental Health

The Contractor, Guild Associates, Inc., aims to develop an electrochemical aptamer-based sensor device for simple, rapid, and low-cost detection and quantification of antiretroviral therapy (ART) drugs in urine and blood samples at the point-of-care (POC).

NIDA - National Institute on Drug Abuse

PROJECT SUMMARY Drug overdose is now a leading cause of death among U.S. adolescents and young adults, rising substantially in the past decade due to the proliferation of highly lethal fentanyl alongside other shifts in drug involvement. In parallel, nonfatal overdoses have risen in adolescents and young adults. Nonfatal overdoses greatly increase the risk of repeat overdose and subsequent death and have lasting consequences, especially life-threatening or near-fatal overdose events that may indicate greater need for behavioral health treatment and higher risk of future morbidity and mortality. Thus, nonfatal overdoses treated in acute care settings represent critical opportunities for intervention; however, limited data are available to inform discharge planning, with existing studies indicating an unmet need to improve connections to behavioral health treatment. Our overall goal is to generate evidence that can be used to tailor effective prevention and treatment strategies in the high-risk population of youth with a nonfatal drug overdose. To accomplish this goal, we will build on current work by the investigative team to study a critical developmental window from adolescence to young adulthood when the prevalence of illicit substance involvement in overdoes increases, risk factors may shift, and treatment options widen. We will capture a range of overdose types, including those that are nonfatal, near-fatal, and fatal; involvement of multiple illicit and commonly misused drugs as well as polydrug involvement; and events with suicidal intent in addition to unintentional overdose to improve understanding of the complex relationship of substance use and co-occurring mental illness. An extended study period from 2016-2025 will detect trends related to an evolving drug environment and changing levels of risk, and data linkages will integrate individual and clinically relevant predictors of overdose and death with health systems and other structural factors known to influence treatment delivery and health outcomes. We will focus on a sample of adolescents and young adults aged 12-29 years with initial drug overdoses treated in emergency department or inpatient settings. Specific aims are to: (1) assess trends in near-fatal and fatal overdose events from 2016-2025 by overdose type (drugs involved, intent) and age group (early/late adolescence, emerging/early adulthood); (2) identify behavioral health treatment trajectories in the six months after nonfatal overdose and differences by overdose type; and (3) quantify the one-year incidence of repeat overdose and all-cause mortality and develop a predictive model to ascertain modifiable risk factors contributing to these adverse outcomes. To achieve the aims, the study team will leverage national longitudinal Medicaid claims data (2016-2025) comprising an estimated 678,000 index overdose events in youth aged 12-29 years. Individual-level Medicaid data will further be linked with mortality, health system, and population data for a valid and timely approach to yield novel, generalizable, and up-to-date evidence on sentinel events and critical opportunities for intervention. Findings will fill a significant gap in research that is required to successfully target future overdose prevention and treatment strategies for adolescents and young adults.

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

The largest contributors to maternal postpartum mortality are mental health and cardiovascular conditions and women that give birth prematurely are at the highest risk. To prevent maternal deaths, the American Academy of Pediatrics and American College of Obstetricians and Gynecologists have clear recommendations focused on screening for depression and treatment if necessary, and monitoring and management of high blood pressure in the first weeks after birth. Of the ~100,000 mothers that give birth annually to preterm infants <34 weeks, more than 40,000 do not receive recommended postpartum care because they are engaged in the care of their sick newborns in the neonatal intensive care unit (NICU), typically far away from home and separate from their own obstetric clinicians’ offices for weeks to months. Evidence is mounting that engaging doulas, peers with lived experience that provide emotional and logistical support for mothers, is associated with improved perinatal health care the routine antepartum, intrapartum and postpartum domains, but there have been no investigations of doulas in the NICU. Our team conducted a 1:1 randomized control pilot randomized controlled trial (RCT) of doulas in Postpartum Care in the NICU (PeliCaN) in a single center and found significant improvement in postpartum care receipt by 12 weeks among intervention (doula care) compared to control. Building on our pilot work, we now propose a Type 1 hybrid effectiveness- implementation, stepped-wedge cluster RCT in 10 metro-Philadelphia NICUs to rigorously test the effectiveness of doulas in promoting receipt of evidenced-based postpartum care to improve mental health and postpartum blood pressure – outcomes strongly associated with postpartum morbidity and mortality. We will analyze individual-level effectiveness outcomes for 900 mother- infant dyads (450 intervention, 450 usual care). In Aim 1, we will examine primary effectiveness of PeliCaN during NICU stay, to improve maternal adherence to recommended postpartum health screenings for depression and high blood pressure (BP) (or adherence to BP management if directed by obstetric clinician for existing hypertension), as well as attendance at a postpartum visit with an obstetric clinician by 12 weeks. In Aim 2, we will examine secondary effectiveness of PeliCaN to improve health outcomes at 6 months by decreasing the proportion of mothers’ screening positive for depression symptoms and increasing the proportion of mothers with hypertensive disorders attending a primary care physician or cardiologist for blood pressure management. In Aim 3, we will examine implementation outcomes of feasibility, acceptability, and fidelity of this innovative doula-driven healthcare delivery model in the NICU.

