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PHARMA-GIRL: Empowering adolescent girls and young women with choice and prevention in pharmacy-based HIV interventions

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

ABSTRACT Sub-Saharan Africa's (SSA) 400 million adolescent girls and young women (AGYW, age 15-24) face disproportionate rates of HIV acquisition and suboptimal HIV care engagement. Despite the widespread availability of oral PrEP at public health facilities, uptake is impeded by low awareness, socio-cultural and access barriers, provider bias, and user dissatisfaction. Moreover, among PrEP-aware AGYW, uptake and continuation of PrEP is low due to side effects, fear of being seen with medicines, and low adherence support, undermining PrEP's preventative effects and leaving AGYW in need of critical HIV prevention. Our team and others have demonstrated that AGYW are interested in PrEP, especially newer modalities such as injectables, and that they prefer to seek HIV care at locations that foster privacy, are convenient, and are girl-friendly. Given the growing recognition that pharmacies, staffed by health workers who can be trained to provide expanded services, outnumber health facilities, can promote beneficial health behaviors, bridge gaps in health services, and mitigate health workforce shortages, we aim to expand this body of research to conduct an implementation science study on potential implementation models of pharmacy-based PrEP provision and adherence support for AGYW. In Uganda, the Community Retail Private Pharmacy Drug Distribution Point (CRPDDP) already provides pharmacy-based anti-retroviral therapy (ART) to over 48,000 clients across 160+ pharmacies (and increasing). Given the Uganda Ministry of Health's interest to expand this pharmacy-based differentiated service delivery model for increased reach and extended prevention offerings, we propose a mixed-methods study to garner foundational evidence to evaluate how this cadre of pharmacies already providing ART refills to PLHIV can include PrEP services generally and specifically tailored to AGYW. We hypothesize that these pharmacies can be well-equipped to reach AGYW with PrEP, given the critical role they already play in the community providing expanded care. As such, we propose to conduct formative research among CRPDDP pharmacies and their AGYW clients to advance implementation of pharmacy-based PrEP and adherence support. Guided by participatory processes of human-centered design, including in-depth interviews with AGYW who are potential PrEP users, pharmacists, and focus groups with pharmacy and youth advisory boards and MOH stakeholders, we will conduct formative research to understand barriers, facilitators, and desires for pharmacy-based PrEP to inform a discrete choice experiment (DCE) (Aim 1). We will then evaluate a series of implementation science outcomes—willingness, acceptability, feasibility, and readiness—among CRPDDP pharmacists (n=~160) (Aim 2), and conduct parallel DCE surveys among CRPDDP pharmacists and their AGYW clients (n=300) to evaluate preferences for pharmacy-based PrEP implementation models (Aim 3). By the end of the study, we will understand how a potentially ready platform of pharmacies can be expanded to provide PrEP care to a key population, and will have identified potential implementation gaps from user, provider, and policy perspectives .

Up to $151K
2028-01-31
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

Photochemical Tissue Passivation (PTP) to Reduce Temporomandibular Joint (TMJ) Osteoarthritis (OA)

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NIDCR - National Institute of Dental and Craniofacial Research

