Brief Alcohol Intervention for HIV-Infected Men Who Have Sex With Men (MSM) in a Primary Care Setting

Study Overview
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Brief Summary
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This is a randomized clinical trial to examine the effects of a brief counseling intervention for heavy drinking HIV-infected men who have sex with men compared to HIV care as usual. The study tests the hypothesis that brief counseling will lower drinking in these patients and that reductions in drinking will be associated with better HIV-related outcomes.

Detailed Description
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This study is a randomized clinical trial in which 224 heavy drinking men who have sex with men (MSM), who receive their HIV primary care at Fenway Health in Boston, are randomly assigned to treatment as usual (TAU) or TAU plus a brief intervention to reduce alcohol use (TAU-BI). TAU-BI will be based in Motivational Interviewing and include personalized feedback tailored to an HIV-infected MSM population. Follow-ups will occur at 3, 6, and 12 months. The first primary aim of the study is to test the hypothesis that TAU-BI, compared to TAU, will result in reduced alcohol consumption over a 12-month follow-up period as indicated by: (1) a lower number of alcoholic drinks consumed per week; (2) a lower number of drinking days within each follow-up period; and (3) a lower number of heavy drinking days within each follow-up period. The second primary aim is to test the hypothesis that greater reductions in alcohol use will be associated with (1) greater adherence to HIV medication regimens; (2) less engagement in high-risk sexual behavior that could result in HIV transmission; (3) lower plasma HIV RNA levels (viral load) (CD4 cell counts will be a secondary outcome in this sub-aim); (4) improved liver function tests; and (5) improved neurocognitive function.

Official Title
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Brief Alcohol Intervention for HIV-Infected Men Who Have Sex With Men (MSM) in a Primary Care Setting

Conditions
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HIV, Hazardous Drinking

Intervention / Treatment
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* Behavioral: Brief alcohol intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be at least 18 years of age drink heavily at least once per month on average (≥5 drinks) or drink more than 14 drinks per week have a confirmed diagnosis of HIV/AIDS be a male who has had sex (oral or anal) with a male partner in the past 3 months. Exclusion Criteria: current intravenous drug use currently psychotic, suicidal, or manic are currently being treated or have been treated in the past 3 months for an HIV-related opportunistic infection currently receiving treatment for an alcohol or drug problem

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as usual<br>Treatment as usual in an HIV primary care setting. Participants receive assessment of alcohol use but not counseling or advice regarding drinking. | |
| Experimental: Brief Alcohol Intervention<br>Participants receive 3 face-to-face sessions of counseling on alcohol use and 2 follow-up phone calls | Behavioral: Brief alcohol intervention<br>* 3 sessions of individual face-to-face counseling at baseline, 3 and 6 months. Sessions are motivationally focused including discussion of pros and cons of drinking and feedback on health and its relation to heavy drinking<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Alcoholic Drinks Consumed | Number of standard alcoholic drinks consumed per week in the past month | 12 months | 
| Number of Heavy Drinking Days | Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month | 12 months | 
| Number of Heavy Drinking Days | Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month | 6 months | 
| Number of Heavy Drinking Days | Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month | 3 months | 
| Number of Alcoholic Drinks Consumed | Number of standard alcoholic drinks consumed per week in the past month | 3 months | 
| Number of Alcoholic Drinks Consumed | Number of standard alcoholic drinks consumed per week in the past month | 6 months |