CompletedNot Applicable

Rapid HCV Treatment Access for Persons Who Use Drugs

United States, Canada198 participantsStarted 2021-08-06

Plain-language summary

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: 1. 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. 2. 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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 subj…

What they're measuring

Participants Who Initiate HCV Therapy

Timeframe: Within 12 weeks of randomization

Trial details

NCT IDNCT04677153

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-23

Results submitted2026-03-24