PROJECT SUMMARY/ABSTRACT Temporomandibular joint (TMJ) osteoarthritis (OA) is characterized by chronic inflammation, resulting in cartilage degradation and subchondral bone erosion, leading to jaw pain and a compromised quality of life. With no effective treatment currently available, there is a pressing need for new clinical approaches to the problem. Our innovative approach, which could potentially prevent the progression of TMJ-OA to more advanced stages, has the potential to reduce the need for complex and costly surgical procedures. Photocrosslinking tissue proteins (i.e., collagen) is a straightforward and clinically advantageous procedure. It involves applying an aqueous Rose Bengal (RB) solution to the tissue and exposure to green light. Protein crosslinking has been investigated for wound closure, anastomosis, nerve repair, and enhanced wound healing in many tissues. It has also been shown to reduce inflammatory responses in treated tissues, hence the term photochemical tissue passivation (PTP). Published data from our group shows that the network formed by extracellular protein crosslinking prevents inflammatory markers from infiltrating the treatment site. We also showed in rodent knee and shoulder models of fibrosis and post-traumatic arthritis that PTP reduces inflammation in the joint capsule. PTP was initially applied in other tissues by Dr. Redmond’s group. Only after collaborations with Dr. Guastaldi the leap was made to TMJ and this proposal. Dr. Redmond is a pioneer of photocrosslinking therapeutics, and Dr. Guastaldi has extensive experience with animal models, TMJ disease, and regeneration. We believe this innovative approach is only possible due to this partnership's unique combination of expertise. In addition, utilizing state-of-the-art optical diagnostic imaging techniques via Dr. Redmond’s and Dr. Guastaldi’s collaborators at the Wellman Center for Photomedicine (MGH) is another powerful and innovative step in assessing TMJ disease progression and therapeutic efficacy. Polarization- sensitive optical coherence tomography (PS-OCT) is an optical technique that has recently demonstrated the ability to measure cartilage fiber structure and orientation. Dr. Vakoc is a leader in the field of PS-OCT, and his lab is well-equipped to conduct rapid volumetric PS-OCT imaging. We propose to apply to the TMJ for the first time. The overall goal is to explore the potential of PTP to reduce inflammation and prevent the progression of TMJ-OA. A well-established rat model of TMJ-OA will be used to achieve this goal. We hypothesize that PTP of the TMJ capsule offers a promising, minimally invasive approach to halting TMJ-OA progression by reducing inflammation within the TMJ. The following specific aims will address the hypothesis: SA1) To assess the effect of PTP on the whole TMJ structure. PS-OCT imaging, micro-CT, histology, and pain assessment will assess the impact of PTP on the whole TMJ structure. SA2) To assess the efficacy of PTP to reduce TMJ-OA-related inflammation. Whole TMJ specimens tissues will undergo quantitative (Q-PCR) and qualitative (IHC staining) assessment for the presence of inflammatory markers.

Up to $409K
2028-02-14
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

Portable Echo for Aging Hearts: Assessing Cardiac Health in Older Adults with HIV

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NHLBI - National Heart Lung and Blood Institute

Abstract In Tanzania, over 1.5 million people are living with HIV (PLH). With improvements in access to effective ART, the number of PLH surviving into older age has increased substantially. Currently, 30% of PLH in Tanzania are aged 50 years and older, with this population expected to increase by 25% by 2040. Ageing PLH face a significant burden of cardiovascular disease (CVD) due to a combination of traditional risk factors, HIV associated inflammation, and immune dysfunction. Heart failure is one of the leading causes of cardiac disease in adults in Tanzania, with hypertension accounting for about half of all cases. Cardiac echocardiography is a valuable, non-invasive tool for detecting structural and functional abnormalities associated with heart failure, including left ventricular dysfunction, valvular disease, and diastolic impairment. However, access is limited in resource constrained settings like Tanzania and as a result diagnoses are often made very late. Point-of-care cardiac ultrasound (POCUS) offers a potentially scalable solution for cardiovascular screening in ageing PLH in HIV clinics and early detection of cardiac abnormalities that could lead to heart failure. This R21 exploratory/developmental grant proposes to assess the clinical utility, feasibility and impact of implementing AI-POCUS for early detection of cardiac dysfunction in aging PLH in Tanzania. 400 PLH equal to or greater than 50 years enrolled in the Tanzania HIV ageing longitudinal cohort study (THALCS), a multisite observational cohort study of ageing outcomes and quality of life, will undergo a focused AI-POCUS assessment using the Butterfly iQ3™ portable AI-driven ultrasound system, performed by trained non-specialist providers (HCP) at THALCS study sites. Specifically, we will (1) evaluate the utility of POCUS for identifying key markers of cardiac dysfunction (e.g., left ventricular hypertrophy, systolic/diastolic dysfunction, pericardial effusion) and need for cardiology referral; and (2) assess the feasibility and acceptability of AI-POCUS among healthcare providers and participants and the clinical impact of AI-POCUS on short term (12 month) participant outcomes. The proposed work also has direct relevance to the United States, where more than half of PLH in care are now aged 50 years and older and experience disproportionately high rates of hypertension, heart failure, and other cardiovascular complications. Findings from this study may inform scalable, task-shifted approaches for integrating AI-assisted cardiac screening into HIV primary care settings in the US, including federally qualified health centers and rural clinics with limited access to cardiology and echocardiography services. This project will generate critical pilot data to inform scalable strategies for CVD screening in aging PLWH and lay the groundwork for future trials of POCUS-guided interventions. Ultimately, it seeks to reduce cardiovascular morbidity and improve quality of life in a vulnerable and growing population.

