Kristen J. Wells, Ph.D. - US grants

DESCRIPTION (provided by applicant): Despite life-saving benefits of anti-hormonal medications, surveillance mammography, and physical exams, many breast cancer survivors do not adhere to these recommendations and experience decreased physical quality of life due to the adverse effects of cancer and its treatment. Research also indicates that some racial and ethnic minority women and women of low socioeconomic status (hereafter described as underserved), are less likely to get optimal health care following treatment for breast cancer than Caucasian women and women of higher socioeconomic status. Patient navigation, a barrier-focused intervention designed to reduce health care disparities, has demonstrated some degree of efficacy in improving adherence to breast cancer screening and diagnostic services. No known research has focused on development and evaluation of patient navigation interventions during the cancer survivorship period. Therefore, the objectives of the proposed project are to develop and pilot test a culturally relevant patient navigation program focused on underserved breast cancer survivors prescribed anti-hormonal medications. It is expected that a nurse patient navigation intervention can improve access and adherence to breast cancer survivorship care and quality of life in underserved hormone receptor positive breast cancer survivors who have completed surgery, chemotherapy, and radiation. The proposed project will be conducted in two phases. In Phase I, a patient navigation intervention will be developed using the structure of two existing patient navigation programs combined with information obtained from qualitative data collected through in-depth interviews. In Phase II, the patient navigation intervention will be pilot-tested to evaluate its feasibility and potential in improving adherence to survivorship care recommendations and quality of life for underserved breast cancer survivors by comparing it to receipt of usual medical care plus the National Cancer Institute's booklet entitled Facing Forward: Life After Cancer Treatment. Hormone receptor positive breast cancer survivors randomized to patient navigation will receive the services of a patient navigator for 8 months. Adherence and quality of life outcomes will be evaluated at 4 and 8 month follow ups. The specific aims of the study are to (1) evaluate underserved breast cancer survivors' facilitating factors (resources) and barriers related to obtaining survivorship care; and (2) develop a patient navigation intervention, infused with the results of qualitative research, designed to improve adherence to survivorship care and quality of life in underserved hormone receptor positive breast cancer survivors; and (3) conduct a pilot test of the patient navigation intervention by evaluating its effect on adherence to survivorship care and quality of life in underserved hormone receptor positive breast cancer survivors. The implementation of the proposed project is consistent with the long-term objective of this line of research: to develop, evaluate, and disseminate culturally, literacy, and linguistically relevant interventions to improve quality of life and adherence to recommended health care in underserved breast cancer survivors. PUBLIC HEALTH RELEVANCE: Research has shown that adherence to life saving recommendations for breast cancer survivorship, including anti-hormonal medications, surveillance mammography, and physical exams, is low among some breast cancer survivors. The proposed study is the first to develop and pilot test a patient navigator program that focuses specifically on underserved breast cancer survivors who are prescribed anti-hormonal medicines. An intervention that increases adherence to recommendations for breast cancer survivorship care meets national priorities for providing quality care to cancer survivors and has the potential to reduce breast cancer mortality.

