Trial Outcomes & Findings for CHAMPS Study: Chronic HepAtitis C Management to ImProve OutcomeS (NCT NCT02402218)
NCT ID: NCT02402218
Last Updated: 2020-04-14
Results Overview
The percentage of participants who initiated HCV therapy \[Ledipasvir/Sofosbuvir (LDV/SOF)\] with Usual Care (UC), Incentive Care (IC), and Peer-Mentor Care (PMC).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
144 participants
Primary outcome timeframe
at week 1
Results posted on
2020-04-14
Participant Flow
Participants were enrolled between August 2015 and October 2016 at an outpatient clinic in Baltimore, MD, USA.
Participant milestones
| Measure |
Usual Care
Participants receive standard of care for Hepatitis C in the clinic.
Usual Care: Participants receive standard of care in the clinic from their health care team.
|
Usual Care Plus Peer-mentors
In addition to receiving standard of care for hepatitis C virus (HCV) in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.
Usual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.
|
Usual Care Plus Incentives
In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.
Usual care plus incentives: Participants are given incentives after completing treatment goals.
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
54
|
54
|
|
Overall Study
Initiated Treatment With LDV/SOF
|
24
|
45
|
41
|
|
Overall Study
Completed Treatment With LDV/SOF
|
23
|
42
|
39
|
|
Overall Study
Achieved Sustained Virologic Response
|
22
|
41
|
37
|
|
Overall Study
COMPLETED
|
22
|
41
|
37
|
|
Overall Study
NOT COMPLETED
|
14
|
13
|
17
|
Reasons for withdrawal
| Measure |
Usual Care
Participants receive standard of care for Hepatitis C in the clinic.
Usual Care: Participants receive standard of care in the clinic from their health care team.
|
Usual Care Plus Peer-mentors
In addition to receiving standard of care for hepatitis C virus (HCV) in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.
Usual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.
|
Usual Care Plus Incentives
In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.
Usual care plus incentives: Participants are given incentives after completing treatment goals.
|
|---|---|---|---|
|
Overall Study
Did not pickup study medication
|
12
|
9
|
13
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
1
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Reinfection
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
Baseline Characteristics
5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
Baseline characteristics by cohort
| Measure |
Usual Care
n=36 Participants
Participants receive standard of care for Hepatitis C in the clinic.
Usual Care: Participants receive standard of care in the clinic from their health care team.
|
Usual Care Plus Peer-mentors
n=54 Participants
In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.
Usual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.
|
Usual Care Plus Incentives
n=54 Participants
In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.
Usual care plus incentives: Participants are given incentives after completing treatment goals.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.8 years
n=36 Participants
|
55.1 years
n=54 Participants
|
54.0 years
n=54 Participants
|
54.9 years
n=144 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=36 Participants
|
19 Participants
n=54 Participants
|
23 Participants
n=54 Participants
|
56 Participants
n=144 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=36 Participants
|
35 Participants
n=54 Participants
|
31 Participants
n=54 Participants
|
88 Participants
n=144 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=36 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=144 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=36 Participants
|
54 Participants
n=54 Participants
|
54 Participants
n=54 Participants
|
144 Participants
n=144 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=36 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=144 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=36 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=144 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=36 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=144 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=36 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=144 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=36 Participants
|
52 Participants
n=54 Participants
|
48 Participants
n=54 Participants
|
133 Participants
n=144 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=36 Participants
|
2 Participants
n=54 Participants
|
6 Participants
n=54 Participants
|
11 Participants
n=144 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=36 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=144 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=36 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=144 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=36 Participants
|
54 participants
n=54 Participants
|
54 participants
n=54 Participants
|
144 participants
n=144 Participants
|
|
Marital Status
Never Married
|
19 Participants
n=36 Participants
|
27 Participants
n=54 Participants
|
26 Participants
n=54 Participants
|
72 Participants
n=144 Participants
|
|
Marital Status
Married
|
5 Participants
n=36 Participants
|
13 Participants
n=54 Participants
|
5 Participants
n=54 Participants
|
23 Participants
n=144 Participants
|
|
Marital Status
Separated
|
3 Participants
n=36 Participants
|
3 Participants
n=54 Participants
|
5 Participants
n=54 Participants
|
11 Participants
n=144 Participants
|
|
Marital Status
Divorced
|
6 Participants
n=36 Participants
|
8 Participants
n=54 Participants
|
9 Participants
n=54 Participants
|
23 Participants
n=144 Participants
|
|
Marital Status
Widowed
|
3 Participants
n=36 Participants
|
3 Participants
n=54 Participants
|
9 Participants
n=54 Participants
|
15 Participants
n=144 Participants
|
|
Employment Status
Employed
|
6 Participants
n=36 Participants
|
7 Participants
n=54 Participants
|
9 Participants
n=54 Participants
|
22 Participants
n=144 Participants
|
|
Employment Status
Unemployed
|
30 Participants
n=36 Participants
|
47 Participants
n=54 Participants
|
45 Participants
n=54 Participants
|
122 Participants
n=144 Participants
|
|
Has Health Insurance
Has Health Insurance
|
36 Participants
n=36 Participants
|
54 Participants
n=54 Participants
|
54 Participants
n=54 Participants
|
144 Participants
n=144 Participants
|
|
Has Health Insurance
Does Not Have Health Insurance
|
0 Participants
n=36 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=144 Participants
|
|
Substance Use History- Self Report
Self-report use of cocaine or heroin- lifetime · Yes
|
35 Participants
n=36 Participants
|
48 Participants
n=54 Participants
|
48 Participants
n=54 Participants
|
131 Participants
n=144 Participants
|
|
Substance Use History- Self Report
Self-report use of cocaine or heroin- lifetime · No
|
1 Participants
n=36 Participants
|
6 Participants
n=54 Participants
|
6 Participants
n=54 Participants
|
13 Participants
n=144 Participants
|
|
Substance Use History- Self Report
Self-report use of cocaine or heroin- last 30 days · Yes
|
12 Participants
n=36 Participants
|
12 Participants
n=54 Participants
|
12 Participants
n=54 Participants
|
36 Participants
n=144 Participants
|
|
Substance Use History- Self Report
Self-report use of cocaine or heroin- last 30 days · No
|
24 Participants
n=36 Participants
|
42 Participants
n=54 Participants
|
42 Participants
n=54 Participants
|
108 Participants
n=144 Participants
|
|
Substance Use History- Self Report
Self-Report of Drug Use (any) in the Last 2 Years · Yes
|
24 Participants
n=36 Participants
|
33 Participants
n=54 Participants
|
33 Participants
n=54 Participants
|
90 Participants
n=144 Participants
|
|
Substance Use History- Self Report
Self-Report of Drug Use (any) in the Last 2 Years · No
|
12 Participants
n=36 Participants
|
21 Participants
n=54 Participants
|
21 Participants
n=54 Participants
|
54 Participants
n=144 Participants
|
|
Urine Toxicology
Not Done
|
5 Participants
n=31 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
3 Participants
n=51 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
0 Participants
n=54 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
8 Participants
n=136 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
|
Urine Toxicology
Benzodiazepine
|
3 Participants
n=31 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
5 Participants
n=51 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
6 Participants
n=54 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
14 Participants
n=136 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
|
Urine Toxicology
Cocaine
|
12 Participants
n=31 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
12 Participants
n=51 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
19 Participants
n=54 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
43 Participants
n=136 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
|
Urine Toxicology
Heroin
|
6 Participants
n=31 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
16 Participants
n=51 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
14 Participants
n=54 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
36 Participants
n=136 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
|
Urine Toxicology
Cannabinoid
|
9 Participants
n=31 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
19 Participants
n=51 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
13 Participants
n=54 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
41 Participants
n=136 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
|
Urine Toxicology
Methadone
|
10 Participants
n=31 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
15 Participants
n=51 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
13 Participants
n=54 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
38 Participants
n=136 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
|
Urine Toxicology
Oxycod/ Oxymorph
|
4 Participants
n=31 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
1 Participants
n=51 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
4 Participants
n=54 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
9 Participants
n=136 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
|
Urine Toxicology
None of the Above Detected
|
7 Participants
n=31 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
13 Participants
n=51 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
16 Participants
n=54 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
36 Participants
n=136 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
|
Urine Toxicology
Negative or only methadone
|
10 Participants
n=31 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
16 Participants
n=51 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
19 Participants
n=54 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
45 Participants
n=136 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
|
Urine Toxicology
Negative or only methadone or oxycodone
|
11 Participants
n=31 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
17 Participants
n=51 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
20 Participants
n=54 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
48 Participants
n=136 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
|
Urine Toxicology
Negative or only methadone or oxycodone or benzodi
|
11 Participants
n=31 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
18 Participants
n=51 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
23 Participants
n=54 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
52 Participants
n=136 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
|
Urine Toxicology
Negative or only methadone or oxycodone or marijua
|
17 Participants
n=31 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
27 Participants
n=51 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
24 Participants
n=54 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
68 Participants
n=136 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
|
Urine Toxicology
Positive for cocaine only
|
1 Participants
n=31 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
3 Participants
n=51 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
4 Participants
n=54 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
8 Participants
n=136 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
|
Urine Toxicology
Positive for Heroin only
|
1 Participants
n=31 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
2 Participants
n=51 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
4 Participants
n=54 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
7 Participants
n=136 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
|
Urine Toxicology
Positive for cocaine and heroin only
|
1 Participants
n=31 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
2 Participants
n=51 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
1 Participants
n=54 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
4 Participants
n=136 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
|
Urine Toxicology
Positive for cocaine OR heroin
|
13 Participants
n=31 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
23 Participants
n=51 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
27 Participants
n=54 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
63 Participants
n=136 Participants • 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.
