NCT00371969

Brief Summary

The main aim of this study is to test an intervention to reduce unsafe drinking among HIV-positive primary care patients. The intervention consists of a brief motivational interview, which is combined with daily alcohol monitoring through the use of an interactive voice response system IVR (automated telephone system). Subjects who receive the enhanced motivational interview are expected to show greater improvements in drinking than individuals who receive the standard motivational interview or view a DVD on HIV self-care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
254

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
27 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 30, 2015

Status Verified

October 1, 2015

Enrollment Period

5 years

First QC Date

August 31, 2006

Last Update Submit

October 28, 2015

Conditions

Alcohol Abuse

Keywords

Unsafe drinkingHuman Immunodeficiency VirusMotivational Interviewing

Outcome Measures

Primary Outcomes (1)

  • Alcohol consumption in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed.

    As measured by number of drinks per drinking day and percentage of days abstinent.

    Baseline, 30, 60 days (end-of-treatment), 3, 6, 12 months

Study Arms (2)

1 - enhanced MI

ACTIVE COMPARATOR

Enhanced brief motivational interview (including an IVR component for alcohol self-monitoring purposes)

Behavioral: Enhanced Motivational Interview

2- standard MI

ACTIVE COMPARATOR

The intervention consists of a standard motivational interview or viewing a DVD on HIV self-care.

Behavioral: Standard Motivational Interview or viewing DVD

Interventions

Enhanced Motivational InterviewBEHAVIORAL

The intervention consists of a brief motivational interview, which is combined with daily alcohol monitoring through the use of an interactive voice response system IVR (automated telephone system).

1 - enhanced MI
Standard Motivational Interview or viewing DVDBEHAVIORAL

Brief motivational interview, viewing a DVD on HIV self-care.

2- standard MI

Eligibility Criteria

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

You may qualify if:

  • Male and females 18 years of age or older.
  • Participants have had 4 or more drinks on any day in the prior 30 days assessed via standardized questions.
  • Participants are referred to a study MI counselor by clinic staff as needing an intervention for drinking
  • Participants agree to random assignment and provide informed consent

You may not qualify if:

  • Participants who are currently psychotic, suicidal or homicidal.
  • Participants who have definite plans to leave the greater New York metropolitan area within the study period.
  • Participants who demonstrate gross cognitive impairment as evidenced on the Halstead-Reitain Trails (A).
  • Participants who do not speak English or Spanish, or have hearing impairments that preclude use of the telephone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute/ St. Vincent's Hospital

New York, New York, 10032, United States

Location

Related Publications (1)

  • Hasin DS, Aharonovich E, O'Leary A, Greenstein E, Pavlicova M, Arunajadai S, Waxman R, Wainberg M, Helzer J, Johnston B. Reducing heavy drinking in HIV primary care: a randomized trial of brief intervention, with and without technological enhancement. Addiction. 2013 Jul;108(7):1230-40. doi: 10.1111/add.12127. Epub 2013 Apr 17.

    PMID: 23432593DERIVED

MeSH Terms

Conditions

AlcoholismAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Selvija G. Marovic, PhD

    New York State Psychiatric Institute (NYSPI)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Epidemiology

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 4, 2006

Study Start

October 1, 2006

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

October 30, 2015

Record last verified: 2015-10

Locations

US(1)