DESCRIPTION (provided by applicant): Latinas experience higher cervical cancer (CC) incidence and mortality when compared to the general population in the United States. Many Latinas lack access to health care and experience literacy, communication, and knowledge barriers that prevent them from obtaining CC screening. Patient navigator (PN) and other similar interventions have been implemented to increase CC screening rates; however, few have focused directly on the needs of Latinas. Interactive technological interventions, like embodied conversational agents (ECA), are currently used in other populations, settings, and for other health topics, but no known initiative has used culturally and literacy appropriate technology to deliver Spanish-language CC education as part of a PN intervention. This study aims to create and conduct a preliminary evaluation of a Spanish-language Virtual Patient Educator (VPE) multimedia application to augment a PN intervention for increasing CC screening rates among Latinas in a rural agricultural community. Using the Social Cognitive Theory, the proposed project will be conducted in 2 phases. In Phase 1, the research team will engage community members to develop a low literacy Spanish-language interactive multimedia application consisting of an ECA. Using theoretical principles and drawing from our formative research, the project team will design the VPE through systematic and technical processes. Ongoing feedback (usability testing) from members of the intended audience will be carried out to ensure that patients (users) can perform intended system tasks efficiently, effectively, and satisfactoril. Once usability testing is complete, a series of learner verification interviews will be conducted t assess initial suitability of the VPE. Since the VPE will be the first known Spanish-language ECA used to augment a PN intervention, it is important to see whether patients accept the VPE and whether it is feasible to conduct a study of patient navigation augmented by the VPE. In Phase 2, a preliminary evaluation of 2 methods of patient navigation delivery (with and without VPE) will be conducted with 60 participants who are not up to date with recommended CC screening according to American College of Gynecologists and Obstetricians' guidelines. Cluster randomization will be used to randomize patients to 1 of 2 PN intervention conditions: (1) PN; or (2) PN plus VPE (PN+VPE) using date of clinic as unit of randomization. The preliminary evaluation will examine the feasibility of recruitment, randomization, data collection, and acceptability of VPE application. Exploratory data will also be collected regarding the potential impact of PN+VPE on behavioral capacity and self-efficacy for obtaining CC screening, Pap test adherence, and satisfaction with care. The proposed project will advance our research towards the development of interactive technology interventions to disseminate health education to disparate populations.

PROJECT SUMMARY Men who have sex with men (MSM) are the most at-risk group for contracting human immunodeficiency virus (HIV) in the U.S., comprising 67% of new HIV diagnoses in 2014. However, the HIV epidemic impacts some groups of MSM disproportionately. Latino MSM comprise 25.1% of new HIV infections among MSM between the ages of 13 and 29 years. The daily medication tenofovir/emtricitabine was approved by the Food and Drug Administration for pre-exposure prophylaxis (PrEP) in 2012 and has demonstrated strong efficacy in reducing the risk of HIV infection. When taken consistently, PrEP has been shown to reduce new incidence of HIV by 92%. Despite the promise of PrEP to transform HIV prevention, there remain significant barriers to PrEP use among those who would benefit the most, resulting in low rates of uptake. Although Latino MSM have reported the lowest use of PrEP (6.6%), they also reported the greatest willingness to use PrEP compared to White and Black MSM. There have been no known interventions that have been designed to assist Latino MSM with accessing PrEP-related health care or adhering to PrEP. Patient navigation may be an ideal intervention to aid in PrEP uptake among Latino MSM by assisting individuals in overcoming barriers to obtaining and using PrEP. To our knowledge, no known patient navigation programs for PrEP have been developed for Latino MSM. The objectives of this proposed study are to develop, pretest, produce, and pilot test a patient navigation intervention designed to address multiple components of the PrEP cascade among Latino MSM between the age of 18 and 29. During Phase 1, qualitative data will be collected through 30 in-depth interviews to assess needs and assets of young adult Latino MSM regarding engagement and retention in the PrEP cascade. From these findings, health care provider and staff feedback, and through the guidance of a Participatory Planning Group, a patient navigation intervention will be developed and pre-tested through 25 in-depth interviews. During Phase 2, the patient navigation intervention will be pilot-tested with 60 young adult Latino MSM. The patient navigation intervention will be compared to usual care plus written information to evaluate the feasibility and acceptability of the intervention and study methods, as well as the intervention's potential in improving engagement and retention in PrEP-related care. The project will investigate the following specific aims: 1) to assess the needs and assets of young adult Latino MSM regarding engagement and retention in the PrEP cascade; 2) to develop, pretest, and produce a patient navigation intervention designed to facilitate engagement and retention in the PrEP cascade among young adult Latino MSM; and 3) to conduct a pilot randomized controlled trial of the patient navigation intervention by comparing it to usual care to assess feasibility, acceptability, and preliminary impact. The proposed study has significant public health implications and is expected to contribute to efforts to reduce HIV-related disparities and increase adherence to PrEP.

