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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA041298 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Development and Research Institutes, Inc. | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
| Weill Medical College of Cornell University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accessible Care | Experimental | "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. |
|
| Usual Care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accessible Care | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | each participant will be assessed at 1 year post entry |
| 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 | each participant will be assessed at 1 year post entry |
| 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. | end of study (12 months) |
| 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 | each participant will be assessed at 1 year post entry |
| 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) | Each participant will be assessed 1 year post entry |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Kristen Marks | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lower East Side Harm Reduction Center | New York | New York | 10022 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35285851 | Background | Eckhardt B, Mateu-Gelabert P, Aponte-Melendez Y, Fong C, Kapadia S, Smith M, Edlin BR, Marks KM. Accessible Hepatitis C Care for People Who Inject Drugs: A Randomized Clinical Trial. JAMA Intern Med. 2022 May 1;182(5):494-502. doi: 10.1001/jamainternmed.2022.0170. | |
| 37501180 | Derived | Kapadia SN, Aponte-Melendez Y, Rodriguez A, Pai M, Eckhardt BJ, Marks KM, Fong C, Mateu-Gelabert P. "Treated like a Human Being": perspectives of people who inject drugs attending low-threshold HCV treatment at a syringe service program in New York City. Harm Reduct J. 2023 Jul 27;20(1):95. doi: 10.1186/s12954-023-00831-9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
2 ineligible participants excluded post-randomization (both accessible care arm) are not included
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analyses | Posted | Count of Participants | Participants | each participant will be assessed at 1 year post entry |
|
12 months
2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalizations related to overdose | Injury, poisoning and procedural complications | Systematic Assessment |
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he study limitations to generalizability include that the study was conducted at a single site and in an urban environment with a high concentration of harm reduction services and minimal state HCV DAA prescribing restrictions. As observed in this trial, most patients were insured or eligible for insurance, and no participants had their insurance company deny treatment with HCV DAA therapy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ben Eckhardt | University School of Medicine, New York | 212-562-1000 | benjamin.eckhardt@nyumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2021 | Mar 31, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D000092863 | Access to Primary Care |
| ID | Term |
|---|---|
| D006297 | Health Services Accessibility |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Usual Care | Other | Usual care entails referral to an on site HCV care coordinator (not provided by study) |
|
| 34819070 | Derived | Aponte-Melendez Y, Mateu-Gelabert P, Fong C, Eckhardt B, Kapadia S, Marks K. The impact of COVID-19 on people who inject drugs in New York City: increased risk and decreased access to services. Harm Reduct J. 2021 Nov 24;18(1):118. doi: 10.1186/s12954-021-00568-3. |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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) |
|
|
|
| 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 | 2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis | Posted | Count of Participants | Participants | each participant will be assessed at 1 year post entry |
|
|
|
| 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. | 2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis | Posted | Count of Participants | Participants | end of study (12 months) |
|
|
|
| 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 | 2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis | Posted | Count of Participants | Participants | each participant will be assessed at 1 year post entry |
|
|
|
| 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) | 2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis | Posted | Count of Participants | Participants | Each participant will be assessed 1 year post entry |
|
|
|
| 3 |
| 82 |
| 12 |
| 82 |
| 0 |
| 82 |
| EG001 | 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) | 1 | 83 | 11 | 83 | 0 | 83 |
| Skin/soft tissue infection | Infections and infestations | Systematic Assessment |
|
| miscarriage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| leg surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| mental health hospitalization | Psychiatric disorders | Systematic Assessment |
|
| gallbladder surgery | Hepatobiliary disorders | Systematic Assessment |
|
| pneumonia | Infections and infestations | Systematic Assessment |
|
| Alcohol withdrawal seizure | Psychiatric disorders | Systematic Assessment |
|
| asthma/shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| chest pain/palpitations | Cardiac disorders | Systematic Assessment |
|
| acute renal insufficiency | Renal and urinary disorders | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |