Status:
COMPLETED
Integrated Stepped Care for Unhealthy Alcohol Use in HIV
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
US Department of Veterans Affairs
Conditions:
Liver Diseases, Alcoholic
Alcoholism
Eligibility:
All Genders
21+ years
Phase:
NA
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 bio...
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, mot...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2018
Estimated Enrollment :
319 Patients enrolled
Trial Details
Trial ID
NCT01410123
Start Date
January 1 2013
End Date
August 31 2018
Last Update
December 21 2022
Active Locations (5)
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1
Washington DC VAMC
Washington D.C., District of Columbia, United States, 20422
2
VAMC Atlanta
Atlanta, Georgia, United States, 30033
3
New York VAMC - New York Harbor Healthcare System
New York, New York, United States, 10010
4
Dallas VA Medical Center
Dallas, Texas, United States, 75216