Hepatitis CNCT04036760
Implementation and Evaluation of Care Coordination in Linkage to Care for Hepatitis C Following Release From New York City Jails
An observational study of Hepatitis C, run by NYU Langone Health at 1 site in United States.
Trial summary
This study assesses the impact of a hepatitis C care coordination program on rates of linkage to hepatitis C care following release from New York City jails. Adult patients (age 18 years and above) with chronic Hepatitis C infection at Bellevue Hospital Center 19 North prison clinic from July 1, 2015 through December… Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Research transitional care coordination
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 14 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Males and gender self-identified females age 18 or over with HCV infection seen in Bellevue's 19N prison Infectious Diseases clinic.
Who may be able to join
- HCV infection seen in Bellevue's 19N prison Infectious Diseases clinic.
Who cannot join
- Individuals who refuse to participate in the study when approached
- Individuals who are unable or unwilling to sign a consent form agreeing to participate. Participants must have sufficient literacy to sign their name, as written informed consent is required for study participation
- Individuals who are unable to successfully negotiate the use of a telephone interpreter if required
- Individuals who have received a sentence that extends beyond the interval of follow up (one year sentence in city jail)
- Individuals who will be moved upstate to prison directly from jail
- Individuals who die prior to discharge from Rikers Island
Trial locations and contacts
1 site in 1 country.
About this study
This study assesses the impact of a hepatitis C care coordination program on rates of linkage to hepatitis C care following release from New York City jails. Adult patients (age 18 years and above) with chronic Hepatitis C infection at Bellevue Hospital Center 19 North prison clinic from July 1, 2015 through December 31, 2016 will be offered participation in a transitional care coordination program. The rates of linkage of these individuals following release from jail will be compared to a historical cohort of adult patients with chronic Hepatitis C infection at the 19 North prison clinic from January 1, 2014 through June 31, 2015.
- Conditions
- Hepatitis C
- Being tested
- Research transitional care coordination
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research transitional care coordinationBehavioural
Though care coordination was offered to all HCV positive inmates who are approached,the care coordination will still constitute a research intervention that requires informed consent, rather than a new uniform standard of care, to allow maximum autonomy for this incarcerated population.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care transitional care coordination | Not described | |
| Research transitional care coordination | Not described Receives: Behavioral: Research transitional care coordination |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of adult inmates linked to care following release from jail between the period of January 1st 2014 to January 31st 2014 compared with February 1st 2015 to December 31st 2015 after the implementation of care coordination.
Measured: 2 Years
Secondary outcomes (7)
The proportion of those adult inmates who were successfully linked to care at Bellevue Hospital Center (BHC) during the period before and after the implementation of care coordination who subsequently had at least two visits with an HCV provider.
Measured: 2 Years
The proportion of those adult inmates who were linked to care at BHC during the period before and after the implementation of care coordination who then initiated Hepatitis C Virus (HCV) treatment.
Measured: 2 Years
The proportion of those adult inmates who were linked to care at BHC during the period before and after the implementation of care coordination who then went onto achieve an Sustained Virologic Response (SVR) when treated.
Measured: 2 Years
The proportion of those adult inmates who were linked to care at BHC during the period before and after the implementation of care coordination who were linked to ancillary services.
Measured: 2 Years
Retention in care as defined as two sequential clinic ID clinic visits during 12 months
Number of patients who are able to retain 2 sequential visits during 12 months
Measured: 2 Years
Documented sustained virologic response (SVR)
no detectable RNA in 2 years post treatment
Measured: 2 Years
Documented sustained HCV cure
Showing no symptoms of HCV for 2 years
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study startMay 2015
- Primary completionApr 2017
- Study completion14 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Eckhardt, MD, Principal investigator, New York Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036760
- Sponsor's protocol ID
- 14-02105
- Status last verified
- Jul 2019
- First submitted
- 19 Jul 2019
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akiyama MJ, Columbus D, MacDonald R, Jordan AO, Schwartz J, Litwin AH, Eckhardt B, Carmody E. Linkage to hepatitis C care after incarceration in jail: a prospective, single arm clinical trial. BMC Infect Dis. 2019 Aug 8;19(1):703. doi: 10.1186/s12879-019-4344-1.
