CTN-0064: Linkage to Hepatitis C Virus (HCV) Care among HIV/HCV Co-infected Substance Users

Lisa R. Metsch, PhD
Lead Investigator
Associate Professor, Dept. of Epidemiology and Public Health
University of Miami Miller School of Medicine

Using the existing CTN-0049 cohort as a research platform, the proposed RCT will assess the effectiveness of an efficacious linkage to care intervention for HIV/HCV co-infected substance users. Linkage to care will be operationalized as receipt of clinical evaluation/treatment for HCV infection. Secondary objectives will be to assess: 1) relative success at each step in the cascade, 2) engagement in substance use treatment and HIV care, and 3) HIV viral suppression as well as 4) to examine other long-run outcomes of the CTN-0049 cohort.

Primary Findings

Three hundred and eighty-one individuals were screened and 113 randomized. Median age was 51 years; 58.4% male and 72.6% Black/African American. Median HIV-1 viral load was 27,209 copies/ml with 69% having a detectable viral load. Mean number of steps completed was statistically significantly higher in the intervention (2.44 steps) vs. control group (1.68 steps) [χ 2(1)=7.36, p=0.0067]. Men in the intervention (vs. control) group completed a statistically significantly higher number of steps. Eleven participants achieved sustained viral response with no difference by treatment group. The care facilitation intervention increased progress along the HCV/HIV care continuum, as observed for men and not women. Study findings also highlight the continued challenges to achieve individual patient sustained viral responses and population level HCV elimination.

Primary Outcomes Article: Metsch L, et al. Care Facilitation Advances Movement Along The Hepatitis C Care Continuum For Persons With HIV, Hepatitis C And Substance Use: A Randomized Clinical Trial (CTN-0064). Open Forum Infectious Diseases 2021; ofab334. [get article]

Related Studies

    Node Involvement

    Lead Node(s):

  • Florida Node Alliance
  • New England Consortium

  • All Participating Nodes:

  • Appalachian Tri-State Node
  • Delaware Valley Node
  • Florida Node Alliance
  • Mid-Atlantic Node
  • New England Consortium
  • Ohio Valley Node
  • Pacific Region Node
  • Southern Consortium Node
  • Texas Node