Clinical trial NCT01328743: Brief Alcohol Intervention for HIV-Infected Men Who Have Sex With Men (MSM) in a Primary Care Setting
Official title: Brief Alcohol Intervention for HIV-Infected Men Who Have Sex With Men (MSM) in a Primary Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hazardous Drinking
HIV
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2011-04-05
Enrollment: 180
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Number of Alcoholic Drinks Consumed
timeFrame: 12 months
measure: Number of Heavy Drinking Days
timeFrame: 12 months
measure: Number of Heavy Drinking Days
timeFrame: 6 months
measure: Number of Heavy Drinking Days
timeFrame: 3 months
measure: Number of Alcoholic Drinks Consumed
timeFrame: 3 months
measure: Number of Alcoholic Drinks Consumed
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Fenway Health
state: Massachusetts
Study officials:
affiliation: Brown University
name: Peter Monti, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Christopher Kahler, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.