|
|
phosphatidylethanol (ng/mL)
<50 ng/mL
|
18 Participants
n=33 Participants • 3 participants in the usual care group, 2 participants in the peer mentor group and 4 participants in the incentive care group did not complete a phosphatidylethanol test at baseline.
|
33 Participants
n=52 Participants • 3 participants in the usual care group, 2 participants in the peer mentor group and 4 participants in the incentive care group did not complete a phosphatidylethanol test at baseline.
|
37 Participants
n=50 Participants • 3 participants in the usual care group, 2 participants in the peer mentor group and 4 participants in the incentive care group did not complete a phosphatidylethanol test at baseline.
|
88 Participants
n=135 Participants • 3 participants in the usual care group, 2 participants in the peer mentor group and 4 participants in the incentive care group did not complete a phosphatidylethanol test at baseline.
|
|
phosphatidylethanol (ng/mL)
≥50 ng/mL
|
15 Participants
n=33 Participants • 3 participants in the usual care group, 2 participants in the peer mentor group and 4 participants in the incentive care group did not complete a phosphatidylethanol test at baseline.
|
19 Participants
n=52 Participants • 3 participants in the usual care group, 2 participants in the peer mentor group and 4 participants in the incentive care group did not complete a phosphatidylethanol test at baseline.
|
13 Participants
n=50 Participants • 3 participants in the usual care group, 2 participants in the peer mentor group and 4 participants in the incentive care group did not complete a phosphatidylethanol test at baseline.
|
47 Participants
n=135 Participants • 3 participants in the usual care group, 2 participants in the peer mentor group and 4 participants in the incentive care group did not complete a phosphatidylethanol test at baseline.
|
|
Self-report current alcohol use
Never
|
14 Participants
n=36 Participants
|
23 Participants
n=54 Participants
|
22 Participants
n=54 Participants
|
59 Participants
n=144 Participants
|
|
Self-report current alcohol use
Monthly or Less
|
9 Participants
n=36 Participants
|
12 Participants
n=54 Participants
|
12 Participants
n=54 Participants
|
33 Participants
n=144 Participants
|
|
Self-report current alcohol use
2-4x per month
|
5 Participants
n=36 Participants
|
12 Participants
n=54 Participants
|
7 Participants
n=54 Participants
|
24 Participants
n=144 Participants
|
|
Self-report current alcohol use
2-3x per week
|
5 Participants
n=36 Participants
|
4 Participants
n=54 Participants
|
5 Participants
n=54 Participants
|
14 Participants
n=144 Participants
|
|
Self-report current alcohol use
≥4x per week
|
3 Participants
n=36 Participants
|
3 Participants
n=54 Participants
|
8 Participants
n=54 Participants
|
14 Participants
n=144 Participants
|
|
alcohol use disorders identification test (AUDIT)
Male <8
|
20 Participants
n=36 Participants
|
28 Participants
n=54 Participants
|
22 Participants
n=54 Participants
|
70 Participants
n=144 Participants
|
|
alcohol use disorders identification test (AUDIT)
Male ≥8
|
2 Participants
n=36 Participants
|
7 Participants
n=54 Participants
|
9 Participants
n=54 Participants
|
18 Participants
n=144 Participants
|
|
alcohol use disorders identification test (AUDIT)
Female <4
|
7 Participants
n=36 Participants
|
13 Participants
n=54 Participants
|
16 Participants
n=54 Participants
|
36 Participants
n=144 Participants
|
|
alcohol use disorders identification test (AUDIT)
Female ≥4
|
7 Participants
n=36 Participants
|
6 Participants
n=54 Participants
|
7 Participants
n=54 Participants
|
20 Participants
n=144 Participants
|
|
alcohol use disorders identification test (AUDIT)
0-3
|
19 Participants
n=36 Participants
|
34 Participants
n=54 Participants
|
35 Participants
n=54 Participants
|
88 Participants
n=144 Participants
|
|
alcohol use disorders identification test (AUDIT)
4-7
|
13 Participants
n=36 Participants
|
10 Participants
n=54 Participants
|
8 Participants
n=54 Participants
|
31 Participants
n=144 Participants
|
|
alcohol use disorders identification test (AUDIT)
8-11
|
4 Participants
n=36 Participants
|
6 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
11 Participants
n=144 Participants
|
|
alcohol use disorders identification test (AUDIT)
≥12
|
0 Participants
n=36 Participants
|
4 Participants
n=54 Participants
|
10 Participants
n=54 Participants
|
14 Participants
n=144 Participants
|
|
HIV RNA copies
≤50
|
30 Participants
n=36 Participants
|
43 Participants
n=54 Participants
|
42 Participants
n=54 Participants
|
115 Participants
n=144 Participants
|
|
HIV RNA copies
>50
|
6 Participants
n=36 Participants
|
11 Participants
n=54 Participants
|
12 Participants
n=54 Participants
|
29 Participants
n=144 Participants
|
|
HIV RNA if ≥50 copies/mL
|
20767 copies/mL
n=36 Participants
|
645 copies/mL
n=54 Participants
|
15903 copies/mL
n=54 Participants
|
5702 copies/mL
n=144 Participants
|
|
Alanine Aminotransferase
|
39 U/L
n=36 Participants • ALT not done for 1 participant in peer mentor group
|
33 U/L
