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
  Purpose

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.


Condition Intervention Phase
Hazardous Drinking
HIV
Behavioral: Brief alcohol intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 240
Study Start Date: May 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328743

Contacts
Contact: Christopher W. Kahler, Ph.D. Christopher_Kahler@brown.edu

Locations
United States, Massachusetts
Fenway Health Recruiting
Boston, Massachusetts, United States, 02215
Contact: Julia Gaggin, MS    617-927-6464    jgaggin@fenwayhealth.org   
Sponsors and Collaborators
Brown University
Investigators
Principal Investigator: Peter Monti, Ph.D. Brown University
Study Director: Christopher Kahler, Ph.D. Brown University
  More Information

No publications provided

Responsible Party: Peter Monti, Professor of Behavioral and Social Sciences, Brown University
ClinicalTrials.gov Identifier: NCT01328743     History of Changes
Other Study ID Numbers: NIAAA-P01-AA019072-1
Study First Received: March 31, 2011
Last Updated: October 4, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014