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源性病毒感染， 影响无家可归者和吸毒者，造成显着的健康差距，并成为一个关键焦点 在个人和社区层面进行有效的预防。与一般人口相比，无家可归者 HCV 患病率增加了 26 倍，这一诊断与注射吸毒 (IDU) 密切相关。集中筛选， 无家可归的成年人的早期发现和治疗对于有效治疗至关重要。然而，虽然基于干扰素的 HCV 治疗方案对 60% 的患者显示出疗效，许多患者由于严重的副作用而不再继续治疗 影响。此外，尽管目前正在接受治疗，但只有 1-6% 的丙型肝炎病毒感染者接受任何治疗 指导方针。使用直接作用抗病毒 (DAA) 药物方案成功治疗 HCV 可能会提供另一种选择 解决方案，针对 HCV 生命周期中的特定步骤。这些治疗方法尚未在无家可归者中进行评估 成年人。无家可归的成年人对肝炎治疗依从性低的相关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 人群中，感染 HCV 的无家可归者。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 感染无家可归成年人提供治疗。首次， 我们的 CHW/RN 团队将采用基于社区的方法实施干预计划，其中包括 DAA 在参与者居住的社区而非医疗保健机构进行管理。在第一阶段，使用 社区参与方法，我们计划制定和完善文化敏感的干预计划， 重点关注缩小健康差距。可接受性和可行性将受到严格评估。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， 主要关注丙肝病毒治疗的完成和治愈，其次关注心理健康、药物使用、获得护理和治疗的机会 与基于初级保健诊所的标准护理 (cbSOC) 模型相比，住房稳定性。个人因素 这些是导致完成 HCV 治疗过程中健康差异的潜在机制（例如社会支持、稳定的 住房、精神疾病）将受到评估。我们假设我们的基于 CHW/RN 的模型将优于 cbSOC 提高 HCV 治疗完成度、预防 HCV 疾病进展和改善继发性的计划 结果（例如心理健康、获得护理的机会等）。推而广之，我们的干预如果有效的话，可以帮助减少 丙型肝炎病毒感染在高危无家可归者中传播，并有助于改善某些健康差距。我们 计划为未来 R01 NIH 申请中的更大规模试验提供信息的研究结果。这种将治疗作为预防的做法是 由于这一 HCV 感染群体是普通人群中 HCV 感染的储存库，因此这一问题十分紧迫。