TY - JOUR
T1 - Patient-centered HCV care via telemedicine for individuals on medication for opioid use disorder
T2 - Telemedicine for Evaluation, Adherence and Medication for Hepatitis C (TEAM-C)
AU - Talal, Andrew H.
AU - Markatou, Marianthi
AU - Sofikitou, Elisavet M.
AU - Brown, Lawrence S.
AU - Perumalswami, Ponni
AU - Dinani, Amreen
AU - Tobin, Jonathan N.
N1 - Funding Information:
This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Award (IHS-1507-31640) and partially supported by the Troup Fund of the Kaleida Health Foundation . The statements in this work are solely the responsibility of the authors and do not necessarily represent the views of PCORI, its Board of Governors or Methodology Committee. Additional support was provided by Abbott Laboratories. The funding sources had no role in the study design, in the collection, analysis and interpretation of data, in writing of the manuscript, or in the decision to submit the manuscript for publication.
Funding Information:
This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Award (IHS-1507-31640) and partially supported by the Troup Fund of the Kaleida Health Foundation. The statements in this work are solely the responsibility of the authors and do not necessarily represent the views of PCORI, its Board of Governors or Methodology Committee. Additional support was provided by Abbott Laboratories. The funding sources had no role in the study design, in the collection, analysis and interpretation of data, in writing of the manuscript, or in the decision to submit the manuscript for publication.AHT has received research support from Merck, Gilead, Abbott Laboratories, AbbVie Inc., Intercept, Genfit, BMS, and Eli Lilly and Co. He has served on committees or as an advisor to AbbVie, Gilead, Eli Lilly, Intercept, Regeneron, and Merck. JNT has received research support from PCORI, NIH, AHRQ, ACL, as well as Astra-Zeneca, Purdue Pharma, Syneos and the Campbell Foundation.
Publisher Copyright:
© 2021 The Authors
PY - 2022/1
Y1 - 2022/1
N2 - Background: Telemedicine has the potential to increase healthcare access especially for vulnerable populations. Telemedicine for Evaluation, Adherence, and Medication for Hepatitis C (TEAM-C) is comparing telemedicine access to specialty medical care to usual care for management of hepatitis C virus (HCV) infection among persons with opioid use disorder (PWOUD). PWOUD have the highest hepatitis C virus (HCV) prevalence and incidence, yet they infrequently receive HCV care. The study objectives are to compare access to specialty care via telemedicine to offsite specialty referral (usual care) on 1) treatment initiation, completion, and sustained virological response, 2) patient satisfaction with health care delivery, and 3) HCV reinfection after successful HCV cure. Methods: TEAM-C is a multi-site, non-blinded, randomized pragmatic clinical trial conducted at 12 opioid treatment programs (OTP) throughout New York State that utilizes the stepped-wedge design. The unit of randomization is the OTP with a total sample size of 624 participants. HCV-infected PWOUD were treated via telemedicine or referral. Telemedicine encounters are conducted onsite in the OTP with co-administration of direct acting antivirals for HCV with medications for opioid use disorder. The primary outcome is undetectable HCV RNA obtained 12 weeks post-treatment cessation. We also follow participants for two years to assess for reinfection. Conclusions: The study utilizes a rigorous study design to evaluate the effectiveness and implementation of virtual treatment for HCV integrated into behavioral treatment. We demonstrate the feasibility, engagement principles and lessons learned from the initial prospective randomized trial of telemedicine targeted to a vulnerable population.
AB - Background: Telemedicine has the potential to increase healthcare access especially for vulnerable populations. Telemedicine for Evaluation, Adherence, and Medication for Hepatitis C (TEAM-C) is comparing telemedicine access to specialty medical care to usual care for management of hepatitis C virus (HCV) infection among persons with opioid use disorder (PWOUD). PWOUD have the highest hepatitis C virus (HCV) prevalence and incidence, yet they infrequently receive HCV care. The study objectives are to compare access to specialty care via telemedicine to offsite specialty referral (usual care) on 1) treatment initiation, completion, and sustained virological response, 2) patient satisfaction with health care delivery, and 3) HCV reinfection after successful HCV cure. Methods: TEAM-C is a multi-site, non-blinded, randomized pragmatic clinical trial conducted at 12 opioid treatment programs (OTP) throughout New York State that utilizes the stepped-wedge design. The unit of randomization is the OTP with a total sample size of 624 participants. HCV-infected PWOUD were treated via telemedicine or referral. Telemedicine encounters are conducted onsite in the OTP with co-administration of direct acting antivirals for HCV with medications for opioid use disorder. The primary outcome is undetectable HCV RNA obtained 12 weeks post-treatment cessation. We also follow participants for two years to assess for reinfection. Conclusions: The study utilizes a rigorous study design to evaluate the effectiveness and implementation of virtual treatment for HCV integrated into behavioral treatment. We demonstrate the feasibility, engagement principles and lessons learned from the initial prospective randomized trial of telemedicine targeted to a vulnerable population.
KW - Hepatitis C virus
KW - Persons with opioid use disorder
KW - Pragmatic clinical trial
KW - Stepped-wedge design
KW - Telemedicine
UR - http://www.scopus.com/inward/record.url?scp=85121658695&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2021.106632
DO - 10.1016/j.cct.2021.106632
M3 - Article
C2 - 34813962
AN - SCOPUS:85121658695
SN - 1551-7144
VL - 112
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 106632
ER -