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.
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.
Brief Title
Patient-Centered Models of HCV Care for People Who Inject Drugs
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Hepatitis C
Medication Adherence
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* Pregnant or breast feeding
* Hepatocellular carcinoma
* 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
Exclusion Criteria:
* Pregnant or breast feeding
* Hepatocellular carcinoma
Inclusion Criteria
Inclusion Criteria:
* 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
* 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
Gender
All
Gender Based
false
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
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
70 Years
Minimum Age
18 Years
NCT Id
NCT02824640
Org Class
Other
Org Full Name
Prisma Health-Upstate
Org Study Id
2015-5723
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Patient-Centered Models of HCV Care for People Who Inject Drugs
Primary Outcomes
Outcome Description
HCV viral load undetectable 12 weeks after treatment completion.
Outcome Measure
Sustained Viral Response (SVR)
Outcome Time Frame
12 weeks after treatment completion
Secondary Outcomes
Outcome Description
(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.
Outcome Time Frame
Up to 12 weeks after study enrollment
Outcome Measure
HCV DAA Treatment Initiation
Outcome Description
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.
Outcome Time Frame
During 12 weeks of treatment
Outcome Measure
Adherence (by Electronic Monitors)
Outcome Description
(Yes/No) Treatment completion was declared if there were ≥84 days between the treatment initiation and completion.
Outcome Time Frame
After 12 weeks of treatment
Outcome Measure
HCV DAA Treatment Completion
Outcome Description
NS5A resistance by Monogram assays.
Outcome Time Frame
At weeks 12 or 24
Outcome Measure
Resistance (to NS5A)
Outcome Description
NS5B resistance by Monogram assays
Outcome Time Frame
At weeks 12 or 24
Outcome Measure
Resistance (to NS5B)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
70
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Brianna Norton
Investigator Email
bnorton@montefiore.org
Investigator Phone