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 - 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 -