Trial Outcomes & Findings for Intensive Models of HCV Care for Injection Drug Users (NCT NCT01857245)
NCT ID: NCT01857245
Last Updated: 2025-02-03
Results Overview
Hepatitis C medication adherence will be measured using electronic blister pack monitoring.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
1-12 weeks
Results posted on
2025-02-03
Participant Flow
Hepatitis C virus-infected PWID from 3 OAT programs in Bronx, New York, were enrolled beginning in October 2013, and participants were followed until April 2017. Potential participants were referred by clinicians if they were eligible for HCV treatment on the basis of guidelines from the American Association for the Study of Liver Diseases and Infectious Diseases Society of America (AASLD/IDSA). Eligibility was assessed by an oral screener and a confirmatory chart review.
Participant milestones
| Measure |
Modified Directly Observed Therapy (mDOT)
In our mDOT model, pegylated interferon is administered once weekly, and one daily dose of oral medication is administered at the methadone window.
Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
|
Concurrent Group Treatment (CGT)
In our CGT model, patients initiate HCV treatment within a once weekly treatment group which provides social support to mitigate fears of side effects, promote efficient education, and deliver weekly injections.
Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
|
Treatment as Usual
In the TAU arm, subjects will receive all medications monthly (or more often as needed) at the clinic.
Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
48
|
51
|
|
Overall Study
COMPLETED
|
51
|
48
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intensive Models of HCV Care for Injection Drug Users
Baseline characteristics by cohort
| Measure |
Modified Directly Observed Therapy (mDOT)
n=51 Participants
In our mDOT model, pegylated interferon is administered once weekly, and one daily dose of oral medication is administered at the methadone window.
Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
|
Concurrent Group Treatment (CGT)
n=48 Participants
In our CGT model, patients initiate HCV treatment within a once weekly treatment group which provides social support to mitigate fears of side effects, promote efficient education, and deliver weekly injections.
Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
|
Treatment as Usual
n=51 Participants
In the TAU arm, subjects will receive all medications monthly (or more often as needed) at the clinic.
Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.4 Years
STANDARD_DEVIATION 10 • n=99 Participants
|
51.2 Years
STANDARD_DEVIATION 11 • n=107 Participants
|
51.0 Years
STANDARD_DEVIATION 11 • n=206 Participants
|
51.2 Years
STANDARD_DEVIATION 11 • n=7 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
97 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
84 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
66 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
32 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
91 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=99 Participants
|
48 participants
n=107 Participants
|
51 participants
n=206 Participants
|
150 participants
n=7 Participants
|
|
Homelessness
Homeless
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
|
Homelessness
Housed
|
42 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
116 Participants
n=7 Participants
|
|
Employment Status
Employed
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
|
Employment Status
Unemployed
|
43 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
122 Participants
n=7 Participants
|
|
Marital Status
Married (Living with partner)
|
18 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
55 Participants
n=7 Participants
|
|
Marital Status
Not Married
|
33 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
95 Participants
n=7 Participants
|
|
Urine Drug Screen (6 mo before baseline)
Any Drug
|
34 Number of participants
n=99 Participants
|
34 Number of participants
n=107 Participants
|
30 Number of participants
n=206 Participants
|
98 Number of participants
n=7 Participants
|
|
Urine Drug Screen (6 mo before baseline)
Opioids
|
23 Number of participants
n=99 Participants
|
26 Number of participants
n=107 Participants
|
21 Number of participants
n=206 Participants
|
70 Number of participants
n=7 Participants
|
|
Urine Drug Screen (6 mo before baseline)
Cocaine
|
24 Number of participants
n=99 Participants
|
23 Number of participants
n=107 Participants
|
24 Number of participants
n=206 Participants
|
71 Number of participants
n=7 Participants
|
|
Urine Drug Screen (6 mo before baseline)
Benzodiazepines
|
15 Number of participants
n=99 Participants
|
15 Number of participants
n=107 Participants
|
13 Number of participants
n=206 Participants
