Patient Adherence, Chronic Hepatitis C, Alcohol-related DisordersVBMI SUD/HCVNCT02823457

VBMI to Increase Treatment Completion With MK-MK-5172/MK-8742 Among Veterans With Active Substance Use Disorders Genotype 1 Chronic Hepatitis C

A study testing VBMI in people with Patient Adherence, Chronic Hepatitis C, Alcohol-related Disorders, run by G.V. (Sonny) Montgomery VA Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Patient Adherence, Chronic Hepatitis C, Alcohol-related Disorders
What is being tested?: VBMI
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 5 Apr 2017to 30 Jan 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

GV Sonny Montgomery VAMC
Jackson, Mississippi, 39216

Other trials in United States

About this study

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

Read the 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.

Conditions: Patient Adherence, Chronic Hepatitis C, Alcohol-related Disorders
Being tested: VBMI
Medical subject headings: Patient Compliance, Hepatitis C, Chronic, Alcohol-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VBMIBehavioural
Also called Values Based Motivational Interviewing
12 week values based motivational interviewing intervention with a licensed psychologist

Study groups in NCT02823457
Study group	Role	What they receive
VBMI intervention group	Other	All patients will receive a 12 week VBMI intervention to promote treatment completion Receives: Behavioral: VBMI

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment Completion
Number of participants who completed treatment
Measured: 12 weeks after initiation treatment

Secondary outcomes (1)

Sustained Virologic Response
Number of participants who achieved SVR
Measured: an average of 3 months after treatment completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Apr 201730 Jan 2020

First posted6 Jul 2016 (estimated)
Study start5 Apr 2017
Primary completion30 Jan 2020
Study completion30 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Patient Adherence, Chronic Hepatitis C, Alcohol-related DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02823457
Sponsor's protocol ID: 53635
Acronym: VBMI SUD/HCV
Status last verified: Jan 2022
First submitted: 1 Jul 2016
Last updated: 18 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 38918869

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02823457
Acronym / sponsor ID: VBMI SUD/HCV / 53635
Conditions: Patient Adherence, Chronic Hepatitis C, Alcohol-related Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: G.V. (Sonny) Montgomery VA Medical CenterUS federal agency
Collaborators: Merck Sharp & Dohme LLC
Study start: 5 Apr 2017 (actual)
Primary completion: 30 Jan 2020 (actual)
Study completion: 30 Jan 2020 (actual)
First posted: 6 Jul 2016 (estimated)
Results: Posted 12 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
VBMI intervention group	Other	Behavioral: VBMIAll patients will receive a 12 week VBMI intervention to promote treatment completion

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VBMIAlso: Values Based Motivational Interviewing12 week values based motivational interviewing intervention with a licensed psychologist	Behavioural	VBMI intervention group

Primary outcome

Treatment Completion
Time frame: 12 weeks after initiation treatment
Number of participants who completed treatment

1 secondary outcome

Sustained Virologic Response
Time frame: an average of 3 months after treatment completion

Results and safety

Results posted to the registry on 12 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VBMI Intervention Group	20	15

Primary outcome: Treatment Completion

Time frame: 12 weeks after initiation treatment. Count of participants. Unit: Participants

Measure	VBMI Intervention Group n = 20
Value	15

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Six months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VBMI Intervention Group	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38918869Burton 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mary Burton, MD principal investigator

G.V. (Sonny) Montgomery VAMC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing VBMI in people with Patient Adherence, Chronic Hepatitis C, Alcohol-related Disorders, run by G.V. (Sonny) Montgomery VA Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Completion (time frame: 12 weeks after initiation treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02823457, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.