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=5 Participants
|
51.2 Years
STANDARD_DEVIATION 11 • n=7 Participants
|
51.0 Years
STANDARD_DEVIATION 11 • n=5 Participants
|
51.2 Years
STANDARD_DEVIATION 11 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
32 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
48 participants
n=7 Participants
|
51 participants
n=5 Participants
|
150 participants
n=4 Participants
|
|
Homelessness
Homeless
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Homelessness
Housed
|
42 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
|
Employment Status
Employed
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Employment Status
Unemployed
|
43 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
|
Marital Status
Married (Living with partner)
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Marital Status
Not Married
|
33 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Urine Drug Screen (6 mo before baseline)
Any Drug
|
34 Number of participants
n=5 Participants
|
34 Number of participants
n=7 Participants
|
30 Number of participants
n=5 Participants
|
98 Number of participants
n=4 Participants
|
|
Urine Drug Screen (6 mo before baseline)
Opioids
|
23 Number of participants
n=5 Participants
|
26 Number of participants
n=7 Participants
|
21 Number of participants
n=5 Participants
|
70 Number of participants
n=4 Participants
|
|
Urine Drug Screen (6 mo before baseline)
Cocaine
|
24 Number of participants
n=5 Participants
|
23 Number of participants
n=7 Participants
|
24 Number of participants
n=5 Participants
|
71 Number of participants
n=4 Participants
|
|
Urine Drug Screen (6 mo before baseline)
Benzodiazepines
|
15 Number of participants
n=5 Participants
|
15 Number of participants
n=7 Participants
|
13 Number of participants
n=5 Participants
|
43 Number of participants
n=4 Participants
|
|
Self-Reported Durg Use (30 days before baseline)
Heroin
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Self-Reported Durg Use (30 days before baseline)
Other opioids/analgesics
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Self-Reported Durg Use (30 days before baseline)
Cocaine
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Self-Reported Durg Use (30 days before baseline)
Sedative/hypnotics/tranquilizers
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Self-Reported Durg Use (30 days before baseline)
Amphetamines
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Alcohol use to intoxication (30 days before baseline)
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Injection drug use
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Comorbid psychiatric conditions
Any
|
20 participants
n=5 Participants
|
22 participants
n=7 Participants
|
25 participants
n=5 Participants
|
67 participants
n=4 Participants
|
|
Comorbid psychiatric conditions
Major depressive episode
|
11 participants
n=5 Participants
|
15 participants
n=7 Participants
|
12 participants
n=5 Participants
|
38 participants
n=4 Participants
|
|
Comorbid psychiatric conditions
Generalized anxiety disorder
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
28 participants
n=4 Participants
|
|
Comorbid psychiatric conditions
Psychotic disorder
|
12 participants
n=5 Participants
|
17 participants
n=7 Participants
|
20 participants
n=5 Participants
|
49 participants
n=4 Participants
|
|
Comorbid psychiatric conditions
Current manic episode
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Depression (PHQ-9)
None or mild
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
|
Depression (PHQ-9)
Moderate or severe
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
HIV/HCV co-infection
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
HCV subtype
1a
|
43 participants
n=5 Participants
|
41 participants
n=7 Participants
|
44 participants
n=5 Participants
|
128 participants
n=4 Participants
|
|
HCV subtype
1b
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
22 participants
n=4 Participants
|
|
Cirrhosis
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Treatment experienced
|
43 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
DAA regimen
SOF/LDV
|
31 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
DAA regimen
SOF/SMV
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
DAA regimen
SOF/RBV
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
DAA regimen
SOF/IFN/RBV
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
DAA regimen
TVR/IFN/RBV
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Opioid agonist therapy
Methadone
|
51 participants
n=5 Participants
|
47 participants
n=7 Participants
|
49 participants
n=5 Participants
|
147 participants
n=4 Participants
|
|
Opioid agonist therapy
Buprenorphine
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Opioid agonist pick-up schedule
1-3 per week
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Opioid agonist pick-up schedule
4-6 per week
|
45 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
Urine drug screen (at baseline)
Any drug
|
26 participants
n=5 Participants
|
23 participants
n=7 Participants
|
25 participants
n=5 Participants
|
74 participants
n=4 Participants
|
|
Urine drug screen (at baseline)
Opioids/oxycodone
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
11 participants
n=5 Participants
|
37 participants
n=4 Participants
|
|
Urine drug screen (at baseline)
Cocaine
|
17 participants
n=5 Participants
|
11 participants
n=7 Participants
|
16 participants
n=5 Participants
|
44 participants
n=4 Participants
|
|
Urine drug screen (at baseline)
Benzodiazepines
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Urine drug screen (at baseline)
Amphetamines
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
IL28B Genotype
CC
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
IL28B Genotype
TC
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
IL28B Genotype
TT
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
38 Participants
n=4 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