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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2016-08-31

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.

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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.

Conditions

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Hazardous Drinking HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment as usual

Treatment as usual in an HIV primary care setting. Participants receive assessment of alcohol use but not counseling or advice regarding drinking.

Group Type NO_INTERVENTION

No interventions assigned to this group

Brief Alcohol Intervention

Participants receive 3 face-to-face sessions of counseling on alcohol use and 2 follow-up phone calls

Group Type EXPERIMENTAL

Brief alcohol intervention

Intervention Type BEHAVIORAL

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

Interventions

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Brief alcohol intervention

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

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No