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
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.
2 other identifiers
interventional
422
1 country
11
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2015
Typical duration for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 13, 2015
CompletedFirst Posted
Study publicly available on registry
December 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 9, 2018
CompletedJuly 22, 2020
July 1, 2020
2.4 years
December 13, 2015
July 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
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
14 months post-randomization (this is the outside window for the 12-month follow-up visit)
Secondary Outcomes (3)
HIV viral suppression
Assessed at the CTN 0064 baseline visit
HIV care visit attendance
Assessed in the 6-month time period before the CTN 0064 baseline visit
All-cause mortality
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.
Study Arms (2)
Control Group
OTHERCare Facilitation Group
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- By virtue of participating individuals being recruited from the CTN-0049 cohort, they will be:
- HIV-infected and
- 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
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
- Jackson Health Systemcollaborator
- Grady Memorial Hospitalcollaborator
- St. Luke's-Roosevelt Hospital Centercollaborator
- University of Texascollaborator
- Johns Hopkins Universitycollaborator
- University Hospital Birminghamcollaborator
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Centercollaborator
- University of Pittsburgh Medical Centercollaborator
- Hahnemann University Hospitalcollaborator
- Cook County Healthcollaborator
- Boston Universitycollaborator
- Weill Medical College of Cornell Universitycollaborator
- Icahn School of Medicine at Mount Sinaicollaborator
- The Emmes Company, LLCcollaborator
- University of Miamicollaborator
- University of California, San Franciscocollaborator
Study Sites (11)
University Hospital at University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Los Angeles BioMedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Jackson Health System Adult HIV Outpatient Clinics / University of Miami
Miami, Florida, 33136, United States
Grady Memorial Hospital / Ponce de Leon Center
Atlanta, Georgia, 30322, United States
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, 60612, United States
Johns Hopkins Hospital / Moore Clinic
Baltimore, Maryland, 21287, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
Mount Sinai - St. Luke's Roosevelt Hospital Center
New York, New York, 10025, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102, United States
University of Pittsburgh Medical Center Presbyterian / Pittsburgh AIDS Center for Treatment
Pittsburgh, Pennsylvania, 15213, United States
University of Texas Southwestern
Dallas, Texas, 75390, United States
Related Publications (2)
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.
PMID: 35042101DERIVEDMetsch 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.
PMID: 34377726DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Stephen Smith Professor and Chair of Sociomedical Sciences Department
Study Record Dates
First Submitted
December 13, 2015
First Posted
December 29, 2015
Study Start
December 1, 2015
Primary Completion
May 9, 2018
Study Completion
May 9, 2018
Last Updated
July 22, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Within 18 months.
- Access Criteria
- Information will be de-identified.
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.