CHAMPS Study: Chronic HepAtitis C Management to ImProve OutcomeS

NCT02402218 | Completed Results DMC

• 2 other identifiers: IRB000555915R01DA016065-12
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to compare three strategies to deliver HCV treatment with ledipasvir/sofosbuvir which is an approved therapy which is administered as one tablet by mouth daily for 12 weeks. The study population is persons living with HIV and hepatitis C virus (HCV) coinfection who also use drugs. Participants will be randomized into one of three treatment groups:

1. 1.Usual care in the clinic. This treatment group will receive the standard of care for HCV treatment from their health care team.
2. 2.Usual care plus peer-mentors. In addition to the usual care, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.
3. 3.Usual care plus incentives. In addition to the usual care, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain treatment goals during the course of the study.

Conditions

Hepatitis C Virus Infection, Response to Therapy of; Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• Participants Who Initiated HCV Therapy by Intervention Group

  The percentage of participants who initiated HCV therapy \[Ledipasvir/Sofosbuvir (LDV/SOF)\] with Usual Care (UC), Incentive Care (IC), and Peer-Mentor Care (PMC).

  at week 1

Secondary Outcomes (5)

• Sustained Virologic Response (SVR) Following Treatment by Intervention Group

  at post-treatment week 12

• Number of Participants With Adverse Events During HCV Treatment by Intervention Group

  at post-treatment week 12

• Change in Alcohol Use by Blood Test During HCV Treatment

  Pre-treatment and at treatment week 6

• Change in Illicit Drug Use During HCV Treatment

  Pre-treatment and at treatment week 6

• Number of Participants With Re-Infection After Achieving Sustained Virologic Response by Intervention Group

  at post-treatment week 12

Study Arms (3)

Usual Care

ACTIVE COMPARATOR

Participants receive standard of care for Hepatitis C in the clinic.

Other: Usual Care

Usual care plus peer-mentors

EXPERIMENTAL

In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.

Other: Usual care plus peer-mentors

Usual care plus incentives

EXPERIMENTAL

In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.

Other: Usual care plus incentives

Interventions

Usual care plus peer-mentors OTHER

Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.

Usual care plus peer-mentors

Usual care plus incentives OTHER

Participants are given incentives after completing treatment goals.

Usual care plus incentives

Usual Care OTHER

Participants receive standard of care in the clinic from their health care team.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or greater
• Hepatitis C genotype 1 infection for at least 6 months
• No evidence of Hepatocellular Carcinoma or End-Stage Liver Disease (e.g., history of ascites, bleeding varices, and/or encephalopathy)
• Cluster of Differentiation 4 (CD4) cell count \> 100 cells/mm3 for more than 3 months
• HIV RNA positive for more than 3 months
• Ability to communicate effectively with key study personnel
• Willing to give written informed consent and comply with the study requirements
• Life expectancy \> 2 year

You may not qualify if:

• Currently receiving Hepatitis C treatment
• Renal insufficiency - estimated glomerular filtration rate, calculated by the chronic kidney disease epidemiology collaboration formula: \<30 mL/min/1.73 m2
• Antiretroviral therapy inclusive of STRIBILD or APTIVUS
• Inability or unwillingness to avoid pregnancy for woman of child-bearing potential and/or to father children during treatment and for a period of 3 months following completion

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Johns Hopkins Hospital : The John G. Bartlett Specialty Practice

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Ward KM, Falade-Nwulia O, Moon J, Sutcliffe CG, Brinkley S, Haselhuhn T, Katz S, Herne K, Arteaga L, Mehta SH, Latkin C, Brooner RK, Sulkowski MS. A Randomized Controlled Trial of Cash Incentives or Peer Support to Increase HCV Treatment for Persons With HIV Who Use Drugs: The CHAMPS Study. Open Forum Infect Dis. 2019 Apr 9;6(4):ofz166. doi: 10.1093/ofid/ofz166. eCollection 2019 Apr.

  PMID: 31049365 DERIVED

MeSH Terms

Conditions

Hepatitis C; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; HIV Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Mark Sulkowski
• Organization: Johns Hopkins School of Medicine

msulkowski@jhmi.edu

443-997-1900

Study Officials

• Mark Sulkowski, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: March 18, 2015
• First Posted: March 30, 2015
• Study Start: August 1, 2015
• Primary Completion: January 4, 2017
• Study Completion: June 21, 2017
• Last Updated: April 14, 2020
• Results First Posted: September 6, 2019

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)