NCT02823457

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

July 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

April 5, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 12, 2021

Completed
Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

2.8 years

First QC Date

July 1, 2016

Results QC Date

December 11, 2020

Last Update Submit

January 6, 2022

Conditions

Patient Adherence, Chronic Hepatitis C, Alcohol-related Disorders

Outcome Measures

Primary Outcomes (1)

  • Treatment Completion

    Number of participants who completed treatment

    12 weeks after initiation treatment

Secondary Outcomes (1)

  • Sustained Virologic Response

    an average of 3 months after treatment completion

Study Arms (1)

VBMI intervention group

OTHER

All patients will receive a 12 week VBMI intervention to promote treatment completion

Behavioral: VBMI

Interventions

VBMIBEHAVIORAL

12 week values based motivational interviewing intervention with a licensed psychologist

Also known as: Values Based Motivational Interviewing
VBMI intervention group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GV Sonny Montgomery VAMC

Jackson, Mississippi, 39216, United States

Location

Related Publications (1)

  • Burton MJ, Voluse AC, Patel AB. Supporting direct acting antiviral medication adherence and treatment completion in a sample of predominantly rural veterans with hepatitis C and substance use disorders. Addict Sci Clin Pract. 2024 Jun 25;19(1):51. doi: 10.1186/s13722-024-00480-8.

    PMID: 38918869DERIVED

MeSH Terms

Conditions

Patient ComplianceHepatitis C, ChronicAlcohol-Related Disorders

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorHepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Mary Jane Burton
Organization
GV Sonny Montgomery VAMC
mary.burton2@va.gov
6013624471

Study Officials

  • Mary Burton, MD

    G.V. (Sonny) Montgomery VAMC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
open label
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

July 1, 2016

First Posted

July 6, 2016

Study Start

April 5, 2017

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

January 18, 2022

Results First Posted

January 12, 2021

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)