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.
Completed · Not applicable
Conditions studied: Hepatitis C, HIV, AIDS, Substance Use
In brief
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
Key facts
- Study ID
- NCT02641158
- Run by
- Columbia University
- People needed
- 422
- Starts
- 2015-12-01
- Expected to finish
- 2018-05-09
- Last updated by the study team
- 2020-07-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- 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.
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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