Up to $79K
2028-06-30
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

Portable Echo for Aging Hearts: Assessing Cardiac Health in Older Adults with HIV

open

NHLBI - National Heart Lung and Blood Institute

Abstract In Tanzania, over 1.5 million people are living with HIV (PLH). With improvements in access to effective ART, the number of PLH surviving into older age has increased substantially. Currently, 30% of PLH in Tanzania are aged 50 years and older, with this population expected to increase by 25% by 2040. Ageing PLH face a significant burden of cardiovascular disease (CVD) due to a combination of traditional risk factors, HIV associated inflammation, and immune dysfunction. Heart failure is one of the leading causes of cardiac disease in adults in Tanzania, with hypertension accounting for about half of all cases. Cardiac echocardiography is a valuable, non-invasive tool for detecting structural and functional abnormalities associated with heart failure, including left ventricular dysfunction, valvular disease, and diastolic impairment. However, access is limited in resource constrained settings like Tanzania and as a result diagnoses are often made very late. Point-of-care cardiac ultrasound (POCUS) offers a potentially scalable solution for cardiovascular screening in ageing PLH in HIV clinics and early detection of cardiac abnormalities that could lead to heart failure. This R21 exploratory/developmental grant proposes to assess the clinical utility, feasibility and impact of implementing AI-POCUS for early detection of cardiac dysfunction in aging PLH in Tanzania. 400 PLH equal to or greater than 50 years enrolled in the Tanzania HIV ageing longitudinal cohort study (THALCS), a multisite observational cohort study of ageing outcomes and quality of life, will undergo a focused AI-POCUS assessment using the Butterfly iQ3™ portable AI-driven ultrasound system, performed by trained non-specialist providers (HCP) at THALCS study sites. Specifically, we will (1) evaluate the utility of POCUS for identifying key markers of cardiac dysfunction (e.g., left ventricular hypertrophy, systolic/diastolic dysfunction, pericardial effusion) and need for cardiology referral; and (2) assess the feasibility and acceptability of AI-POCUS among healthcare providers and participants and the clinical impact of AI-POCUS on short term (12 month) participant outcomes. The proposed work also has direct relevance to the United States, where more than half of PLH in care are now aged 50 years and older and experience disproportionately high rates of hypertension, heart failure, and other cardiovascular complications. Findings from this study may inform scalable, task-shifted approaches for integrating AI-assisted cardiac screening into HIV primary care settings in the US, including federally qualified health centers and rural clinics with limited access to cardiology and echocardiography services. This project will generate critical pilot data to inform scalable strategies for CVD screening in aging PLWH and lay the groundwork for future trials of POCUS-guided interventions. Ultimately, it seeks to reduce cardiovascular morbidity and improve quality of life in a vulnerable and growing population.

