Development of a Community-based HCV Treatment Completion Intervention Among HCV Positive Homeless Adults

针对 HCV 阳性无家可归成年人制定基于社区的 HCV 治疗完成干预措施

• 批准号: 10022164
• 负责人: Lillian Gelberg
• 金额: $ 27.75万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-20 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10022164
• 关键词: Address; Adherence; Adult; Affect; Aftercare; Alcohol consumption; Alcohol or Other Drugs use; Antiviral Agents; Area; Behavioral; Blood; Care given by nurses; Caring; Chronic; Client; Clinic; Communities; Community Health Aides; Complex; Development; Diagnosis; Directly Observed Therapy; Drug usage; Drug user; Early Diagnosis; Early treatment; Future; General Population; Guidelines; Health; Health Services Accessibility; Health Status; Health care facility; Healthcare; Hepatitis; Hepatitis B Vaccination; Hepatitis C; Hepatitis C Prevalence; Hepatitis C Therapy; Hepatitis C Transmission; Hepatitis C virus; Homeless persons; Homelessness; Housing; Individual; Injecting drug user; Interferons; Intervention; Los Angeles; Mediating; Mental Health; Mental disorders; Methods; Modeling; Nurses; Outcome; Participant; Patients; Persons; Pharmaceutical Preparations; Phase; Population; Prevention; Primary Health Care; Randomized Controlled Trials; Regimen; Registered nurse; Research; Research Design; Research Personnel; Ribavirin; Risk; Science; Shelter facility; Social support; Structure; Team Nursing; Testing; Time; Treatment Efficacy; Treatment Protocols; Treatment outcome; United States National Institutes of Health; Veterans; Virus Diseases; Vulnerable Populations; base; care providers; community based participatory research; design; effective therapy; follow-up; health care availability; health disparity; housing instability; illicit drug use; improved; injection drug use; innovation; intervention program; medication compliance; member; novel; nursing intervention; peer support; prevent; programs; psychologic; psychosocial; reduced substance use; response; screening; secondary outcome; side effect; social determinants; standard of care; time use; treatment adherence; treatment guidelines; treatment program; virology

ABSTRACT Hepatitis C Virus (HCV) infection, the most common chronic blood-borne viral infection in the US, disproportionately affects homeless and drug-using populations, creating a significant health disparity and representing a critical focus for effective prevention at the individual and community level. Compared to the general population, homeless persons have a 26-fold increase in HCV prevalence, a diagnosis strongly associated with injection drug use (IDU). Focused screening, early detection and treatment for homeless adults are critical for effective treatment. Yet while interferon-based HCV treatment protocols have shown efficacy in 60% of patients, many do not continue treatment as a result of severe side- effects. Further, only 1-6% of illicit drug-using HCV-infected persons receive any treatment, despite current treatment guidelines. Successful treatment for HCV with direct acting antiviral (DAA) drug regimens may provide an alternative solution, targeting specific steps along the HCV lifecycle. These treatments have not been assessed among homeless adults. Factors associated with low adherence to hepatitis treatment among homeless adults include untreated mental illness, ongoing drug and alcohol use, unstable housing, and limited access to care. To address these disparities, we will pilot test a theoretically-based innovative model of care, successfully implemented by our team in other vulnerable populations, among HCV-infected homeless persons. Utilizing a community-based delivery approach, a community health worker (CHW), guided by a registered nurse (RN), will deliver a CHW/RN program, with HCV medication treatment delivered using directly observed therapy (DOT) to eligible HCV-infected homeless adults. For the first time, using a community-based approach, our CHW/RN team will implement the intervention program which includes administration of DAA in the community where the participant lives, rather than a health care facility. In Phase I, using community participatory approaches, we plan to develop and refine the culturally-sensitive intervention program, focusing on reducing health disparities. Acceptability and feasibility will be rigorously evaluated. In Phase 2, we will assess the impact of the CHW/RN intervention among 108 eligible HCV-infected homeless adults in Los Angeles, primarily on HCV treatment completion, and cure, and secondarily on mental health, substance use, access to care and shelter stability, as compared with a primary care clinic-based standard of care (cbSOC) model. Individual-level factors that are potential mechanisms that underlie health disparities in completing HCV treatment (e.g., social support, stable housing, mental illness) will be evaluated. We hypothesize that our CHW/RN-based model will be superior to the cbSOC program at improving HCV treatment completion, preventing progression of HCV disease, and improving secondary outcomes (e.g., mental health, access to care, etc). By extension, our intervention, if effective, could help reduce transmission of HCV infection among at-risk homeless persons and could help ameliorate certain health disparities. We plan for findings to inform a larger trial in a future R01 NIH application. This engagement in treatment as prevention is urgent since this HCV-infected group represents a reservoir for HCV infection in the general population.

摘要 丙型肝炎病毒（HCV）感染是美国最常见的慢性血液传播病毒感染， 影响到无家可归者和吸毒人群，造成了巨大的健康差距，并成为 在个人和社区层面进行有效预防。与一般人口相比，无家可归者 HCV流行率增加26倍，这一诊断与注射毒品使用（IDU）密切相关。重点筛查， 对无家可归的成年人进行早期发现和治疗是有效治疗的关键。然而，尽管基于干扰素的HCV 治疗方案已在60%的患者中显示出疗效，许多患者由于严重的副作用而不继续治疗， 方面的影响.此外，尽管目前有治疗方法，但只有1-6%的使用非法药物的HCV感染者接受任何治疗 指南直接作用抗病毒药物（DAA）方案成功治疗HCV可能提供一种替代方案 解决方案，针对HCV生命周期中的特定步骤沿着。这些治疗尚未在无家可归者中进行评估 成年人了与无家可归的成年人中肝炎治疗依从性低相关的因素包括未经治疗的精神疾病 疾病、持续吸毒和酗酒、住房不稳定以及获得护理的机会有限。为了解决这些差异，我们将 试点测试基于理论的创新护理模式，我们的团队在其他弱势群体中成功实施 在感染HCV的无家可归者中。利用基于社区的交付方法，社区 卫生工作者（CHW）在注册护士（RN）的指导下，将提供CHW/RN计划，并提供HCV药物 使用直接观察疗法（DOT）向符合条件的HCV感染无家可归的成年人提供治疗。第一次， 我们的CHW/RN团队将采用以社区为基础的方法实施干预计划，其中包括 在参与者居住的社区而不是医疗保健机构进行DAA管理。在第一阶段，使用 社区参与的方法，我们计划制定和完善文化敏感的干预方案， 重点是减少健康差距。将严格评估可接受性和可行性。在第二阶段，我们将 评估CHW/RN干预对洛杉矶108名符合条件的HCV感染无家可归成年人的影响， 主要是关于HCV治疗完成和治愈，其次是关于心理健康，物质使用，获得护理和 与基于初级保健诊所的护理标准（cbSOC）模型相比，住房稳定性。个人层面因素 这些是在完成HCV治疗方面造成健康差异的潜在机制（例如，社会支持，稳定 精神疾病（精神疾病）将被评估。我们假设基于CHW/RN的模型将优于cbSOC的上级模型 提高HCV治疗完成率，预防HCV疾病进展，并改善继发性 结果（例如，心理健康、获得护理等）。推而广之，我们的干预如果有效， 这可能有助于减少高危无家可归者中HCV感染的传播，并有助于改善某些健康差距。我们 计划在未来的R 01 NIH申请中进行更大规模的试验。这种将治疗作为预防的参与， 这是一个紧迫的问题，因为这一HCV感染群体代表了普通人群中HCV感染的储存库。