TY - JOUR
T1 - Rationale and design of a randomized pragmatic trial of patient-centered models of hepatitis C treatment for people who inject drugs
T2 - The HERO study
AU - the HERO Study Group
AU - Litwin, Alain H.
AU - Jost, John
AU - Wagner, Katherine
AU - Heo, Moonseong
AU - Karasz, Alison
AU - Feinberg, Judith
AU - Kim, Arthur Y.
AU - Lum, Paula J.
AU - Mehta, Shruti H.
AU - Taylor, Lynn E.
AU - Tsui, Judith I.
AU - Pericot-Valverde, Irene
AU - Page, Kimberly
N1 - Funding Information:
Authors: AHL is a consultant/advisor and has received research grants from AbbVie, Gilead Sciences, and Merck Pharmaceuticals. JJ, KW, MH, AK, SM, AK, LT, PL, and IPV have nothing to declare. JF is a consultant/advisor and has received research grants from Gilead. JT is the recipient of a Small Business Innovation Research (SBIR) grant from NIH/NIDA (R44DA044053; PI: Seiguer/Tsui) in partnership with a health technology company (emocha) to research the feasibility of using smartphone app to improve adherence to office-based buprenorphine treatment. KP has received research funding from Gilead Sciences for research unrelated to this project. HERO Study Group: BN has received research grants from Merck Pharmaceuticals. WS, VL, MH, EM, LA, JA, DMM, PM, CB, OF-N, SW, CM-K, KT, ES, KB, JW, AA, NJ, AR have nothing to declare.
Funding Information:
This research was funded through a Patient-Centered Outcomes Research Institute (PCORI) Award HPC-1503-28122 with additional support by Gilead Sciences, Quest Diagnostics, Monogram Biosciences, and OraSure Technologies.
Funding Information:
The HERO Research Group includes the PI and Co-Investigators from each of the 9 sites, PIs from the CDC and the NYC DOH, statisticians and key staff (such as project directors and patient representatives), and key stakeholders. HERO study sites include: Prisma Health and Clemson University, Albert Einstein College of Medicine/Montefiore Medical Center, University of Rhode Island, Johns Hopkins Bloomberg School of Public Health, Massachusetts General Hospital, University of California, San Francisco, University of New Mexico, University of Washington, and West Virginia University. The opinions presented in this work are solely the responsibility of the author and do not necessarily represent the views of PCORI, its Board of Governors or Methodology Committee. This research was funded through a Patient-Centered Outcomes Research Institute (PCORI) AwardHPC-1503-28122 with additional support by Gilead Sciences, Quest Diagnostics, Monogram Biosciences, and OraSure Technologies.
Publisher Copyright:
© 2019
PY - 2019/12
Y1 - 2019/12
N2 - Background: Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk. As direct-acting antiviral agents (DAAs) have achieved sustained virologic response (SVR) rates of 95% or more, evidence-based strategies are urgently needed to demonstrate real-world effectiveness in marginalized patient populations such as PWID. The objectives of this study are: 1) to determine whether either of two patient-centered treatment models – patient navigation (PN) or modified directly observed therapy (mDOT) – results in more forward movement along the HCV care cascade including treatment initiation, adherence, and SVR; 2) using quantitative and qualitative methods, to understand factors associated with lack of treatment uptake, poor adherence (<80%), failure to achieve SVR, DAA resistance, and HCV reinfection. Methods: The HERO study is a multi-site, pragmatic randomized clinical trial conducted in eight states where 754 HCV-infected PWID were randomly assigned to either PN or mDOT. Conclusions: This study addresses an urgent need for timely and accurate information on optimal models of care to promote HCV treatment initiation, adherence, treatment completion and SVR among PWID, as well as rates and factors associated with reinfection and resistance after treatment. This clinical trial has the potential to provide valuable information on how to reduce the burden of the HCV epidemic in PWID.
AB - Background: Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk. As direct-acting antiviral agents (DAAs) have achieved sustained virologic response (SVR) rates of 95% or more, evidence-based strategies are urgently needed to demonstrate real-world effectiveness in marginalized patient populations such as PWID. The objectives of this study are: 1) to determine whether either of two patient-centered treatment models – patient navigation (PN) or modified directly observed therapy (mDOT) – results in more forward movement along the HCV care cascade including treatment initiation, adherence, and SVR; 2) using quantitative and qualitative methods, to understand factors associated with lack of treatment uptake, poor adherence (<80%), failure to achieve SVR, DAA resistance, and HCV reinfection. Methods: The HERO study is a multi-site, pragmatic randomized clinical trial conducted in eight states where 754 HCV-infected PWID were randomly assigned to either PN or mDOT. Conclusions: This study addresses an urgent need for timely and accurate information on optimal models of care to promote HCV treatment initiation, adherence, treatment completion and SVR among PWID, as well as rates and factors associated with reinfection and resistance after treatment. This clinical trial has the potential to provide valuable information on how to reduce the burden of the HCV epidemic in PWID.
KW - Antiviral therapy
KW - Hepatitis C
KW - Injection drug use
KW - Sustained virologic response
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U2 - 10.1016/j.cct.2019.105859
DO - 10.1016/j.cct.2019.105859
M3 - Article
C2 - 31669450
AN - SCOPUS:85074345494
SN - 1551-7144
VL - 87
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 105859
ER -