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通过远程医疗为使用阿片类药物治疗物质使用障碍的个体提供以患者为中心的丙型肝炎护理:丙型肝炎远程医疗评估、依从性与药物治疗(TEAM-C)。

Patient-centered HCV care via telemedicine for individuals on medication for opioid use disorder: Telemedicine for Evaluation, Adherence and Medication for Hepatitis C (TEAM-C).

作者信息

Talal Andrew H, Markatou Marianthi, Sofikitou Elisavet M, Brown Lawrence S, Perumalswami Ponni, Dinani Amreen, Tobin Jonathan N

机构信息

Division of Gastroenterology, Hepatology, and Nutrition, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, 875 Ellicot Street, Suite 6090, Buffalo, NY 14203, USA.

Department of Biostatistics, University at Buffalo, 726 Kimball Tower, Buffalo, NY 14214, USA.

出版信息

Contemp Clin Trials. 2022 Jan;112:106632. doi: 10.1016/j.cct.2021.106632. Epub 2021 Nov 20.

Abstract

BACKGROUND

Telemedicine has the potential to increase healthcare access especially for vulnerable populations. Telemedicine for Evaluation, Adherence, and Medication for Hepatitis C (TEAM-C) is comparing telemedicine access to specialty medical care to usual care for management of hepatitis C virus (HCV) infection among persons with opioid use disorder (PWOUD). PWOUD have the highest hepatitis C virus (HCV) prevalence and incidence, yet they infrequently receive HCV care. The study objectives are to compare access to specialty care via telemedicine to offsite specialty referral (usual care) on 1) treatment initiation, completion, and sustained virological response, 2) patient satisfaction with health care delivery, and 3) HCV reinfection after successful HCV cure.

METHODS

TEAM-C is a multi-site, non-blinded, randomized pragmatic clinical trial conducted at 12 opioid treatment programs (OTP) throughout New York State that utilizes the stepped-wedge design. The unit of randomization is the OTP with a total sample size of 624 participants. HCV-infected PWOUD were treated via telemedicine or referral. Telemedicine encounters are conducted onsite in the OTP with co-administration of direct acting antivirals for HCV with medications for opioid use disorder. The primary outcome is undetectable HCV RNA obtained 12 weeks post-treatment cessation. We also follow participants for two years to assess for reinfection.

CONCLUSIONS

The study utilizes a rigorous study design to evaluate the effectiveness and implementation of virtual treatment for HCV integrated into behavioral treatment. We demonstrate the feasibility, engagement principles and lessons learned from the initial prospective randomized trial of telemedicine targeted to a vulnerable population.

摘要

背景

远程医疗有潜力增加医疗服务的可及性,尤其是对弱势群体而言。丙型肝炎评估、依从性和药物治疗远程医疗(TEAM-C)正在比较远程医疗获取专科医疗服务与常规护理,以管理阿片类药物使用障碍患者(PWOUD)中的丙型肝炎病毒(HCV)感染。PWOUD的丙型肝炎病毒(HCV)患病率和发病率最高,但他们很少接受HCV治疗。研究目标是比较通过远程医疗获取专科护理与非现场专科转诊(常规护理)在以下方面的情况:1)治疗启动、完成和持续病毒学应答;2)患者对医疗服务提供的满意度;3)HCV成功治愈后的再感染情况。

方法

TEAM-C是一项在纽约州12个阿片类药物治疗项目(OTP)中进行的多中心、非盲、随机实用临床试验,采用阶梯楔形设计。随机分组的单位是OTP,总样本量为624名参与者。HCV感染的PWOUD通过远程医疗或转诊进行治疗。远程医疗会诊在OTP现场进行,同时联合使用针对HCV的直接作用抗病毒药物和治疗阿片类药物使用障碍的药物。主要结局是治疗停止12周后检测不到HCV RNA。我们还对参与者进行两年随访以评估再感染情况。

结论

该研究采用严格的研究设计来评估整合到行为治疗中的HCV虚拟治疗的有效性和实施情况。我们展示了针对弱势群体的远程医疗初始前瞻性随机试验的可行性、参与原则和经验教训。

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