Clinical trials

This investigator-initiated, non-randomized pilot study evaluates the effect of daily consumption of fermented poi on the maternal microbiome and gestational diabetes risk during pregnancy. Fifty pregnant participants between approximately 12 and 24 weeks of gestation will receive one pound of poi daily for four weeks, accompanied by culturally tailored nutrition education delivered via secure text messaging. Changes in vaginal, oral, and rectal microbiome composition, diet quality, gestational diabetes diagnosis, and pregnancy-related outcomes will be assessed and compared with matched controls derived from an existing cohort. This study aims to inform the feasibility and design of a larger culturally grounded dietary intervention for gestational diabetes prevention.

The goal of this study is to examine if e-cigarette education messages delivered using a source and presentation tailored to one's vaping status influences young adults' vaping behaviors. The main questions it aims to answer are: 1. Does receiving e-cigarette education messages presented using a source (expert or peer) and sidedness (one or two-sided) optimized for the current vaper group influence vaping cessation among young adults who vape daily? 2. Does receiving e-cigarette education messages presented using a source (expert or peer) and sidedness (one or two-sided) optimized for the non-vaper group influence vaping initiation among young adults who are susceptible to vaping? Participants will be randomly assigned to either the treatment (receiving messages tailored to one's vaping status) or the control (receiving non-tobacco messages) condition and receive SMS three times per week over the course of 6 months. They will complete self-report assessment and show salivary cotinine results for nicotine testing at 4 timepoints.

The purpose of this research proposal is to develop and evaluate a culturally grounded, ENDS prevention intervention for rural Hawaiian youth. This will be accomplished through two specific aims. AIM 1 (Years 1-3) are focused on pre-intervention and intervention development. In Year 1, youth focus groups will be conducted to assess the environmental demands related to ENDS use in rural Hawai'i. In Year 2, specific ENDS-related problem situations (i.e., situations that increase risk for ENDS use) will be extracted from the Year 1 focus groups and prioritized through survey methods with 200-250 predominately Native Hawaiian youth across 16 different middle/intermediate schools on Hawai'i Island. In Year 3, five situations found to be the most frequently experienced and/or difficult to manage by youth surveyed in Year 2 will serve as the foundation for the development of narrative scripts. Three of these scripts will be cast and filmed on location on Hawai'i Island by a professional film director, and will be edited into three short films, 6-8 video clips, and 6-8 professional photos or production stills. Similar to the investigators' prior drug prevention research in rural Hawai'i, classroom-based lessons will be created to support the short films. Additional lessons and videos from an evidence-based, culturally grounded substance abuse prevention curriculum for Hawaiian youth (Ho'ouna Pono) will be used to create a modular classroom curriculum. The video clips and professional photography/production stills will be embedded with prevention messaging, and will be used for a social and print media campaign to reinforce the classroom curriculum. AIM 2 (Years 4-5) is to evaluate the ENDS prevention intervention (classroom curriculum plus social/print media campaign) across all middle/intermediate public or public-charter schools (N = 16) and up to 11 different cultural immersion charter schools on Hawai'i Island using a dynamic wait-listed control group design.

This is a prospective cohort study of 12 overweight (with one or more weight-related condition) or obese adults with well controlled HIV-1 on antiretroviral therapy (ART). An initial dose of tirzepatide (TZP) 2.5 mg subcutaneous (SQ) once weekly will be given, escalated by 2.5 mg at 4-week intervals to a final dose of 7.5mg. The investigators will collect the following information via review of the medical record: age, race/ethnicity, sex, medical conditions, medications, most recent standard of care HIV labs (including T-cell panel and HIV-1 viral load). The primary outcome will be the change in baseline body weight at 12 weeks. Secondary outcomes will be changes in body composition, liver fat content and liver stiffness, inflammatory markers, cardiometabolic markers (lipids and HbA1c), and monocytes at 12 weeks. There will be a 4-week safety follow up off TZP.