n=53 Participants • ALT not done for 1 participant in peer mentor group
|
29 U/L
n=54 Participants • ALT not done for 1 participant in peer mentor group
|
33 U/L
n=143 Participants • ALT not done for 1 participant in peer mentor group
|
|
Aspartate Aminotransferase
|
45 U/L
n=36 Participants • AST not done for 2 participants in peer group and 3 participants in incentive group
|
39 U/L
n=52 Participants • AST not done for 2 participants in peer group and 3 participants in incentive group
|
36 U/L
n=51 Participants • AST not done for 2 participants in peer group and 3 participants in incentive group
|
40 U/L
n=139 Participants • AST not done for 2 participants in peer group and 3 participants in incentive group
|
|
Patient taking antiretroviral therapy
Yes
|
35 Participants
n=36 Participants
|
52 Participants
n=54 Participants
|
52 Participants
n=54 Participants
|
139 Participants
n=144 Participants
|
|
Patient taking antiretroviral therapy
No
|
1 Participants
n=36 Participants
|
2 Participants
n=54 Participants
|
2 Participants
n=54 Participants
|
5 Participants
n=144 Participants
|
|
HIV antiretroviral therapy (ART) Changed Pre-Treatment with Harvoni
Yes
|
10 Participants
n=31 Participants • This baseline measure only applies to the n=129 participants that saw a provider after enrollment in the study.
|
11 Participants
n=50 Participants • This baseline measure only applies to the n=129 participants that saw a provider after enrollment in the study.
|
7 Participants
n=48 Participants • This baseline measure only applies to the n=129 participants that saw a provider after enrollment in the study.
|
28 Participants
n=129 Participants • This baseline measure only applies to the n=129 participants that saw a provider after enrollment in the study.
|
|
HIV antiretroviral therapy (ART) Changed Pre-Treatment with Harvoni
No
|
21 Participants
n=31 Participants • This baseline measure only applies to the n=129 participants that saw a provider after enrollment in the study.
|
39 Participants
n=50 Participants • This baseline measure only applies to the n=129 participants that saw a provider after enrollment in the study.
|
41 Participants
n=48 Participants • This baseline measure only applies to the n=129 participants that saw a provider after enrollment in the study.
|
101 Participants
n=129 Participants • This baseline measure only applies to the n=129 participants that saw a provider after enrollment in the study.
|
|
HCV Genotype/Subtype
1A
|
29 Participants
n=36 Participants
|
40 Participants
n=54 Participants
|
43 Participants
n=54 Participants
|
112 Participants
n=144 Participants
|
|
HCV Genotype/Subtype
1B
|
7 Participants
n=36 Participants
|
14 Participants
n=54 Participants
|
11 Participants
n=54 Participants
|
32 Participants
n=144 Participants
|
|
HCV RNA
|
2730000 IU/mL
n=36 Participants
|
4790000 IU/mL
n=54 Participants
|
2730000 IU/mL
n=54 Participants
|
2975000 IU/mL
n=144 Participants
|
|
Liver Disease Stage by FibroScan
|
7.8 kPa
n=35 Participants • 7 unsuccessful FibroScan measurements due to participant's body type
|
6.8 kPa
n=52 Participants • 7 unsuccessful FibroScan measurements due to participant's body type
|
6.7 kPa
n=50 Participants • 7 unsuccessful FibroScan measurements due to participant's body type
|
6.9 kPa
n=137 Participants • 7 unsuccessful FibroScan measurements due to participant's body type
|
|
Liver Disease Stage by FibroScan
≤8 kPa
|
20 Participants
n=36 Participants
|
34 Participants
n=54 Participants
|
36 Participants
n=54 Participants
|
90 Participants
n=144 Participants
|
|
Liver Disease Stage by FibroScan
8.1-11.9 kPa
|
11 Participants
n=36 Participants
|
13 Participants
n=54 Participants
|
7 Participants
n=54 Participants
|
31 Participants
n=144 Participants
|
|
Liver Disease Stage by FibroScan
≥12 kPa
|
4 Participants
n=36 Participants
|
5 Participants
n=54 Participants
|
7 Participants
n=54 Participants
|
16 Participants
n=144 Participants
|
|
Liver Disease Stage by FibroScan
Unsuccessful
|
1 Participants
n=36 Participants
|
2 Participants
n=54 Participants
|
4 Participants
n=54 Participants
|
7 Participants
n=144 Participants
|
|
Cluster of differentiation 4 (CD4) Count
|
453 cells/mm^3
n=36 Participants
|
581 cells/mm^3
n=54 Participants
|
509 cells/mm^3
n=54 Participants
|
530 cells/mm^3
n=144 Participants
|
|
Centers for Depression Epidemiology Scale (CES-D)
<16
|
16 Participants
n=36 Participants
|
20 Participants
n=54 Participants
|
20 Participants
n=54 Participants
|
56 Participants
n=144 Participants
|
|
Centers for Depression Epidemiology Scale (CES-D)
≥16
|
20 Participants
n=36 Participants
|
34 Participants
n=54 Participants
|
34 Participants
n=54 Participants
|
88 Participants
n=144 Participants
|
|
Centers for Depression Epidemiology Scale (CES-D)
<21
|
22 Participants
n=36 Participants
|
29 Participants
n=54 Participants
|
31 Participants
n=54 Participants
|
82 Participants
n=144 Participants
|
|
Centers for Depression Epidemiology Scale (CES-D)
≥21
|
14 Participants
n=36 Participants
|
25 Participants
n=54 Participants
|
23 Participants
n=54 Participants
|
62 Participants
n=144 Participants
|
|
Number of times rescheduled or missed week 0 clinical appointment for initial evaluation
0
|
26 Participants
n=36 Participants
|
39 Participants
n=54 Participants
|
35 Participants
n=54 Participants
|
100 Participants
n=144 Participants
|
|
Number of times rescheduled or missed week 0 clinical appointment for initial evaluation
1-2
|
9 Participants
n=36 Participants
|
10 Participants
n=54 Participants
|
16 Participants
n=54 Participants
|
35 Participants
n=144 Participants
|
|
Number of times rescheduled or missed week 0 clinical appointment for initial evaluation
3+
|
1 Participants
n=36 Participants
|
5 Participants
n=54 Participants
|
3 Participants
n=54 Participants
|
9 Participants
n=144 Participants
|
|
Emotional Support
<33
|
11 Participants
n=36 Participants
|
24 Participants
n=54 Participants
|
21 Participants
n=54 Participants
|
56 Participants
n=144 Participants
|
|
Emotional Support
≥33
|
25 Participants
n=36 Participants
|
30 Participants
n=54 Participants
|
33 Participants
n=54 Participants
|
88 Participants
n=144 Participants
|
|
Self-report fatigue
<16
|
18 Participants
n=36 Participants
|
24 Participants
n=54 Participants
|
22 Participants
n=54 Participants
|
64 Participants
n=144 Participants
|
|
Self-report fatigue
≥16
|
18 Participants
n=36 Participants
|
30 Participants
n=54 Participants
|
32 Participants
n=54 Participants
|
80 Participants
n=144 Participants
|
|
Primary Care Visit in the last 12 months
Yes
|
36 Participants
n=36 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
48 Participants
n=52 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
52 Participants
n=53 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
136 Participants
n=141 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
|
Primary Care Visit in the last 12 months
No
|
0 Participants
n=36 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
4 Participants
n=52 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
1 Participants
n=53 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
5 Participants
n=141 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
|
Self-report "Do you think your doctor understands the pressure you are under outside of the clinic?"
Yes
|
6 Participants
n=36 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
7 Participants
n=52 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
9 Participants
n=53 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
22 Participants
n=141 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
|
Self-report "Do you think your doctor understands the pressure you are under outside of the clinic?"
No
|
29 Participants
n=36 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
42 Participants
n=52 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
41 Participants
n=53 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
112 Participants
n=141 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
|
Self-report "Do you think your doctor understands the pressure you are under outside of the clinic?"
Under No Pressure
|
1 Participants
n=36 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
2 Participants
n=52 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
2 Participants
n=53 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
5 Participants
n=141 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
|
Self-report "Do you think your doctor understands the pressure you are under outside of the clinic?"
Don't Know
|
0 Participants
n=36 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
1 Participants
n=52 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
1 Participants
n=53 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
2 Participants
n=141 Participants • Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.
|
PRIMARY outcome
Timeframe: at week 1The percentage of participants who initiated HCV therapy \[Ledipasvir/Sofosbuvir (LDV/SOF)\] with Usual Care (UC), Incentive Care (IC), and Peer-Mentor Care (PMC).
Outcome measures
| Measure |
Usual Care
n=36 Participants
Participants receive standard of care for Hepatitis C in the clinic.
Usual Care: Participants receive standard of care in the clinic from their health care team.
|
Usual Care Plus Peer-mentors
n=54 Participants
In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.
Usual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.
|
Usual Care Plus Incentives
n=54 Participants
In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.
Usual care plus incentives: Participants are given incentives after completing treatment goals.
|
|---|---|---|---|
|
Participants Who Initiated HCV Therapy by Intervention Group
|
24 Participants
|
45 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: at post-treatment week 12The number of participants who achieved SVR, defined as HCV RNA not detected at 12 weeks after completion of the HCV treatment regimen
Outcome measures
| Measure |
Usual Care
n=36 Participants
Participants receive standard of care for Hepatitis C in the clinic.
