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 丙型肝炎病毒感染，美国最常见的慢性血液传播病毒感染，不成比例 影响无家可归者和吸毒人群，造成显著的健康差距，并成为 在个人和社区层面进行有效预防。与普通人群相比，无家可归者 丙型肝炎病毒流行率增加26倍，这一诊断与注射毒品使用(IDU)密切相关。重点筛选， 对无家可归的成年人及早发现和治疗是有效治疗的关键。然而，尽管基于干扰素的丙型肝炎病毒 治疗方案对60%的患者有效，许多人由于严重的副作用而不再继续治疗- 效果。此外，尽管目前正在接受治疗，但只有1-6%的使用非法药物的丙型肝炎病毒感染者接受了治疗。 指导方针。用直接作用抗病毒(DAA)药物方案成功治疗丙型肝炎病毒可能提供另一种选择 解决方案，目标是丙型肝炎病毒生命周期中的特定步骤。这些治疗还没有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接受治疗的精神疾病 疾病、持续使用毒品和酒精、住房不稳定以及获得护理的机会有限。为了解决这些差距，我们将 试点测试一种基于理论的创新护理模式，由我们的团队在其他弱势群体中成功实施 在感染了丙型肝炎病毒的无家可归者中，这一比例很高。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计划和丙型肝炎药物 使用直接观察疗法(DOT)向符合条件的感染丙型肝炎病毒的无家可归成年人提供治疗。这是第一次， 使用基于社区的方法，我们的CHW/RN团队将实施干预计划，其中包括 在参与者居住的社区而不是医疗机构管理DAA。在第一阶段，使用 社区参与式方法，我们计划开发和完善文化敏感干预计划， 着力缩小健康差距。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干预措施对洛杉矶108名合格的感染丙型肝炎病毒的无家可归成年人的影响， 主要是关于丙型肝炎治疗的完成和治愈，其次是精神健康、药物使用、获得护理和 住房稳定性，与以初级保健诊所为基础的护理标准(CbSOC)模式进行比较。个人层面的因素 这些是在完成丙型肝炎治疗过程中造成健康差异的潜在机制(例如，社会支持、稳定 住房、精神疾病)将进行评估。我们假设我们的基于CHW/RN的模型将优于cbSOC 提高丙型肝炎治疗完成率、防止丙型肝炎进展和改善继发性肝炎的计划 结果(例如，精神健康、获得护理的机会等)。推而广之，如果我们的干预有效，可能有助于减少 这有助于减少丙型肝炎病毒感染在高危无家可归者中的传播，并有助于改善某些健康差距。我们 计划在未来的R01 NIH应用中为更大规模的试验提供参考。这种将治疗作为预防的承诺是 紧急情况，因为这一丙型肝炎病毒感染群体是普通人群中丙型肝炎病毒感染的蓄水池。