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.
NCT ID: NCT02641158
Last Updated: 2020-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
422 participants
INTERVENTIONAL
2015-12-31
2018-05-09
Brief Summary
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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
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Group
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.
Care Facilitation Group
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Jackson Health System
OTHER
Grady Memorial Hospital
OTHER
St. Luke's-Roosevelt Hospital Center
OTHER
University of Texas
OTHER
Johns Hopkins University
OTHER
University Hospital Birmingham
OTHER
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
OTHER
University of Pittsburgh Medical Center
OTHER
Hahnemann University Hospital
OTHER
Cook County Health
OTHER_GOV
Boston University
OTHER
Weill Medical College of Cornell University
OTHER
Icahn School of Medicine at Mount Sinai
OTHER
The Emmes Company, LLC
INDUSTRY
University of Miami
OTHER
University of California, San Francisco
OTHER
Columbia University
OTHER
Responsible Party
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Lisa Metsch
Stephen Smith Professor and Chair of Sociomedical Sciences Department
Principal Investigators
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Lisa R. Metsch, PhD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Carlos del Rio, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Daniel J. Feaster, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Carmen Masson, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
David Perlman, MD
Role: PRINCIPAL_INVESTIGATOR
Mount Sinai Icahn School of Medicine
Lauren K. Gooden, PhD
Role: STUDY_DIRECTOR
Columbia University
Locations
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University Hospital at University of Alabama at Birmingham
Birmingham, Alabama, United States
Los Angeles BioMedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States
Jackson Health System Adult HIV Outpatient Clinics / University of Miami
Miami, Florida, United States
Grady Memorial Hospital / Ponce de Leon Center
Atlanta, Georgia, United States
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, United States
Johns Hopkins Hospital / Moore Clinic
Baltimore, Maryland, United States
Boston University Medical Center
Boston, Massachusetts, United States
Mount Sinai - St. Luke's Roosevelt Hospital Center
New York, New York, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Presbyterian / Pittsburgh AIDS Center for Treatment
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern
Dallas, Texas, United States
Countries
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References
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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.
Metsch 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.
Other Identifiers
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AAAP8757
Identifier Type: -
Identifier Source: org_study_id
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