Integrated Stepped Care for Unhealthy Alcohol Use in HIV

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Yale University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
David Fiellin, Yale University
ClinicalTrials.gov Identifier:
NCT01410123
First received: July 28, 2011
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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 Intervention
Liver Diseases, Alcoholic
Alcoholism
HIV
Hepatitis C
Other: Integrated Stepped Care (ISC)
Other: Treatment as Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Integrated Stepped Care for Unhealthy Alcohol Use in HIV

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • At risk drinking: Drinks per week [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Alcohol abuse or dependence: Drinks per week [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Moderate Alcohol + Liver Disease group: Abstinence. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in biological markers as measured by the VACS index. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 642
Study Start Date: January 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment as Usual (TAU) Other: Treatment as Usual
The TAU arm will receive a handout with alcohol information embedded within general health-related information (diet, exercise, smoking cessation, ART adherence) 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.


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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410123

Contacts
Contact: David A Fiellin, MD 203-737-3347 david.fiellin@yale.edu
Contact: Cheryl M Danton, MHS 203-737-3347 cheryl.danton@yale.edu

Locations
United States, District of Columbia
Washington DC VAMC Recruiting
Washington, District of Columbia, United States, 20422
Contact: Cynthia Gibert, MD    202-745-8000 ext 7560      
United States, Georgia
VAMC Atlanta Recruiting
Atlanta, Georgia, United States, 30033
Contact: David Rimland, MD    404-728-7748      
United States, New York
New York VAMC - New York Harbor Healthcare System Recruiting
New York, New York, United States, 10010
Contact: Michael Simberkoff, MD    212-951-3417      
United States, Texas
Dallas VA Medical Center Recruiting
Dallas, Texas, United States, 75216
Contact: Roger Bedimo, MD    214-857-1415    roger.bedimo@va.gov   
Contact: Holly Wise    214-857-1415    holly.wise@va.gov   
Principal Investigator: Roger Bedimo, MD         
VAMC Houston Recruiting
Houston, Texas, United States, 77030
Contact: Maria Rodriguez-Barradas, MD    713-794-8856      
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: David Fiellin, MD Yale University
Study Director: Jennifer Edelman, M.D., MHS Yale University
  More Information

No publications provided

Responsible Party: David Fiellin, Professor of Medicine, Investigative Medicine and Public Health, Yale University
ClinicalTrials.gov Identifier: NCT01410123     History of Changes
Other Study ID Numbers: HIC1105008544, UO1AA020795
Study First Received: July 28, 2011
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alcohol Drinking
Alcoholism
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Liver Diseases, Alcoholic
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Alcohol-Induced Disorders

ClinicalTrials.gov processed this record on September 14, 2014