OVERALL ? Project Summary San Diego State University (SDSU) is a Hispanic-Serving Institution with health-related doctoral programs in several disciplines. One of the goals in SDSU's Strategic Plan, ?Building on Excellence? is to continue to enhance its research and creative endeavors profile, with particular emphasis on building areas of excellence and addressing national and international challenges. Faculty at SDSU excel at conducting research that improves minority health and reduces health disparities. However, the university currently lacks adequate research infrastructure to meet this strategic goal and bring diverse disciplines together to support innovative minority health and health disparities (MHHD) research. The proposed SDSU HealthLINK Center for Transdisciplinary Health Disparities Research (Center) will address critical needs identified by faculty, staff, and the administration to achieve the university's vision of enhancing its research profile as well as facilitate innovative MHHD research. Thus, in response to RFA-MD-17-006, National Institute of Minority Health and Health Disparities request for applications to create Research Centers in Minority Institutions (U54), we propose four aims that align with the goals of the RCMI specialized centers. We will enhance our institutional capacity to engage in basic biomedical, behavioral, and clinical MHHD research by developing a Research Infrastructure Core (RIC) that will house the following sources of support: clinical treatment and data collection rooms and a lab to collect, process, and store biospecimens; expertise in using wireless technology and big data (electronic health record, US Census) to answer significant and innovative research questions; development and adaptation of evidence-based interventions across diverse health disparity populations and across health conditions using well-tested formative research methods; a repository of relevant survey items and research protocols for use by MHHD researchers; and data management and analytic approaches for combining these with other sources of data (e.g., biomarkers, survey). These resources and services, coupled with pilot project funding through the Investigator Development Core and career enhancement activities through the Administrative Core, are designed to improve the competitiveness of SDSU investigators to procure NIH support to engage in significant and innovative MHHD research. Finally, partnerships on the Community Engagement Core will foster long-term relationships with organizations whose missions align with our own; their engagement and participation will ensure we meet the needs of the communities we serve and allow for bidirectional capacity building and knowledge transfer. It is clear that the Center will generate, use, and disseminate findings derived from basic biomedical, behavioral, and clinical research to inform additional innovations in research, practices, and policies to improve minority health and reduce health disparities.

RESEARCH INFRASTRUCTURE CORE - Summary The overarching theme of the ?SDSU HealthLINK Center for Transdisciplinary Health Disparities Research? (Center) is to generate new knowledge aimed at improving minority health and reducing health disparities. It is widely recognized that transdisciplinary approaches are required to understand and reduce the burden of disease because they draw on concepts from multiple scientific disciplines. However, transdisciplinary research also relies on being able to access support, resources, and the expertise of investigators and professionals from multiple disciplines. The Center Research Infrastructure Core (RIC) will maximize the quality and productivity of MHHD research conducted at San Diego State University (SDSU) by serving as a hub for technical and other sources of support to conduct rigorous and relevant MHHD research. We strive to support basic biomedical, behavioral and clinical research. The RIC will streamline and expand the technical capabilities identified by SDSU faculty and staff as critically necessary to conduct innovative, transdisciplinary MHHD research, including: 1) use of wireless sensors, mobile applications, telehealth, and other e/mhealth strategies for intervention and/or data collection purposes, 2) collection and processing of various biospecimens; 3) collection of self-report data using innovative approaches, such as ecological momentary assessment (EMA); 4) development, adaptation/translation, and dissemination of linguistically- and culturally- relevant interventions for improving minority health and reducing health disparities; and 5) management and analysis of electronic health record (EHR) data and other types of `big data'. Ultimately, these protocols and data will be housed in a Health Data Analytic Portal and a Health Science Knowledge Repository to ensure easy access to evidence-based resources to support transdisciplinary MHHD research. The RIC will support the career advancement of junior investigators at SDSU by collaborating with the Administrative Core and the Investigator Development Core on developing and delivering workshops and seminars, providing mentorship to pilot project awardees, and encouraging use of core resources and services to support their research. The RIC will collaborate with the Community Engagement Core to build the capacity of the academic and partners to engage in meaningful research and knowledge transfer. The proposed RIC will build on existing resources available at SDSU, including the SDSU HealthLINK Endowment, Computational Science Research Center (CSRC), the Human Research Protection Program (HRPP), and the resources and services available from a multitude of SDSU colleges and research institutes. These activities and infrastructure will have a significant and lasting impact on the quality and quantity of MHHD research conducted at SDSU.

By 2022, there will be nearly 4 million breast cancer survivors in the USA. Adherence to long-term endocrine therapy is crucial for survivors of hormone receptor-positive breast cancer prescribed these daily medications to prevent cancer recurrence. Despite the life-saving benefits of these medications, rates of adherence are low. Medication-taking behavior is simultaneously influenced by multiscale factors, including personal and environmental factors, and a patient's other behavioral patterns. Despite advances in smart and connected health, there have been few attempts to develop and deliver personalized interventions for medication adherence. Existing technology-based interventions focus on cognitive reasons for non-adherence to medications experienced by some people (e.g., forgetting), but fail to account for interactions between cognitive factors and other types of factors (i.e., environmental, behavioral) that contribute to adherence. Furthermore, few technology-driven interventions have been assessed for efficacy in supporting medication adherence. Tools to understand interactions between multiscale factors and the effect that personalized interventions have on these factors would ultimately improve medication adherence. This 3-phase project will overcome these fundamental scientific barriers by developing and employing a Multiscale Modeling and Intervention (MMI) system. First, a system consisting of sensor-rich smartphones, wireless medication event monitoring systems (MEMS), wireless beacons, and wearable sensors that collect in situ data on medication adherence, will be developed to provide continuous, noninvasive adherence assessment and multiscale monitoring of factors. Second, the MMI system will be deployed to breast cancer survivors to model relationships between adherence and multiscale factors, identify patterns associated with medication-taking behavior, and develop interventions. Third, a proof-of-concept for MMI will be demonstrated through a human subjects study, with subjects receiving multiscale interventions. The proposed research has significant public health implications as it is expected to increase our understanding of medication adherence in breast cancer survivors, thus providing a general framework that will be applicable to oral chemotherapy use across multiple cancers.

Abstract Objectives: The Advanced Data Analytics Program To (ADAPT) will enhance behavioral and social sciences research, by training a diverse next generation of data scientists who will learn interdisciplinary skills needed for successful careers in behavioral and social sciences health-related data science. Rationale: San Diego is a hub for genomics, mobile technology, behavioral health research and data science in Southern California, yet no data science curriculum for behavioral scientists currently exists. The ADAPT program will fill this gap and intersect the areas of health sciences, informatics, computer science, and statistics in Southern California. Design: ADAPT will educate doctoral students in the behavioral and social sciences to build and further expand an ecosystem for big data analytics that promotes finding, accessing, interoperating, and reusing digital objects and responsibly computing with human subjects? data in cloud environments. The ADAPT program will be based at the University of California, San Diego (UCSD), with faculty collaborators from San Diego State University. It will be based on two joint doctoral programs (JDPs) at these universities (Clinical Psychology and Public Health/Behavioral Health). Dual mentoring by faculty with expertise in behavioral and social sciences and computer science, biomedical informatics, or statistics will ensure a truly interdisciplinary focus that will cover team science and responsible conduct of research. Key Activities: Trainees will gain expertise through coursework, research experience during rotations and external internships, mentoring and other activities. Existing data science courses were selected for the curriculum, which will also include a new course in cloud-based human subjects? data computing. Through individualized development plans, ADAPT trainees will work with their faculty mentors to tailor the curriculum and career paths according to students? interests and skills. Data science coursework will utilize elective course slots in the JDP curricula, will typically be completed in years 1 and 2 of the JDPs. They will provide the foundational knowledge needed for academic and industry rotations and for the start of the trainees? research phase. Projected Number of Trainees: 6 first or second year JDP students Planned Duration of Appointments: 3 years, renewed annually based on good academic standing Intended Trainee Outcomes: Metrics for success will include number and quality of publications, and rate of academic milestone completion. Trainees who complete the ADAPT program will possess the scientific knowledge needed to be a behavioral health data scientist, understand ethical and regulatory aspects of computing with protected health information, and will become critical members of scientific teams working in academia, government, for-profit and non-profit research institutions.