Usual Care: Participants receive standard of care in the clinic from their health care team.
|
Usual Care Plus Peer-mentors
n=54 Participants
In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.
Usual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.
|
Usual Care Plus Incentives
n=54 Participants
In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.
Usual care plus incentives: Participants are given incentives after completing treatment goals.
|
|---|---|---|---|
|
Sustained Virologic Response (SVR) Following Treatment by Intervention Group
|
22 Participants
|
41 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: at post-treatment week 12Population: Among participants that initiated treatment only.
Number of Participants who self-reported Adverse Events During HCV Treatment by Intervention Group
Outcome measures
| Measure |
Usual Care
n=24 Participants
Participants receive standard of care for Hepatitis C in the clinic.
Usual Care: Participants receive standard of care in the clinic from their health care team.
|
Usual Care Plus Peer-mentors
n=45 Participants
In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.
Usual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.
|
Usual Care Plus Incentives
n=41 Participants
In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.
Usual care plus incentives: Participants are given incentives after completing treatment goals.
|
|---|---|---|---|
|
Number of Participants With Adverse Events During HCV Treatment by Intervention Group
|
13 Participants
|
24 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Pre-treatment and at treatment week 6Population: Participants that completed PEth tests at enrollment and week 6 of treatment
Alcohol intake during HCV treatment measured using dried whole blood spots to measure the level of phosphatidylethanol (PEth) at pre-treatment and treatment week 6
Outcome measures
| Measure |
Usual Care
n=22 Participants
Participants receive standard of care for Hepatitis C in the clinic.
Usual Care: Participants receive standard of care in the clinic from their health care team.
|
Usual Care Plus Peer-mentors
n=41 Participants
In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.
Usual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.
|
Usual Care Plus Incentives
n=35 Participants
In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.
Usual care plus incentives: Participants are given incentives after completing treatment goals.
|
|---|---|---|---|
|
Change in Alcohol Use by Blood Test During HCV Treatment
No change in alcohol use from week 0 to week 6
|
20 Participants
|
38 Participants
|
32 Participants
|
|
Change in Alcohol Use by Blood Test During HCV Treatment
Increase in alcohol use from week 0 to week 6
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Change in Alcohol Use by Blood Test During HCV Treatment
Decrease in alcohol use from week 0 to week 6
|
2 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Pre-treatment and at treatment week 6Population: Participants that completed urine toxicology tests at enrollment and week 6 of treatment
Illicit drug use during HCV treatment measured by urine toxicology testing pre-treatment and at treatment week 6
Outcome measures
| Measure |
Usual Care
n=24 Participants
Participants receive standard of care for Hepatitis C in the clinic.
Usual Care: Participants receive standard of care in the clinic from their health care team.
|
Usual Care Plus Peer-mentors
n=45 Participants
In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.
Usual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.
|
Usual Care Plus Incentives
n=41 Participants
In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.
Usual care plus incentives: Participants are given incentives after completing treatment goals.
|
|---|---|---|---|
|
Change in Illicit Drug Use During HCV Treatment
Increase in cocaine or heroin use from wk 0 to 6
|
5 Participants
|
4 Participants
|
2 Participants
|
|
Change in Illicit Drug Use During HCV Treatment
No change in cocaine or heroin use from wk 0 to 6
|
16 Participants
|
37 Participants
|
34 Participants
|
|
Change in Illicit Drug Use During HCV Treatment
Decrease in cocaine or heroin use from wk 0 to 6
|
3 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: at post-treatment week 12Population: Among participants that initiated treatment only.
Number of persons who achieved sustained virologic response following treatment who subsequently have HCV RNA detected with a new strain of the virus.
Outcome measures
| Measure |
Usual Care
n=24 Participants
Participants receive standard of care for Hepatitis C in the clinic.
Usual Care: Participants receive standard of care in the clinic from their health care team.
|
Usual Care Plus Peer-mentors
n=45 Participants
In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.
Usual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.
|
Usual Care Plus Incentives
n=41 Participants
In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.
Usual care plus incentives: Participants are given incentives after completing treatment goals.
|
|---|---|---|---|
|
Number of Participants With Re-Infection After Achieving Sustained Virologic Response by Intervention Group
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Usual Care With LDV/SOF
Serious events: 3 serious events
Other events: 11 other events
Deaths: 1 deaths
Usual Care Plus Peer-mentors With LDV/SOF
Serious events: 9 serious events
Other events: 18 other events
Deaths: 0 deaths
Usual Care Plus Incentives With LDV/SOF
Serious events: 9 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual Care With LDV/SOF
n=24 participants at risk
Participants receive standard of care for Hepatitis C in the clinic.
Usual Care: Participants receive standard of care in the clinic from their health care team. This group of patients initiated treatment with LDV/SOF.
|
Usual Care Plus Peer-mentors With LDV/SOF
n=45 participants at risk
In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.
Usual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with LDV/SOF. This group of patients initiated treatment with LDV/SOF.
|
Usual Care Plus Incentives With LDV/SOF
n=41 participants at risk
In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.
Usual care plus incentives: Participants are given incentives after completing treatment goals. This group of patients initiated treatment with LDV/SOF.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Emphysema/COPD/SOB
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
2.2%
1/45 • Number of events 1 • From treatment initiation to post-treatment week 12
|
7.3%
3/41 • Number of events 6 • From treatment initiation to post-treatment week 12
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
4.4%
2/45 • Number of events 2 • From treatment initiation to post-treatment week 12
|
14.6%
6/41 • Number of events 6 • From treatment initiation to post-treatment week 12
|
|
General disorders
Back Pain
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
0.00%
0/45 • From treatment initiation to post-treatment week 12
|
4.9%
2/41 • Number of events 2 • From treatment initiation to post-treatment week 12
|
|
General disorders
Leg Pain
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
0.00%
0/45 • From treatment initiation to post-treatment week 12
|
2.4%
1/41 • Number of events 1 • From treatment initiation to post-treatment week 12
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
2.2%
1/45 • Number of events 2 • From treatment initiation to post-treatment week 12
|
2.4%
1/41 • Number of events 2 • From treatment initiation to post-treatment week 12
|
|
Ear and labyrinth disorders
Otitis media with effusion
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
2.2%
1/45 • Number of events 1 • From treatment initiation to post-treatment week 12
|
2.4%
1/41 • Number of events 1 • From treatment initiation to post-treatment week 12
|
|
General disorders
Syncope
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
4.4%
2/45 • Number of events 3 • From treatment initiation to post-treatment week 12
|
0.00%
0/41 • From treatment initiation to post-treatment week 12
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
4.4%
2/45 • Number of events 3 • From treatment initiation to post-treatment week 12
|
2.4%
1/41 • Number of events 1 • From treatment initiation to post-treatment week 12
|
|
Cardiac disorders
Hypertension
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
4.4%
2/45 • Number of events 2 • From treatment initiation to post-treatment week 12
|
2.4%
1/41 • Number of events 1 • From treatment initiation to post-treatment week 12
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
2.2%
1/45 • Number of events 1 • From treatment initiation to post-treatment week 12
|
0.00%
0/41 • From treatment initiation to post-treatment week 12
|
|
Infections and infestations
Scabies
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
0.00%
0/45 • From treatment initiation to post-treatment week 12
|
2.4%
1/41 • Number of events 1 • From treatment initiation to post-treatment week 12
|
|
Endocrine disorders
Poorly-controlled diabetes
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
0.00%
0/45 • From treatment initiation to post-treatment week 12
|
2.4%
1/41 • Number of events 2 • From treatment initiation to post-treatment week 12
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
0.00%
0/45 • From treatment initiation to post-treatment week 12
|
2.4%
1/41 • Number of events 1 • From treatment initiation to post-treatment week 12
|
|
Endocrine disorders
Hyperglycemia
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
0.00%
0/45 • From treatment initiation to post-treatment week 12
|
2.4%
1/41 • Number of events 1 • From treatment initiation to post-treatment week 12
|
|
General disorders
Anion gap metabolic acidosis
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
0.00%
0/45 • From treatment initiation to post-treatment week 12
|
2.4%
1/41 • Number of events 1 • From treatment initiation to post-treatment week 12
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
0.00%
0/45 • From treatment initiation to post-treatment week 12
|
2.4%
1/41 • Number of events 1 • From treatment initiation to post-treatment week 12
|
|
Cardiac disorders
Acute Decompensated Heart Failure
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
0.00%
0/45 • From treatment initiation to post-treatment week 12
|
2.4%
1/41 • Number of events 1 • From treatment initiation to post-treatment week 12
|
|
Renal and urinary disorders
Kidney Stones
|
4.2%
1/24 • Number of events 1 • From treatment initiation to post-treatment week 12
|
0.00%
0/45 • From treatment initiation to post-treatment week 12
|
0.00%
0/41 • From treatment initiation to post-treatment week 12
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
0.00%
0/45 • From treatment initiation to post-treatment week 12
|
2.4%
1/41 • Number of events 1 • From treatment initiation to post-treatment week 12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
2.2%
1/45 • Number of events 2 • From treatment initiation to post-treatment week 12
|
0.00%
0/41 • From treatment initiation to post-treatment week 12
|
|
Gastrointestinal disorders
Elevated liver enzymes
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
2.2%
1/45 • Number of events 2 • From treatment initiation to post-treatment week 12
|
0.00%
0/41 • From treatment initiation to post-treatment week 12
|
|
Social circumstances
Motor Vehicle Accident
|
4.2%
