NCT01328743

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2011

Completed
26 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

September 9, 2019

Completed
Last Updated

September 9, 2019

Status Verified

August 1, 2019

Enrollment Period

5.2 years

First QC Date

March 31, 2011

Results QC Date

July 30, 2018

Last Update Submit

August 1, 2019

Conditions

Hazardous DrinkingHIV

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (2)

Treatment as usual

NO INTERVENTION

Treatment as usual in an HIV primary care setting. Participants receive assessment of alcohol use but not counseling or advice regarding drinking.

Brief Alcohol Intervention

EXPERIMENTAL

Participants receive 3 face-to-face sessions of counseling on alcohol use and 2 follow-up phone calls

Behavioral: Brief alcohol intervention

Interventions

Brief alcohol interventionBEHAVIORAL

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

Brief Alcohol Intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fenway Health

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • 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.

    PMID: 35687187DERIVED

MeSH Terms

Interventions

EthanolMethods

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsInvestigative Techniques

Results Point of Contact

Title
Christopher Kahler
Organization
Brown University
christopher_kahler@brown.edu
4018636651

Study Officials

  • Peter Monti, Ph.D.

    Brown University

    PRINCIPAL INVESTIGATOR

  • Christopher Kahler, Ph.D.

    Brown University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Behavioral and Social Sciences

Study Record Dates

First Submitted

March 31, 2011

First Posted

April 5, 2011

Study Start

May 1, 2011

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

September 9, 2019

Results First Posted

September 9, 2019

Record last verified: 2019-08

Locations

US(1)