|
43 Number of participants
n=7 Participants
|
|
Self-Reported Durg Use (30 days before baseline)
Heroin
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
|
Self-Reported Durg Use (30 days before baseline)
Other opioids/analgesics
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
|
Self-Reported Durg Use (30 days before baseline)
Cocaine
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
|
Self-Reported Durg Use (30 days before baseline)
Sedative/hypnotics/tranquilizers
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
|
Self-Reported Durg Use (30 days before baseline)
Amphetamines
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Alcohol use to intoxication (30 days before baseline)
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
|
Injection drug use
|
38 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
113 Participants
n=7 Participants
|
|
Comorbid psychiatric conditions
Any
|
20 participants
n=99 Participants
|
22 participants
n=107 Participants
|
25 participants
n=206 Participants
|
67 participants
n=7 Participants
|
|
Comorbid psychiatric conditions
Major depressive episode
|
11 participants
n=99 Participants
|
15 participants
n=107 Participants
|
12 participants
n=206 Participants
|
38 participants
n=7 Participants
|
|
Comorbid psychiatric conditions
Generalized anxiety disorder
|
8 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
28 participants
n=7 Participants
|
|
Comorbid psychiatric conditions
Psychotic disorder
|
12 participants
n=99 Participants
|
17 participants
n=107 Participants
|
20 participants
n=206 Participants
|
49 participants
n=7 Participants
|
|
Comorbid psychiatric conditions
Current manic episode
|
1 participants
n=99 Participants
|
6 participants
n=107 Participants
|
4 participants
n=206 Participants
|
11 participants
n=7 Participants
|
|
Depression (PHQ-9)
None or mild
|
33 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
97 Participants
n=7 Participants
|
|
Depression (PHQ-9)
Moderate or severe
|
18 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
|
HIV/HCV co-infection
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
|
HCV subtype
1a
|
43 participants
n=99 Participants
|
41 participants
n=107 Participants
|
44 participants
n=206 Participants
|
128 participants
n=7 Participants
|
|
HCV subtype
1b
|
8 participants
n=99 Participants
|
7 participants
n=107 Participants
|
7 participants
n=206 Participants
|
22 participants
n=7 Participants
|
|
Cirrhosis
|
15 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
|
Treatment experienced
|
43 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
55 Participants
n=7 Participants
|
|
DAA regimen
SOF/LDV
|
31 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
104 Participants
n=7 Participants
|
|
DAA regimen
SOF/SMV
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
DAA regimen
SOF/RBV
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
DAA regimen
SOF/IFN/RBV
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
DAA regimen
TVR/IFN/RBV
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Opioid agonist therapy
Methadone
|
51 participants
n=99 Participants
|
47 participants
n=107 Participants
|
49 participants
n=206 Participants
|
147 participants
n=7 Participants
|
|
Opioid agonist therapy
Buprenorphine
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Opioid agonist pick-up schedule
1-3 per week
|
6 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
|
Opioid agonist pick-up schedule
4-6 per week
|
45 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
118 Participants
n=7 Participants
|
|
Urine drug screen (at baseline)
Any drug
|
26 participants
n=99 Participants
|
23 participants
n=107 Participants
|
25 participants
n=206 Participants
|
74 participants
n=7 Participants
|
|
Urine drug screen (at baseline)
Opioids/oxycodone
|
12 participants
n=99 Participants
|
14 participants
n=107 Participants
|
11 participants
n=206 Participants
|
37 participants
n=7 Participants
|
|
Urine drug screen (at baseline)
Cocaine
|
17 participants
n=99 Participants
|
11 participants
n=107 Participants
|
16 participants
n=206 Participants
|
44 participants
n=7 Participants
|
|
Urine drug screen (at baseline)
Benzodiazepines
|
9 participants
n=99 Participants
|
4 participants
n=107 Participants
|
10 participants
n=206 Participants
|
23 participants
n=7 Participants
|
|
Urine drug screen (at baseline)
Amphetamines
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
IL28B Genotype
CC
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
|
IL28B Genotype
TC
|
26 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
79 Participants
n=7 Participants
|
|
IL28B Genotype
TT
|
16 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 1-12 weeksHepatitis C medication adherence will be measured using electronic blister pack monitoring.
