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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01328743
• Other study ID #: NIAAA-P01-AA019072-1
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: August 2016

Study information

• Verified date: August 2019
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hazardous Drinking
• HIV

Intervention

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

Locations

Country	Name	City	State
United States	Fenway Health	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Alcoholic Drinks Consumed	Number of standard alcoholic drinks consumed per week in the past month	12 months
Primary	Number of Heavy Drinking Days	Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month	12 months
Primary	Number of Heavy Drinking Days	Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month	6 months
Primary	Number of Heavy Drinking Days	Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month	3 months
Primary	Number of Alcoholic Drinks Consumed	Number of standard alcoholic drinks consumed per week in the past month	3 months
Primary	Number of Alcoholic Drinks Consumed	Number of standard alcoholic drinks consumed per week in the past month	6 months