Hepatitis CCTN 0064NCT02641158
Assessing Long-term CTN 0049 Outcomes, HCV Prevalence and Progression Along the HCV Care Continuum Among HIV/HCV Co-infected Substance Users in the U.S.
A study testing Care Facilitation Group in people with Hepatitis C and HIV, run by Columbia University at 11 sites in United States.
Trial summary
Primary Objective: This study will evaluate the effectiveness of an HCV Care Facilitation intervention in moving HIV/HCV co-infected substance users forward along the HCV care continuum (compared with a Control group). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, HIV, AIDS
- What is being tested?
- Care Facilitation Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 422 participants
- Where
- 11 sitesUnited States
- Study dates
- Dec 2015to 9 May 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- By virtue of participating individuals being recruited from the CTN-0049 cohort, they will be:
- HIV-infected and
- 18 years of age or older
- Be able to communicate in English
- Additionally, to be eligible for Component 1 they must:
- provide informed consent, which includes being willing to provide sufficient locator information and to be tested for anti-HCV antibodies and, if antibody positive, tested for active HCV infection
Show all 14Show fewer
- sign a HIPAA form / medical record release form to facilitate medical record abstraction
- Finally, to continue on to Component 2, they must:
- provide sufficient locator information
- report living in the vicinity and being able to return for follow-up visits
- complete the baseline assessments
- complete the blood draw
- test as HCV antibody positive via study Component 1 and,
- agree to be randomized in Component 2
Who cannot join
- Individuals will be excluded from participation if they:
- have significant cognitive or developmental impairment
- are terminated via Site Principal Investigator decision/discretion with agreement from study Lead Investigator
- are currently in jail, prison or any inpatient overnight facility as required by court of law or have a pending legal action which may prevent an individual from completing the study
- Additionally, individuals may participate in Component 1, but will be excluded from Component 2 if they:
- are currently on HCV therapy/medications at baseline
- have completed a course of HCV medications in the last 12 weeks based on self-report.
- It should be noted that pregnancy is not an exclusion criterion. Therefore, sites may enroll pregnant women and/or follow-up with already enrolled women who become pregnant after enrollment in the study provided that they have local IRB approval to do so.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Grady Memorial Hospital / Ponce de Leon Center
Atlanta, Georgia, 30322
Johns Hopkins Hospital / Moore Clinic
Baltimore, Maryland, 21287
University Hospital at University of Alabama at Birmingham
Birmingham, Alabama, 35294
Boston University Medical Center
Boston, Massachusetts, 02118
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, 60612
University of Texas Southwestern
Dallas, Texas, 75390
Jackson Health System Adult HIV Outpatient Clinics / University of Miami
Miami, Florida, 33136
Mount Sinai - St. Luke's Roosevelt Hospital Center
New York, New York, 10025
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102
University of Pittsburgh Medical Center Presbyterian / Pittsburgh AIDS Center for Treatment
Pittsburgh, Pennsylvania, 15213
Los Angeles BioMedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
Official title: CTN 0064: Assessing Long-term CTN 0049 Outcomes, HCV Prevalence and Progression Along the HCV Care Continuum Among HIV/HCV Co-infected Substance Users in the U.S.
Primary Objective: This study will evaluate the effectiveness of an HCV Care Facilitation intervention in moving HIV/HCV co-infected substance users forward along the HCV care continuum (compared with a Control group).
Primary Hypothesis: The number of steps achieved along the HCV care continuum will differ between the two study groups over the 14-month follow-up period.
Read more
Secondary Objectives:
Component 1 (Long-term CTN 0049 follow-up):
Using the CTN 0064 baseline data (self-report, medical record abstraction and biological data), the following CTN 0049 primary and secondary outcomes in participants who consented to the CTN 0064 protocol will be re-analyzed to evaluate latent and/or enduring effects of the CTN 0049 interventions:
- HIV virological suppression
- HIV primary care visit attendance
- All-cause mortality
Read the detailed description
The CTN 0064 study leverages the existing research infrastructure and cohort of the CTN 0049 (NCT01612169) randomized, controlled trial (RCT). CTN 0049 ("Project HOPE -- Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users") is a three-group RCT that evaluated the most effective strategy to achieve HIV virologic suppression among HIV-infected substance users who were recruited from hospital settings. Between July 2012 and January 2014, a total of 801 HIV-infected hospitalized patients were recruited from 11 participating sites throughout the U.S. and randomized to one of the following three groups: 1) Patient Navigator intervention, 2) Patient Navigator plus Contingency Management intervention, and 3) Treatment as Usual. All CTN 0049 participants provided informed consent and completed baseline computer assisted personal interviews or CAPI (computer assisted personal interview: focusing on drug use, mental health, demographics and socio-economic factors, HIV care and drug treatment history) and blood draws (for HIV viral load and CD4 count). The two intervention groups received up to 11 patient navigation sessions over a 6-month period to actively assist participants in linking to HIV primary care and substance use treatment. Participants in all three groups completed follow-up assessments consisting of CAPI, blood draws, urine collection and breath analysis at approximately 6 and 12 months post-randomization. Medical records were reviewed to document receipt of HIV care and treatment during the study period. CTN 0064 will leverage the CTN 0049 research infrastructure and cohort by utilizing the 11 participating CTN 0049 research teams to recruit their randomized participants into the CTN 0064 study.
CTN 0064 has two main components: Component 1 is the baseline assessment for CTN 0064. It will also serve as a long-term follow-up assessment for CTN 0049 for those who consent to participate in CTN 0064. Participants whose HCV antibody test result is positive in this baseline assessment will be invited to enroll in Component 2. Component 2 is an RCT that will assess the effectiveness of a Care Facilitation intervention (compared to Control) in moving HIV/HCV co-infected substance users forward along the HCV care continuum. The study's primary objective is based on Component 2 and will be operationalized as movement through a series of (potentially non-sequential) pre-defined, clinical steps along the HCV care continuum (including the ultimate step, sustained virologic response to treatment at 12 weeks post treatment completion [SVR12]) (AASLD/IDSA/IAS-USA). Secondary objectives will be to assess: 1) success at each step in the HCV care continuum, 2) engagement in HIV care and substance use treatment, and 3) HIV viral suppression as well as 4) to examine other long-term outcomes of the CTN 0049 cohort.
All adults who were randomized into the CTN 0049 study and who provided consent to be contacted about future studies (hereafter, referred to as the "CTN 0049 cohort") will be invited to enroll in the CTN 0064 study. All participants will provide informed consent and complete Component 1, consisting of: 1) a computer assisted personal interview or CAPI (capturing history of HIV care, HCV testing and care, substance use and substance use treatment; mental health; demographics; and socio-economic factors), 2) HCV antibody screening via rapid HCV test (and, if HCV antibody positive, HCV RNA testing via venipuncture), 3) associated pre-/post-HCV test information and counseling, 4) blood specimen collection via venipuncture, and 5) drug/alcohol toxicology screening (via urine evaluation). The blood specimens of all participants will be assessed for HIV viral load and CD4 count. The blood specimens for the subset of participants who screen as HCV antibody positive will be assessed for HCV RNA to determine if their HCV infection is active.
Participants who screen as HCV antibody positive will be randomized into Component 2 and assigned to one of two groups: 1) HCV Care Facilitation intervention or 2) Control. The Care Facilitation intervention group will receive up to 12 sessions during a 6-month intervention period. Follow-up visits with both groups will be conducted at approximately 6 and 12 months post-randomization. These visits will consist of CAPI, blood specimen collection, and drug/alcohol toxicology screening. Medical records will be reviewed to document HCV testing, receipt and use of HCV clinical evaluation, care and treatment (as applicable); and HIV care and treatment before and during the study period.
- Conditions
- Hepatitis C, HIV, AIDS, Substance Use
- Being tested
- Control Group, Care Facilitation Group
- Keywords
- HIV, Hepatitis C, Substance users, Drug users
- Medical subject headings
- Hepatitis C, Acquired Immunodeficiency Syndrome, Substance-Related Disorders, Drug Misuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupOther
After screening HCV antibody positive, participants will receive an appointment and reminder card to return for their HCV RNA results. If HCV RNA positive, study staff will attempt to make an appointment for the participant's next step in the HCV continuum. If a participant attends the "next step" visit, the participant would be subject to whatever is the local standard of care at that clinic/agency from that point forward.
Care Facilitation GroupBehavioural
The same will occur for intervention participants, yet an HCV care facilitator will motivate them to return for their HCV RNA results; appointment reminders will be made prior to the "next step" visit; follow-up contact will be made for missed appointments; and the HCV care facilitator will coordinate and link the participant to available community resources (e.g., mental health, housing agencies) by scheduling appointments, arranging transportation, and helping to complete any clinic registration (or other) paperwork that agencies may require to access services.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | Not described Receives: Other: Control Group |
| Care Facilitation Group | Experimental | Not described Receives: Behavioral: Care Facilitation Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forward movement along the HCV care continuum assessed as the difference between the number of steps completed pre- and post-randomization (among Component 2 participants)
The primary outcome is a count variable: total # of completed steps along the HCV care continuum by 14 months post-randomization (this is the outside window for the 12-month follow-up visit) minus the total number of steps completed within 12 months prior to baseline. Participants' final step on the HCV care continuum will be assessed the last time they are observed in medical records within the 14-month-long follow-up period. Because the entire sample has HIV, we include 2 HIV-related steps:
- Receipt of HCV RNA result -- result received within 3 months of baseline
- HIV primary care visit -- completion of 1 visit with an HIV primary care provider
- Initiated HIV ART
- HCV evaluation
- HCV treatment offered and declined or prescription process initiated
- HCV treatment initiated
- Course of HCV treatment completed
- SVR12 (sustained virologic response) achieved at 12 or more weeks after treatment completion
Measured: 14 months post-randomization (this is the outside window for the 12-month follow-up visit)
Secondary outcomes (3)
HIV viral suppression
Suppression binary defined as viral load <=200 copies/ml (yes) vs. viral load >200 copies/ml or all-cause mortality (no)
Measured: Assessed at the CTN 0064 baseline visit
HIV care visit attendance
Measured: Assessed in the 6-month time period before the CTN 0064 baseline visit
All-cause mortality
Measured: Time period will vary by participant between 9 months and 4 years depending when they were randomized into CTN 0049 and when they complete the CTN 0064 baseline assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startDec 2015
- Primary completion9 May 2018
- Study completion9 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Columbia UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Jackson Health System, Grady Memorial Hospital, St. Luke's-Roosevelt Hospital Center, University of Texas, Johns Hopkins University, University Hospital Birmingham, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, University of Pittsburgh Medical Center, Hahnemann University Hospital, Cook County Health, Boston University, Weill Medical College of Cornell University, Icahn School of Medicine at Mount Sinai, The Emmes Company, LLC, University of Miami, University of California, San Francisco
- Responsible party
- Principal investigator, Lisa Metsch, Columbia University
- Investigators
- Lisa R. Metsch, PhD, Principal investigator, Columbia UniversityCarlos del Rio, MD, Principal investigator, Emory UniversityDaniel J. Feaster, PhD, Principal investigator, University of MiamiCarmen Masson, PhD, Principal investigator, University of California, San FranciscoDavid Perlman, MD, Principal investigator, Mount Sinai Icahn School of MedicineLauren K. Gooden, PhD, Study director, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641158
- Sponsor's protocol ID
- AAAP8757
- Other IDs
- U10DA013720
- Acronym
- CTN 0064
- Status last verified
- Jul 2020
- First submitted
- 13 Dec 2015
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Information about the study and the de-identified study data will be available at https://datashare.nida.nih.gov/ within 18 months of the date the data are locked, as per the procedures of the National Drug Abuse Treatment Clinical Trials Network.
Publications
Gutkind S, Starbird LE, Murphy SM, Teixeira PA, Gooden LK, Matheson T, Feaster DJ, Jain MK, Masson CL, Perlman DC, Del Rio C, Metsch LR, Schackman BR. Cost of Hepatitis C care facilitation for HIV/Hepatitis C Co-infected people who use drugs. Drug Alcohol Depend. 2022 Mar 1;232:109265. doi: 10.1016/j.drugalcdep.2022.109265. Epub 2022 Jan 10.
