Alcohol Use Reduction in Methadone Individuals With Hepatitis C Virus(HCV)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The Alcohol Use Reduction in Methadone Individuals with HCV was designed to compare three
      different types of programs for methadone maintained men and women to determine which of the
      three programs is most effective for:1) reducing alcohol consumption; 2) improving knowledge
      of and attitudes toward the disease of hepatitis and the treatment of hepatitis; 3) improving
      willingness to seek medical care for hepatitis C; 4) completing the 3 sessions on alcohol use
      reduction; 5) completing the 3 session Hepatitis A and B vaccine; and 6) determining the
      number of self-reported 12 step alcohol treatment program sessions attended.
    

Detailed description: 
      Nationwide, major strides have been made in treatment for HCV-infected patients using
      pegylated interferon and ribaviron; however use of these medications with HCV-infected opioid
      maintained (OM) IDUs in methadone maintenance (MM) treatment is problematic. Further, as many
      HCV-infected OM clients are continuing to drink alcohol, ongoing liver fibrosis and other
      social and behavioral consequences of alcohol use and abuse continue. Despite the fact that
      brief Motivational Interviewing (MI) has demonstrated effectiveness, these programs are not
      conducted in MM treatment settings. Moreover, the effectiveness of group delivery, as opposed
      to one-on-one delivery, of MI is unknown in terms of alcohol use reduction. In Phase I of
      this two-phased exploratory R21, a qualitative assessment will be conducted with 40 OM
      HCV-infected adults, 20 moderate alcohol users and 20 heavy alcohol users, equally divided by
      gender and readiness to change alcohol use, to explore with these clients: 1) factors
      impacting access to alcohol use reduction and health promotion services and free vaccination
      for HAV/HBV; and 2) strategies that MM staff can use to assist their clients in seeking
      services. Staff of a MM clinic will also explore the feasibility of providing these services.
      In Phase II, we plan to pilot an alcohol use reduction and liver health promotion
      intervention with 250 eligible, HCV-infected, alcohol-using OM clients receiving MM. Two
      intervention groups incorporating MI) will provide on-site brief MI (3 sessions) counseling
      to participants using either one-on-one delivery (MI-Single) or the group-delivery
      (MI-Group). In addition, each group will be offered the Liver Health Promotion (LHP) program,
      which includes a 30-minute health promotion education session, referral to a community
      12-Step alcohol outpatient program, and an offer for free screening for HAV/HBV, and the
      HAV/HBV vaccination series, if eligible (defined as being HAV and/or HBV seronegative). All
      these services will be integrated within participants' usual MM clinic onsite services. A
      third group, the Usual Care (UC) group will receive the same components offered to the
      intervention groups except for a time balanced on-site brief 3 session health promotion
      counseling as opposed to the MI. The short-term goals of the proposed study are to refine
      strategies that can be fully tested in a large-scale intervention trial. The long-term goals
      are to contribute to knowledge about promoting alcohol-related health-seeking and treatment
      completion behaviors in MM clinic settings that serve OM HCV-positive clients, so that
      population-specific intervention strategies can be developed.
    

Intervention name(s): Motivational Interviewing, Single - MIS; Motivational Interviewing Group; Usual Care Group - UCG
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): The Motivational Interviewing Single Arm is delivered individually to participants in 3 separate sessions to address a specific concept (alcohol use, cravings and what to do with them, and concomitant behaviors and/or consequences of alcohol use). Participants will be encouraged to explore the pros and cons for each of these topics with the facilitator, who will remain non-judgmental. Participants who are eligible for the Hepatitis A/B vaccine are also offered the vaccine in conjunction with each session.; The Motivational Interviewing Group Arm is delivered to participants in groups in 3 separate sessions to address a specific concept (alcohol use, cravings and what to do with them, and concomitant behaviors and/or consequences of alcohol use). Participants will be encouraged to explore the pros and cons for each of these topics with the facilitator and with the group, who will remain non-judgmental. Participants who are eligible for the Hepatitis A/B vaccine are also offered the vaccine in conjunction with each session.; The Usual Care Arm is delivered to participants in three brief time-equivalent health promotion sessions. Each session focuses on health promoting activities such as the importance of diet and exercise, need for physical and mental health assessment and enhanced coping for those afflicted with a history of drug and alcohol addiction. In addition participants receive liver health promotion education. Participants are also provided referrals to alcohol treatment programs in the community and offered the 3 series hepatitis A/B vaccine
Other intervention name(s): MIS; MIG; UCG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HCV; Alcohol; Methadone Maintained