Up to $122K
2028-06-30
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

Portland Oral Health Research Training (PORT) T32

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NIDCR - National Institute of Dental and Craniofacial Research

PROJECT SUMMARY The Portland Oral Health Research Training (PORT) Program at the Oregon Health & Science University (OHSU) School of Dentistry develops the next generation of oral health researchers. PORT leverages OHSU’s strong record of mentoring and training, rigorous scientific research, and newly renovated state-of-the-art laboratory and education facilities. The program builds on the School’s strengths in microbial sciences, biomaterials/tissue engineering, regenerative medicine, and clinical and translational research, supported by major NIH funding, including two R35 awards to mid-career faculty. PORT is closely integrated with OHSU’s campus-wide research ecosystem, which includes multiple NIH training programs and partnerships with Portland State University and Oregon State University, providing access to a robust pool of research-experienced students. PORT is facilitated by an institutionally supported prematriculation summer research program for incoming D.M.D. students that creates an early research exposure and provides continuity into advanced predoctoral and postdoctoral T32 training after matriculation/eligibility. The program’s four complementary tracks include: (I) D.M.D. summer research with post-matriculation continuation; (II) D.M.D./Ph.D.; (III) Ph.D. predoctoral training; and (IV) postdoctoral training, including a sub-track with a Master of Science in Clinical & Translational Research. We are requesting five (5) slots for Track I each summer; one (1) slot in Year 1 and two (2) slots in Years 2-5 for the Track II DMD/PhD training program; three (3) slots for the Track III predoctoral training, and four (4) slots for Track IV postdoctoral training. We anticipate that trainees will participate in Track I for eight (8) weeks, Track II for up to five (5) years, or Tracks III or IV for approximately 2-3 years. The goal is that each trainee in Tracks II-IV will apply for and receive individual funding toward the end of their tenure. Training experience emphasizes rigorous scientific reasoning and reproducibility, Responsible Conduct of Research, quantitative and computational methods, and effective scientific communication. Structured activities include seminars, workshops in grant writing, leadership, team science, and presentation skills, and formal mentor training for faculty. Trainees engage in institutional scholarly events such as the Dean’s Seminar Series and OHSU Research Week, develop Individual Development Plans with near-peer and alumni mentoring, and may pursue short, mentored externships to explore research careers across academia, industry, and government/regulatory enterprise. Program evaluation tracks skills acquisition, research outputs, time to degree or next stage, and career destinations, with aggregate training and career outcomes publicly posted on an OHSU webpage. By providing a rigorous, interdisciplinary, and professionally structured training environment, PORT will accelerate the transition of motivated dental, dual-degree, predoctoral, and postdoctoral trainees into productive research and related careers and advance the NIH mission to improve health through discovery.

Up to $577K
2031-06-30
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

Predictors of Airway Dysanapsis in Early Life (PADEL)

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NHLBI - National Heart Lung and Blood Institute

PROJECT SUMMARY/ABSTRACT Chronic obstructive pulmonary disease (COPD) accounts for 6% of all deaths worldwide and is potentially preventable, with well-described but poorly elucidated childhood origins. Improved understanding of early life origins of COPD could lead to interventions to substantially reduce morbidity and mortality from COPD, particularly in high-risk populations. Dysanapsis refers to a mismatch between airway tree caliber and lung volume that arises early in life. Our research team recently identified that dysanapsis is: 1) prevalent among older adults, 2) is a major predictor of COPD risk – exceeding tobacco smoke and other established risk factors, and 3) is not fully explained by genetics. We also know that there are heterogenous structural presentations of dysanapsis. However, the early life origins of dysanapsis are poorly understood. This R01 study will leverage 8 longitudinal birth cohorts of children to examine the relationship between early- life exposures and events and both structural (imaging-confirmed) and functional (spirometry-assessed) dysanapsis throughout childhood and adolescence to identify modifiable risk factors and help reduce risk of COPD in future generations at risk. Building on our preliminary data showing that magnetic resonance imaging (MRI) is as accurate as computed tomography (CT) at identifying dysanapsis, we will integrate state-of-the-art lung MRI data with extensive early-life exposure and lung function data. Aim 1 will establish relationships between early life dysanapsis and childhood lung function trajectories, and their relationship to structural dysanapsis at late adolescence. Aim 2 will determine if individual-level factors, specifically obesity and viral infections, contribute to functional dysanapsis (spirometry-assessed) and distinct structural subtypes of dysanapsis (imaging-confirmed). Aim 3 will examine community-level factors and associations with functional dysanapsis (spirometry-assessed). This study aligns with NHLBI’s strategic objective to investigate factors accounting for health differences among populations. We will establish the early-life risk factors that contribute to airway-to-lung phenotypes and enhance our understanding of the utility of both imaging- and spirometry-based measures of dysanapsis. Moreover, our findings will inform targeted interventions in high-risk groups of children to reduce their subsequent risk of COPD.

