Primary Care-Based Interventions to Reduce Alcohol Use Among HIV Patients
Condition: HIV; Acquired Immunodeficiency Syndrome; Alcoholism; Alcoholic Intoxication; Substance-Related Disorders
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes; Alcoholism; Substance-Related Disorders; Alcoholic Intoxication
Study type: Interventional

Summary: 
      This randomized clinical trial uses a health plan's electronic medical record (EMR) alcohol
      screen; and examines innovative behavioral interventions, and their cost effectiveness, for
      hazardous drinking within a large HIV primary care clinic. We will compare Motivational
      Interviewing (MI) and Email Feedback (EF) to usual care; and evaluate the effect of the
      interventions on unhealthy drinking, comorbid drug use, enrollment in substance use treatment
      programs, and HIV outcomes including antiretroviral therapy adherence, HIV RNA control, and
      unsafe sex. Given the well-known adverse effects of unhealthy drinking on HIV care and
      outcomes, the proposed study has the potential to make a significant impact in the care of
      HIV patients.
    

Detailed description: 
      This application responds to RFA-AA12-009, Interventions to Improve HIV/AIDS and
      Alcohol-Related Outcomes (U01). The proposed study takes place in a HIV primary care clinic
      and uses the health plan's electronic medical record (EMR) for screening; it has the
      potential to provide a significant benefit to HIV-infected individuals by reducing unhealthy
      drinking and the associated complications. Prior studies have identified high rates of
      co-occurrence of HIV and unhealthy drinking (defined as drinking over threshold limits, i.e.,
      4+ daily or 14+ weekly drinks for men and 3+ daily or 7+ weekly drinks for women). Drinking
      at these levels can compromise antiretroviral (ART) treatment, and increase rates of drug
      use, depression, unsafe sex, and mortality. The proposed randomized trial examines the
      comparative effectiveness of two highly implementable behavioral interventions for reducing
      unhealthy drinking, each with an adaptive, stepped-care component: 1) Motivational
      Interviewing (MI), consisting of one in-person session with a study clinician and two phone
      sessions, with three additional phone sessions for those who report unhealthy drinking at 6
      months; and 2) Interactive Email Feedback (EF) on alcohol use risks using a secure messaging
      system integrated into the Electronic Medical Record (EMR), with additional emailed feedback
      for those who report unhealthy drinking at 6 months. MI and EF are delivered by study staff.
      A third arm will be usual care only. Participants in all three arms are eligible to receive
      alcohol screening, brief intervention, and referral to treatment (SBIRT) from usual care
      clinic staff. We will also evaluate the cost-effectiveness of the two interventions which
      have the potential for wide adoption in other similar healthcare settings. The two proposed
      interventions, MI and EF, are promising approaches for reducing unhealthy drinking in the
      setting of behavioral health and/or primary care. EF also uses secure messaging, an emerging
      technology that has been tested in other health, behavior change and mental health treatment
      settings, for problems including alcohol use but not among HIV-infected individuals. In this
      trial, 600 patients (200 in each arm) will be recruited from Kaiser Permanente Northern
      California (KPNC) San Francisco. The study population and clinic are ideal to examine such
      interventions since NIAAA-based screening questions are recorded in the EMR, and
      comprehensive data are available on health care utilization, ART adherence, and HIV clinical
      outcomes, including the Veterans Aging Cohort Study (VACS) index, a recently validated
      prognostic index based on routine clinical laboratory measures. The research team is
      well-qualified with complementary expertise in clinical psychology, drug and alcohol abuse
      treatment, HIV epidemiology, and biostatistics. Thus, the team and study setting provide the
      ideal environment to test MI and EF, two innovative approaches for reducing unhealthy alcohol
      use in this population, and may provide powerful, and generalizable tools for assisting
      individuals with HIV infection.
    

Intervention name(s): Motivational Interviewing; Email Feedback; Usual Care
Intervention type(s): Behavioral; Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: HIV; Acquired Immunodeficiency Syndrome; Alcoholism; Alcoholic Intoxication; Substance-Related Disorders; Intervention Studies; Primary Health Care; therapy; prevention & control