NIDA-CTN-0064
Division
HEAL Study
Investigator(s)
Title
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.
Short Description
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).
Release Date
Oct 24, 2024
Description
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.
Keywords
Assessments
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