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.

抽象的 丙型肝炎病毒（HCV）感染是美国最常见的慢性血传播病毒感染，不成比例 影响无家可归者和吸毒的人群，造成重大的健康差异，并代表着关键的重点 在个人和社区层面有效预防。与普通人群相比，无家可归者有 HCV患病率增加了26倍，这是与注射药物使用（IDU）密切相关的诊断。专注的筛选， 无家可归成年人的早期检测和治疗对于有效治疗至关重要。然而，基于干扰素的HCV 治疗方案显示60％的患者有功效，许多人因严重的侧面而不会继续治疗 效果。此外，尽管目前的治疗 指南。直接作用抗病毒药（DAA）药物方案成功治疗HCV可能会提供替代方案 解决方案，针对沿HCV生命周期的特定步骤。这些治疗尚未在无家可归者中评估 成年人。无家可归的成年人中与低依从性肝炎治疗相关的因素包括未经治疗的心理 疾病，持续的毒品和饮酒，不稳定的住房以及有限的护理机会。为了解决这些差异，我们将 试点测试一种基于理论上的创新护理模型，由我们的团队在其他脆弱的人中成功实施 人口，在HCV感染的无家可归者中。利用基于社区的交付方法，社区 由注册护士（RN）指导的卫生工作者（CHW）将提供CHW/RN计划，并使用HCV用药 使用直接观察到的治疗（DOT）对合格的HCV感染无家可归的成年人进行的治疗。首次， 使用基于社区的方法，我们的CHW/RN团队将实施包括 参与者居住的社区中的DAA管理，而不是医疗保健机构。在第一阶段，使用 社区参与式方法，我们计划制定和完善对文化敏感的干预计划， 专注于降低健康差异。可接受性和可行性将进行严格评估。在第二阶段，我们将 评估CHW/RN干预措施对洛杉矶108个合格的HCV感染无家可归者的影响 主要是基于HCV治疗完成，并治愈，其次是精神健康，药物使用，获得护理和 庇护所稳定性，与基于初级保健诊所的护理标准（CBSOC）模型相比。个人级别因素 这是完成HCV治疗方面健康差异的潜在机制（例如，社会支持，稳定 住房，精神疾病）将被评估。我们假设我们的基于CHW/RN的模型将优于CBSOC 改善HCV治疗完成，防止HCV疾病进展并改善次级的计划 结果（例如，心理健康，获得护理等）。通过扩展，我们的干预措施，即使有效，可以帮助减少 高危无家可归者之间的HCV感染传播，可以帮助改善某些健康差异。我们 计划调查结果为未来的R01 NIH申请中的更大试验提供了信息。这种预防的治疗参与 紧急的是，因为该HCV感染的组代表了普通人群中HCV感染的储层。