Stepped-Wedge Randomized Control Trial to Compare Integrated, Co-located, Telemedicine-based HCV Management for Individuals on Opiate Agonist Treatment Versus Usual Care Treatment of HCV of Individuals on Opiate Agonist Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 602
- 试验地点
- 2
- 主要终点
- Observed Percentage of Patients in Both Arms Who Achieve Viral Eradication
研究概览
简要总结
To compare the effectiveness of a patient-centered, opiate agonist treatment (OAT)-integrated telemedicine-based approach for management and delivery of hepatitis C virus (HCV) treatment to persons with substance use disorders (PWSUD) versus usual care, which we anticipate in most cases will be referral to an offsite location for HCV management. The effectiveness will be expressed through the primary patient centered and clinical outcome, achievement of viral eradication, defined as undetectable HCV RNA 12 weeks post-treatment cessation.
详细描述
The study is a non-blinded stepped wedge cluster randomized controlled trial with two arms: onsite HCV management through telemedicine versus HCV management through usual care, referral to an offsite hepatitis specialist (Referral). The arm assignment is at the cluster (clinic) level. After an initial period (9 months) in which all clinics implement the control intervention (usual care), at regular intervals (i.e., the "steps") of 9 months duration each, one group of clinics is randomized to cross over from the Usual Care arm to the Telemedicine arm. The process continues until all clinics have crossed over to implement telemedicine, and thus all clinics contribute data to both interventions. In addition, patients cured of HCV are followed for two years post-treatment cessation to assess for reinfection or relapse of HCV RNA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV antibody detected
- •Ability and willingness of subject or legal representative to provide written informed consent.
- •18 years of age
- •A minimum of 12-month enrollment in the opiate agonist treatment program
- •Likely to be adherent to the therapeutic regimen
- •Covered by medical insurance
排除标准
- •Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain.
- •<18 years of age
- •< 12 months enrolled in an opiate agonist treatment program.
- •Non-compliance with therapeutic regimen defined as three consecutive missed appointments that will result in a discussion between the principal investigator at the site and the study participant to determine the reason for the missed appointments. Continuation in the study for the participant will be assessed on a case-by-case basis between the study PI and the site PI.
- •Lack of medical insurance coverage
- •Ineligibility for HCV treatment
- •Active treatment for HCV at the time of the study enrollment
结局指标
主要结局
Observed Percentage of Patients in Both Arms Who Achieve Viral Eradication
时间窗: 12 weeks post treatment cessation
Percentage of patients who achieve viral eradication (defined as undetectable HCV RNA for 12 weeks post treatment cessation)
次要结局
- Comparison of Treatment Initiation Percentages(Up to 160 weeks)
- Comparison of Treatment Completion Rates(Up to 210 weeks)
- Comparison of Patient Satisfaction(Baseline (initial time point) and at time HCV is cured, i.e., sustained virological response (up to 210 weeks).)
研究者
Andrew Talal
Professor
State University of New York at Buffalo