Comparison of Telemedicine to Usual Care for HCV Management for Methadone-maintained Individuals
| Status: | Recruiting |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/9/2018 |
| Start Date: | February 28, 2017 |
| End Date: | March 2022 |
| Contact: | Andrew H Talal, MD |
| Email: | ahtalal@buffalo.edu |
| Phone: | 716 829-6208 |
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
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.
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.
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.
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.
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
We found this trial at
1
site
Buffalo, New York 14215
Principal Investigator: Andrew H Talal
Phone: 716-888-4739
Click here to add this to my saved trials
