Comparison of Telemedicine to Usual Care for HCV Management for Methadone-maintained Individuals

Hepatitis C Clinical Trial

Official title:

Stepped-Wedge Randomized Control Trial to Compare Integrated, Co-located, Telemedicine-based HCV Management for Individuals on Opiate Agonist Treatment Versus Usual Care Treatment of HCV of Individuals on Opiate Agonist Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02933970
• Other study ID #: Telemedicine vs. Usual Care
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 28, 2017
• Est. completion date: April 2024

Study information

• Verified date: November 2022
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the effectiveness of a patient-centered, opiate agonist treatment (OAT)-integrated telemedicine-based approach for management and delivery of hepatitis C virus (HCV) treatment to persons with substance use disorders (PWSUD) versus usual care, which we anticipate in most cases will be referral to an offsite location for HCV management. The effectiveness will be expressed through the primary patient centered and clinical outcome, achievement of viral eradication, defined as undetectable HCV RNA 12 weeks post-treatment cessation.

Description:

The study will be conducted as a non-blinded stepped wedge cluster randomized controlled trial with two arms: onsite HCV management through telemedicine versus HCV management through usual care, which in most cases will be referral to an offsite liver specialist (Referral). The arm assignment will be at the cluster (clinic) level. After an initial period (6 months) in which all clinics implement the control intervention (usual care), at regular intervals (i.e., the "steps") of 6 months duration each, one group of clinics will be randomized to cross over from the Usual Care arm to the Telemedicine arm. In this way, there will be enough time for implementation and assessment of the intervention within each time period. The process continues until all clinics have crossed over to implement telemedicine, and thus all clinics contribute data to both interventions. In addition, patients will be followed for two years post-treatment cessation to assess for reinfection or relapse of HCV RNA.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 602
• Est. completion date: April 2024
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. HCV antibody detected

2. Ability and willingness of subject or legal representative to provide written informed consent.

3. 18 years of age

4. A minimum of 12-month enrollment in the opiate agonist treatment program

5. Likely to be adherent to the therapeutic regimen

6. Covered by medical insurance

Exclusion Criteria:

1. Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain.

2. <18 years of age

3. < 12 months enrolled in an opiate agonist treatment program.

4. Non-compliance with therapeutic regimen defined as three consecutive missed appointments that will result in a discussion between the principal investigator at the site and the study participant to determine the reason for the missed appointments. Continuation in the study for the participant will be assessed on a case-by-case basis between the study PI and the site PI.

5. Lack of medical insurance coverage

6. Ineligibility for HCV treatment

7. Active treatment for HCV at the time of the study enrollment

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Other:
• Telemedicine
Patients will be linked with the provider via two-way video-teleconferencing facilitated by an onsite OAT program staff member

Locations

Country	Name	City	State
United States	Andrew H Talal	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Andrew Talal	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients in both arms who achieve viral eradication	Percentage of patients who achieve viral eradication (defined as undetectable HCV RNA for 12 weeks post treatment cessation)	12 weeks post treatment cessation
Secondary	Comparison of treatment initiation rates	Comparison of treatment initiation rates between the two arms, as measured by the proportion of patients that take an initial medication dose.	Up to 160 weeks
Secondary	Comparison of treatment completion rates	Comparison of treatment completion rates between the two arms.	Up to 210 weeks
Secondary	Comparison of patient satisfaction	Comparison of patient satisfaction with healthcare delivery between the two arms as assessed through HCV Patient Satisfaction Questionnaire.	Up to 210 weeks
Secondary	Treatment adherence rates	Comparison of treatment adherence rates between the two arms as measured by attendance at scheduled specialist, telemedicine visits and medication adherence.	Up to 210 weeks

External Links

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