Oregon HIV/Hepatitis and Opioid Prevention and Engagement (OR-HOPE) Study: Tele-HCV Treatment Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 3
- 主要终点
- Viral Response
研究概览
简要总结
The main goal of this study is to test the efficacy of a peer-facilitated telemedicine HCV treatment implementation strategy for people who use drugs versus local HCV treatment referral for achieving HCV sustained viral response at 12 weeks post-treatment (SVR12).
详细描述
Non-blinded, randomized controlled trial. In-depth qualitative interviews assess attitudes and barriers to treatment.
In Phase 1, potential participants will be pulled from a convenience sample at a Portland clinic providing care for the urban area. An initial target sample of 100 Hepatitis C positive participants will be enrolled for DBS validation. Power will be reassessed based on feedback from receiver operating curve model and additional participants enrolled up to a total of 100 Hepatitis C Positive participants, if necessary. A total of 500 potential participants can be screened expecting 1 in every 4 participants will be positive HCV.
In Phase 2, rural peer care coordinators (PCCs) and research assistants recruit up to 200 PWUD participants from high-needs rural Oregon counties. Study staff specifically target untreated populations recruited from local syringe exchange programs and direct community outreach (e.g. community barbeques, parks, homeless shelters, food pantries, etc.). Participants are encouraged to refer others for study screening.
A subset of up to 40 study participants will complete in-depth qualitative interviews regarding their experiences of hepatitis C treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •live in the study area
- •have injected drugs or report recreational opioid use without injection in the last 90 days
- •are age 18 or greater
- •have chronic active, untreated hepatitis C (defined as positive HCV RNA)
- •are seeking treatment for hepatitis C infection.
- •are able to communicate in English (this is due to the fact that less than 5% of the population in which we are targeting will be non-English speaking; see "Non-English Speaking Subjects" for additional information).
- •are enrolled in health insurance
排除标准
- •Have decompensated cirrhosis, defined as Child-Turcotte-Pugh (CTP) score of 7 or greater, or CTP B cirrhosis. CTP scoring is a composite of laboratory metrics (bilirubin, albumin, PT/INR) and clinical findings, including:
- •increased abdominal or lower extremity swelling
- •confusion consistent with hepatic encephalopathy
- •Are pregnant or breastfeeding
研究组 & 干预措施
Tele-HCV Treatment
Participants allocated to telemedicine intervention arm are scheduled for treatment assessment by a study clinician. For a majority of participants, this will also be the treatment initiation visit. If additional studies are necessary for routine treatment decision making, peers will assist participants in navigating health system barriers and arrangement of second telemedicine visit.
干预措施: Tele-HCV (Other)
Community Linkage to Care
Participants allocated to the community linkage-to-care arm will complete screening, be offered enrollment, and undergo informed consent as in the telemedicine arm. Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment.
干预措施: Community Linkage to Care (Other)
结局指标
主要结局
Viral Response
时间窗: 12 weeks post treatment
Number of participants with sustained viral response post HCV treatment. The viral response will be measured via a blood test.
次要结局
- Treatment Initiation(4 weeks)
- Treatment Completion(36 weeks post treatment)
- Engagement in Harm Reduction Resources(Baseline, 12 weeks, and 36 Weeks)
研究者
P. Todd Korthuis, MD
Associate Professor
Oregon Health and Science University