Patient-Centered Models of HCV Care for People Who Inject Drugs
HERO
1 other identifier
interventional
755
1 country
1
Brief Summary
People who inject drugs (PWID) have higher rates of hepatitis C virus (HCV) than do other groups. Effective, safe new treatments called direct-acting antiviral agents (DAAs) have been developed recently. Unfortunately, PWID rarely get these treatments. The drugs are expensive, so insurers often do not cover the cost of DAAs. Sometimes providers hesitate to prescribe DAAs because they are concerned that PWID won't take their medication or that these patients might become reinfected. Several good models for treating PWID exist. One of them is to provide directly observed treatment (DOT). Another model provides treatment to PWID with the support of patient navigators (PN), public health workers who offer support and education to patients. Though both the DOT and PN models have been successful, we still don't know which model works best. In this study, the investigators will study both DOT and PN models for treating HCV in PWID. The investigators' goal is to find out which model produces the best results and is preferred by patients. Up to 1,000 HCV-infected PWID will participate in the study in eight sites around the country. Patients will be randomized into either the PN or the DOT groups. Patients who end up in the PN group will get a biweekly blister pack of medication to take home. Their PN will provide education and support. The investigators will find out whether patients adhered to medication using an electronic adherence monitoring system. Patients who are randomly assigned to the DOT group will take their medication in front of a staff member.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2016
CompletedFirst Posted
Study publicly available on registry
July 7, 2016
CompletedStudy Start
First participant enrolled
September 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2021
CompletedResults Posted
Study results publicly available
September 26, 2024
CompletedSeptember 26, 2024
June 1, 2022
3.5 years
June 23, 2016
June 30, 2022
September 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sustained Viral Response (SVR)
HCV viral load undetectable 12 weeks after treatment completion.
12 weeks after treatment completion
Secondary Outcomes (5)
HCV DAA Treatment Initiation
Up to 12 weeks after study enrollment
Adherence (by Electronic Monitors)
During 12 weeks of treatment
HCV DAA Treatment Completion
After 12 weeks of treatment
Resistance (to NS5A)
At weeks 12 or 24
Resistance (to NS5B)
At weeks 12 or 24
Study Arms (2)
Patient Navigation
ACTIVE COMPARATORThe study will follow a PN model (Check Hep C) developed by NYCDOH in collaboration with Montefiore and the community. HCV PNs will provide the following interventions to those randomized to the PN arm: coordination of HCV treatment; health promotion; assisting patients to overcome barriers; and psychosocial support. Health Promotion Sessions: PNs will deliver 4 standardized health promotion sessions to all patients either individually or within a group. Optional Weekly Support Groups: Subjects randomized to the PN arm will be offered weekly support groups led by Peers.
modified Directly Observed Therapy
ACTIVE COMPARATOROAT clinic setting: Observation of HCV medications will be linked to methadone visits among patients receiving methadone. Patients will be receiving methadone as part of routine clinical care for opioid addiction and not as an intervention related to this study. The schedule of five days per week will be considered modified DOT (mDOT). Subjects will initiate HCV treatment on Mondays if feasible. Take home medications will be packed in a weekly electronic blister pack. Community health clinic setting: This intervention is considered modified DOT (mDOT) since between 3-5 weekly doses will be directly observed. A minimum of one dose will be observed in person by clinic/study staff. For the remaining observed doses, the research staff and provider will present the participant with a menu of options and determine what will work best for that participant.
Interventions
The study will follow a PN model (Check Hep C) developed by NYCDOH in collaboration with Montefiore and the community. HCV PNs will provide the following interventions to those randomized to the PN arm: coordination of HCV treatment; health promotion; assisting patients to overcome barriers; and psychosocial support.
Subjects will be observed taking medications, a minimum of 5 times a week for those enrolled in the OAT setting, and a minimum of 3 times a week for those enrolled in the community health clinic setting.
Eligibility Criteria
You may qualify if:
- HCV infection
- Actively injecting drugs (any substance within 3 months)
- Not previously treated with HCV direct-acting antiviral medications
- Age 18 - 70
- Willing to receive HCV treatment with sofosbuvir/velpatasvir
- Willing to be randomized to either PN vs mDOT
- If receiving methadone, be attending methadone clinic a minimum of 5 times per week
- Able to provide informed consent
- English or Spanish fluency
You may not qualify if:
- Pregnant or breast feeding
- Hepatocellular carcinoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Prisma Health-Upstatelead
- Massachusetts General Hospitalcollaborator
- University of Rhode Islandcollaborator
- Johns Hopkins Universitycollaborator
- West Virginia Universitycollaborator
- University of New Mexicocollaborator
- University of Californiacollaborator
- University of Washingtoncollaborator
- Montefiore Medical Centercollaborator
Study Sites (1)
Alain Litwin
The Bronx, New York, 10467, United States
Related Publications (6)
Pericot-Valverde I, Lopes SS, Obeysekare J, Batchelder AW, Groome M, Taylor LE, Page K, Tsui JI, Lum PJ, Mehta SH, Feinberg J, Kim AY, Norton BL, Arnsten J, Baker A, Heo M, Litwin AH; HERO Study Group. Depression profiles and hepatitis C treatment outcomes among people who inject drugs: The HERO study. J Psychosom Res. 2025 Dec;199:112417. doi: 10.1016/j.jpsychores.2025.112417. Epub 2025 Oct 17.
