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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Brown University
Sponsor:
Information provided by (Responsible Party):
Peter Monti, Brown University
ClinicalTrials.gov Identifier:
NCT01328743
First received: March 31, 2011
Last updated: October 4, 2012
Last verified: October 2012

March 31, 2011
October 4, 2012
May 2011
April 2015   (final data collection date for primary outcome measure)
  • Number of alcoholic drinks consumed [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of standard alcoholic drinks consumed in the past month
  • Number of heavy drinking days [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month
  • Number of heavy drinking days [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month
  • Number of heavy drinking days [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month
  • Number of alcoholic drinks consumed [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number of standard alcoholic drinks consumed in the past month
  • Number of alcoholic drinks consumed [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of standard alcoholic drinks consumed in the past month
Same as current
Complete list of historical versions of study NCT01328743 on ClinicalTrials.gov Archive Site
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Brief Alcohol Intervention for HIV-Infected Men Who Have Sex With Men (MSM) in a Primary Care Setting
Not Provided

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Hazardous Drinking
  • HIV
Behavioral: 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
  • No Intervention: 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.
  • Experimental: Brief Alcohol Intervention
    Participants receive 3 face-to-face sessions of counseling on alcohol use and 2 follow-up phone calls
    Intervention: Behavioral: Brief alcohol intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
September 2015
April 2015   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact: Christopher W. Kahler, Ph.D. Christopher_Kahler@brown.edu
United States
 
NCT01328743
NIAAA-P01-AA019072-1
No
Peter Monti, Brown University
Brown University
Not Provided
Principal Investigator: Peter Monti, Ph.D. Brown University
Study Director: Christopher Kahler, Ph.D. Brown University
Brown University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP