Integrated Stepped Care for Unhealthy Alcohol Use in HIV

Unhealthy alcohol use threatens the health benefits seen with antiretroviral therapy (ART)
for HIV-infected (HIV+) patients. Although research has demonstrated the efficacy of brief
interventions, motivational counseling, and medications to treat unhealthy alcohol use in HIV
uninfected patients, there is limited research or use of these treatments in HIV+ patients.
We have demonstrated that integrated treatment of addiction in HIV clinics is feasible.
Stepped care algorithms can facilitate the evaluation of varying intensities of treatments
for unhealthy alcohol use. The proposed study will compare onsite Integrated Stepped Care
treatment (ISC) to treatment as usual (TAU) in three, linked, 6-month randomized clinical
trials in 642 HIV+ patients with unhealthy alcohol use. Screened patients are randomized to
ISC or TAU after determining that they meet criteria for either 1) at-risk drinking, 2)
alcohol abuse or dependence or 3) moderate alcohol consumption in the presence of liver
disease. ISC and TAU are tailored to the drinking category. ISC for at-risk drinkers and
those with Moderate Alcohol use and Liver Disease begins with a brief intervention and is
stepped up to Motivational Enhancement Therapy (MET) in those who meet predefined failure
criteria. ISC for abuse or dependence begins with addiction physician management (APM)
including alcohol pharmacotherapy if not contraindicated. APM is stepped up to include MET if
predefined failure criteria are met. The study will test the hypothesis that ISC leads to
decreased alcohol consumption and improved HIV biomarkers. Data analyses will be conducted on
the intention to treat sample.

Inclusion Criteria:

1. Be HIV-infected and receiving HIV care at one of the participating medical centers.

2. Meet one of the following criteria for unhealthy alcohol use:

- At-risk Drinking Study- greater than 14 drinks per week or greater than 4 drinks
per occasion in men and greater than 7 drinks per week or greater than 3 drinks
per occasion in women and those over 65.

- Alcohol Abuse or Dependence Study - Meet DSM-IV TR criteria for alcohol abuse or
dependence, not in remission.

- Moderate Alcohol + Liver Disease Study - Report alcohol consumption in the past
month, are HCV co-infected, confirmed by HCV viral load or have liver fibrosis -
Fib-4 (>1.45). Do not meet criteria for at-risk drinking, alcohol abuse or
dependence.

3. Be able to understand English and provide informed consent.

Exclusion Criteria:

1. Be acutely suicidal, or with a psychiatric condition that affects the ability to
provide informed consent or participate in counseling interventions (e.g. psychotic,
dementia, delusional).

2. Be currently enrolled in formal treatment for alcohol (excluding self-help, e.g.
Alcoholics Anonymous)

3. Have medical conditions that would preclude completing or be of harm during the course
of the study.

4. Pregnant or nursing women or women who do not agree to use a reliable form of birth
control.