Outcome measures
| Measure |
Modified Directly Observed Therapy (mDOT)
n=51 Participants
In our mDOT model, pegylated interferon is administered once weekly, and one daily dose of oral medication is administered at the methadone window.
Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
|
Concurrent Group Treatment (CGT)
n=48 Participants
In our CGT model, patients initiate HCV treatment within a once weekly treatment group which provides social support to mitigate fears of side effects, promote efficient education, and deliver weekly injections.
Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
|
Treatment as Usual
n=51 Participants
In the TAU arm, subjects will receive all medications monthly (or more often as needed) at the clinic.
Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
|
|---|---|---|---|
|
Electronically Monitored Medication Adherence
|
86 Percentage of medication taken
Interval 80.0 to 92.0
|
80 Percentage of medication taken
Interval 74.0 to 86.0
|
75 Percentage of medication taken
Interval 70.0 to 81.0
|
SECONDARY outcome
Timeframe: 12 weeks after treatment completionUndetectable HCV RNA at posttreatment week 12.
Outcome measures
| Measure |
Modified Directly Observed Therapy (mDOT)
n=51 Participants
In our mDOT model, pegylated interferon is administered once weekly, and one daily dose of oral medication is administered at the methadone window.
Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
|
Concurrent Group Treatment (CGT)
n=48 Participants
In our CGT model, patients initiate HCV treatment within a once weekly treatment group which provides social support to mitigate fears of side effects, promote efficient education, and deliver weekly injections.
Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
|
Treatment as Usual
n=51 Participants
In the TAU arm, subjects will receive all medications monthly (or more often as needed) at the clinic.
Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
|
|---|---|---|---|
|
Sustained Virologic Response
|
50 Participants
|
45 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Up to 48 weeksCompletion of ≥80% of the planned treatment course. For example, ≥10 wk of a 12-wk course, or ≥20 wk of a 24-wk course.
Outcome measures
| Measure |
Modified Directly Observed Therapy (mDOT)
n=51 Participants
In our mDOT model, pegylated interferon is administered once weekly, and one daily dose of oral medication is administered at the methadone window.
Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
|
Concurrent Group Treatment (CGT)
n=48 Participants
In our CGT model, patients initiate HCV treatment within a once weekly treatment group which provides social support to mitigate fears of side effects, promote efficient education, and deliver weekly injections.
Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
|
Treatment as Usual
n=51 Participants
In the TAU arm, subjects will receive all medications monthly (or more often as needed) at the clinic.
Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
|
|---|---|---|---|
|
HCV Treatment Completion
|
50 Participants
|
47 Participants
|
48 Participants
|
Adverse Events
Modified Directly Observed Therapy (mDOT)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Concurrent Group Treatment (CGT)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Treatment as Usual
Serious events: 0 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Modified Directly Observed Therapy (mDOT)
n=51 participants at risk
In our mDOT model, pegylated interferon is administered once weekly, and one daily dose of oral medication is administered at the methadone window.
Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
|
Concurrent Group Treatment (CGT)
n=48 participants at risk
In our CGT model, patients initiate HCV treatment within a once weekly treatment group which provides social support to mitigate fears of side effects, promote efficient education, and deliver weekly injections.
Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
|
Treatment as Usual
n=51 participants at risk
In the TAU arm, subjects will receive all medications monthly (or more often as needed) at the clinic.
Intensive Models (mDOT and CGT) of HCV Care: Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
|
|---|---|---|---|
|
Hepatobiliary disorders
Virologic Failure (HCV)
|
2.0%
1/51 • Number of events 1 • 8 months / 36 weeks
|
6.2%
3/48 • Number of events 3 • 8 months / 36 weeks
|
9.8%
5/51 • Number of events 5 • 8 months / 36 weeks
|
Additional Information
Dr. Claire Stam - Director, Addiction Medicine Center
Prisma Health
Phone: (864) 979-6749
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place