Comparison of Telemedicine to Usual Care for HCV Management for Methadone-maintained Individuals
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02933970|
Recruitment Status : Active, not recruiting
First Posted : October 14, 2016
Last Update Posted : April 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Other: Telemedicine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||602 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|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|
|Actual Study Start Date :||February 28, 2017|
|Actual Primary Completion Date :||February 11, 2021|
|Estimated Study Completion Date :||November 2022|
No Intervention: Control
Referral-HCV seropositive subjects enrolled for at least 12 months in an opiate agonist treatment (OAT) program will be referred to an off-site liver specialist
Telemedicine - HCV seropositive subjects enrolled for at least 12 months in an OAT program will be treated on site by a liver specialist via two-way video conferencing. (telemedicine)
Patients will be linked with the provider via two-way video-teleconferencing facilitated by an onsite OAT program staff member
Other Name: Two way video conferencing
- Percentage of patients in both arms who achieve viral eradication [ Time Frame: 12 weeks post treatment cessation ]Percentage of patients who achieve viral eradication (defined as undetectable HCV RNA for 12 weeks post treatment cessation)
- Comparison of treatment initiation rates [ Time Frame: Up to 160 weeks ]Comparison of treatment initiation rates between the two arms, as measured by the proportion of patients that take an initial medication dose.
- Comparison of treatment completion rates [ Time Frame: Up to 210 weeks ]Comparison of treatment completion rates between the two arms.
- Comparison of patient satisfaction [ Time Frame: Up to 210 weeks ]Comparison of patient satisfaction with healthcare delivery between the two arms as assessed through HCV Patient Satisfaction Questionnaire.
- Treatment adherence rates [ Time Frame: Up to 210 weeks ]Comparison of treatment adherence rates between the two arms as measured by attendance at scheduled specialist, telemedicine visits and medication adherence.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933970
|United States, New York|
|University at Buffalo|
|Buffalo, New York, United States, 14203|
|Principal Investigator:||Andrew H Talal, MD||SUNY Buffalo|