Reducing Alcohol Dependence Among HIV-Positive Individuals

The purpose of this study is to compare the effects of interventions for drinking-reduction and antiretroviral therapy (ART) adherence among HIV-positive primary care patients. The interventions consist of brief meetings to discuss drinking and ART adherence enhanced with daily self-monitoring through the use of a smart phone application that tracks drinking and other aspects of health. These meetings will either be based on the Clinician's Guide, a brief intervention for heavy drinking in primary care settings advocated by the National Institute on Alcohol Abuse and Alcoholism, or Motivational Interviewing. Participants will be assessed at baseline, 30, 60, 90 days, 6 and 12 months after baseline. By the end of treatment (60 days) and throughout the follow-up period, alcohol use is expected to highest among participants who receive the Clinician's Guide alone, intermediate among participants who receive the enhanced Clinician's Guide, and lowest among participants who receive enhanced Motivational Interviewing.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcohol Dependence Acquired Immunodeficiency Syndrome Alcohol-Related Disorders Alcoholism Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

HIV infection is a widespread health problem in the U.S. Antiretroviral (ART) therapy has increased longevity and changed the nature of risk factors for morbidity and mortality. Alcohol consumption has become an increasingly serious health issue among HIV primary care patients. Drinking is a key factor in progression to severe liver damage (especially those co-infected with hepatitis), and liver disease is now one of the most common causes of death among those with HIV. Excess drinking is also associated with medication noncompliance, reduces the effect of antiretroviral treatment, and is linked to other health problems. Therefore, helping HIV patients reduce unsafe drinking is crucial to their long-term health. This study aims to evaluate two evidence-based approaches when combined with an innovative smart phone application designed to help users track drinking and other aspects of health. An effective, easily implemented alcohol-reduction intervention could be incorporated into standard care in HIV clinics to help prevent or slow the progress of some medical problems in HIV-infected individuals, improve medication compliance, prolong lifespan and decrease risk behavior associated with alcohol use.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 18 and older
Patient had 4 or more drinks on any day in prior 30 days
Patient meets criteria for DSM-IV current alcohol dependence
HIV+

Exclusion criteria

Patient is psychotic, suicidal, or homicidal
Patient has gross cognitive impairment
Patient does not speak English or Spanish
Patient has plans to leave the greater New York metropolitan area within the study period
Patient has vision/hearing impairment that would preclude participation

Treatment and study plan

Clinician's Guide

Behavioral

An evidence-based, NIAAA-advocated approach to brief intervention for heavy drinking in primary care settings.

Enhanced Motivational Interviewing

Behavioral

Brief motivational interview plus the use of a smart phone application to monitor alcohol use and health behaviors.

Enhanced Clinician's Guide

Behavioral

An evidence-based, NIAAA-advocated approach to brief intervention for heavy drinking in primary care settings plus the use of a smart phone application to monitor alcohol use and health behaviors.

Primary outcomes

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

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

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

Sponsors and collaborators

Lead sponsor

Research Foundation for Mental Hygiene, Inc.

Other

Registry information

Official study title

HealthCall: Enhancing Brief Intervention for HIV Primary Care Alcohol Dependence

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Jul 17, 2015
Registry last updated: Oct 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed