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Integrated Stepped Care for Unhealthy Alcohol Use in HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01410123
Recruitment Status : Active, not recruiting
First Posted : August 4, 2011
Last Update Posted : January 10, 2018
Information provided by (Responsible Party):

July 28, 2011
August 4, 2011
January 10, 2018
January 2013
July 2018   (Final data collection date for primary outcome measure)
  • At risk drinking: Drinks per week [ Time Frame: 6 months ]
  • Alcohol abuse or dependence: Drinks per week [ Time Frame: 6 months ]
  • Moderate Alcohol + Liver Disease group: Abstinence. [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT01410123 on ClinicalTrials.gov Archive Site
  • Alcohol consumption by phosphatidylethanol (PEth), an alcohol biomarker [ Time Frame: 6 months ]
  • Change in biological markers as measured by the VACS index. [ Time Frame: 6 months ]
Change in biological markers as measured by the VACS index. [ Time Frame: 6 months ]
Not Provided
Not Provided
Integrated Stepped Care for Unhealthy Alcohol Use in HIV
Integrated Stepped Care for Unhealthy Alcohol Use in HIV
The study is a series of 3 linked randomized clinical trials of 6 month duration, with a total of 12 month follow-up, to evaluate the effect of Integrated Stepped Care on drinking outcomes and HIV biologic markers (including VACS index) in HIV-infected patients with unhealthy alcohol use.
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.
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Liver Diseases, Alcoholic
  • Alcoholism
  • HIV
  • Hepatitis C
  • Other: Integrated Stepped Care (ISC)
    1. At risk drinking:

      Step 1: Brief negotiated interview (BNI) + booster; Step 2: Motivational Enhancement Therapy; Step 3: Addiction Physician Management + Alcohol pharmacotherapy

    2. Alcohol abuse/dependence:

      Step 1: Addiction Physician Management + Alcohol Pharmacotherapy; Step 2: Motivational Enhancement Therapy; Step 3: Detoxification and aftercare

    3. Moderate Alcohol + Liver Disease:

    Step 1: Brief Negotiated Interview (BNI)+ booster; Step 2: Motivational Enhancement Therapy; Step 3: Addiction physician management + alcohol pharmacotherapy.

  • Other: Treatment as Usual
    The TAU arm will receive a handout with alcohol information embedded within general health-related information (exercise, smoking cessation, and flu vaccination) and standard care as provided by their treating physician. All patients will have access to a NIAAA informational website.
  • Treatment as Usual (TAU)
    Intervention: Other: Treatment as Usual
  • Integrated Stepped Care (ISC)
    Intervention: Other: Integrated Stepped Care (ISC)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Active, not recruiting
July 2018
July 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
U01AA020795 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Yale University
Yale University
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • VA Office of Research and Development
Principal Investigator: David Fiellin, MD Yale University
Study Director: Jennifer Edelman, M.D., MHS Yale University
Yale University
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP