Research Center for HIV/AIDS Research, Education and Service (UF CARES) Top The University of Florida Division of Pediatric Infectious Diseases and Immunology – Jacksonville has a robust research program that includes both HIV and non-HIV research. The research program has several principal investigators and research coordinators and conducts both hospital and community based research. HIV-related research is accomplished at the University of Florida Center for HIV/AIDS Research, Education and Service (UF CARES). In addition the division hosts the University of Florida Clinical and Translational Science Institutes office in Jacksonville and an Agency for Healthcare Research and Quality (AHRQ) registered Community Based Pediatric Research Network. The UF CARES multi-disciplinary team approach to research allows transparency for sharing ideas among professionals of different educational backgrounds to develop some of the most effective patient-centered research. HIV/AIDS Research HIV/AIDS research is conducted primarily at UF CARES through the division of pediatric infectious diseases and immunology. Since 1993 the division of pediatric infectious diseases and immunology has participated in over 100 clinical research trials designed to advance medical knowledge and improve patient care in the area of HIV and infectious diseases. Hundreds of patients have participated in research studies at UF CARES. This research has provided insights into management of HIV and made available new medical treatment options. The center's research team is composed of highly-trained and experienced individuals who are committed to improving the health of HIV infected including pregnant women, adults, adolescents and children living with HIV and other infectious diseases by offering research studies that are designed to increase our understanding of these diseases and develop better treatment options. Research conducted at UF CARES is broad. Studies currently approved by the Institutional Review Board and being conducted by UF CARES include: National Institute of Health (NIH) sponsored clinical trials networks: AIDS Clinical Trials Group (ACTG) Adolescent Medicine Trials Network (ATN) for HIV/AIDS Interventions Collaborative Antiviral Study Group (CASG) HIV Prevention Trials Network (HPTN) International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) International Network for Strategic Initiatives in Global HIV Trails (INSIGHT) Pediatrics HIV/AIDS Cohort Study Network (PHACS) Pediatric Trials Network (PTN) Industry-sponsored Phase I, II and III medication, treatment and vaccine clinical trials. The center has partnered with 20 various prominent pharmaceutical companies to conduct a variety of industry-sponsored clinical trials. Investigator-initiated studies such as: Pharmacotherapy for Hazardous Drinking in HIV-infected women: Randomized Trial - also known as WHAT-IF? Study [Will Having Alcohol Treatment Improve my Functioning?]: Robert Cook, M.D., M.P.H., Associate Professor, University of Florida College of Public Health and Health Professions, Department of Epidemiology, College of Medicine, Department of Medicine, Gainesville, FL and Mobeen H. Rathore, M.D. Molecular Mechanisms of Skeletal Muscle Loss in HIV-infected Older Persons: Todd Manini, Ph.D., Assistant Professor, University of Florida College of Medicine, Department of Aging and Geriatric Research, Gainesville, FL Vitamin D and Calcium Deficiency in HIV Infected Children and Adolescents: Saran Wells, M.D., Pediatric Infectious Disease Fellow and Ayesha Mirza, M.D. Protective CMI Mechanisms of a Dual-subtype FIV Vaccine; Subtitle: HIV/FIV-Cat Model to Identify Vaccine Epitopes: Janet Yamamoto, Ph.D., Professor, University of Florida College of Veterinary Medicine, Department of Infectious Diseases and Pathology, Gainesville, FL UF CARES participated in several landmark studies that have shaped the current management of HIV infected infants, children, adolescent, pregnant women and adults. The studies to prevent the mother to child transmission of HIV during pregnancy and antiretroviral management strategies for children, adults and pregnant women are two significant studies. UF CARES has been involved in HIV vaccine and immune modulating trials. UF CARES participated in two important clinical trials that investigated the H1N1 Virus Vaccine in young adults and pregnant women. UF CARES is also participating in long term follow-up of HIV infected and exposed children. UF CARES collaborates with researchers from the University of Florida as well as other academic institutions. UF collaborating researchers include: Robert L. Cook, M.D., M.P.H., Associate Professor of Epidemiology and Biostatistics and Medicine; Associate Director of the Florida Center for Medicaid and the Uninsured - UF CARES is a coordinating site for the Randomized Trial on Pharmacotherapy for Hazardous Drinking in HIV-infected women. The study aims to determine whether an alcohol treatment intervention involving naltrexone can reduce hazardous drinking in HIV-infected women and whether it can improve antiretroviral medication adherence, reduce disease progression and reduce risky sexual behavior. Janet K. Yamamoto, Ph.D., Professor of Immunology - UF CARES is a coordinating site for the HIV/FIV-Cat Model Study. The purpose of this research study is to determine whether FIV (Feline Immunodeficiency virus) can affect human beings and to identify the viral parts that cross react between HIV and FIV, proposing a model to identify vaccine epitopes. Infectious Disease Research Non-HIV related infectious diseases research is focused primarily on vaccines, hospital epidemiology, MRSA and C. difficile. Hospital epidemiology research is mainly conducted at Wolfson Children’s Hospital. The division has collaborated with the Emerging Pathogens Institute (EPI) and the Center for Disease Control (CDC) in investigating important infectious diseases clinical challenges. A community based MRSA research project involving all the acute care hospitals in Jacksonville was done in collaboration with EPI. The division collaborated with CDC on several initiatives, in addition to the Florida Department of Health and all of the hospitals in Jacksonville and several long-term care facilities to study C. difficile. Other Research UF Clinical Translational Institute’s Community Engagement and Research Program (CERP) The division is also engaged in non-infectious disease research through the UF Clinical Translational Institute’s (CTSI) Community Engagement and Research Program (CERP) which collaborates with clinical, research and community groups statewide. The program develops relationships with community leaders through its Community Advisory Boards, Community Research Associates and partnerships. It also provides consultation on designing and conducting health-focused studies and outreach in community settings. Program Co-Directors: Linda Cottler, Ph.D., M.P.H.; UF College of Medicine and College of Health And Health Professionals, Department of Epidemiology Mobeen Rathore, M.D.; UF College of Medicine – Jacksonville,Department of Pediatrics, Division of Pediatric Infectious Diseases and Immunology Betsy Shenkman, Ph.D.; UF College of Medicine, Department of Health Outcomes and Policy North Florida Pediatric Community Research Network Through the UF CTSI Community Engagement and Research Program, the North Florida Pediatric Community Research Network was established in 2011 to encourage and facilitate practice-based research in primary care settings with a specific emphasis on pediatric and adolescent health, facilitate connections between UF’s academic researchers and community-based clinicians to create mutually beneficial research partnerships and accelerate the development of practice-based evidence that supports better health care outcomes in our diverse communities. It is registered with the Agency for Healthcare Research and Quality as a Practice-Based Research Network. The network includes 16 pediatric and adolescent primary care clinics with more than 60 physicians and health care providers throughout Jacksonville and the surrounding counties. Leadership team: Mobeen Rathore, M.D.; UF College of Medicine – Jacksonville, Department of Pediatrics, Division of Pediatric Infectious Diseases and Immunology Jerry Bridgham, M.D.; General Pediatrics, Wolfson Children’s Hospital Medical Director, Duval County Department of Health Health IMPAACTS for Florida Another program within the CTSI’s Community Engagement and Research Program is Health IMPAACTS for Florida - International Maternal Pediatric Adolescent AIDS Clinical Trials. This program is a unique collaboration between UF and Florida State University to facilitate community-based clinical research throughout the state. It combines the extensive clinical training network of FSU’s College of Medicine with the UF CTSI’s clinical research expertise. For its first two research studies, Health IMPAACTS is partnering with primary care practices in the Tallahassee, Jacksonville, Gainesville and Orlando areas to gather data related to concussion management and health risks for youth. Adolescent Health Risk Assessment in Primary Care - This protocol will test the feasibility of using HIT in the form of iPads to gather Health Risk Assessment information from adolescents seen in a range of primary care settings. Feasibility will be assessed based on provider, office staff and adolescent feedback about their satisfaction with and ease of participating in the intervention. It will also gather important information about adolescent risk behaviors. Concussion Surveillance/Management Training Protocol - Traumatic brain injury is one of the most significant public health problems in the United States and it is the leading cause of death among young people. Although systematic concussion protocols exist in professional and intercollegiate sports, wide variability exists in presence, quality and thoroughness of concussion assessments in youth sports, where the majority of such assessments are conducted by community-based physicians. This collaboration between UF and Florida State University aims to assess the feasibility of this recommendation and to engage Florida youth involved in organized sport activities (community programs, Pop Warner, high school athletics) in systematic baseline and incident concussion testing when they undergo qualifying physicals from participating physician practices. The Program also seeks to assist physician practices in implementing a clear medical decision-making procedure for return to play. Sentinel Network Project The University of Florida is one of six universities and two community health partnerships across the U.S. that are part of the National Institute of Health’s Clinical and Translational Science Awards Sentinel Network. The purpose of the network is to increase the number and types of people who participate in clinical trials and other types of health-related research, especially women, older adults, racial, ethnic and rural populations. The goals of the network include: Developing procedures to increase community participation in research which ensures more generalizable and representative research findings Building capacity for community health workers and expanding their role in research Increasing the rigor of community health evaluations and research Building trust and connections with the community Detecting emerging community issues regarding participation of underrepresented populations in health research Utilizing existing nationally developed education curricula to address clinical trial participation and pertinent health and social service needs During 2010-2011, the five universities who composed the National Institute of Health’s Clinical and Translational Science Awards conducted Sentinel Network Phase I which reached out to 5,000 lay people to educate them on the importance of health research participation and conducted a short health assessment. The University of Florida was recently added as the sixth university site and will participate in Sentinel Network Phase II, which will again educate community members on the importance of health research participation and engage them in a health assessment more detailed than the Sentinel Network Phase I. The Phase II health assessment will provide data on demographics, health and neighborhood concerns, perceptions of research, education, family life, physical and mental health history, medication and drug use. The information collected will be used to link community members to medical and social services (including a medical care “home") and research opportunities. A 30-day follow-up will be conducted with each of the community members to ascertain whether the services and opportunities were useful to them. This data will be compiled and shared with the National Center for Research Resources (NCRR) as well as the research communities and their communities at large. HealthStreet Located on UF’s East Campus, HealthStreet has a team of community health workers who interview residents about their health concerns and connect them to opportunities to participate in research as well as medical and social services. HealthStreet links community members to studies based on primary health concerns, medical history and eligibility criteria. Recruitment through HealthStreet is free and provides opportunities for UF researchers to learn from and improve the health of diverse and underrepresented populations in Alachua County. UF CARES Consumer Advisory Board (CAB) A strong provider-staff-patient relationship and consumer involvement, in addition to the quality services provided by the multidisciplinary research team, is a key component in supporting our research program. UF CARES sponsors a Consumer Advisory Board (CAB) composed of patients and community members that meets monthly to review research program and clinic activities, provide input into planning and review any challenges facing clients/research subjects. Consumers and CAB members are offered a variety of training and educational opportunities. Several of our CAB members also represent our site at the national level through the IMPAACT and PHACS Clinical Trials Network and have attended the annual national conferences. UF CARES research and clinical staff are invited to attend the CAB meetings to allow for increased communication between providers and consumers. This supports the goal of engaging clients in their research and care by furthering their trust in their providers, leading to a better relationship between caregivers and patients/clients.