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Motivational Interviewing for HCV Elimination

Primary Purpose

Hepatitis C

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Motivational Interviewing Training
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hepatitis C focused on measuring Motivational Interviewing, Healthcare delivery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nova Scotia Health Authority

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Motivational Interviewing Training

Standard Clinical Encounter

Arm Description

Health care providers will be trained in motivational interviewing for use in Hepatitis C patient encounters.

Health care providers will not be trained in motivational interviewing for use in Hepatitis C patient encounters.

Outcomes

Primary Outcome Measures

HCV Treatment Completion
To measure the number of patients who complete HCV therapy

Secondary Outcome Measures

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

Full Information

First Posted
December 6, 2018
Last Updated
February 7, 2023
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT03804814
Brief Title
Motivational Interviewing for HCV Elimination
Official Title
Assessing a Model for Hepatitis C Elimination: Measuring Patient and Health System Outcomes After Motivational Interviewing Interventions to Increase Treatment Engagement
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Pandemic impacted ability to recruit and enroll
Study Start Date
May 21, 2019 (Actual)
Primary Completion Date
October 4, 2021 (Actual)
Study Completion Date
October 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Motivational Interviewing, Healthcare delivery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational Interviewing Training
Arm Type
Active Comparator
Arm Description
Health care providers will be trained in motivational interviewing for use in Hepatitis C patient encounters.
Arm Title
Standard Clinical Encounter
Arm Type
No Intervention
Arm Description
Health care providers will not be trained in motivational interviewing for use in Hepatitis C patient encounters.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
HCV Treatment Completion
Description
To measure the number of patients who complete HCV therapy
Time Frame
Through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
Time from care engagement to treatment initiation
Time Frame
Through study completion, an average of 2 years
Title
Number of unique Hepatitis C related and unrelated health system visits
Time Frame
Through study completion, an average of 2 years
Title
Number of scheduled and attended medical care appointments
Time Frame
Through study completion, an average of 2 years
Title
Self-reported intent to initiate and maintain HCV treatment assessed by questionnaire
Time Frame
Through study completion, an average of 2 years
Title
Healthcare provider knowledge, attitudes, and behavior about motivational interviewing and training assessed by questionnaire
Time Frame
Through study completion, an average of 2 years
Title
Time to complete prescribed HCV treatment course
Time Frame
Through study completion, an average of 2 years
Title
Percentage of eligible individuals that initiate HCV therapy
Time Frame
Through study completion, an average of 2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Motivational Interviewing for HCV Elimination

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