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Clinical Trials/NCT03804814
NCT03804814TerminatedNot Applicable

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

Nova Scotia Health Authority1 site in 1 country2 target enrollmentStarted: May 21, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
2
Locations
1
Primary Endpoint
HCV Treatment Completion

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

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

Arms & Interventions

Motivational Interviewing Training

Active Comparator

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

Intervention: Motivational Interviewing Training (Behavioral)

Standard Clinical Encounter

No Intervention

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

Outcomes

Primary Outcomes

HCV Treatment Completion

Time Frame: Through study completion, an average of 2 years

To measure the number of patients who complete HCV therapy

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lisa Barrett

Assistant Professor

Dalhousie University

Study Sites (1)

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