This multi-site randomized controlled trial uses a community-based approach to evaluate a Food as Medicine program for Native Hawaiian and Pacific Islander (NHPI) adults in Hawaii who have high blood pressure and difficulty affording healthy food. The study has two main goals: (1) to implement a produce prescription program and see if adding personal support from Community Health Workers (CHW) improves blood pressure among other health outcomes, and (2) to determine the program's cost-effectiveness. The study will take place across three Federally Qualified Health Centers in Hawaii. Produce prescription program participants at each site will receive $100 per month, either in the form of produce boxes or monthly vouchers to purchase fruits and vegetables, for 12 months (totaling $1200). In past studies, personal challenges (e.g., lack of transportation, lack of cooking skills) have made it difficult for participants to use the vouchers and/or the purchased produce. In other food as medicine interventions, participants have similarly faced various personal, social, and environmental barriers that limit the program's efficacy. To help participants navigate through these challenges, the investigators want to test adding 1-on-1 support from a CHW throughout the program. Other studies have found that health interventions delivered by CHWs have been effective in reducing blood pressure, blood glucose and weight, especially among vulnerable populations, such as NHPIs and those with food insecurity. The CHWs in this study will receive a training using a curriculum tailored specifically to their community and that is in alignment with the Pilinahā: The Four Connections Framework, which focuses on key connections that Indigenous people seek to attain health and can be employed to overcome health disparities. To test the effectiveness of the added CHW support, there will be two groups of participants: Group 1 (Intervention) will receive the monthly produce prescription ($100 vouchers or produce box) plus meet with a CHW every two months for support with program challenges. Group 2 (Control) will receive the same monthly produce prescription, but will not have meetings with a CHW. The investigators want to see if the added support from CHWs leads to better blood pressure results, among other health outcomes. Upon providing informed consent and enrolling into the program, produce prescription program participants will: * Attend 5 study visits over the one year program. These happen at the start, and then at 3, 6, 9, and 12 months. * Complete health checks at the first visit. This includes getting a home blood pressure monitor and learning about heart health and nutrition. Staff will measure height, weight, waist size, and blood pressure. * Answer surveys about their demographic background, health habits, diet, and culture. * Receive $100 in vouchers every month for 12 months to redeem for fruits and vegetables at a local retailer. * Group 1 will additionally meet with a CHW every two months for 1-on-1 support with any challenges related to the program. * Group 2 will receive monthly reminders to use their vouchers but no CHW meetings. After the program ends, researchers will analyze the financial value of the intervention. This involves calculating the total cost to run the program (including vouchers, CHW training and salaries, and administrative costs) and comparing it to potential savings in healthcare costs. By looking at improvements in blood pressure, researchers can estimate how many heart-related health problems were prevented and how much money was saved on medical care.

Hepatocellular carcinoma (HCC) is a major cause of cancer-related deaths globally, with Native Hawaiian and Pacific Islander (NHPI) populations experiencing significantly higher mortality rates compared to other groups in Hawaii. This disparity is influenced by factors such as higher prevalence of chronic hepatitis B, non-alcoholic fatty liver disease, limited access to early detection, and delayed diagnoses. NHPI patients are also underrepresented in clinical trials, limiting the relevance of treatment advances for this population. The standard treatment for HCC is surgical resection; however, many NHPI patients present with unresectable disease. Recent advances with immune checkpoint inhibitors (ICIs), such as nivolumab and ipilimumab, have shown promise in treating advanced HCC and improving survival in previously untreatable cases. Additionally, stereotactic body radiotherapy (SBRT) has been shown to enhance survival and local control when combined with systemic therapies like ICIs. However, without surgery, outcomes remain suboptimal, with response rates for ICIs alone at 20-30%, and combination ICI-SBRT treatment showing slightly better results but still a high risk of progression. Despite improvements in HCC treatment, significant gaps remain in managing borderline resectable disease, especially in NHPI patients. This study aims to evaluate the safety and efficacy of combining ICIs and SBRT with curative surgery for patients with borderline resectable HCC, focusing on NHPI populations. The study will also explore the use of biomarkers such as cell-free DNA (cfDNA), CD8+ T-cell infiltration, and serum cytokine markers to guide personalized treatment strategies. Preliminary findings suggest that this multimodal approach may improve outcomes and enable surgical resection for patients previously considered inoperable. This study seeks to address the unmet need for effective treatment strategies in borderline resectable HCC and to improve survival outcomes for underserved NHPI populations.

This study aims to help Native Hawaiian adults quit smoking by testing two common methods: nicotine gum and group-based counseling. Participants will be assigned to one of three groups: (1) nicotine gum only, (2) group counseling only, or (3) a combination of both. The study will take place at public housing sites on O'ahu. Researchers will check if these approaches-alone or in combination-can support people in successfully quitting smoking. The goal is to find out which method works best and is most acceptable in this community.

The Ku Ola Project: The goal of this study is to determine if community-based discussion groups and small educational sessions enhance health awareness and behaviors among Native Hawaiian men. The study will examine if these interventions improve participants' health knowledge, attitudes, and self-efficacy while fostering local networks to support ongoing health promotion. Participants will engage in group discussions and educational sessions designed to build capacity and encourage healthy lifestyle choices.

The overall goal of the project is to pilot test CTNow, a multilevel intervention designed to facilitate access and referrals to cancer clinical trials in rural areas through patient and provider education and teleconference resources.

Native Hawaiians' traditional lifestyles and diets ensured the mutual health and well-being of the land and its inhabitants, which stand in stark contrast to the disproportionately high prevalence of diet-related, cardiometabolic diseases they experience today. In this project, the investigators will adapt and test an evidence-based multilevel intervention entitled PILI 'Āina to improve the self-management of prevalent cardiometabolic diseases and reduce risk factors for developing new diet-related illnesses and implement and evaluate the impact and sustainability of community-wide cooking demonstrations. The objectives of this project are to optimize the effectiveness and sustainability of PILI 'Āina, improve diet quality, cardiometabolic markers, promote traditional Native Hawaiian diets, and improve social cohesion.

Native Hawaiians' traditional lifestyles and diets ensured the mutual health and well-being of the land and its inhabitants, which stand in stark contrast to the disproportionately high prevalence of diet-related, cardiometabolic diseases they experience today. In this project, the investigators will adapt and test an evidence-based multilevel intervention entitled PILI 'Āina to improve the self-management of prevalent cardiometabolic diseases and reduce risk factors for developing new diet-related illnesses and implement and evaluate the impact and sustainability of community-wide cooking demonstrations. The objectives of this project are to optimize the effectiveness and sustainability of PILI 'Āina, improve diet quality, cardiometabolic markers, promote traditional Native Hawaiian diets, and improve social cohesion.

Objectives: This study aims to test whether a mobile app called PortionSize Ed can help adults who have had a recent stroke and also have prediabetes or type 2 diabetes improve their diet. Specifically, we want to see if the app can help people follow a Mediterranean-style diet, which may lower the risk of future strokes and improve overall health. The main goals are to: * Test if the app is easy to use and acceptable to participants. * See whether the app helps people follow a healthier diet. * Look at changes in health indicators like blood sugar, cholesterol, blood pressure, and body fat. Design and Outcome: This is a randomized controlled pilot study that will involve 40 participants. All participants will be recruited from Queen's Medical Center after a recent stroke and will be randomly assigned to one of two groups: Intervention Group: Uses the full PortionSize Ed app, gets weekly reminders and educational videos, and has 3 sessions with a registered dietitian (RDN) over 12 weeks. Control Group: Uses a basic version of the app without feedback or RDN support, and receives usual care for stroke recovery. All participants will continue to receive standard care from Queen's, including the My Stroke Recovery Guide. The study lasts 12 weeks, with visits at the beginning and end to collect health data and feedback on the app. Schedule and Type of Evaluations/Interventions: Participants will complete the following: Baseline and Week 12 Visits: In-person assessments for blood sugar (HbA1c), cholesterol, blood pressure, height, weight, and body composition (using DXA, BIA, and 3D imaging), as well as surveys about their diet and activity levels. Intervention Group Only: * Three virtual counseling sessions with a registered dietitian (Week 1, 6, 12) * Weekly nutrition goal tracking and texting with the dietitian * Watching short educational videos through the app * Receiving app-based feedback on how well their diet follows Mediterranean Diet recommendations Duration of Study: The study will last 12 weeks for each participant, with an optional long-term follow-up using medical records. Sample Size and Population: The study will include 40 adults, ages 30 to 65, who: * Recently experienced a stroke * Have a history of prediabetes or type 2 diabetes * Are medically stable and able to use a smartphone (or willing to use a study-provided iPhone) * People will be excluded if they have severe swallowing issues, cognitive problems, or dietary needs that would make it hard to follow a Mediterranean-style diet.

This study is guided by Maslach's Burnout Theory and with Normalization Process Theory supporting the implementation of the GAINS intervention by facilitating its integration into routine system-level practice. In Year 1, the investigative team will collaborate with hospital-based nursing leadership and key stakeholders to identify staffing-specific factors essential for operationalizing the GAINS AI model/intervention. In Year 1, the investigators will also conduct a survey amongst nursing staff to measure baseline burnout. In Year 2, the AI-staffing intervention will be implemented with the medical-surgical nursing float pool team. In Year 3, the investigators will first repeat the nurse burnout survey and second, expand the intervention to include the nursing assistant float pool team. In Year 4, the investigators will conduct the final burnout survey with nurses, assess feasibility of GAINS (target vs. actual staffing- nurses and nursing assistants), and assess preliminary efficacy of GAINS to reduce costs related to staffing. the investigators will compare outcomes at three time points (pre, mid, and post-intervention). Interviews with nurses, nursing assistants, unit nurse managers, and leadership will further explicate the intervention's acceptability, feasibility, and impact on burnout.

Native Hawaiians (NH) are 9.5 times more likely to be on dialysis or need a kidney transplant compared to Whites. They have the highest end-stage kidney disease (ESKD) incidence rates in the nation, begin dialysis at younger ages (30-50 years), and one of the most under-studied racial/ethnic groups in chronic kidney disease (CKD) research. This project's outcome is to improve kidney disease follow-up among early stage NHs at high risk by aligning health equity with a culturally appropriate care coordination systems model.

Native Hawaiians' traditional lifestyles and diets ensured the mutual health and well-being of the land and its inhabitants, which stand in stark contrast to the disproportionately high prevalence of diet-related, cardiometabolic diseases they experience today. In this project, the investigators will adapt and test an evidence-based multilevel intervention entitled PILI 'Āina to improve the self-management of prevalent cardiometabolic diseases and reduce risk factors for developing new diet-related illnesses and implement and evaluate the impact and sustainability of community-wide cooking demonstrations. The objectives of this project are to optimize the effectiveness and sustainability of PILI 'Āina, improve diet quality, cardiometabolic markers, promote traditional Native Hawaiian diets, and improve social cohesion.

This study will conduct a group randomized trial to test the effects of a hula-based intervention in improving vascular risk factors for ADRD and cognitive complaints and function over 12 months.

The objective is to better identify suspicious breast lesions that need to be biopsied for malignancy in women currently recommended for biopsy. The long-term goal is to reduce unnecessary biopsies and increase biopsy yield. To do this, the investigators have developed an innovative way to use FDA-approved breast imaging protocols to acquire multispectral images to measure the composition of suspicious breast lesions. The central hypothesis is that breast tissue composition in combination with analysis of morphological and textural tissue characteristics on digital breast tomosynthesis (DBT) imaging will yield significantly higher breast cancer specificity than conventional interpretation of DBT alone.