Hepatitis CHERONCT02824640
Patient-Centered Models of HCV Care for People Who Inject Drugs
A study testing Patient Navigation and modified Directly Observed Therapy in people with Hepatitis C and Medication Adherence, run by Prisma Health-Upstate at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C, Medication Adherence
- What is being tested?
- Patient Navigation and modified Directly Observed Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 755 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2016to 4 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- If receiving methadone, be attending methadone clinic a minimum of 5 times per week
- Able to provide informed consent
- English or Spanish fluency
Who cannot join
- Pregnant or breast feeding
- Hepatocellular carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This is a multi-site national study (8 U.S. cities), where up to 1000 HCV-infected PWIDs (injecting illicit substances within the last 3 months) will be randomized to either PN plus biweekly blister pack dispensation versus mDOT. Among patients who go on to initiate HCV treatment (n=600 targeted) with a once-daily combination regimen, a comparison will be conducted of the proportion of patients in each arm who: (a) optimally adhere (>=80%), (b) complete treatment, (c) achieve SVR, and (d) develop resistance. The primary outcome will be SVR. The 8 sites offer geographic and policy diversity: New York City, Baltimore, Providence, Boston, Morgantown, Seattle, San Francisco, and Albuquerque.
Participants will be recruited from diverse venues: OAT clinics, community health centers, syringe exchange programs, community-based organizations, homeless programs, and cohorts established by research studies. The clinical sites will determine eligibility based on clinical records, or on-site testing including for HCV tests (anti-HCV and HCV viremia) and drug toxicology testing as needed. Study participants will be screened, consented and enrolled on-site at OAT and non-OAT clinic settings.
Patients will be randomized to one of two models of care: patient navigation (PN) vs. modified directly observed treatment (mDOT). Patients enrolled from OAT clinics who are receiving methadone and randomized to mDOT will receive doses of once daily medication at the same time as they receive methadone. Patients enrolled from community health settings and randomized to mDOT may receive observed doses in a range of settings including: at their clinic, at home, a community site (e.g. at a coffee shop or other gathering place), or using a mobile health app on a smartphone. Subjects randomized to PN will receive a standardized PN intervention and additional support through a peer-led support group.
Participants will be followed for up to 140 weeks: 12 weeks of pre-treatment evaluation, 12 weeks of treatment, 12 weeks of follow-up to determine SVR12, and 104 weeks of follow-up to determine long-term SVR and reinfection. Data sources will include clinical lab and imaging results from medical records, blood tests (HCV viral load during long-term follow-up and resistance assays), urine toxicology, questionnaires, electronic monitors for assessing adherence, and interview.
- Conditions
- Hepatitis C, Medication Adherence
- Being tested
- Patient Navigation, modified Directly Observed Therapy
- Keywords
- Addiction, Adherence, Adverse Effects, Direct Acting Antiviral Agent, Chronic Hepatitis C, Resistance Development, Methadone Clinic, Primary Care, Directly Observed Therapy, Randomized Controlled Trial, Resistance, Reinfection, Treatment Outcome, Patient Navigation, Multi-Site, Liver Disease, Intervention, Sustained Viral Response
- Medical subject headings
- Hepatitis C, Medication Adherence, Behavior, Addictive, Hepatitis C, Chronic, Directly Observed Therapy, Reinfection, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigationBehavioural
Also called PN
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.
modified Directly Observed TherapyBehavioural
Also called mDOT
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient Navigation | Active comparator | 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.
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. Receives: Behavioral: Patient Navigation |
| modified Directly Observed Therapy | Active comparator | OAT 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. Receives: Behavioral: modified Directly Observed Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Viral Response (SVR)
HCV viral load undetectable 12 weeks after treatment completion.
Measured: 12 weeks after treatment completion
Secondary outcomes (5)
HCV DAA Treatment Initiation
(Yes/No). Subject who receive at least one dose of HCV medication (sofosbuvir + velpatasvir) will be considered to have initiated HCV treatment. Those who do not receive one dose within 12 weeks of study enrollment will have been considered not to have initiated HCV treatment.
