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Completed

NCT Number: NCT01328743

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

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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Key information

Conditions

Hazardous Drinking HIV

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Fenway Health

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief alcohol intervention

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

Primary outcomes

  1. Number of Alcoholic Drinks Consumed

    Time frame: 12 months

    Number of standard alcoholic drinks consumed per week in the past month

  2. Number of Heavy Drinking Days

    Time frame: 12 months

    Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month

  3. Number of Heavy Drinking Days

    Time frame: 6 months

    Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month

  4. Number of Heavy Drinking Days

    Time frame: 3 months

    Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month

  5. Number of Alcoholic Drinks Consumed

    Time frame: 3 months

    Number of standard alcoholic drinks consumed per week in the past month

  6. Number of Alcoholic Drinks Consumed

    Time frame: 6 months

    Number of standard alcoholic drinks consumed per week in the past month

Sponsors and collaborators

Lead sponsor

Brown University

Other

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Apr 5, 2011
Registry last updated
Sep 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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