Rapid HCV Test and Treat to Increase HCV Treatment Uptake Among People Who Use Drugs

Johns Hopkins University8 个研究点分布在 2 个国家目标入组 198 人2021年8月6日

适应症Hepatitis C Virus Infection, Response to Therapy of

干预措施Test and treat plus peer mentors Usual care

概览

阶段: 不适用
干预措施: Test and treat plus peer mentors
疾病 / 适应症: Hepatitis C Virus Infection, Response to Therapy of
发起方: Johns Hopkins University
入组人数: 198
试验地点: 8
主要终点: Participants Who Initiate HCV Therapy
状态: 已完成
最后更新: 19天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2021年8月6日

结束日期

2024年9月23日

最后更新

19天前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Johns Hopkins University

责任方

Sponsor

入排标准

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.

研究组 & 干预措施

Test and Treat plus Peer Mentors Intervention Arm

Participants offered 8 weeks of glecaprevir/pibrentasvir (GLE/PIB) at OTP plus peer support.

干预措施: Test and treat plus peer mentors

Standard of Care Referral Arm

Participants referred to offsite (non-OTP) location for HCV treatment.

干预措施: Usual care

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)