NCT04677153已完成不适用
Rapid HCV Test and Treat to Increase HCV Treatment Uptake Among People Who Use Drugs
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 8
- 主要终点
- Participants Who Initiate HCV Therapy
研究概览
简要总结
This study is being done to compare two strategies to deliver HCV treatment to persons with hepatitis C virus (HCV) who also use drugs and are participating in an outpatient opioid treatment program (OTP). Participants will be randomized into one of two treatment groups:
- Test and treat plus peer-mentors: This treatment group will be offered 8 weeks of glecaprevir/pibrentasvir (an FDA approved HCV treatment) within days of HCV diagnosis at the OTP. Participants in this group will receive treatment adherence support from a peer-mentor who is someone who has been cured of HCV infection.
- Standard of care HCV treatment referral: This treatment group will be referred to an offsite HCV treatment location. This is the usual care for anyone who tests positive for HCV at the OTP who is not participating in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability and willingness of participant to provide written informed consent
- •Men and women age ≥18 to ≤70 years at study entry
- •HCV antibody positive/detectable HCV RNA
- •HCV treatment naïve (no prior treatment with an approved or investigational oral Direct-Acting Antivirals (DAA) therapy
- •Negative pregnancy test at screening or at the day of treatment initiation (females of childbearing potential only)
- •If co-infection with Human Immunodeficiency Virus (HIV) is documented, the subject must be anti-retroviral treatment (ART) naïve with CD4 T cell count >500 cells/mm3 OR on a stable ART regimen (containing only permissible ART - Raltegravir; dolutegravir; Rilpivirine; Elvitegravir/cobicistat; Tenofovir disoproxil fumarate; Tenofovir alafenamide; Emtricitabine; Lamivudine and/or Abacavir, bictegravir)
排除标准
- •Women who are pregnant or breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug
- •Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation
- •Current or history of decompensated liver disease (including but not limited to encephalopathy, variceal bleeding, or ascites) prior to study entry
- •History of hepatocellular carcinoma (HCC)
- •Any history of active Hepatitis B or positive HBsAg test
- •Platelet count < 150,000/mm3
- •HCV RNA undetectable
- •History of clinically significant abnormalities or co-morbidities that make the subject an unsuitable candidate for this study, in the opinion of the investigator.
- •Women of childbearing potential that are not practicing at least one specified method of birth control that is effective from Study Day 1 through at least 30 days after the last dose of study drug.
- •Subject is currently taking any of the following prohibited medications: red yeast rice (monacolin K), St. John's Wort, carbamazepine, dabigatran, efavirenz, phenytoin, pentobarbital, phenobarbital, primidone, rifabutin, rifampin.
- •Subject is not able or willing to safely discontinue the prohibited medications or supplements listed below at least 14 days prior to the first dose of GLE/PIB: some HMG-CoA reductase inhibitors, astemizole, cisapride, terfenadine, ethinyl estradiol.
研究组 & 干预措施
Test and Treat plus Peer Mentors Intervention Arm
Experimental
Participants offered 8 weeks of glecaprevir/pibrentasvir (GLE/PIB) at OTP plus peer support.
干预措施: Test and treat plus peer mentors (Other)
Standard of Care Referral Arm
Active Comparator
Participants referred to offsite (non-OTP) location for HCV treatment.
干预措施: Usual care (Other)
结局指标
主要结局
Participants Who Initiate HCV Therapy
时间窗: Within 12 weeks of randomization
Participants who start HCV treatment in each arm.
次要结局
- HCV Treatment Completion(At expected end of treatment date, up to 20 weeks)
- Sustained Virologic Response (SVR) Following Treatment by Intervention Group(Post-treatment week 12)
- HCV Treatment Completion(At expected end of treatment date, up to 20 weeks)
- Sustained Virologic Response (SVR) Following Treatment by Intervention Group(Post-treatment week 12)
- Time to HCV Treatment Initiation(From randomization to initiation of treatment, up to 24 weeks)
研究者
研究点 (8)
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