Integrated Stepped Care for Unhealthy Alcohol Use in HIV

December 16, 2022 updated by: Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

319

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Washington DC VAMC
    • Georgia
      • Atlanta, Georgia, United States, 30033
        • VAMC Atlanta
    • New York
      • New York, New York, United States, 10010
        • New York VAMC - New York Harbor Healthcare System
    • Texas
      • Dallas, Texas, United States, 75216
        • Dallas VA Medical Center
      • Houston, Texas, United States, 77030
        • VAMC Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
At risk drinking: Drinks per week
Time Frame: 6 months
6 months
Alcohol abuse or dependence: Drinks per week
Time Frame: 6 months
6 months
Moderate Alcohol + Liver Disease group: Abstinence.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Alcohol consumption by phosphatidylethanol (PEth), an alcohol biomarker
Time Frame: 6 months
6 months
Change in biological markers as measured by the VACS index.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
US Department of Veterans Affairs

Investigators

  • Principal Investigator: David Fiellin, MD, Yale University
  • Study Director: Jennifer Edelman, M.D., MHS, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

July 31, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

July 28, 2011

First Submitted That Met QC Criteria

August 2, 2011

First Posted (Estimate)

August 4, 2011

Study Record Updates

Last Update Posted (Estimate)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 16, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1105008544
  • U01AA020795 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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