Accessible Care Intervention for Engaging People who Inject Illicit Drugs (PWID) in Hepatitis C Care

让注射非法药物 (PWID) 的人参与丙型肝炎护理的无障碍护理干预措施

基本信息

批准号：
9979800
负责人：
KRISTEN M MARKS
金额：
$ 53.42万
依托单位：
GRADUATE SCHOOL OF PUBLIC HEALTH AND HEALTH POLICY
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-08-01 至 2023-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9979800
关键词：
AIDS prevention Adherence Adverse event Affect Alcohol consumption Alcohol or Other Drugs use Antiviral Agents Antiviral Therapy Caring Collaborations Communities Country Data Dose-Limiting Drug usage Effectiveness Enrollment Epidemic Evaluation Frequencies Fright HIV Infections HIV risk HIV/HCV Health Care Costs Health Personnel Health Services Accessibility Healthcare Systems Hepatitis Hepatitis C Hepatitis C Therapy Hepatitis C virus Housing Infection Injecting drug user Injections Intervention Legal Liver Failure Location Measures Medical Mental disorders Methods Modeling Needle-Exchange Programs Oral Outcome Participant Patient Self-Report Patients Persons Pharmaceutical Preparations Population Prevalence Prevention Preventive Intervention Provider Randomized Regimen Reporting Risk Behaviors Safety Sampling Services Shame Side Social Problems State Interests Structure Time Toxic effect Toxicology Treatment Protocols United States Urine Visit addiction arm base burden of illness comorbidity compare effectiveness cost design follow-up health disparity high risk illicit drug use intervention cost liver transplantation prevent primary outcome programs public health relevance recruit reduced substance use response secondary outcome sexual risk behavior side effect social stigma substance abuse treatment transmission process treatment as usual usual care arm virology

项目摘要

DESCRIPTION (provided by applicant): The proposed study will examine the feasibility, acceptability, safety, effectiveness, and cost of an Accessible Care intervention for engaging people who inject illicit drugs (PWID) in hepatitis C care. Four times as prevalent in the US as HIV infection, hepatitis C is already the leading cause of liver failure and liver transplantation, and the disease burden and health care costs will continue to rise in the coming decades. The 1.5-2.0 million PWID constitute the core of the hepatitis C epidemic in the United States, with prevalence rates >70% in most studies. New, all-oral antiviral treatment regimens can eradicate HCV in nearly 100% of previously untreated patients. Nonetheless, few studies have reported successful treatment of this infection in active PWID - none with the new all-oral regimens - and they are rarely offered antiviral treatment. As more advantaged populations gain access to the treatments and are cured, health disparities in hepatitis C outcomes will sharpen. Accessible Care for PWID is low-threshold care provided in programs designed specifically for PWID, in community-based locations where they can comfortably access care without fear of shame or stigma. The proposed study will compare the effectiveness of Accessible Care with Usual Care (referrals to existing services) in facilitating linkage, engagement, and retention of PWID in care for hepatitis C, addiction, and HIV prevention. Our primary outcome is sustained virologic response (SVR), which constitutes virologic cure. Substance use and HIV and HCV risk behaviors are secondary outcomes. The Specific Aims of this study are to compare active PWID receiving Accessible Care or Usual Care on the following outcomes: 1. Hepatitis C Outcomes: (1a) Linkage and engagement in hepatitis C care, (1b) Successful hepatitis C treatment, (1c) Safety of hepatitis C treatment, and (1d) Rates of reinfection. 2. Substance use outcomes: (2a) Substance abuse treatment entry and retention, and (2b) Reductions in substance use. 3. Reductions in self-reported HIV and HCV risk behaviors. As all-oral regimens become available to patients who do not inject drugs, the substantial health disparities in hepatitis C already evident will become worse, as the haves are cured and the have-nots are not. Data are needed on effective methods to provide successful antiviral therapy to the core population affected by the epidemic, persons who are currently using illicit drugs, so that they, too, may benefit. Treatment can also help end the HCV epidemic by preventing onward transmission - Treatment as Prevention - but only if we have effective models for delivering treatment to people actively injecting drugs.

描述（由申请人提供）：拟议的研究将审查无障碍护理干预措施的可行性、可接受性、安全性、有效性和成本，以让注射非法药物的人 (PWID) 参与丙型肝炎护理，其发病率是美国的四倍。与艾滋病毒感染一样，丙型肝炎已经是肝衰竭和移植肝的主要原因，未来几十年，疾病负担和医疗费用将继续上升，15-200万吸毒者构成了美国丙型肝炎流行的核心，大多数研究表明其患病率>70%。口服抗病毒治疗方案可以根除近 100% 以前未接受治疗的患者的 HCV 然而，很少有研究报告成功治疗活动性吸毒者的这种感染 - 没有一个采用新的全口服方案 - 而且它们是有效的。很少提供抗病毒治疗，随着更多的优势人群获得治疗并得到治愈，丙型肝炎结果的健康差异将加剧。针对注射吸毒者的无障碍护理是专门为注射吸毒者设计的项目，在社区地点提供低门槛护理。他们可以轻松地获得护理，而不必担心羞耻或耻辱。拟议的研究将比较无障碍护理与常规护理（转介至现有服务）在促进注射吸毒者护理中的联系、参与和保留方面的有效性。我们的主要结果是持续病毒学应答（SVR），它构成病毒学治愈，而艾滋病毒和丙型肝炎病毒危险行为是本研究的具体目的是比较主动吸毒者的情况。针对以下结果的无障碍护理或常规护理： 1. 丙型肝炎结果：(1a) 丙型肝炎护理的联系和参与，(1b) 成功的丙型肝炎治疗， (1c) 丙型肝炎治疗的安全性，以及 (1d) 再感染率 2. 药物滥用结果：(2a) 药物滥用治疗的进入和保留，以及 (2b) 药物使用的减少 3. 自我报告的艾滋病毒的减少。随着不注射药物的患者可以使用全口服疗法，丙型肝炎已经很明显的巨大健康差异将变得更加严重，因为富人得到了治愈。需要有关有效方法的数据，以便为受该流行病影响的核心人群（目前正在使用非法药物的人）提供成功的抗病毒治疗，以便他们也能受益于治疗。通过预防继续传播来控制丙肝病毒流行——治疗即预防——但前提是我们有有效的模型为主动注射毒品的人提供治疗。