Measured: Up to 12 weeks after study enrollment
Adherence (by Electronic Monitors)
Electronic blister pack data were used to estimate daily adherence, calculated as a binary measure indicating whether one or more doses was taken per day. Weekly adherence levels were then computed in terms of percentages, that is, the number of adherent days out of 7 days for each participant.
Measured: During 12 weeks of treatment
HCV DAA Treatment Completion
(Yes/No) Treatment completion was declared if there were ≥84 days between the treatment initiation and completion.
Measured: After 12 weeks of treatment
Resistance (to NS5A)
NS5A resistance by Monogram assays.
Measured: At weeks 12 or 24
Resistance (to NS5B)
NS5B resistance by Monogram assays
Measured: At weeks 12 or 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start15 Sep 2016
- Primary completion20 Mar 2020
- Study completion4 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 755 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, University of Rhode Island, Johns Hopkins University, West Virginia University, University of New Mexico, University of California, University of Washington, Montefiore Medical Center
- Responsible party
- Sponsor
- Investigators
- Alain Litwin, MD, MPH, Principal investigator, Prisma Health-Upstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824640
- Sponsor's protocol ID
- 2015-5723
- Acronym
- HERO
- Status last verified
- Jun 2022
- First submitted
- 23 Jun 2016
- Last updated
- 26 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lopes SS, Pericot-Valverde I, Lum PJ, Taylor LE, Mehta SH, Tsui JI, Feinberg J, Kim AY, Norton BL, Page K, Murray-Krezan C, Anderson J, Karasz A, Arnsten J, Moschella P, Heo M, Litwin AH. Substance use and mental health before versus during COVID-19 pandemic among persons who inject drugs with HCV infection history-the HERO study. Harm Reduct J. 2026 Apr 21;23(1):102. doi: 10.1186/s12954-026-01445-7.
PubMed 42015166Pericot-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.
PubMed 41124945Tsui 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.
PubMed 39475112Litwin 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.
PubMed 39186268Heo 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.
PubMed 38242324Lopes SS, Pericot-Valverde I, Arnsten J, Lum PJ, Taylor LE, Mehta SH, Tsui JI, Feinberg J, Kim AY, Norton BL, Page K, Murray-Krezan C, Anderson J, Moschella P, Heo M, Litwin AH. Self-reported and measured adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs: The HERO study. Int J Drug Policy. 2024 Jan;123:104288. doi: 10.1016/j.drugpo.2023.104288. Epub 2023 Dec 15.
PubMed 38103458Tsui 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.
PubMed 37150144Litwin 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.
PubMed 36370741
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Models of HCV Care for People Who Inject Drugs
- ClinicalTrials.gov ID
- NCT02824640
- Acronym / sponsor ID
- HERO / 2015-5723
- Conditions
- Hepatitis C, Medication Adherence
- Keywords
- Addiction, Adherence, Adverse Effects, Direct Acting Antiviral Agent, Chronic Hepatitis C, Resistance Development, Methadone Clinic, Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 755 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, University of Rhode Island, Johns Hopkins University, West Virginia University, University of New Mexico, University of California, University of Washington, Montefiore Medical Center
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 4 Aug 2021 (actual)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Posted 26 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-site national study (8 U.S. cities), where up to 1000 HCV-infected PWIDs (injecting illicit substances within the last 3 months) will be randomized to either PN plus biweekly blister pack dispensation versus mDOT. Among patients who go on to initiate HCV treatment (n=600 targeted) with a once-daily combination regimen, a comparison will be conducted of the proportion of patients in each arm who: (a) optimally adhere (>=80%), (b) complete treatment, (c) achieve SVR, and (d) develop resistance. The primary outcome will be SVR. The 8 sites offer geographic and policy diversity: New York City, Baltimore, Providence, Boston, Morgantown, Seattle, San Francisco, and Albuquerque.