NIMH - National Institute of Mental Health

PROJECT SUMMARY / ABSTRACT It has been hypothesized that some neurodevelopmental disabilities may have roots in early development. This early period is one in which our knowledge regarding brain functional organization is limited, while at the same time is also believed to be critical for identifying deviations from normal developmental trajectories. Therefore, a reliable and precise functional characterization of the human brain during the first year of life could be indispensable in the effort to identify individuals who are likely to show atypical developmental trajectories and would be candidates for early intervention, which is thought to be most effective during this early period where brain plasticity is high. To date, the quantitative neuroimaging data that has been generated during this early developmental period has been limited due to the many technical challenges in obtaining high quality data in this cohort. This has resulted in sub-optimal acquisition and post-processing strategies, which are not catered towards the infant brain, but rather simply adopted from adult studies. The FDA has recently approved 7T MRI for clinical use, however, thus far it has not been used in the U.S. for studying the infant brain due to the lack of vendor support and safety guidelines specific to infants. Our preliminary data demonstrate the potential for 7T MRI to advance developmental neuroimaging to levels that could allow researchers to uncover individual specific developmental trajectories, including atypical trajectories that manifest during these early months. With the proposed techniques we will achieve SNR levels that allow us to push the spatial resolution, while not sacrificing sensitivity, of functional images in the infant to voxel sizes that are 2-4 times smaller compared to conventional 3T approaches, which use spatial resolutions that are not proportional to the smaller infant brain. We will use these technological advances to follow developmental trajectories of infants within their first year of life, including infants with agenesis of the corpus callosum, a group at high risk for atypical developmental outcomes. Our unique team of inter-disciplinary investigators that have expertise in MRI safety, MRI protocol development and optimization, and in developmental research, are uniquely positioned to carry out the aims. Further, we will share our insights, including infant appropriate safety limits, with the growing community of 7T sites, to provide a template for safe and optimal scanning of infants at this high field.

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

Background: Early academic success and positive mental health are critical for all children, because they are linked to long-term outcomes such as high school graduation, lower criminal involvement, lower likelihood of teen pregnancy, and higher earnings. While community childcare centers play a vital role in supporting early childhood education and psychosocial development for young children, their teachers often lack access to evidence-based resources, including traditional Early Childhood Mental Health Consultation (ECMHC) models. To address this gap, we developed Jump Start on the Go (JS Go)—a hybrid ECMHC intervention that delivers an AI-enhanced mobile application with human consultation. Methods: JS Go is based on our successful R01- funded Jump Start ECMHC program. JS Go, developed in English and Spanish, was designed using a community-based participatory research approach to ensure the intervention is relevant and culturally appropriate for all populations it serves. In a pilot randomized controlled trial (N=114 across six centers, three Jump Start vs three JS Go), JS Go demonstrated high feasibility, usability, and acceptability. The trial showed similar improvements in teacher-child interactions, reduced problem behaviors, and increased child prosocial skills, for JS and JS Go. User feedback identified key areas for intervention adaptation that were iteratively incorporated. Building on this work, we propose a Type 1 hybrid effectiveness-implementation trial (N=480 children, across 24 childcare centers) to rigorously evaluate JS Go’s impact on children’s psychosocial functioning, while also enhancing teacher skills and childcare center capacity to sustain effective mental health support. Using a 3-arm cluster-randomized controlled design, guided by the RE-AIM framework, we will compare (1) JS Go (AI-enhanced digital ECMHC + human consultation), to (2) traditional JS (human consultation only), and (3) attention control (digital + human consultation obesity prevention curriculum). Our hypotheses are: (1) children in both JS Go and JS arms will show greater improvement in psychosocial outcomes than the control arm; and (2) there will be no significant difference between JS Go and JS arms. In Aim 1, we will examine JS Go’s impact on child psychosocial outcomes over 24 months. In Aim 2, we will evaluate how teacher skills mediate child outcomes, and how family characteristics moderate these mechanisms. In Aim 3, we will Identify center-level implementation factors that contribute to sustained improvements in child psychosocial functioning. Our mixed-methods design will explore implementation barriers and facilitators to promote scalability. Impact: This project fills a critical gap in preventive mental health tools for childcare centers by offering a scalable and accessible hybrid mobile health intervention. If effective, JS Go could reduce early childhood behavioral challenges and improve social-emotional outcomes for children during the most formative years of development. By strengthening the daily childcare center environment where children grow and learn, this approach has the potential to create lasting improvements in academic success and long-term mental health outcomes.