Up to $868K
2031-02-28
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

Prenatal Exposure to Lithium and Autism Spectrum Disorder

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NIEHS - National Institute of Environmental Health Sciences

Project Summary/Abstract: Autism spectrum disorder (ASD) is a growing public health concern, with rising prevalence and substantial economic and societal costs. Epidemiologic evidence links abnormal maternal thyroid function during pregnancy to increased risk of child ASD and other neurodevelopmental disorders. Lithium, widely used as a psychiatric medication for bipolar disorder and depression due to its mood-stabilizing effects, also presents concerns as an environmental exposure during pregnancy. Lithium inhibits thyroidal iodine uptake, is concentrated in the thyroid, and has known neurotoxic effects. Additionally, more than 56% of U.S. groundwater samples exceed the EPA’s health advisory level for lithium, and conventional water treatment processes do not remove it. Findings from prior case-control studies on the relationship between prenatal lithium exposure and ASD risk are limited by retrospective exposure assessment, emphasizing the need for direct measures of lithium exposure during pregnancy. Our central hypothesis is that higher prenatal lithium exposure increases the risk of maternal thyroid dysfunction, which in turn elevates the risk of child ASD. To our knowledge, no prior study has explored a pathway linking prenatal lithium exposure to ASD through thyroid dysfunction as a potential mechanism. To test our hypothesis, we plan to take advantage of two established ASD studies: (1) MARBLES (Markers of Autism Risk in Babies – Learning Early Signs), a prospective cohort of over 550 pregnant women who have a child with ASD and CHARGE (CHildhood Autism Risk from Genetics and Environment), a population-based, case-control study with over 2000 children and families enrolled. In this project, after selecting MARBLES pregnant women who provided urine samples during pregnancy and subsequently delivered a child with a final diagnosis, we will analyze their urine samples for lithium. Then, we will examine whether prenatal exposure to lithium is associated with child ASD. We will also examine the impact of prenatal lithium exposure on thyroid dysfunction. For CHARGE, we will reconstruct prenatal residential lithium exposure for 500 cases and 500 controls by integrating lithium levels of national databases with geocoded residential histories and drinking water source data, applying the same hypothesis tests as MARBLES. To explore the broader impact of exposure mixtures, we will apply state-of-the-art modeling strategies, and mediation analyses will be conducted to evaluate thyroid dysfunction as a potential mediator in the pathway from lithium exposure to ASD. This study is expected to (1) provide robust evidence of a causal pathway linking prenatal lithium exposure, thyroid dysfunction, and ASD etiology; (2) identify critical windows of exposure to lithium that contribute to thyroid dysfunction and/or ASD; and (3) elucidate the impact of exposure mixtures on thyroid dysfunction and ASD risk. By focusing on modifiable environmental factors, this research will inform intervention and prevention strategies to reduce lithium exposure and mitigate ASD risk, offering actionable insights for public health.

Up to $467K
2028-05-13
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

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