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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. (CTN 0064)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02641158
Recruitment Status : Active, not recruiting
First Posted : December 29, 2015
Last Update Posted : August 22, 2019
Sponsor:
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
John H. Stroger Hospital
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
Information provided by (Responsible Party):
Lisa Metsch, Columbia University

Brief 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).

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:

  1. HIV virological suppression
  2. HIV primary care visit attendance
  3. All-cause mortality

Condition or disease Intervention/treatment Phase
Hepatitis C HIV AIDS Substance Use Other: Control Group Behavioral: Care Facilitation Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : December 2015
Actual Primary Completion Date : January 2018
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse HIV/AIDS

Arm Intervention/treatment
Control Group Other: Control Group
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.

Experimental: Care Facilitation Group Behavioral: Care Facilitation Group
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. HIV viral suppression [ Time Frame: Assessed at the CTN 0064 baseline visit ]
    Suppression binary defined as viral load <=200 copies/ml (yes) vs. viral load >200 copies/ml or all-cause mortality (no)

  2. HIV care visit attendance [ Time Frame: Assessed in the 6-month time period before the CTN 0064 baseline visit ]
  3. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

By virtue of participating individuals being recruited from the CTN-0049 cohort, they will be:

  1. HIV-infected and
  2. 18 years of age or older
  3. Be able to communicate in English

    Additionally, to be eligible for Component 1 they must:

  4. 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
  5. sign a HIPAA form / medical record release form to facilitate medical record abstraction

    Finally, to continue on to Component 2, they must:

  6. provide sufficient locator information
  7. report living in the vicinity and being able to return for follow-up visits
  8. complete the baseline assessments
  9. complete the blood draw
  10. test as HCV antibody positive via study Component 1 and,
  11. agree to be randomized in Component 2

Exclusion Criteria:

Individuals will be excluded from participation if they:

  1. have significant cognitive or developmental impairment
  2. are terminated via Site Principal Investigator decision/discretion with agreement from study Lead Investigator
  3. 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:

  4. are currently on HCV therapy/medications at baseline
  5. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02641158


Locations
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United States, Alabama
University Hospital at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Los Angeles BioMedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Florida
Jackson Health System Adult HIV Outpatient Clinics / University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Grady Memorial Hospital / Ponce de Leon Center
Atlanta, Georgia, United States, 30322
United States, Illinois
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins Hospital / Moore Clinic
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
United States, New York
Mount Sinai - St. Luke's Roosevelt Hospital Center
New York, New York, United States, 10025
United States, Pennsylvania
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102
University of Pittsburgh Medical Center Presbyterian / Pittsburgh AIDS Center for Treatment
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Columbia University
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
John H. Stroger Hospital
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
Investigators
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Principal Investigator: Lisa R. Metsch, PhD Columbia University
Principal Investigator: Carlos del Rio, MD Emory University
Principal Investigator: Daniel J. Feaster, PhD University of Miami
Principal Investigator: Carmen Masson, PhD University of California, San Francisco
Principal Investigator: David Perlman, MD Mount Sinai Icahn School of Medicine
Study Director: Lauren K. Gooden, PhD Columbia University
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Responsible Party: Lisa Metsch, Stephen Smith Professor and Chair of Sociomedical Sciences Department, Columbia University
ClinicalTrials.gov Identifier: NCT02641158    
Other Study ID Numbers: AAAP8757
U10DA013720 ( U.S. NIH Grant/Contract )
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Time Frame: Within 18 months.
Access Criteria: Information will be de-identified.
URL: https://datashare.nida.nih.gov/
Keywords provided by Lisa Metsch, Columbia University:
HIV
Hepatitis C
Substance users
Drug users
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections