Motivational Interviewing for HCV Elimination

February 7, 2023 updated by: Lisa Barrett, Nova Scotia Health Authority

Assessing a Model for Hepatitis C Elimination: Measuring Patient and Health System Outcomes After Motivational Interviewing Interventions to Increase Treatment Engagement

This study addresses a difficult barrier to hepatitis C elimination, specifically development and maintenance of a productive relationship between the health care provider and patient to ensure both treatment success and engagement in harm reduction services. Improvements in these domains may be observed through the use of a technique called "Motivational Interviewing" (MI). The aim of this study is to determine whether a customized motivational interviewing curriculum by general primary care and addictions medicine primary care providers changes rates of curative hepatitis C therapy completion.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Health Authority

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Patient Inclusion Criteria:

  • Willingness to participate and provide informed consent
  • Positive HCV RNA Result
  • ≥18 years of age

Patient Exclusion Criteria:

  • Unwilling or unable to provide consent

Health Care Provider Inclusion Criteria:

  • Willingness to participate and provide informed consent
  • Has a hepatitis C care experience

Health Care Provider Exclusion Criteria:

  • Unwilling or unable to provide consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Motivational Interviewing Training
Health care providers will be trained in motivational interviewing for use in Hepatitis C patient encounters.
Behavioral: Motivational Interviewing Training

Motivational Interviewing is a directive, client-centered counselling style intended to elicit behavior change by helping patients reach health goals through their own desires and actions.

A certified and experienced Motivational Interviewing trainer will develop and deliver the curriculum to healthcare providers.
NO_INTERVENTION: Standard Clinical Encounter
Health care providers will not be trained in motivational interviewing for use in Hepatitis C patient encounters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCV Treatment Completion
Time Frame: Through study completion, an average of 2 years
To measure the number of patients who complete HCV therapy
Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Time from care engagement to treatment initiation
Time Frame: Through study completion, an average of 2 years
Through study completion, an average of 2 years
Number of unique Hepatitis C related and unrelated health system visits
Time Frame: Through study completion, an average of 2 years
Through study completion, an average of 2 years
Number of scheduled and attended medical care appointments
Time Frame: Through study completion, an average of 2 years
Through study completion, an average of 2 years
Self-reported intent to initiate and maintain HCV treatment assessed by questionnaire
Time Frame: Through study completion, an average of 2 years
Through study completion, an average of 2 years
Healthcare provider knowledge, attitudes, and behavior about motivational interviewing and training assessed by questionnaire
Time Frame: Through study completion, an average of 2 years
Through study completion, an average of 2 years
Time to complete prescribed HCV treatment course
Time Frame: Through study completion, an average of 2 years
Through study completion, an average of 2 years
Percentage of eligible individuals that initiate HCV therapy
Time Frame: Through study completion, an average of 2 years
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 21, 2019

Primary Completion (ACTUAL)

October 4, 2021

Study Completion (ACTUAL)

October 4, 2021

Study Registration Dates

First Submitted

December 6, 2018

First Submitted That Met QC Criteria

January 11, 2019

First Posted (ACTUAL)

January 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAIL-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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