Brief Alcohol Intervention for HIV-Infected Men Who Have Sex With Men (MSM) in a Primary Care Setting
| Status: | Active, not recruiting |
|---|---|
| Conditions: | HIV / AIDS, Psychiatric |
| Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2011 |
| End Date: | June 2016 |
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.
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.
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.
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
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