Adaptation and testing of a primary care HCV group medical treatment intervention

初级保健 HCV 群体医疗干预的调整和测试

• 批准号: 9326265
• 负责人: Brianna Norton
• 金额: $ 18.44万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE, INC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9326265
• 关键词: Address; Adverse effects; American; Antiviral Agents; Applications Grants; Behavior; Behavior Therapy; Behavioral; Caring; Cessation of life; Characteristics; Chronic; Clinic; Clinical; Clinical assessments; Communicable Diseases; Communities; Complex; Data Analyses; Development; Disease; Education; Eligibility Determination; Enrollment; Epidemic; Evaluation; Federally Qualified Health Center; Focus Groups; Foundations; Future; General Population; Goals; HIV; HIV/HCV; Health; Health Personnel; Health behavior; Health education; Hepatitis C; Hepatitis C Prevalence; Hepatitis C Transmission; Injecting drug user; Intervention; Interview; Knowledge; Life; Liver; Liver diseases; Manuals; Mediator of activation protein; Medical; Medical center; Mentorship; Minority; Modeling; Motivation; Oral; Outcome; Participant; Patient Care; Patients; Persons; Pharmaceutical Preparations; Physicians; Population; Primary Health Care; Primary carcinoma of the liver cells; Process; Process Measure; Provider; Qualitative Methods; Questionnaires; Randomized; Randomized Controlled Trials; Research; Research Personnel; Savings; Self Efficacy; Self Management; Self-Administered; Social support; Statistical Data Interpretation; Structure; System; Testing; Time; Training; Training and Education; Treatment Protocols; United States; Virus; Visit; base; behavior change; behavior test; career; career development; design; efficacy testing; efficacy trial; group intervention; health care delivery; high risk; improved; innovation; intervention effect; medical specialties; mortality; multidisciplinary; peer; peer support; prevent; primary care setting; primary outcome; public health relevance; randomized trial; secondary outcome; self esteem; skill acquisition; skills; social norm; social stigma; therapy design; uptake

 DESCRIPTION (provided by applicant): Brianna Norton, DO, MPH is an infectious diseases trained physician-investigator who cares for patients in a community-based Federally Qualified Health Center (FQHC) and conducts research to improve health outcomes among HCV- and HIV/HCV-infected injection drug users (IDUs). Though IDUs comprise the overwhelming majority of all HCV+ and HIV/HCV+ persons in the U.S, our current health care delivery system has failed to engage such patients in HCV care, and without imminent action, HCV-related deaths will triple over the next decade. New HCV medications have cure rates as high as 100% and few side effects, but gaps along the HCV cascade of care prevent IDUs from ever initiating treatment. Innovative health care delivery interventions, based in primary care settings that IDUs are already accessing, are urgently needed to improve uptake of life-saving HCV medications. Group medical visits can harness beneficial peer dynamics to provide support and motivation for positive health behaviors, and improve knowledge and self-efficacy skills through group education and training. The overall goal of this career development application is to test a primary care clinic-based HCV Group Evaluation and Treatment UPtake (HCV GET-UP) intervention for HCV+ and HIV/HCV+ IDUs. The proposal's specific aims are: 1) to conduct a feasibility and acceptability study of HCV GET-UP; 2) to test, in a pilot RCT, the efficacy of the HCV GET-UP intervention for improving HCV treatment uptake among HCV+ and HIV/HCV+ IDUs; and 3) to conduct quantitative and qualitative analyses in order to determine potential moderators and mediators of the HCV GET-UP intervention on HCV treatment uptake. To achieve Aim 1, we will conduct a feasibility and acceptability study of two HCV GET-UP groups (total of 16 participants). Based on these findings, we will refine the intervention and create an HCV GET-UP intervention manual. We anticipate that group medical visits will include HCV clinical assessments, education, peer and provider support, and self-management skill development. To test the efficacy of HCV GET-UP (Aim 2), we will enroll 96 HCV+ and HIV/HCV+ IDUs and randomize them 1:1 to HCV GET-UP vs. onsite treatment alone. The primary outcome will be initiation of HCV treatment; secondary outcomes will include HCV evaluation, treatment completion, and cure. Finally, using a sequential explanatory design, we will determine potential moderators and mediators of the HCV GET-UP intervention on HCV treatment uptake. These findings will help to improve the intervention design for a future R01, as well as enhance our understanding of current barriers and facilitators to HCV treatment uptake for IDUs. Dr. Norton will receive mentorship from a multidisciplinary team of experts. Dr. Norton's training goal is to develop skills in: 1) development and testing of behavioral interventions; 2) design and conduct of randomized controlled trials, 3) statistical analysis of complex data; and 4) qualitative methods. Completion of the proposed project will provide the foundation for Dr. Norton's career as an independent investigator dedicated to improving health outcomes for HCV and HIV/HCV+ IDUs.

