Study to Reduce Intravenous Exposures (STRIVE)
Condition: Hepatitis C; HIV Infections
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether a six-session, small group behavioral
      intervention based on "peer-volunteer activism" is effective in (1) decreasing distributive
      sharing of syringes and other injection paraphernalia and (2) increasing utilization of
      HCV-related healthcare services among HCV-infected injection drug users
    

Detailed description: 
      The purpose of this study is to determine the efficacy of a peer-volunteer intervention to
      reduce high-risk transmission behaviors among hepatitis C virus (HCV)-infected young adult
      injection drug users (IDUs), and to identify the proportion of these individuals who would be
      eligible and willing to undergo treatment to eradicate HCV infection. HCV is one of the most
      frequently occurring human viral infections, having an estimated worldwide prevalence of 3%.
      In many regions of the United States, between 65% and 95% of IDUs are HCV-seropositive and
      capable of transmitting the infection. To date, research studies targeting infected
      individuals to prevent secondary transmission of chronic blood-borne viral infection have
      generally been limited to post-test counseling and case management. In addition, recent data
      suggest that medical treatment of HCV infection may be most effective when offered soon after
      HCV seroconversion. However, the proportion of HCV-infected IDUs who meet strict national
      guidelines for HCV treatment is likely to be small because treatment is usually postponed
      while drug use continues. Determining the proportion of infected individuals who may be both
      eligible and willing to undergo HCV therapy is highly important for guiding national
      standards and objectives to achieve greater numbers of IDUs in HCV therapy. We have
      previously reported that fewer than 1% of HCV-infected IDUs in Baltimore are currently
      receiving such therapy. Early initiation of HCV treatment among young IDUs in conjunction
      with a reduction in HCV transmission risk behaviors may ultimately lead to a reduction in
      incident HCV infection at the individual and the community levels.

      This study is a randomized controlled trial to determine the efficacy of a "peer-volunteer
      activism" intervention to reduce distributive syringe and injection paraphernalia sharing
      behaviors among HCV positive IDUs and promote the uptake of HCV care and treatment. If proven
      effective, this intervention would substantially decrease the risk of HCV infection in the
      community. To address these aims, we plan to recruit, screen, and randomly assign 750 IDUs
      age 18-35 years who are HCV-seropositive but HIV-seronegative in Baltimore, New York and
      Seattle to a behavioral intervention (250 per site), and prospectively monitor participants
      behavior at 3- and 6-month follow-up visits.
    

Intervention name(s): Peer Mentoring Intervention for HCV-Infected IDUs
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: IV Drug Users; Hepatitis C Virus; Human Immunodeficiency Virus; Intervention; HIV Seronegativity