Back to resultsVBMI to Increase Treatment Completion With MK-MK-5172/MK-8742 Among Veterans With Active Substance Use Disorders Genotype 1 Chronic Hepatitis C (VBMI SUD/HCV)
Primary Purpose
Patient Adherence, Chronic Hepatitis C, Alcohol-related Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VBMI
Sponsored by
About this trial
This is an interventional treatment trial for Patient Adherence, Chronic Hepatitis C, Alcohol-related Disorders
Eligibility Criteria
Inclusion Criteria:
- Identified as having treatment-naïve genotype 1 chronic HCV infection; Veterans who are genotype 1a must have baseline NS5a resistance testing
- Current resident of the SARRTP program
- Willing to initiate treatment with FDC MK-5172/MK-8742 during SARRTP and up to 30 days post-discharge.
- Willing to attend coordinated HCV treatment clinic visits and substance abuse aftercare visits every 2 weeks upon SARRTP discharge
Exclusion Criteria:
- Contraindications for therapy with FDC MK-5172/MK-8742
- Unable to provide written informed consent
- Hepatocellular carcinoma or other medical condition precluding HCV treatment
- Acute HCV infection
- Prior treatment for chronic HCV
- History of decompensated cirrhosis
- Platelet count < 75 K/cmm and/or albumin < 3 grams/dL
- Females and male sex partners of females who are pregnant, nursing and/or unwilling to use contraception
- Patients infected with genotype 1a who have not undergone baseline NS5a resistance testing
Sites / Locations
- GV Sonny Montgomery VAMC
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
VBMI intervention group
Arm Description
All patients will receive a 12 week VBMI intervention to promote treatment completion
Outcomes
Primary Outcome Measures
Treatment Completion
Number of participants who completed treatment
Secondary Outcome Measures
Sustained Virologic Response
Number of participants who achieved SVR
Full Information
NCT ID
NCT02823457
First Posted
July 1, 2016
Last Updated
January 6, 2022
Sponsor
G.V. (Sonny) Montgomery VA Medical Center
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT02823457
Brief Title
VBMI to Increase Treatment Completion With MK-MK-5172/MK-8742 Among Veterans With Active Substance Use Disorders Genotype 1 Chronic Hepatitis C
Acronym
VBMI SUD/HCV
Official Title
Evaluating Values-based Motivational Interviewing to Increase Treatment Completion With Fixed Dose Combination MK-5172/MK-8742 Among Veterans With Active Substance Use Disorders and Treatment-naïve Genotype 1 Chronic Hepatitis C
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
January 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
G.V. (Sonny) Montgomery VA Medical Center
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study implement a values-based motivational interviewing (VBMI) intervention to promote treatment completion with fixed dose combination (FDC) MK-5172/MK-8742 x 12 weeks among 30 Veterans with substance use disorder (SUD) and treatment naïve genotype 1 chronic hepatitis C virus (HCV) infection.
Detailed Description
The investigators will conduct a prospective study of 30 Veterans with treatment-naive genotype 1 chronic hepatitis C infection admitted to the Substance Abuse Residential Rehabilitation Treatment Program (SARRTP) at the G.V. (Sonny) Montgomery VA Medical Center. Enrolled veterans will be treated MK-5172/MI-8742 while receiving a 12 week values based motivational intervention to promote completion of HCV treatment. MK-5172/MK-8742 will be prescribed in accordance with the package insert.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Adherence, Chronic Hepatitis C, Alcohol-related Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
open label
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VBMI intervention group
Arm Type
Other
Arm Description
All patients will receive a 12 week VBMI intervention to promote treatment completion
Intervention Type
Behavioral
Intervention Name(s)
VBMI
Other Intervention Name(s)
Values Based Motivational Interviewing
Intervention Description
12 week values based motivational interviewing intervention with a licensed psychologist
Primary Outcome Measure Information:
Title
Treatment Completion
Description
Number of participants who completed treatment
Time Frame
12 weeks after initiation treatment
Secondary Outcome Measure Information:
Title
Sustained Virologic Response
Description
Number of participants who achieved SVR
Time Frame
an average of 3 months after treatment completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Identified as having treatment-naïve genotype 1 chronic HCV infection; Veterans who are genotype 1a must have baseline NS5a resistance testing
Current resident of the SARRTP program
Willing to initiate treatment with FDC MK-5172/MK-8742 during SARRTP and up to 30 days post-discharge.
Willing to attend coordinated HCV treatment clinic visits and substance abuse aftercare visits every 2 weeks upon SARRTP discharge
Exclusion Criteria:
Contraindications for therapy with FDC MK-5172/MK-8742
Unable to provide written informed consent
Hepatocellular carcinoma or other medical condition precluding HCV treatment
Acute HCV infection
Prior treatment for chronic HCV
History of decompensated cirrhosis
Platelet count < 75 K/cmm and/or albumin < 3 grams/dL
Females and male sex partners of females who are pregnant, nursing and/or unwilling to use contraception
Patients infected with genotype 1a who have not undergone baseline NS5a resistance testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Burton, MD
Organizational Affiliation
G.V. (Sonny) Montgomery VAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
GV Sonny Montgomery VAMC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
VBMI to Increase Treatment Completion With MK-MK-5172/MK-8742 Among Veterans With Active Substance Use Disorders Genotype 1 Chronic Hepatitis C
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