NCT03804814

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

May 21, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2021

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

2.4 years

First QC Date

December 6, 2018

Last Update Submit

February 7, 2023

Conditions

Keywords

Motivational InterviewingHealthcare delivery

Outcome Measures

Primary Outcomes (1)

  • HCV Treatment Completion

    To measure the number of patients who complete HCV therapy

    Through study completion, an average of 2 years

Secondary Outcomes (7)

  • Time from care engagement to treatment initiation

    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

  • Number of scheduled and attended medical care appointments

    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

  • Healthcare provider knowledge, attitudes, and behavior about motivational interviewing and training assessed by questionnaire

    Through study completion, an average of 2 years

  • +2 more secondary outcomes

Study Arms (2)

Motivational Interviewing Training

ACTIVE COMPARATOR

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

Behavioral: Motivational Interviewing Training

Standard Clinical Encounter

NO INTERVENTION

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

Interventions

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.

Motivational Interviewing Training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 1V7, Canada

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 6, 2018

First Posted

January 15, 2019

Study Start

May 21, 2019

Primary Completion

October 4, 2021

Study Completion

October 4, 2021

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations