Data Coordinating Center
HERO study will provide critical data on HCV treatment in people who inject drugs
The HERO (Hepatitis Real Options) study is a two arm study evaluating modified directly observed therapy (mDOT) versus patient navigation (PN) to deliver HCV treatment to people who inject drugs in two clinical health settings: (1) opioid treatment program (OTP), (2) community-based health service (CBHS). This is a multi-site study, with eight sites across the country. Participants will be randomized to one of two treatment model arms, A: mDOT or B: PN, at one of the two clinical sites. Up to 1,000 people will be enrolled, with 600 initiating treatment. Participants will be enrolled for up to 132 weeks: up to 12 weeks of pre-treatment evaluation, 12 weeks of treatment, 12 weeks of follow-up to determine Sustained Virologic Response (SVR) 12, and 96 weeks of follow-up to determine long-term SVR and reinfection. This study is funded by PCORI (“Patient-Centered Models of HCV Care for People Who Inject Drugs”) under principal investigator Dr. Alain Litwin of Montefiore Medical Center.
The HERO Statistics and Data Coordinating Center is housed at UNM under the direction of Dr. Kimberly Page. We provide an electronic data capture system for accurate data collection and secure storage of all study data. Our staff designs the database, conducts database maintenance, performs data integrity checks, and produces weekly accrual reports and other pre-specified and ad hoc reports, as requested. Faculty biostatisticians will provide statistical analyses of the final study results and contribute to the final clinical study report(s).