Brief Alcohol Intervention for HIV-Infected Men Who Have Sex With Men (MSM) in a Primary Care Setting
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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 |
- 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 |
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| Contact: Christopher W. Kahler, Ph.D. | Christopher_Kahler@brown.edu |
| United States, Massachusetts | |
| Fenway Health | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Julia Gaggin, MS 617-927-6464 jgaggin@fenwayhealth.org | |
| 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 June 17, 2013