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一项改善阿片类药物使用障碍患者丙型肝炎治疗效果的移动健康干预措施:一项随机对照试验的方案

A Mobile Health Intervention to Improve Hepatitis C Outcomes Among People With Opioid Use Disorder: Protocol for a Randomized Controlled Trial.

作者信息

Hochstatter Karli R, Gustafson David H, Landucci Gina, Pe-Romashko Klaren, Maus Adam, Shah Dhavan V, Taylor Quinton A, Gill Emma K, Miller Rebecca, Krechel Sarah, Westergaard Ryan P

机构信息

Department of Population Health Sciences, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, United States.

Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, United States.

出版信息

JMIR Res Protoc. 2019 Aug 1;8(8):e12620. doi: 10.2196/12620.

DOI:10.2196/12620
PMID:31373273
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6694728/
Abstract

BACKGROUND

People who inject drugs are at a disproportionate risk for contracting hepatitis C virus (HCV). However, use of HCV prevention and treatment services remains suboptimal among people with substance use disorders due to various health system, societal, and individual barriers. Mobile health applications offer promising strategies to support people in recovery from substance use disorders. We sought to determine whether the Addiction-Comprehensive Health Enhancement Support System (A-CHESS), an existing mobile health application for opioid use disorder, could be adapted to improve HCV screening and treatment.

OBJECTIVE

The goals of this paper are to describe: (1) the components and functionality of an HCV intervention incorporated into the existing A-CHESS system; and (2) how data are collected and will be used to evaluate HCV testing, linkage to care, and treatment.

METHODS

People with recent opioid use were enrolled in a randomized controlled trial to test whether A-CHESS reduced relapse. We developed and implemented HCV intervention content within the A-CHESS platform to simultaneously evaluate whether A-CHESS improved secondary outcomes related to HCV care. All A-CHESS users received the HCV intervention content, which includes educational information, private messages tailored to an individual's stage of HCV care, and a public discussion forum. Data on patients' HCV risk behaviors and stage of care were collected through quarterly telephone interviews and weekly surveys delivered through A-CHESS. The proportion of people with opioid use disorder who are HCV untested, HCV-negative, HCV antibody-positive, or HCV RNA-positive, as well as linked to care, treated and cured at baseline is described here. The 24-month follow-up is ongoing and will be completed in April 2020. Survey data will then be used to assess whether individuals who received the HCV-enhanced A-CHESS intervention were more likely to reduce risky injection behaviors, receive HCV testing, link to medical care, initiate treatment, and be cured of HCV compared to the control group.

RESULTS

Between April 2016 and April 2018, 416 individuals were enrolled and completed the baseline interview. Of these individuals, 207 were then randomly assigned to the control arm and 209 were assigned to the intervention arm. At baseline, 202 individuals (49%) self-reported ever testing HCV antibody-positive. Of those, 179 (89%) reported receiving HCV RNA confirmatory testing, 134 (66%) tested HCV RNA-positive, 125 (62%) were linked to medical care and 27 (13%) were treated and cured of HCV. Of the remaining 214 individuals who had never tested HCV antibody-positive, 129 (31%) had tested HCV antibody-negative within the past year and 85 (20%) had not been tested within the past year.

CONCLUSIONS

The A-CHESS mobile health system allows for the implementation of a bundle of services as well as the collection of longitudinal data related to drug use and HCV care among people with opioid use disorders. This study will provide preliminary evidence to determine whether HCV-specific services embedded into the A-CHESS program can improve HCV outcomes for people engaged in addiction treatment.

TRIAL REGISTRATION

ClinicalTrials.gov NCT02712034; https://clinicaltrials.gov/ct2/show/NCT02712034.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12620.

摘要

背景

注射吸毒者感染丙型肝炎病毒(HCV)的风险极高。然而,由于各种卫生系统、社会和个人障碍,物质使用障碍患者对HCV预防和治疗服务的利用率仍不理想。移动健康应用程序为支持物质使用障碍康复者提供了有前景的策略。我们试图确定成瘾综合健康增强支持系统(A-CHESS),一种现有的用于阿片类物质使用障碍的移动健康应用程序,是否可以进行调整以改善HCV筛查和治疗。

目的

本文的目标是描述:(1)纳入现有A-CHESS系统的HCV干预措施的组成部分和功能;(2)数据如何收集以及将如何用于评估HCV检测、与医疗服务的联系以及治疗情况。

方法

近期使用阿片类物质的人员参加了一项随机对照试验,以测试A-CHESS是否能减少复发。我们在A-CHESS平台内开发并实施了HCV干预内容,以同时评估A-CHESS是否能改善与HCV护理相关的次要结果。所有A-CHESS用户都收到了HCV干预内容,包括教育信息、根据个人HCV护理阶段量身定制的私信以及一个公共讨论论坛。通过季度电话访谈和通过A-CHESS进行的每周调查收集患者HCV风险行为和护理阶段的数据。本文描述了在基线时未进行HCV检测、HCV阴性、HCV抗体阳性或HCV RNA阳性,以及与医疗服务建立联系、接受治疗并治愈的阿片类物质使用障碍患者的比例。24个月的随访正在进行中,将于2020年4月完成。然后,调查数据将用于评估与对照组相比,接受了增强HCV功能的A-CHESS干预的个体是否更有可能减少危险的注射行为、接受HCV检测、与医疗护理建立联系、开始治疗并治愈HCV。

结果

2016年4月至2018年4月期间,416人入组并完成了基线访谈。在这些个体中,207人随后被随机分配到对照组,209人被分配到干预组。在基线时,202人(49%)自我报告曾检测HCV抗体呈阳性。其中,179人(89%)报告接受了HCV RNA确证检测,134人(66%)检测HCV RNA呈阳性,125人(62%)与医疗护理建立了联系,27人(13%)接受了治疗并治愈了HCV。在其余214名从未检测HCV抗体呈阳性的个体中,129人(31%)在过去一年中检测HCV抗体呈阴性,85人(20%)在过去一年中未进行检测。

结论

A-CHESS移动健康系统允许实施一系列服务,并收集与阿片类物质使用障碍患者的药物使用和HCV护理相关的纵向数据。本研究将提供初步证据,以确定纳入A-CHESS项目的HCV特定服务是否可以改善接受成瘾治疗的患者的HCV治疗结果。

试验注册

ClinicalTrials.gov NCT02712034;https://clinicaltrials.gov/ct2/show/NCT02712034。

国际注册报告识别码(IRRID):DERR1-10.2196/12620。

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