PubMed 31395019
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of Care Coordination in Linkage to Care for Hepatitis C Following Release From New York City Jails
- ClinicalTrials.gov ID
- NCT04036760
- Acronym / sponsor ID
- 14-02105
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- 14 Dec 2017 (actual)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assesses the impact of a hepatitis C care coordination program on rates of linkage to hepatitis C care following release from New York City jails. Adult patients (age 18 years and above) with chronic Hepatitis C infection at Bellevue Hospital Center 19 North prison clinic from July 1, 2015 through December 31, 2016 will be offered participation in a transitional care coordination program. The rates of linkage of these individuals following release from jail will be compared to a historical cohort of adult patients with chronic Hepatitis C infection at the 19 North prison clinic from January 1, 2014 through June 31, 2015.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care transitional care coordination | – | – |
| Research transitional care coordination | – | Behavioral: Research transitional care coordination |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males and gender self-identified females age 18 or over with HCV infection seen in Bellevue's 19N prison Infectious Diseases clinic.
Key inclusion criteria (1 listed)
- HCV infection seen in Bellevue's 19N prison Infectious Diseases clinic.
Key exclusion criteria (6 listed)
- Individuals who refuse to participate in the study when approached
- Individuals who are unable or unwilling to sign a consent form agreeing to participate. Participants must have sufficient literacy to sign their name, as written informed consent is required for study participation
- Individuals who are unable to successfully negotiate the use of a telephone interpreter if required
- Individuals who have received a sentence that extends beyond the interval of follow up (one year sentence in city jail)
- Individuals who will be moved upstate to prison directly from jail
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Research transitional care coordinationThough care coordination was offered to all HCV positive inmates who are approached,the care coordination will still constitute a research intervention that requires informed consent, rather than a new uniform standard of care, to allow maximum autonomy for this incarcerated population. | Behavioural | Research transitional care coordination |
Primary outcome
The proportion of adult inmates linked to care following release from jail between the period of January 1st 2014 to January 31st 2014 compared with February 1st 2015 to December 31st 2015 after the implementation of care coordination.
Time frame: 2 Years
7 secondary outcomes
The proportion of those adult inmates who were successfully linked to care at Bellevue Hospital Center (BHC) during the period before and after the implementation of care coordination who subsequently had at least two visits with an HCV provider.
Time frame: 2 Years
The proportion of those adult inmates who were linked to care at BHC during the period before and after the implementation of care coordination who then initiated Hepatitis C Virus (HCV) treatment.
Time frame: 2 Years
The proportion of those adult inmates who were linked to care at BHC during the period before and after the implementation of care coordination who then went onto achieve an Sustained Virologic Response (SVR) when treated.
Time frame: 2 Years
The proportion of those adult inmates who were linked to care at BHC during the period before and after the implementation of care coordination who were linked to ancillary services.
Time frame: 2 Years
Retention in care as defined as two sequential clinic ID clinic visits during 12 months
Time frame: 2 Years
Documented sustained virologic response (SVR)
Time frame: 2 Years
Documented sustained HCV cure
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Derived from this study: PubMed 31395019Akiyama MJ, Columbus D, MacDonald R, Jordan AO, Schwartz J, Litwin AH, Eckhardt B, Carmody E. Linkage to hepatitis C care after incarceration in jail: a prospective, single arm clinical trial. BMC Infect Dis. 2019 Aug 8;19(1):703. doi: 10.1186/s12879-019-4344-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Eckhardt, MD principal investigator
New York Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of adult inmates linked to care following release from jail between the period of January 1st 2014 to January 31st 2014 compared with February 1st 2015 to December 31st 2015 after the implementation of care coordination. (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04036760, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.