Project Summary Numerous strategies have been identified to promote rural, border health disparities research. These efforts have led to an awareness of the complexities of these health disparities. Rural, border communities are overburdened by a complex set of social determinants that affect community members? health and well-being. They are also under-resourced and their needs are not recognized by urban and suburban-working decision- makers. However, as is frequently concluded, changes from grass roots and research efforts are often not maintained nor disseminated due to resource limitations. From this perspective, the proposed ?Multi-sector, Rural-Border Health Disparities Research and Innovation Initiative (Our Health)? was conceived. The Our Health initiative will convene 15 representatives from diverse sectors to identify research priorities relevant to the health and well-being of people living and working along the US-Mexico border in Imperial County, California. Imperial County has been engaged in the California Accountable Community for Health Initiative; thus all proposed coalition members are actively engaged in research within their own organizations, have participated in a countywide collective effort to improve population health, and know first-hand what it is like to live and work in a persistent poverty county. All coalition members have enthusiastically agreed to engage in a year-long process that involves formal data collection that builds on previous efforts to form a unified approach to building and using evidence to improve practices and policies that address these disparities. Formal data collection methods will include secondary data analyses that do not require human subjects? approval (e.g., use of existing de-identified data from previous research studies; use of state and national data with specific ties to Imperial County) and focus groups with coalition members to identify research priorities that address health disparities in Imperial County, as well as the infrastructure needed to do this research. These infrastructure needs include, but are not limited to: data repository and data sharing infrastructure; organizational partners with research needs that impact vulnerable populations and the capacity and/or interest to engage in research; academics with expertise and interest in rural, border health disparities research; and, funding for research activities. These activities will converge on the selection of a pilot project that is responsive to the priorities and needs identified by coalition members. This administrative supplement is supported by the parent award, the SDSU HealthLINK Center for Transdisciplinary Health Disparities Research. Through their integration with the Center, it is anticipated that coalition members and their organizations will identify new partnerships to advance research in rural, border health disparities.

PROJECT SUMMARY Suicide is the 10th leading cause of death among all U.S. citizens and is the 2nd leading cause of death among youth and emerging adults between the ages of 15 and 29. One group that is particularly vulnerable to suicide is sexual and gender minorities (SGMs). SGM is an umbrella term used to describe individuals who identify as non-exclusively heterosexual (e.g., gay, lesbian, bisexual) and/or as transgender/non-binary (e.g., identify as a gender different from their birth sex). Indeed, recent U.S. representative findings from 2017 underscore striking disparities in suicidality between sexual minority and heterosexual adolescents, with 23% of sexual minority youth reporting one or more suicide attempts (in the past 12 months) vs. 5.4% of heterosexual youth. Prevalence of lifetime suicide attempts among gender minorities is also substantially elevated compared to the general population, with 45% of 18-24-year-old transgender individuals reporting a history of one more suicide attempts. Despite these substantial health disparities in suicide among SGM youth/emerging adults, no known suicide prevention programs exist for this highly vulnerable population. Given this crucial gap in the literature, the proposed study will adapt and test an innovative intervention that integrates patient navigation with the Safety Planning Intervention (PN+SPI) for SGM youth/emerging adults designed to target mechanisms (e.g., reductions in thwarted belongingness and increases in suicide-related coping skills) that theoretically underlie suicide. If the PN+SPI intervention displays a clinically meaningful effect on the purported targets (i.e., reductions in thwarted belongingness and increases in suicide-related coping skills) during the open-phase trial (R61 phase) and is feasible and acceptable, we will subsequently move to the R33 phase. In the R33 phase, we will conduct a pilot randomized controlled trial of the PN+SPI by comparing it to SPI alone to assess feasibility, acceptability, and preliminary efficacy. During the randomized controlled trial, in which we will sample 170 youth and emerging adult SGMs, we will also evaluate the mechanisms of action of the PN+SPI intervention through longitudinal analysis. The proposed project has substantial public health significance as SGMs are one of the most vulnerable groups for suicidality globally. Given the brevity of the PN+SPI intervention and its emphasis on safety planning and accessing community resources, the PN+SPI intervention has high potential for wide dissemination and public health impact.