Integrated Stepped Care for Unhealthy Alcohol Use in HIV
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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 |
- 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 ]
- 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)
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 |
Inclusion Criteria:
- Be HIV-infected and receiving HIV care at one of the participating medical centers.
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.
- Be able to understand English and provide informed consent.
Exclusion Criteria:
- 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).
- Be currently enrolled in formal treatment for alcohol (excluding self-help, e.g. Alcoholics Anonymous)
- Have medical conditions that would preclude completing or be of harm during the course of the study.
- Pregnant or nursing women or women who do not agree to use a reliable form of birth control.
Contacts and Locations| Contact: David A Fiellin, MD | 203-737-3347 | david.fiellin@yale.edu |
| Contact: Lisa G Niichols, BA | 203-737-3347 | lisa.nichols@yale.edu |
| 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 | |
| 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: | January 29, 2013 |
| 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 |
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 March 03, 2013
