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

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.

Study Overview

• Status: Completed
• Conditions: HIV; Hazardous Drinking
• Intervention / Treatment: Behavioral: Brief alcohol intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Fenway Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brown University
• Investigators: Principal Investigator: Peter Monti, Ph.D., Brown University; Study Director: Christopher Kahler, Ph.D., Brown University

Publications and helpful links

General Publications

• Zelaya DG, Guy AA, Surace A, Mastroleo NR, Pantalone DW, Monti PM, Mayer KH, Kahler CW. Modeling the Impact of Race, Socioeconomic Status, Discrimination and Cognitive Appraisal on Mental Health Concerns Among Heavy Drinking HIV+ Cisgender MSM. AIDS Behav. 2022 Dec;26(12):3925-3938. doi: 10.1007/s10461-022-03719-0. Epub 2022 Jun 10.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: March 31, 2011
• First Submitted That Met QC Criteria: April 4, 2011
• First Posted (Estimate): April 5, 2011

Study Record Updates

• Last Update Posted (Actual): September 9, 2019
• Last Update Submitted That Met QC Criteria: August 1, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: NIAAA-P01-AA019072-1