PMID: 41124945DERIVEDTsui JI, Ludwig-Barron NT, James JR, Heo M, Sivaraj LB, Arnsten J, Lum PJ, Taylor LE, Mehta SH, Falade-Nwulia O, Feinberg J, Kim AY, Norton B, Page K, Litwin AH. Current Self-reported Pain Before and After Cure of Hepatitis C Among Persons Who Actively Inject Drugs. J Addict Med. 2025 May-Jun 01;19(3):248-253. doi: 10.1097/ADM.0000000000001398. Epub 2024 Oct 30.
PMID: 39475112DERIVEDLitwin AH, Tsui JI, Heo M, Mehta SH, Taylor LE, Lum PJ, Feinberg J, Kim AY, Norton BL, Pericot-Valverde I, Arnsten J, Meissner P, Karasz A, McKee MD, Ward JW, Johnson N, Agyemang L, Stein ES, Thomas A, Borsuk C, Blalock KL, Wilkinson S, Wagner K, Carty J, Murray-Krezan C, Anderson J, Jacobsohn V, Luetkemeyer AF, Falade-Nwulia O, Groome M, Davies S, Costello K, Page K; HERO Study Group. Hepatitis C Virus Reinfection Among People Who Inject Drugs: Long-Term Follow-Up of the HERO Study. JAMA Netw Open. 2024 Aug 1;7(8):e2430024. doi: 10.1001/jamanetworkopen.2024.30024.
PMID: 39186268DERIVEDHeo M, Norton BL, Pericot-Valverde I, Mehta SH, Tsui JI, Taylor LE, Lum PJ, Feinberg J, Kim AY, Arnsten JH, Sprecht-Walsh S, Page K, Murray-Krezan C, Anderson J, Litwin AH; HERO Study Group. Optimal hepatitis C treatment adherence patterns and sustained virologic response among people who inject drugs: The HERO study. J Hepatol. 2024 May;80(5):702-713. doi: 10.1016/j.jhep.2023.12.020. Epub 2024 Jan 17.
PMID: 38242324DERIVEDTsui JI, Lum PJ, Taylor LE, Mehta SH, Feinberg J, Kim AY, Norton BL, Niu J, Heo M, Arnsten J, Pericot-Valverde I, Thomas A, Blalock KL, Radick A, Murray-Krezan C, Page K, Litwin AH; HERO Study Group. Injecting practices during and after hepatitis C treatment and associations with not achieving cure among persons who inject drugs. Drug Alcohol Depend. 2023 Jun 1;247:109878. doi: 10.1016/j.drugalcdep.2023.109878. Epub 2023 Apr 17.
PMID: 37150144DERIVEDLitwin AH, Lum PJ, Taylor LE, Mehta SH, Tsui JI, Feinberg J, Kim AY, Norton BL, Heo M, Arnsten J, Meissner P, Karasz A, Mckee MD, Ward JW, Johnson N, Pericot-Valverde I, Agyemang L, Stein ES, Thomas A, Borsuk C, Blalock KL, Wilkinson S, Wagner K, Roche J, Murray-Krezan C, Anderson J, Jacobsohn V, Luetkemeyer AF, Falade-Nwulia O, Page K; HERO Study Group. Patient-centred models of hepatitis C treatment for people who inject drugs: a multicentre, pragmatic randomised trial. Lancet Gastroenterol Hepatol. 2022 Dec;7(12):1112-1127. doi: 10.1016/S2468-1253(22)00275-8.
PMID: 36370741DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Megan Groome
- Organization
- Prisma Health
Study Officials
- PRINCIPAL INVESTIGATOR
Alain Litwin, MD, MPH
Prisma Health-Upstate
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2016
First Posted
July 7, 2016
Study Start
September 15, 2016
Primary Completion
March 20, 2020
Study Completion
August 4, 2021
Last Updated
September 26, 2024
Results First Posted
September 26, 2024
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share