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Integrated Stepped Care for Unhealthy Alcohol Use in HIV

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ClinicalTrials.gov Identifier: NCT01410123
Recruitment Status : Completed
First Posted : August 4, 2011
Last Update Posted : December 21, 2022
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
US Department of Veterans Affairs
Information provided by (Responsible Party):
Yale University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Liver Diseases, Alcoholic Alcoholism HIV Hepatitis C Other: Integrated Stepped Care (ISC) Other: Treatment as Usual Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 319 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Integrated Stepped Care for Unhealthy Alcohol Use in HIV
Study Start Date : January 2013
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol HIV/AIDS

Arm Intervention/treatment
Treatment as Usual (TAU) 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.

Integrated Stepped Care (ISC) 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.

Primary Outcome Measures :
  1. At risk drinking: Drinks per week [ Time Frame: 6 months ]
  2. Alcohol abuse or dependence: Drinks per week [ Time Frame: 6 months ]
  3. Moderate Alcohol + Liver Disease group: Abstinence. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Alcohol consumption by phosphatidylethanol (PEth), an alcohol biomarker [ Time Frame: 6 months ]
  2. Change in biological markers as measured by the VACS index. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410123

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United States, District of Columbia
Washington DC VAMC
Washington, District of Columbia, United States, 20422
United States, Georgia
VAMC Atlanta
Atlanta, Georgia, United States, 30033
United States, New York
New York VAMC - New York Harbor Healthcare System
New York, New York, United States, 10010
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
VAMC Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
US Department of Veterans Affairs
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Principal Investigator: David Fiellin, MD Yale University
Study Director: Jennifer Edelman, M.D., MHS Yale University
Publications of Results:

Other Publications:
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01410123    
Other Study ID Numbers: 1105008544
U01AA020795 ( U.S. NIH Grant/Contract )
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: December 21, 2022
Last Verified: December 2022
Additional relevant MeSH terms:
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Hepatitis C
Liver Diseases
Liver Diseases, Alcoholic
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alcohol-Induced Disorders