NCT04677153

Brief 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. 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. 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

August 6, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2024

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 13, 2026

Completed
Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2.6 years

First QC Date

December 17, 2020

Results QC Date

March 24, 2026

Last Update Submit

March 24, 2026

Conditions

Hepatitis C Virus Infection, Response to Therapy of

Outcome Measures

Primary Outcomes (1)

  • Participants Who Initiate HCV Therapy

    Participants who start HCV treatment in each arm.

    Within 12 weeks of randomization

Secondary Outcomes (3)

  • 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

Study Arms (2)

Test and Treat plus Peer Mentors Intervention Arm

EXPERIMENTAL

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

Other: Test and treat plus peer mentors

Standard of Care Referral Arm

ACTIVE COMPARATOR

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

Other: Usual care

Interventions

Test and treat plus peer mentorsOTHER

Rapid start of HCV treatment at OTP within days of HCV diagnosis. Participants will receive 8 weeks of glecaprevir/pibrentasvir and will work with a peer mentor during and after treatment.

Also known as: On-site treatment with peer support HCV treatment implementation strategy
Test and Treat plus Peer Mentors Intervention Arm
Usual careOTHER

Participants are referred to another location for HCV treatment.

Also known as: Standard of care referral HCV treatment implementation strategy
Standard of Care Referral Arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

University Health Network Toronto

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Coal Tar

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

TarsComplex Mixtures

Results Point of Contact

Title
Oluwaseun Falade-Nwulia, MBBS, MPH
Organization
Johns Hopkins University
ofalade1@jhmi.edu
4105506234

Study Officials

  • Oluwaseun Falade-Nwulia, MBBS, MPH

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2020

First Posted

December 21, 2020

Study Start

August 6, 2021

Primary Completion

February 23, 2024

Study Completion

September 23, 2024

Last Updated

April 13, 2026

Results First Posted

April 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)CA(1)