Participants will be recruited from diverse venues: OAT clinics, community health centers, syringe exchange programs, community-based organizations, homeless programs, and cohorts established by research studies. The clinical sites will determine eligibility based on clinical records, or on-site testing including for HCV tests (anti-HCV and HCV viremia) and drug toxicology testing as needed. Study participants will be screened, consented and enrolled on-site at OAT and non-OAT clinic settings.
Patients will be randomized to one of two models of care: patient navigation (PN) vs. modified directly observed treatment (mDOT). Patients enrolled from OAT clinics who are receiving methadone and randomized to mDOT will receive doses of once daily medication at the same time as they receive methadone. Patients enrolled from community health settings and randomized to mDOT may receive observed doses in a range of settings including: at their clinic, at home, a community site (e.g. at a coffee shop or other gathering place), or using a mobile health app on a smartphone. Subjects randomized to PN will receive a standardized PN intervention and additional support through a peer-led support group.
Participants will be followed for up to 140 weeks: 12 weeks of pre-treatment evaluation, 12 weeks of treatment, 12 weeks of follow-up to determine SVR12, and 104 weeks of follow-up to determine long-term SVR and reinfection. Data sources will include clinical lab and imaging results from medical records, blood tests (HCV viral load during long-term follow-up and resistance assays), urine toxicology, questionnaires, electronic monitors for assessing adherence, and interview.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Navigation | Active comparator | Behavioral: Patient NavigationThe 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 comparator | Behavioral: modified Directly Observed TherapyOAT 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant or breast feeding
- Hepatocellular carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient NavigationAlso: PNThe 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. | Behavioural | Patient Navigation |
| modified Directly Observed TherapyAlso: mDOTSubjects 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. | Behavioural | modified Directly Observed Therapy |
Primary outcome
Sustained Viral Response (SVR)
Time frame: 12 weeks after treatment completion
HCV viral load undetectable 12 weeks after treatment completion.
5 secondary outcomes
HCV DAA Treatment Initiation
Time frame: Up to 12 weeks after study enrollment
Adherence (by Electronic Monitors)
Time frame: During 12 weeks of treatment
HCV DAA Treatment Completion
Time frame: After 12 weeks of treatment
Resistance (to NS5A)
Time frame: At weeks 12 or 24
Resistance (to NS5B)
Time frame: At weeks 12 or 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42015166Lopes SS, Pericot-Valverde I, Lum PJ, Taylor LE, Mehta SH, Tsui JI, Feinberg J, Kim AY, Norton BL, Page K, Murray-Krezan C, Anderson J, Karasz A, Arnsten J, Moschella P, Heo M, Litwin AH. Substance use and mental health before versus during COVID-19 pandemic among persons who inject drugs with HCV infection history-the HERO study. Harm Reduct J. 2026 Apr 21;23(1):102. doi: 10.1186/s12954-026-01445-7.
- Derived from this study: PubMed 41124945Pericot-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.
- Derived from this study: PubMed 39475112Tsui 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.
- Derived from this study: PubMed 39186268Litwin 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.
- Derived from this study: PubMed 38242324Heo 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.
- Derived from this study: PubMed 38103458Lopes SS, Pericot-Valverde I, Arnsten J, Lum PJ, Taylor LE, Mehta SH, Tsui JI, Feinberg J, Kim AY, Norton BL, Page K, Murray-Krezan C, Anderson J, Moschella P, Heo M, Litwin AH. Self-reported and measured adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs: The HERO study. Int J Drug Policy. 2024 Jan;123:104288. doi: 10.1016/j.drugpo.2023.104288. Epub 2023 Dec 15.
- Derived from this study: PubMed 37150144Tsui 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.
- Derived from this study: PubMed 36370741Litwin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Litwin, MD, MPH principal investigator
Prisma Health-Upstate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation and modified Directly Observed Therapy in people with Hepatitis C and Medication Adherence, run by Prisma Health-Upstate at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Viral Response (SVR) (time frame: 12 weeks after treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02824640, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.