Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV
Condition: Alcohol Use Disorder; HIV/AIDS; Hepatitis C; Binge Drinking
MeSH terms: Hepatitis C; Hepatitis; Alcoholism; Binge Drinking
Study type: Interventional

Summary: 
      Among patients with HIV, especially those also infected with HCV, heavy drinking is
      associated with significant risks to health. However, little is known about how to best
      intervene with co-infected heavy drinkers, a particularly high risk group for whom targeted
      intervention has not been developed. Therefore, this study proposes to test a newly developed
      drinking-reduction intervention for patients with both HIV and HCV, which combines components
      of successful interventions developed for HIV and for liver disease patients.

      60 HIV/HCV co-infected drinkers from HIV primary care will be recruited in order to ensure an
      adequate final sample size of 45 participants completing the study. A clinic recruiter will
      identify and refer potential participants based on their medical record, who will then be
      screened for eligibility by the research coordinator. Potential participants from outside of
      this clinic will also be recruited through self-referrals via flyers and through RecruitMe,
      an online based recruitment tool. Participants will be randomly assigned to an intervention
      or control condition, while ensuring that equal numbers of individuals with alcohol use
      disorder are assigned to each condition. The intervention condition will receive brief
      in-person sessions with a counselor and will be asked to use a smartphone app daily to keep
      track of drinking and other health behaviors for two months. The intervention sessions will
      include information about HIV, HCV and alcohol, and the counselor will give the participant
      information about their liver function and alcohol use to try to motivate them to drink less.
      The control condition will simply be asked to drink less and will be given pamphlets with
      general information on HIV, Hepatitis C, and drinking from educational websites on HIV/HCV
      co-infection. The intervention condition will then be evaluated to see if it was more
      effective at reducing drinking than the control condition.
    

Detailed description: 
      Patients with HIV have high rates of heavy drinking and alcohol problems, and face serious
      medical consequences from this use. Some research suggests that alcohol can increase viral
      load and decrease CD4 (cluster of differentiation 4; e.g., T helper cells) count, although
      this literature is conflicting. It also increases risk for liver damage, as does hepatitis
      co-infection, making liver disease a leading cause of death for patients with HIV. Patients
      with alcohol problems are also less adherent to antiretroviral therapy (ART), and some
      intentionally skip ART to try to avoid hepatotoxic effects of combining ART with alcohol.
      Some studies also show alcohol's interference with other aspects of engagement in HIV care.

      Approximately 25% of HIV-infected patients are co-infected with HCV. Although HCV alone can
      lead to liver damage, HIV accelerates this progression, as does heavy drinking. Further,
      individuals with HCV who drink heavily may be less likely to access HCV medication. Despite
      serious health risks associated with alcohol use, some research suggests that HIV/HCV
      patients drink more than HIV mono-infected patients.

      Growing recognition of alcohol-related harm in HIV patients has stimulated the development of
      drinking reduction interventions for HIV infected heavy drinkers, some of which have been
      successful. Some interventions for HCV mono-infected drinkers and liver disease patients have
      also shown promise. Yet there are no known successful interventions that target HIV/HCV
      co-infected patients, a group with elevated drinking and particularly high consequences of
      drinking. Interventions for HIV patients address HIV health, but do not address liver
      fibrosis, which is an urgent threat to survival for co-infected patients. Interventions for
      liver disease patients discuss fibrosis to motivate drinking reduction, but neglect HIV and
      important topics such as ART adherence. Given that the drinking interventions for HIV and
      liver disease patients both effectively target drinking in medical patients, albeit through
      attention to different medical issues, such approaches can and should be integrated to
      provide an intervention that best meets the needs of patients with both HIV and HCV, a
      particularly high-risk group. In order to meet this need, an intervention will be tested for
      HIV/HCV co-infected drinkers. A total of 60 patients will be recruited and randomized to
      receive either the newly developed intervention or an educational control.
    

Intervention name(s): Intervention: (Clinician's Guide + HealthCall for HIV/HCV)
Intervention type(s): Behavioral
Intervention description(s): This intervention consists of an adaptation of the National Institutes of Health (NIH) Clinician's Guide (CG; NIAAA, 2007) in conjunction with the previously tested HealthCall smartphone app program (Hasin et al., 2013; Hasin et al., 2014). Participants will complete a brief baseline meeting (~20 minutes) with a counselor to discuss alcohol use, liver function, and HIV medication adherence. They will track their drinking using HealthCall for 60 days, with brief follow-up meetings with their counselor to check in about their drinking 30 and 60 days later.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heavy Drinking; HIV; Hepatitis C