HCV Coinfection, Hepatitis C, People Who Inject Drugs, PWID
Conditions
Keywords
Hepatitis C, HCV, People who inject drugs
Brief summary
The proposed study will examine the feasibility, acceptability, safety, effectiveness, and cost of an Accessible Care intervention for engaging people who inject illicit drugs (PWID) in hepatitis C care. Accessible Care for PWID is low-threshold care provided in programs designed specifically for PWID where they can comfortably access care without fear of shame or stigma. Accessible Care will be provided by co-locating a hepatitis treatment provider, together with a Hepatitis C Care Coordinator (HCCC), on-site at a collaborating needle exchange program. The proposed study will compare the effectiveness of Accessible Care with Usual Care (referrals to existing services) in facilitating linkage, engagement, and retention of PWID in care for hepatitis C, addiction, and HIV prevention. The primary outcome is sustained virologic response, which constitutes virologic cure. Substance use and HIV and HCV risk behaviors are secondary outcomes.
Interventions
OTHERAccessible Care
Accessible Care will be provided by co-locating a hepatitis treatment provider, together with a Hepatitis C Care Coordinator, on-site at our collaborating needle exchange program.
OTHERUsual Care
Usual care entails referral to an on site HCV care coordinator (not provided by study)
Sponsors
National Development and Research Institutes, Inc.
National Institute on Drug Abuse (NIDA)
Weill Medical College of Cornell University
City University of New York, School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years or older, 2. injected heroin, cocaine, or other drugs in the past 90 days. 3. test HCV Ab and RNA positive 4. provide written consent (including consent for researchers to examine their hepatitis C medical records)
Exclusion criteria
Persons already in care for hepatitis C, defined as having had at least 2 visits with a hepatitis treatment provider within the past 6 months, will be excluded. People with decompensated cirrhosis will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients to Achieve SVR12 at 1 Year | each participant will be assessed at 1 year post entry | SVR12 is a sustained virologic response to HCV treatment defined as HCV RNA below the limit of quantification 12 weeks post completion of HCV treatment |
| Proportion of Patients in Each Arm Referred to Hepatitis C Treatment Provider | each participant will be assessed at 1 year post entry | Proportion of patients in each arm referred to hepatitis C treatment provider by 12 months |
| The Proportion of Participants With Hepatitis C Treatment Engagement by 12 Months That Attended an Initial Visit | end of study (12 months) | The proportion of participants in each arm who attend an initial visit with a hepatitis treatment provider post randomization. |
| Proportion of Patients in Each Arm Who Complete a Medical Evaluation for Antiviral Treatment | each participant will be assessed at 1 year post entry | Proportion of patients in each arm who complete a medical evaluation for antiviral treatment, including a history, physical examination and laboratory evaluation |
| Proportion of Participants in Each Arm Who Initiated Treatment | Each participant will be assessed 1 year post entry | Proportion of participants in each arm physically receiving the first dose of antiviral medication (without necessarily having confirmed ingestion) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Accessible Care Accessible Care for PWID is low-threshold care provided in the needle exchange programs, where they can comfortably access services without fear of the shame or stigma that often attends them in mainstream institutions.It includes features such as an informal, nonjudgmental atmosphere, availability of walk-in appointments, and a harm reduction framework to help them identify and pursue their own personal health goals. Accessible Care will be provided by co-locating a hepatitis treatment provider, together with a Hepatitis C Care Coordinator, on-site at our collaborating needle exchange program.
Accessible Care: Accessible Care will be provided by co-locating a hepatitis treatment provider, together with a Hepatitis C Care Coordinator, on-site at our collaborating needle exchange program. | 82 |
| Usual Care Usual care represents the current procedure after someone tests positive for HCV antibody on site at the syringe exchange program. An on site care coordinator (not provided by study) assists with insurance and linkage to HCV medical provider at sites throughout NYC through the NYC Dept of Health Check Hep C program.
Usual Care: Usual care entails referral to an on site HCV care coordinator (not provided by study) | 83 |
| Total | 165 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 12 | 14 |
| Overall Study | not eligible | 2 | 0 |
Baseline characteristics
| Characteristic | Accessible Care | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 42.6 years STANDARD_DEVIATION 10.7 | 41.3 years STANDARD_DEVIATION 10.6 | 42.0 years STANDARD_DEVIATION 10.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 45 Participants | 52 Participants | 97 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 31 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity/Race Hispanic | 45 Participants | 52 Participants | 97 Participants |
| Race/Ethnicity, Customized Ethnicity/Race Non Hispanic-Black | 7 Participants | 1 Participants | 8 Participants |
| Race/Ethnicity, Customized Ethnicity/Race Non Hispanic-White | 26 Participants | 27 Participants | 53 Participants |
| Race/Ethnicity, Customized Ethnicity/Race Other ( Includes American Indian or Alaska Native, Asian, and Native Hawaiian or Pacific Islander) | 4 Participants | 3 Participants | 7 Participants |
| Region of Enrollment United States | 82 participants | 83 participants | 165 participants |
| Sex: Female, Male Female | 19 Participants | 17 Participants | 36 Participants |
| Sex: Female, Male Male | 63 Participants | 66 Participants | 129 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 82 | 1 / 83 |
| other Total, other adverse events | 0 / 82 | 0 / 83 |
| serious Total, serious adverse events | 12 / 82 | 11 / 83 |
Outcome results
Primary
Proportion of Participants in Each Arm Who Initiated Treatment
Proportion of participants in each arm physically receiving the first dose of antiviral medication (without necessarily having confirmed ingestion)
Time frame: Each participant will be assessed 1 year post entry
Population: 2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Accessible Care | Proportion of Participants in Each Arm Who Initiated Treatment | 64 Participants |
| Usual Care | Proportion of Participants in Each Arm Who Initiated Treatment | 22 Participants |
Primary
Proportion of Patients in Each Arm Referred to Hepatitis C Treatment Provider
Proportion of patients in each arm referred to hepatitis C treatment provider by 12 months
Time frame: each participant will be assessed at 1 year post entry
Population: 2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Accessible Care | Proportion of Patients in Each Arm Referred to Hepatitis C Treatment Provider | 76 Participants |
| Usual Care | Proportion of Patients in Each Arm Referred to Hepatitis C Treatment Provider | 37 Participants |
Primary
Proportion of Patients in Each Arm Who Complete a Medical Evaluation for Antiviral Treatment
Proportion of patients in each arm who complete a medical evaluation for antiviral treatment, including a history, physical examination and laboratory evaluation
Time frame: each participant will be assessed at 1 year post entry
Population: 2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Accessible Care | Proportion of Patients in Each Arm Who Complete a Medical Evaluation for Antiviral Treatment | 71 Participants |
| Usual Care | Proportion of Patients in Each Arm Who Complete a Medical Evaluation for Antiviral Treatment | 26 Participants |
Primary
Proportion of Patients to Achieve SVR12 at 1 Year
SVR12 is a sustained virologic response to HCV treatment defined as HCV RNA below the limit of quantification 12 weeks post completion of HCV treatment
Time frame: each participant will be assessed at 1 year post entry
Population: 2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analyses
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Accessible Care | Proportion of Patients to Achieve SVR12 at 1 Year | 55 Participants |
| Usual Care | Proportion of Patients to Achieve SVR12 at 1 Year | 19 Participants |
p-value: <0.001Chi-squared
Primary
The Proportion of Participants With Hepatitis C Treatment Engagement by 12 Months That Attended an Initial Visit
The proportion of participants in each arm who attend an initial visit with a hepatitis treatment provider post randomization.
Time frame: end of study (12 months)
Population: 2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Accessible Care | The Proportion of Participants With Hepatitis C Treatment Engagement by 12 Months That Attended an Initial Visit | 71 Participants |
| Usual Care | The Proportion of Participants With Hepatitis C Treatment Engagement by 12 Months That Attended an Initial Visit | 31 Participants |