Hepatitis CNCT03214679

Accessible HCV Care Intervention for People Who Inject Illicit Drugs (PWID)

A study testing Accessible Care in people with Hepatitis C and People Who Inject Drugs, run by City University of New York, School of Public Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C, People Who Inject Drugs, PWID
What is being tested?: Accessible Care
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 167 participants
Where: 1 siteUnited States
Study dates: 20 Jul 2017to 30 Jun 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 years or older,
injected heroin, cocaine, or other drugs in the past 90 days.
test HCV Ab and RNA positive
provide written consent (including consent for researchers to examine their hepatitis C medical records)

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Lower East Side Harm Reduction Center
New York, New York, 10022

Other trials in United States

About this study

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

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: Hepatitis C, People Who Inject Drugs, PWID, HCV Coinfection
Being tested: Accessible Care, Usual Care
Keywords: Hepatitis C, HCV, People who inject drugs
Medical subject headings: Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Accessible CareOther
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 CareOther
Usual care entails referral to an on site HCV care coordinator (not provided by study)

Study groups in NCT03214679
Study group	Role	What they receive
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. Receives: Other: Accessible Care
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. Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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)
Measured: Each participant will be assessed 1 year post entry

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jul 201730 Jun 2021

First posted11 Jul 2017
Study start20 Jul 2017
Primary completion30 Jun 2021
Study completion30 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Hepatitis CStudies of the same condition, open and under way.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 167 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03214679
Sponsor's protocol ID: 1612017838A001
Other IDs: R01DA041298
Status last verified: Jul 2021
First submitted: 29 Jun 2017
Last updated: 22 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 35285851
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.
PubMed 37501180
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.
PubMed 34819070

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Accessible Care Intervention for Engaging People Who Inject Illicit Drugs in HCV Care
ClinicalTrials.gov ID: NCT03214679
Acronym / sponsor ID: 1612017838A001
Conditions: Hepatitis C, People Who Inject Drugs, PWID, HCV Coinfection
Keywords: Hepatitis C, HCV, People who inject drugs
Study type: Interventional
Recruitment status: Completed
Enrolment: 167 participants (actual)
Lead sponsor: City University of New York, School of Public HealthUniversity, hospital or other
Collaborators: National Development and Research Institutes, Inc., National Institute on Drug Abuse (NIDA), Weill Medical College of Cornell University
Study start: 20 Jul 2017 (actual)
Primary completion: 30 Jun 2021 (actual)
Study completion: 30 Jun 2021 (actual)
First posted: 11 Jul 2017 (actual)
Results: Posted 22 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Accessible Care	Experimental	Other: 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.
Usual Care	Active comparator	Other: Usual CareUsual 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

18 years or older,
injected heroin, cocaine, or other drugs in the past 90 days.
test HCV Ab and RNA positive
provide written consent (including consent for researchers to examine their hepatitis C medical records)

Key exclusion criteria (2 listed)

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.

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
Accessible CareAccessible 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.	Other	Accessible Care
Usual CareUsual care entails referral to an on site HCV care coordinator (not provided by study)	Other	Usual Care

Primary outcome

Proportion of Patients to Achieve SVR12 at 1 Year
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)

Results and safety

Results posted to the registry on 22 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Accessible Care	84	70
Usual Care	83	69

Primary outcome: Proportion of Patients to Achieve SVR12 at 1 Year

Time frame: each participant will be assessed at 1 year post entry. Count of participants. Unit: Participants

Measure	Accessible Care n = 82	Usual Care n = 83
Value	55	19

Accessible Care vs Usual Care: p <.001, Chi-squared

Population analysed: 2 ineligible participants excluded post-randomization are not included in any of the outcome or AE analyses

Primary outcome: Proportion of Patients in Each Arm Referred to Hepatitis C Treatment Provider

Time frame: each participant will be assessed at 1 year post entry. Count of participants. Unit: Participants

Measure	Accessible Care n = 82	Usual Care n = 83
Value	76	37

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

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

Time frame: end of study (12 months). Count of participants. Unit: Participants

Measure	Accessible Care n = 82	Usual Care n = 83
Value	71	31

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

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Accessible Care n = 82	Usual Care n = 83
Value	71	26

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

Adverse events

Time frame: 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Accessible Care	12 of 82 (14.6%)	0 of 82 (0%)	3 of 82
Usual Care	11 of 83 (13.3%)	0 of 83 (0%)	1 of 83

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 35285851Eckhardt 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.
Derived from this study: PubMed 37501180Kapadia 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.
Derived from this study: PubMed 34819070Aponte-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.

Related trials for Hepatitis C

RecruitingObservational study
Evaluation of Patients With Liver Disease
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Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
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Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
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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.

Kristen Marks principal investigator

Weill Medical College of Cornell University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Accessible Care in people with Hepatitis C and People Who Inject Drugs, run by City University of New York, School of Public 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 4 inclusion and 2 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 22 Feb 2023. 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?

Yes. Results are posted in the registry (first posted 22 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Patients to Achieve SVR12 at 1 Year (time frame: each participant will be assessed at 1 year post entry). The study lists 5 primary outcomes in all. 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 NCT03214679, which also lists 3 linked publications.

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 22 Feb 2023.