## Protocol Section
### Identification Module
**NCT ID:** NCT03214679

**Brief Title:** Accessible HCV Care Intervention for People Who Inject Illicit Drugs (PWID)

**Official Title:** Accessible Care Intervention for Engaging People Who Inject Illicit Drugs in HCV Care

#### Organization Study ID Info
**ID:** 1612017838A001
#### Organization
**Class:** OTHER
**Full Name:** City University of New York, School of Public Health
#### Secondary ID Infos
**ID:** R01DA041298
**Link:** https://reporter.nih.gov/quickSearch/R01DA041298
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2021-06-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-02-22

**Type:** ACTUAL

**Last Update Submit Date:** 2023-01-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-06-30

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-02-22

**Type:** ACTUAL

**Results First Submit Date:** 2023-01-26

**Results First Submit QC Date:** 2023-01-26

#### Start Date
**Date:** 2017-07-20

**Type:** ACTUAL

**Status Verified Date:** 2021-07

#### Study First Post Date
**Date:** 2017-07-11
**Type:** ACTUAL
**Study First Submit Date:** 2017-06-29
**Study First Submit QC Date:** 2017-07-07
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** National Development and Research Institutes, Inc.

**Class:** NIH

**Name:** National Institute on Drug Abuse (NIDA)

**Class:** OTHER

**Name:** Weill Medical College of Cornell University

#### Lead Sponsor

**Class:** OTHER

**Name:** City University of New York, School of Public Health

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Hepatitis C

- People Who Inject Drugs

- PWID

- HCV Coinfection

**Keywords:**

- Hepatitis C

- HCV

- People who inject drugs

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 167

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** "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.

**Intervention Names:**

- Other: Accessible Care

**Label:** Accessible Care

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Other: Usual Care

**Label:** Usual Care

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Accessible Care

**Description:** 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.

**Name:** Accessible Care

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Usual Care

**Description:** Usual care entails referral to an on site HCV care coordinator (not provided by study)

**Name:** Usual Care

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Proportion of Patients to Achieve SVR12 at 1 Year

**Time Frame:** each participant will be assessed at 1 year post entry

**Description:** Proportion of patients in each arm referred to hepatitis C treatment provider by 12 months

**Measure:** Proportion of Patients in Each Arm Referred to Hepatitis C Treatment Provider

**Time Frame:** each participant will be assessed at 1 year post entry

**Description:** The proportion of participants in each arm who attend an initial visit with a hepatitis treatment provider post randomization.

**Measure:** The Proportion of Participants With Hepatitis C Treatment Engagement by 12 Months That Attended an Initial Visit

**Time Frame:** end of study (12 months)

**Description:** Proportion of patients in each arm who complete a medical evaluation for antiviral treatment, including a history, physical examination and laboratory evaluation

**Measure:** Proportion of Patients in Each Arm Who Complete a Medical Evaluation for Antiviral Treatment

**Time Frame:** each participant will be assessed at 1 year post entry

**Description:** Proportion of participants in each arm physically receiving the first dose of antiviral medication (without necessarily having confirmed ingestion)

**Measure:** Proportion of Participants in Each Arm Who Initiated Treatment

**Time Frame:** Each participant will be assessed 1 year post entry

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New York

**Country:** United States

**Facility:** Lower East Side Harm Reduction Center

**State:** New York

**Zip:** 10022

#### Overall Officials

**Official 1:**

**Affiliation:** Weill Medical College of Cornell University

**Name:** Kristen Marks

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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.

**PMID:** 35285851

**Citation:** 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.

**PMID:** 34819070

## Document Section

### Large Document Module

#### Large Docs

- Date: 2021-04-16

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 1826627

- Type Abbrev: Prot_SAP

- Upload Date: 2022-03-31T14:09

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000006525

- Term: Hepatitis, Viral, Human

- ID: D000014777

- Term: Virus Diseases

- ID: D000007239

- Term: Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000018178

- Term: Flaviviridae Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M9592

- Name: Hepatitis A

- Relevance: LOW

- As Found: Unknown

- ID: M9591

- Name: Hepatitis

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9611

- Name: Hepatitis C

- Relevance: HIGH

- As Found: Hepatitis C

- ID: M29581

- Name: Coinfection

- Relevance: HIGH

- As Found: Coinfection

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9610

- Name: Hepatitis, Viral, Human

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M20324

- Name: Flaviviridae Infections

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006526

- Term: Hepatitis C

- ID: D000060085

- Term: Coinfection

- ID: D000006505

- Term: Hepatitis

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M20971

- Name: Hepatitis C Antibodies

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** 2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis

#### Event Groups

**Group ID:** EG000

**Title:** Accessible Care

**Deaths Num Affected:** 3

**Deaths Num At Risk:** 82

**Description:** "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.

**ID:** EG000

**Other Num at Risk:** 82

**Serious Number Affected:** 12

**Serious Number At Risk:** 82

**Title:** Accessible Care

**Group ID:** EG001

**Title:** Usual Care

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 83

**Description:** 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)

**ID:** EG001

**Other Num at Risk:** 83

**Serious Number Affected:** 11

**Serious Number At Risk:** 83

**Title:** Usual Care

**Frequency Threshold:** 5

#### Serious Events

**Term:** Hospitalizations related to overdose

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 82

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 83

**Num Events:** 3

**Term:** Skin/soft tissue infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 82

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 83

**Num Events:** 3

**Term:** miscarriage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Pregnancy, puerperium and perinatal conditions

##### Stats

**Group ID:** EG000

**Num At Risk:** 82

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 83

**Num Events:** 1

**Term:** leg surgery

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 82

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 83

**Num Events:** 1

**Term:** mental health hospitalization

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 82

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 83

**Num Events:** 2

**Term:** gallbladder surgery

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 82

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 83

**Num Events:** 1

**Term:** pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 82

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 83

**Num Events:** 1

**Term:** Alcohol withdrawal seizure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 82

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 83

**Term:** asthma/shortness of breath

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 82

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 83

**Term:** chest pain/palpitations

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 82

**Num Events:** 3

**Group ID:** EG001

**Num At Risk:** 83

**Term:** acute renal insufficiency

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 82

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 83

**Time Frame:** 12 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 82

**Group ID:** BG001

**Value:** 83

**Group ID:** BG002

**Value:** 165

**Units:** Participants

### Group

**ID:** BG000

**Title:** Accessible Care

**Description:** "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.

### Group

**ID:** BG001

**Title:** Usual Care

**Description:** 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)

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 10.7

**Value:** 42.6

#### Measurement

**Group ID:** BG001

**Spread:** 10.6

**Value:** 41.3

#### Measurement

**Group ID:** BG002

**Spread:** 10.6

**Value:** 42.0

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 19

#### Measurement

**Group ID:** BG001

**Value:** 17

#### Measurement

**Group ID:** BG002

**Value:** 36

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 63

#### Measurement

**Group ID:** BG001

**Value:** 66

#### Measurement

**Group ID:** BG002

**Value:** 129

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 45

#### Measurement

**Group ID:** BG001

**Value:** 52

#### Measurement

**Group ID:** BG002

**Value:** 97

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 37

#### Measurement

**Group ID:** BG001

**Value:** 31

#### Measurement

**Group ID:** BG002

**Value:** 68

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 45

#### Measurement

**Group ID:** BG001

**Value:** 52

#### Measurement

**Group ID:** BG002

**Value:** 97

**Category Title:** Hispanic

#### Measurement

**Group ID:** BG000

**Value:** 26

#### Measurement

**Group ID:** BG001

**Value:** 27

#### Measurement

**Group ID:** BG002

**Value:** 53

**Category Title:** Non Hispanic-White

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 8

**Category Title:** Non Hispanic-Black

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 7

**Category Title:** Other ( Includes American Indian or Alaska Native, Asian, and Native Hawaiian or Pacific Islander)

**Class Title:** Ethnicity/Race

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 82

#### Measurement

**Group ID:** BG001

**Value:** 83

#### Measurement

**Group ID:** BG002

**Value:** 165

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
**Population Description:** 2 ineligible participants excluded post-randomization (both accessible care arm) are not included
## Results Section - More Information Module
### Certain Agreement
### Limitations and Caveats
**Description:** 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.
### Point of Contact
**Email:** benjamin.eckhardt@nyumc.org
**Organization:** University School of Medicine, New York
**Phone:** 212-562-1000
**Title:** Ben Eckhardt
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <.001
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Chi-squared
**Tested Non-Inferiority:** 
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 55
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 19
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 76
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 37
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 71
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 31
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 71
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 26
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 64
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** 2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analyses
**Reporting Status:** POSTED
**Time Frame:** each participant will be assessed at 1 year post entry
**Title:** Proportion of Patients to Achieve SVR12 at 1 Year
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** "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.
**ID:** OG000
**Title:** Accessible Care
##### Group
**Description:** 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)
**ID:** OG001
**Title:** Usual Care
#### Outcome Measure 2
**Description:** Proportion of patients in each arm referred to hepatitis C treatment provider by 12 months
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** 2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
**Reporting Status:** POSTED
**Time Frame:** each participant will be assessed at 1 year post entry
**Title:** Proportion of Patients in Each Arm Referred to Hepatitis C Treatment Provider
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** "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.
**ID:** OG000
**Title:** Accessible Care
##### Group
**Description:** 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)
**ID:** OG001
**Title:** Usual Care
#### Outcome Measure 3
**Description:** The proportion of participants in each arm who attend an initial visit with a hepatitis treatment provider post randomization.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** 2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
**Reporting Status:** POSTED
**Time Frame:** end of study (12 months)
**Title:** The Proportion of Participants With Hepatitis C Treatment Engagement by 12 Months That Attended an Initial Visit
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** "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.
**ID:** OG000
**Title:** Accessible Care
##### Group
**Description:** 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)
**ID:** OG001
**Title:** Usual Care
#### Outcome Measure 4
**Description:** Proportion of patients in each arm who complete a medical evaluation for antiviral treatment, including a history, physical examination and laboratory evaluation
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** 2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
**Reporting Status:** POSTED
**Time Frame:** each participant will be assessed at 1 year post entry
**Title:** Proportion of Patients in Each Arm Who Complete a Medical Evaluation for Antiviral Treatment
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** "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.
**ID:** OG000
**Title:** Accessible Care
##### Group
**Description:** 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)
**ID:** OG001
**Title:** Usual Care
#### Outcome Measure 5
**Description:** Proportion of participants in each arm physically receiving the first dose of antiviral medication (without necessarily having confirmed ingestion)
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** 2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analysis
**Reporting Status:** POSTED
**Time Frame:** Each participant will be assessed 1 year post entry
**Title:** Proportion of Participants in Each Arm Who Initiated Treatment
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** "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.
**ID:** OG000
**Title:** Accessible Care
##### Group
**Description:** 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)
**ID:** OG001
**Title:** Usual Care
### Participant Flow Module
#### Group
**Description:** "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.
**ID:** FG000
**Title:** Accessible Care
#### Group
**Description:** 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)
**ID:** FG001
**Title:** Usual Care
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 12
###### Reason
**Group ID:** FG001
**Number of Subjects:** 14
##### Withdraw
**Type:** not eligible
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 84
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 83
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 70
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 69
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 14
**Has Results:** True