Hepatitis CNCT03804814
Motivational Interviewing for HCV Elimination
A study testing Motivational Interviewing Training in people with Hepatitis C, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Motivational Interviewing Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- 21 May 2019to 4 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hepatitis C
- Being tested
- Motivational Interviewing Training
- Keywords
- Motivational Interviewing, Healthcare delivery
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing Training | Active comparator | Health care providers will be trained in motivational interviewing for use in Hepatitis C patient encounters. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV Treatment Completion
To measure the number of patients who complete HCV therapy
Measured: Through study completion, an average of 2 years
Secondary outcomes (7)
Time from care engagement to treatment initiation
Measured: Through study completion, an average of 2 years
Number of unique Hepatitis C related and unrelated health system visits
Measured: Through study completion, an average of 2 years
Number of scheduled and attended medical care appointments
Measured: Through study completion, an average of 2 years
Self-reported intent to initiate and maintain HCV treatment assessed by questionnaire
Measured: Through study completion, an average of 2 years
Healthcare provider knowledge, attitudes, and behavior about motivational interviewing and training assessed by questionnaire
Measured: Through study completion, an average of 2 years
Time to complete prescribed HCV treatment course
Measured: Through study completion, an average of 2 years
Percentage of eligible individuals that initiate HCV therapy
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start21 May 2019
- Primary completion4 Oct 2021
- Study completion4 Oct 2021
Why it stopped: Pandemic impacted ability to recruit and enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Barrett, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804814
- Sponsor's protocol ID
- SAIL-003
- Status last verified
- Feb 2023
- First submitted
- 6 Dec 2018
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing a Model for Hepatitis C Elimination: Measuring Patient and Health System Outcomes After Motivational Interviewing Interventions to Increase Treatment Engagement
- ClinicalTrials.gov ID
- NCT03804814
- Acronym / sponsor ID
- SAIL-003
- Conditions
- Hepatitis C
- Keywords
- Motivational Interviewing, Healthcare delivery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pandemic impacted ability to recruit and enroll
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 21 May 2019 (actual)
- Primary completion
- 4 Oct 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing Training | Active comparator | Behavioral: Motivational Interviewing TrainingHealth care providers will be trained in motivational interviewing for use in Hepatitis C patient encounters. |
| Standard Clinical Encounter | No intervention | –Health care providers will not be trained in motivational interviewing for use in Hepatitis C patient encounters. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Motivational Interviewing TrainingMotivational 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. | Behavioural | Motivational Interviewing Training |
Primary outcome
HCV Treatment Completion
Time frame: Through study completion, an average of 2 years
To measure the number of patients who complete HCV therapy
7 secondary outcomes
Time from care engagement to treatment initiation
Time frame: 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
Number of scheduled and attended medical care appointments
Time frame: 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
Healthcare provider knowledge, attitudes, and behavior about motivational interviewing and training assessed by questionnaire
Time frame: 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
Percentage of eligible individuals that initiate HCV therapy
Time frame: Through study completion, an average of 2 years
Results and safety
The study was stopped early (reason given: Pandemic impacted ability to recruit and enroll). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing Training in people with Hepatitis C, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2023. 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 Canada. 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?
The study was stopped early (reason given: Pandemic impacted ability to recruit and enroll). Results are not available in the source record.
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?
HCV Treatment Completion (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2023.