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Rapid HCV Treatment Access for Persons Who Use Drugs (RAPID-HCV)

Primary Purpose

Hepatitis C Virus Infection, Response to Therapy of

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Test and treat plus peer mentors

Usual care

About this trial

This is an interventional treatment trial for Hepatitis C Virus Infection, Response to Therapy of

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 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.

Sites / Locations

University of AlabamaRecruiting
University of California, San FranciscoRecruiting
Johns Hopkins UniversityRecruiting
University Health Network Toronto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test and Treat plus Peer Mentors Intervention Arm

Standard of Care Referral Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Participants Who Initiate HCV Therapy

Proportion of participants who start HCV treatment in each arm.

Secondary Outcome Measures

HCV Treatment Completion

Proportion of participants who start HCV treatment and subsequently complete treatment (take more than 90% of prescribed treatment course).

Sustained Virologic Response (SVR) Following Treatment by Intervention Group

Proportion of participants in each arm who achieved SVR, defined as HCV RNA <15 IU/mL between 10 and 36 weeks weeks after completion of the HCV treatment regimen.

Time to HCV Treatment Initiation

Time to HCV Treatment Initiation in weeks.

Full Information

NCT ID

NCT04677153

First Posted

December 17, 2020

Last Updated

December 9, 2022

Sponsor

Johns Hopkins University

Collaborators

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT04677153

Brief Title

Rapid HCV Treatment Access for Persons Who Use Drugs

Acronym

RAPID-HCV

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 6, 2021 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

Collaborators

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C Virus Infection, Response to Therapy of

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Test and Treat plus Peer Mentors Intervention Arm

Arm Type

Experimental

Arm Description

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

Arm Title

Standard of Care Referral Arm

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Test and treat plus peer mentors

Other Intervention Name(s)

On-site treatment with peer support HCV treatment implementation strategy

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Usual care

Other Intervention Name(s)

Standard of care referral HCV treatment implementation strategy

Intervention Description

Participants are referred to another location for HCV treatment.

Primary Outcome Measure Information:

Title

Participants Who Initiate HCV Therapy

Description

Proportion of participants who start HCV treatment in each arm.

Time Frame

Within 12 weeks of randomization

Secondary Outcome Measure Information:

Title

HCV Treatment Completion

Description

Proportion of participants who start HCV treatment and subsequently complete treatment (take more than 90% of prescribed treatment course).

Time Frame

At expected end of treatment date, up to 20 weeks

Title

Sustained Virologic Response (SVR) Following Treatment by Intervention Group

Description

Proportion of participants in each arm who achieved SVR, defined as HCV RNA <15 IU/mL between 10 and 36 weeks weeks after completion of the HCV treatment regimen.

Time Frame

Post-treatment week 12

Title

Time to HCV Treatment Initiation

Description

Time to HCV Treatment Initiation in weeks.

Time Frame

From randomization to initiation of treatment, up to 36 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Oluwaseun Falade-Nwulia, MBBS, MPH

Phone

4422871964

ofalade1@jhmi.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Mark Sulkowski, MD

Phone

410-955-7538

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oluwaseun Falade-Nwulia, MBBS, MPH

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ricardo Franco, MD

rfranco@uabmc.edu

First Name & Middle Initial & Last Name & Degree

Ricardo Franco, MD

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jennifer Price, MD, PhD

Jennifer.Price@ucsf.edu

First Name & Middle Initial & Last Name & Degree

Jennifer Price, MD, PhD

Facility Name

Johns Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Oluwaseun Falade-Nwulia, MBBS, MPH

ofalade1@jhmi.edu

First Name & Middle Initial & Last Name & Degree

Oluwaseun Falade-Nwulia, MD

Facility Name

University Health Network Toronto

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jordan Feld, MD, MPH

Jordan.Feld@uhn.ca

First Name & Middle Initial & Last Name & Degree

Jordan Feld, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD

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