PubMed 35042101Metsch LR, Feaster DJ, Gooden LK, Masson C, Perlman DC, Jain MK, Matheson T, Nelson CM, Jacobs P, Tross S, Haynes L, Lucas GM, Colasanti JA, Rodriguez A, Drainoni ML, Osorio G, Nijhawan AE, Jacobson JM, Sullivan M, Metzger D, Vergara-Rodriguez P, Lubelchek R, Duan R, Batycki JN, Matthews AG, Munoz F, Jelstrom E, Mandler R, Del Rio C. Care Facilitation Advances Movement Along the Hepatitis C Care Continuum for Persons With Human Immunodeficiency Virus, Hepatitis C, and Substance Use: A Randomized Clinical Trial (CTN-0064). Open Forum Infect Dis. 2021 Jun 27;8(8):ofab334. doi: 10.1093/ofid/ofab334. eCollection 2021 Aug.
PubMed 34377726
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CTN 0064: Assessing Long-term CTN 0049 Outcomes, HCV Prevalence and Progression Along the HCV Care Continuum Among HIV/HCV Co-infected Substance Users in the U.S.
- ClinicalTrials.gov ID
- NCT02641158
- Acronym / sponsor ID
- CTN 0064 / AAAP8757
- Conditions
- Hepatitis C, HIV, AIDS, Substance Use
- Keywords
- HIV, Hepatitis C, Substance users, Drug users
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Jackson Health System, Grady Memorial Hospital, St. Luke's-Roosevelt Hospital Center, University of Texas, Johns Hopkins University, University Hospital Birmingham, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, University of Pittsburgh Medical Center, Hahnemann University Hospital, Cook County Health, Boston University, Weill Medical College of Cornell University, Icahn School of Medicine at Mount Sinai, The Emmes Company, LLC, University of Miami, University of California, San Francisco
- Study start
- Dec 2015
- Primary completion
- 9 May 2018 (actual)
- Study completion
- 9 May 2018 (actual)
- First posted
- 29 Dec 2015 (estimated)
- 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.
Primary Objective: This study will evaluate the effectiveness of an HCV Care Facilitation intervention in moving HIV/HCV co-infected substance users forward along the HCV care continuum (compared with a Control group).
Primary Hypothesis: The number of steps achieved along the HCV care continuum will differ between the two study groups over the 14-month follow-up period.
Secondary Objectives:
Component 1 (Long-term CTN 0049 follow-up):
Using the CTN 0064 baseline data (self-report, medical record abstraction and biological data), the following CTN 0049 primary and secondary outcomes in participants who consented to the CTN 0064 protocol will be re-analyzed to evaluate latent and/or enduring effects of the CTN 0049 interventions:
- HIV virological suppression
- HIV primary care visit attendance
- All-cause mortality
Detailed description
The CTN 0064 study leverages the existing research infrastructure and cohort of the CTN 0049 (NCT01612169) randomized, controlled trial (RCT). CTN 0049 ("Project HOPE -- Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users") is a three-group RCT that evaluated the most effective strategy to achieve HIV virologic suppression among HIV-infected substance users who were recruited from hospital settings. Between July 2012 and January 2014, a total of 801 HIV-infected hospitalized patients were recruited from 11 participating sites throughout the U.S. and randomized to one of the following three groups: 1) Patient Navigator intervention, 2) Patient Navigator plus Contingency Management intervention, and 3) Treatment as Usual. All CTN 0049 participants provided informed consent and completed baseline computer assisted personal interviews or CAPI (computer assisted personal interview: focusing on drug use, mental health, demographics and socio-economic factors, HIV care and drug treatment history) and blood draws (for HIV viral load and CD4 count). The two intervention groups received up to 11 patient navigation sessions over a 6-month period to actively assist participants in linking to HIV primary care and substance use treatment. Participants in all three groups completed follow-up assessments consisting of CAPI, blood draws, urine collection and breath analysis at approximately 6 and 12 months post-randomization. Medical records were reviewed to document receipt of HIV care and treatment during the study period. CTN 0064 will leverage the CTN 0049 research infrastructure and cohort by utilizing the 11 participating CTN 0049 research teams to recruit their randomized participants into the CTN 0064 study.
CTN 0064 has two main components: Component 1 is the baseline assessment for CTN 0064. It will also serve as a long-term follow-up assessment for CTN 0049 for those who consent to participate in CTN 0064. Participants whose HCV antibody test result is positive in this baseline assessment will be invited to enroll in Component 2. Component 2 is an RCT that will assess the effectiveness of a Care Facilitation intervention (compared to Control) in moving HIV/HCV co-infected substance users forward along the HCV care continuum. The study's primary objective is based on Component 2 and will be operationalized as movement through a series of (potentially non-sequential) pre-defined, clinical steps along the HCV care continuum (including the ultimate step, sustained virologic response to treatment at 12 weeks post treatment completion [SVR12]) (AASLD/IDSA/IAS-USA). Secondary objectives will be to assess: 1) success at each step in the HCV care continuum, 2) engagement in HIV care and substance use treatment, and 3) HIV viral suppression as well as 4) to examine other long-term outcomes of the CTN 0049 cohort.
All adults who were randomized into the CTN 0049 study and who provided consent to be contacted about future studies (hereafter, referred to as the "CTN 0049 cohort") will be invited to enroll in the CTN 0064 study. All participants will provide informed consent and complete Component 1, consisting of: 1) a computer assisted personal interview or CAPI (capturing history of HIV care, HCV testing and care, substance use and substance use treatment; mental health; demographics; and socio-economic factors), 2) HCV antibody screening via rapid HCV test (and, if HCV antibody positive, HCV RNA testing via venipuncture), 3) associated pre-/post-HCV test information and counseling, 4) blood specimen collection via venipuncture, and 5) drug/alcohol toxicology screening (via urine evaluation). The blood specimens of all participants will be assessed for HIV viral load and CD4 count. The blood specimens for the subset of participants who screen as HCV antibody positive will be assessed for HCV RNA to determine if their HCV infection is active.
Participants who screen as HCV antibody positive will be randomized into Component 2 and assigned to one of two groups: 1) HCV Care Facilitation intervention or 2) Control. The Care Facilitation intervention group will receive up to 12 sessions during a 6-month intervention period. Follow-up visits with both groups will be conducted at approximately 6 and 12 months post-randomization. These visits will consist of CAPI, blood specimen collection, and drug/alcohol toxicology screening. Medical records will be reviewed to document HCV testing, receipt and use of HCV clinical evaluation, care and treatment (as applicable); and HIV care and treatment before and during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: Control Group |
| Care Facilitation Group | Experimental | Behavioral: Care Facilitation Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- By virtue of participating individuals being recruited from the CTN-0049 cohort, they will be:
- HIV-infected and
- 18 years of age or older
- Be able to communicate in English
- provide informed consent, which includes being willing to provide sufficient locator information and to be tested for anti-HCV antibodies and, if antibody positive, tested for active HCV infection
Key exclusion criteria (8 listed)
- have significant cognitive or developmental impairment
- are terminated via Site Principal Investigator decision/discretion with agreement from study Lead Investigator
- are currently in jail, prison or any inpatient overnight facility as required by court of law or have a pending legal action which may prevent an individual from completing the study
- Additionally, individuals may participate in Component 1, but will be excluded from Component 2 if they:
- are currently on HCV therapy/medications at baseline
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 |
|---|---|---|
| Control GroupAfter screening HCV antibody positive, participants will receive an appointment and reminder card to return for their HCV RNA results. If HCV RNA positive, study staff will attempt to make an appointment for the participant's next step in the HCV continuum. If a participant attends the "next step" visit, the participant would be subject to whatever is the local standard of care at that clinic/agency from that point forward. | Other | Control Group |
