Trial Outcomes & Findings for Accessible HCV Care Intervention for People Who Inject Illicit Drugs (PWID) (NCT NCT03214679)
NCT ID: NCT03214679
Last Updated: 2023-02-22
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
167 participants
Primary outcome timeframe
each participant will be assessed at 1 year post entry
Results posted on
2023-02-22
Participant Flow
Participant milestones
| Measure |
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.
|
Usual Care
Usual care represents the current process 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)
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
83
|
|
Overall Study
COMPLETED
|
70
|
69
|
|
Overall Study
NOT COMPLETED
|
14
|
14
|
Reasons for withdrawal
| Measure |
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.
|
Usual Care
Usual care represents the current process 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)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
14
|
|
Overall Study
not eligible
|
2
|
0
|
Baseline Characteristics
Accessible HCV Care Intervention for People Who Inject Illicit Drugs (PWID)
Baseline characteristics by cohort
| Measure |
Accessible Care
n=82 Participants
"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.
|
Usual Care
n=83 Participants
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)
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.6 years
STANDARD_DEVIATION 10.7 • n=99 Participants
|
41.3 years
STANDARD_DEVIATION 10.6 • n=107 Participants
|
42.0 years
STANDARD_DEVIATION 10.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
45 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity/Race · Hispanic
|
45 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity/Race · Non Hispanic-White
|
26 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity/Race · Non Hispanic-Black
|
7 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity/Race · Other ( Includes American Indian or Alaska Native, Asian, and Native Hawaiian or Pacific Islander)
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
82 participants
n=99 Participants
|
83 participants
n=107 Participants
|
165 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: each participant will be assessed at 1 year post entryPopulation: 2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analyses
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
Outcome measures
| Measure |
Accessible Care
n=82 Participants
"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.
|
Usual Care
n=83 Participants
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)
|
|---|---|---|
|
Proportion of Patients to Achieve SVR12 at 1 Year
|
55 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: each participant will be assessed at 1 year post entryPopulation: 2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
Proportion of patients in each arm referred to hepatitis C treatment provider by 12 months
Outcome measures
| Measure |
Accessible Care
n=82 Participants
"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.
|
Usual Care
n=83 Participants
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)
|
|---|---|---|
|
Proportion of Patients in Each Arm Referred to Hepatitis C Treatment Provider
|
76 Participants
|
37 Participants
|
PRIMARY outcome
Timeframe: end of study (12 months)Population: 2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
The proportion of participants in each arm who attend an initial visit with a hepatitis treatment provider post randomization.
Outcome measures
| Measure |
Accessible Care
n=82 Participants
"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.
|
Usual Care
n=83 Participants
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)
|
|---|---|---|
|
The Proportion of Participants With Hepatitis C Treatment Engagement by 12 Months That Attended an Initial Visit
|
71 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: each participant will be assessed at 1 year post entryPopulation: 2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
Proportion of patients in each arm who complete a medical evaluation for antiviral treatment, including a history, physical examination and laboratory evaluation
Outcome measures
| Measure |
Accessible Care
n=82 Participants
"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.
|
Usual Care
n=83 Participants
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)
|
|---|---|---|
|
Proportion of Patients in Each Arm Who Complete a Medical Evaluation for Antiviral Treatment
|
71 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: Each participant will be assessed 1 year post entryPopulation: 2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
Proportion of participants in each arm physically receiving the first dose of antiviral medication (without necessarily having confirmed ingestion)
Outcome measures
| Measure |
Accessible Care
n=82 Participants
"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.
|
Usual Care
n=83 Participants
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)
|
|---|---|---|
|
Proportion of Participants in Each Arm Who Initiated Treatment
|
64 Participants
|
22 Participants
|
Adverse Events
Accessible Care
Serious events: 12 serious events
Other events: 0 other events
Deaths: 3 deaths
Usual Care
Serious events: 11 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Accessible Care
n=82 participants at risk
"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.
|
Usual Care
n=83 participants at risk
Usual care represents the current process 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)
|
|---|---|---|
|
Injury, poisoning and procedural complications
Hospitalizations related to overdose
|
3.7%
3/82 • Number of events 3 • 12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
|
3.6%
3/83 • Number of events 3 • 12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
|
|
Infections and infestations
Skin/soft tissue infection
|
2.4%
2/82 • Number of events 2 • 12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
|
2.4%
2/83 • Number of events 3 • 12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
|
|
Pregnancy, puerperium and perinatal conditions
miscarriage
|
0.00%
0/82 • 12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
|
1.2%
1/83 • Number of events 1 • 12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
|
|
Musculoskeletal and connective tissue disorders
leg surgery
|
0.00%
0/82 • 12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
|
1.2%
1/83 • Number of events 1 • 12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
|
|
Psychiatric disorders
mental health hospitalization
|
4.9%
4/82 • Number of events 4 • 12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
|
2.4%
2/83 • Number of events 2 • 12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
|
|
Hepatobiliary disorders
gallbladder surgery
|
0.00%
0/82 • 12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
|
1.2%
1/83 • Number of events 1 • 12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
|
|
Infections and infestations
pneumonia
|
1.2%
1/82 • Number of events 1 • 12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
|
1.2%
1/83 • Number of events 1 • 12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
|
|
Psychiatric disorders
Alcohol withdrawal seizure
|
1.2%
1/82 • Number of events 1 • 12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
|
1.2%
1/83 • 12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
|
|
Respiratory, thoracic and mediastinal disorders
asthma/shortness of breath
|
2.4%
2/82 • Number of events 2 • 12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
|
0.00%
0/83 • 12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
|
|
Cardiac disorders
chest pain/palpitations
|
1.2%
1/82 • Number of events 3 • 12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
|
0.00%
0/83 • 12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
|
|
Renal and urinary disorders
acute renal insufficiency
|
1.2%
1/82 • Number of events 1 • 12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
|
0.00%
0/83 • 12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place