 描述（由申请人提供）：Brianna Norton，DO，MPH 是一位接受过传染病培训的医生兼调查员，她在社区联邦合格健康中心 (FQHC) 中照顾患者，并开展研究以改善 HCV 和 HIV/HCV 感染的注射吸毒者 (IDU) 的健康结果。尽管注射吸毒者占美国所有 HCV+ 和 HIV/HCV+ 患者的绝大多数，但我们当前的医疗保健服务系统未能让此类患者接受 HCV 护理，如果不立即采取行动，HCV 相关死亡人数将在未来十年增加两倍。新的 HCV 药物治愈率高达 100%，而且副作用很少，但 HCV 级联护理中的差距阻碍了注射吸毒者开始治疗。迫切需要基于注射吸毒者已经获得的初级保健环境的创新医疗保健提供干预措施，以提高对挽救生命的丙型肝炎药物的使用。团体就诊可以利用有益的同伴动态为积极的健康行为提供支持和动力，并通过团体教育和培训提高知识和自我效能技能。此职业发展应用程序的总体目标是测试针对 HCV+ 和 HIV/HCV+ IDU 的基于初级保健诊所的 HCV 团体评估和治疗 UPtake (HCV GET-UP) 干预措施。该提案的具体目标是： 1) 开展 HCV GET-UP 的可行性和可接受性研究； 2) 在试点随机对照试验中测试 HCV GET-UP 干预对于提高 HCV+ 和 HIV/HCV+ 注射吸毒者中 HCV 治疗采用率的有效性； 3) 进行定量和定性分析，以确定 HCV GET-UP 干预对 HCV 治疗摄取的潜在调节因素和调节因素。为了实现目标 1，我们将对两个 HCV GET-UP 小组（总共 16 名参与者）进行可行性和可接受性研究。根据这些发现，我们将完善干预措施并创建 HCV GET-UP 干预手册。我们预计团体医疗就诊将包括 HCV 临床评估、教育、同伴和提供者支持以及自我管理技能发展。为了测试 HCV GET-UP 的功效（目标 2），我们将招募 96 名 HCV+ 和 HIV/HCV+ IDU，并将他们按 1:1 随机分配至 HCV GET-UP 与单独现场治疗。主要结果将是开始 HCV 治疗；次要结果将包括 HCV 评估、治疗完成和治愈。最后，使用序贯解释性设计，我们将确定 HCV GET-UP 干预对 HCV 治疗摄取的潜在调节因素和调节因素。这些发现将有助于改进未来 R01 的干预设计，并增强我们对目前注射吸毒者接受丙型肝炎治疗的障碍和促进因素的了解。诺顿博士将接受多学科专家团队的指导。诺顿博士的培训目标是培养以下方面的技能： 1) 行为干预措施的开发和测试； 2）设计和进行随机对照试验，3）复杂数据的统计分析； 4）定性方法。拟议项目的完成将为诺顿博士作为独立调查员的职业生涯奠定基础，致力于改善丙型肝炎病毒和艾滋病毒/丙型肝炎病毒+注射吸毒者的健康结果。