| Care Facilitation GroupThe same will occur for intervention participants, yet an HCV care facilitator will motivate them to return for their HCV RNA results; appointment reminders will be made prior to the "next step" visit; follow-up contact will be made for missed appointments; and the HCV care facilitator will coordinate and link the participant to available community resources (e.g., mental health, housing agencies) by scheduling appointments, arranging transportation, and helping to complete any clinic registration (or other) paperwork that agencies may require to access services. | Behavioural | Care Facilitation Group |
Primary outcome
Forward movement along the HCV care continuum assessed as the difference between the number of steps completed pre- and post-randomization (among Component 2 participants)
Time frame: 14 months post-randomization (this is the outside window for the 12-month follow-up visit)
The primary outcome is a count variable: total # of completed steps along the HCV care continuum by 14 months post-randomization (this is the outside window for the 12-month follow-up visit) minus the total number of steps completed within 12 months prior to baseline. Participants' final step on the HCV care continuum will be assessed the last time they are observed in medical records within the 14-month-long follow-up period. Because the entire sample has HIV, we include 2 HIV-related steps: 1. Receipt of HCV RNA result -- result received within 3 months of baseline 2. HIV primary care visit -- completion of 1 visit with an HIV primary care provider 3. Initiated HIV ART 4. HCV evaluation 5. HCV treatment offered and declined or prescription process initiated 6. HCV treatment initiated 7. Course of HCV treatment completed 8. SVR12 (sustained virologic response) achieved at 12 or more weeks after treatment completion
3 secondary outcomes
HIV viral suppression
Time frame: Assessed at the CTN 0064 baseline visit
HIV care visit attendance
Time frame: Assessed in the 6-month time period before the CTN 0064 baseline visit
All-cause mortality
Time frame: Time period will vary by participant between 9 months and 4 years depending when they were randomized into CTN 0049 and when they complete the CTN 0064 baseline assessment.
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 22 Jul 2020.
- Derived from this study: PubMed 35042101Gutkind S, Starbird LE, Murphy SM, Teixeira PA, Gooden LK, Matheson T, Feaster DJ, Jain MK, Masson CL, Perlman DC, Del Rio C, Metsch LR, Schackman BR. Cost of Hepatitis C care facilitation for HIV/Hepatitis C Co-infected people who use drugs. Drug Alcohol Depend. 2022 Mar 1;232:109265. doi: 10.1016/j.drugalcdep.2022.109265. Epub 2022 Jan 10.
- Derived from this study: PubMed 34377726Metsch LR, Feaster DJ, Gooden LK, Masson C, Perlman DC, Jain MK, Matheson T, Nelson CM, Jacobs P, Tross S, Haynes L, Lucas GM, Colasanti JA, Rodriguez A, Drainoni ML, Osorio G, Nijhawan AE, Jacobson JM, Sullivan M, Metzger D, Vergara-Rodriguez P, Lubelchek R, Duan R, Batycki JN, Matthews AG, Munoz F, Jelstrom E, Mandler R, Del Rio C. Care Facilitation Advances Movement Along the Hepatitis C Care Continuum for Persons With Human Immunodeficiency Virus, Hepatitis C, and Substance Use: A Randomized Clinical Trial (CTN-0064). Open Forum Infect Dis. 2021 Jun 27;8(8):ofab334. doi: 10.1093/ofid/ofab334. eCollection 2021 Aug.
- Individual participant dataSharing planned: Yes. Information about the study and the de-identified study data will be available at https://datashare.nida.nih.gov/ within 18 months of the date the data are locked, as per the procedures of the National Drug Abuse Treatment Clinical Trials Network.
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
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
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
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.
Lisa R. Metsch, PhD principal investigator
Columbia University
Carlos del Rio, MD principal investigator
Emory University
Daniel J. Feaster, PhD principal investigator
University of Miami
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Facilitation Group in people with Hepatitis C and HIV, run by Columbia University at 11 sites 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 14 inclusion and 8 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 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Forward movement along the HCV care continuum assessed as the difference between the number of steps completed pre- and post-randomization (among Component 2 participants) (time frame: 14 months post-randomization (this is the outside window for the 12-month follow-up visit)). 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 NCT02641158, which also lists 2 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 Jul 2020.