1/24 • Number of events 1 • From treatment initiation to post-treatment week 12
|
0.00%
0/45 • From treatment initiation to post-treatment week 12
|
0.00%
0/41 • From treatment initiation to post-treatment week 12
|
|
Reproductive system and breast disorders
Pregnancy
|
4.2%
1/24 • Number of events 1 • From treatment initiation to post-treatment week 12
|
0.00%
0/45 • From treatment initiation to post-treatment week 12
|
0.00%
0/41 • From treatment initiation to post-treatment week 12
|
|
Psychiatric disorders
Alcohol withdrawal
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
2.2%
1/45 • Number of events 3 • From treatment initiation to post-treatment week 12
|
0.00%
0/41 • From treatment initiation to post-treatment week 12
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
2.2%
1/45 • Number of events 1 • From treatment initiation to post-treatment week 12
|
0.00%
0/41 • From treatment initiation to post-treatment week 12
|
|
Infections and infestations
Abcess
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
0.00%
0/45 • From treatment initiation to post-treatment week 12
|
4.9%
2/41 • Number of events 2 • From treatment initiation to post-treatment week 12
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
2.2%
1/45 • Number of events 1 • From treatment initiation to post-treatment week 12
|
0.00%
0/41 • From treatment initiation to post-treatment week 12
|
|
Cardiac disorders
acute congestive heart failure exacerbation
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
0.00%
0/45 • From treatment initiation to post-treatment week 12
|
2.4%
1/41 • Number of events 1 • From treatment initiation to post-treatment week 12
|
|
General disorders
Chest pain
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
2.2%
1/45 • Number of events 1 • From treatment initiation to post-treatment week 12
|
2.4%
1/41 • Number of events 1 • From treatment initiation to post-treatment week 12
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
0.00%
0/45 • From treatment initiation to post-treatment week 12
|
2.4%
1/41 • Number of events 1 • From treatment initiation to post-treatment week 12
|
|
General disorders
Fall
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
0.00%
0/45 • From treatment initiation to post-treatment week 12
|
2.4%
1/41 • Number of events 1 • From treatment initiation to post-treatment week 12
|
|
General disorders
Abdominal Pain
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
0.00%
0/45 • From treatment initiation to post-treatment week 12
|
2.4%
1/41 • Number of events 1 • From treatment initiation to post-treatment week 12
|
|
Endocrine disorders
Diabetic ketoacidosis
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
2.2%
1/45 • Number of events 1 • From treatment initiation to post-treatment week 12
|
0.00%
0/41 • From treatment initiation to post-treatment week 12
|
|
Infections and infestations
cellulitis of left arm during pregnancy
|
4.2%
1/24 • Number of events 1 • From treatment initiation to post-treatment week 12
|
0.00%
0/45 • From treatment initiation to post-treatment week 12
|
0.00%
0/41 • From treatment initiation to post-treatment week 12
|
Other adverse events
| Measure |
Usual Care With LDV/SOF
n=24 participants at risk
Participants receive standard of care for Hepatitis C in the clinic.
Usual Care: Participants receive standard of care in the clinic from their health care team. This group of patients initiated treatment with LDV/SOF.
|
Usual Care Plus Peer-mentors With LDV/SOF
n=45 participants at risk
In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.
Usual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with LDV/SOF. This group of patients initiated treatment with LDV/SOF.
|
Usual Care Plus Incentives With LDV/SOF
n=41 participants at risk
In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.
Usual care plus incentives: Participants are given incentives after completing treatment goals. This group of patients initiated treatment with LDV/SOF.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
20.8%
5/24 • Number of events 6 • From treatment initiation to post-treatment week 12
|
20.0%
9/45 • Number of events 10 • From treatment initiation to post-treatment week 12
|
29.3%
12/41 • Number of events 23 • From treatment initiation to post-treatment week 12
|
|
General disorders
Fatigue
|
25.0%
6/24 • Number of events 7 • From treatment initiation to post-treatment week 12
|
15.6%
7/45 • Number of events 11 • From treatment initiation to post-treatment week 12
|
14.6%
6/41 • Number of events 12 • From treatment initiation to post-treatment week 12
|
|
Gastrointestinal disorders
Nausea
|
8.3%
2/24 • Number of events 2 • From treatment initiation to post-treatment week 12
|
8.9%
4/45 • Number of events 4 • From treatment initiation to post-treatment week 12
|
9.8%
4/41 • Number of events 5 • From treatment initiation to post-treatment week 12
|
|
Gastrointestinal disorders
Diarrhea
|
4.2%
1/24 • Number of events 1 • From treatment initiation to post-treatment week 12
|
6.7%
3/45 • Number of events 4 • From treatment initiation to post-treatment week 12
|
7.3%
3/41 • Number of events 10 • From treatment initiation to post-treatment week 12
|
|
General disorders
Insomnia
|
0.00%
0/24 • From treatment initiation to post-treatment week 12
|
0.00%
0/45 • From treatment initiation to post-treatment week 12
|
14.6%
6/41 • Number of events 13 • From treatment initiation to post-treatment week 12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place