Clinical trial NCT02402218: CHAMPS Study: Chronic HepAtitis C Management to ImProve OutcomeS
Official title: CHAMPS Study: Chronic HepAtitis C Management to ImProve OutcomeS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C Virus Infection, Response to Therapy of
Human Immunodeficiency Virus
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institutes of Health (NIH)
First posted: 2015-03-30
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. Usual care in the clinic. This treatment group will receive the standard of care for HCV treatment from their health care team.
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. 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.

HCV treatment with ledipasvir/sofosbuvir is considered the standard of care for HCV and is recommended by experts in liver disease and infectious diseases.

Detailed description: Recent advances in Hepatitis C Virus (HCV) treatment represent a paradigm shift for the treatment of HCV-infected persons with Human Immunodeficiency Virus (HIV) coinfection. With potent antiviral activity, excellent safety/tolerability, few drug interactions and once daily, oral dosing, Sofosbuvir (SOF)/Ledipasvir (LDV) have had excellent efficacy in randomized controlled trials and offer great promise for the treatment of hepatitis C in HIV/HCV coinfected patients who are at high risk for progressive liver disease and HCV-related mortality. While the availability of SOF/LDV has great promise for the treatment of patients, the experience with antiretroviral therapy (ART) for the treatment of HIV infection indicates that interferon-free oral therapy is necessary but not sufficient to cure HCV in the real world. While removal of Interferon increases the proportion of coinfected persons who use drugs (PWUD) eligible for treatment, multiple barriers will remain (e.g., medical/psychiatric illness, substance abuse, and social constraints). Effective ART in coinfected PWUDs provides a strategic framework for the delivery of curative HCV treatment; novel and effective strategies for delivering this care for HCV must be evaluated, including incentives and peer-mentoring.

Financial incentives. One method for increasing delivery of care is the contingent administration of monetary incentives; such reinforcements have improved health outcomes related to drug/alcohol abstinence, smoking cessation, childhood vaccination, tuberculosis care and HIV treatment. Contingent reinforcement has also been successfully used to link HIV-infected patients to care and improve adherence to ART. Curative HCV treatments are given for a finite duration (12 weeks) which offers an ideal paradigm for incentive interventions by reducing the overall cost and removing concerns of loss of adherence if incentives are stopped.

Peer support. A second method for improving delivery of care is the use of peers or laypersons with the same illness. By matching on cultural competencies and establishing trust, peers may be particularly effective in some settings. In one study, African American veterans with poorly controlled diabetes assigned to peer-support had better glucose control than those assigned financial incentives. Coinfected patients may benefit from peer support.

The investigators will test two innovative strategies to improve HCV treatment outcomes in HIV/HCV coinfected patients through the delivery of SOF/LDV for 12 weeks as part of a randomized controlled trial. HIV-infected patients will receive SOF/LDV under one of three randomly assigned conditions: usual care (clinic-based nursing model), incentive care (IC) or peer-mentor care (PMC).

Eligibility criteria: Inclusion Criteria:

* 18 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Participants Who Initiated HCV Therapy by Intervention Group
timeFrame: at week 1
Secondary outcomes:
measure: Sustained Virologic Response (SVR) Following Treatment by Intervention Group
timeFrame: at post-treatment week 12
measure: Number of Participants With Adverse Events During HCV Treatment by Intervention Group
timeFrame: at post-treatment week 12
measure: Change in Alcohol Use by Blood Test During HCV Treatment
timeFrame: Pre-treatment and at treatment week 6
measure: Change in Illicit Drug Use During HCV Treatment
timeFrame: Pre-treatment and at treatment week 6
measure: Number of Participants With Re-Infection After Achieving Sustained Virologic Response by Intervention Group
timeFrame: at post-treatment week 12
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital : The John G. Bartlett Specialty Practice
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Mark Sulkowski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.