Integrated Stepped Care for Unhealthy Alcohol Use in HIV

Completed · Not applicable

Conditions studied: Liver Diseases, Alcoholic, Alcoholism, HIV, Hepatitis C

In brief

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.

Key facts

Study ID

NCT01410123

Run by

Yale University

People needed

319

Starts

2013-01-01

Expected to finish

2018-08-31

Last updated by the study team

2022-12-21

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Washington DC VAMC — Washington D.C., District of Columbia, United States
• VAMC Atlanta — Atlanta, Georgia, United States
• New York VAMC - New York Harbor Healthcare System — New York, New York, United States
• Dallas VA Medical Center — Dallas, Texas, United States
• VAMC Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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