Technological Intervention for Reducing Alcohol Use Among People Living With HIV/AIDS

NCT ID: NCT03746600

Last Updated: 2024-08-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-23

Study Completion Date

2023-06-07

Brief Summary

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While advances in medication have led to greatly improved outcomes for people living with HIV/AIDS, less than one-third of all people living with the disease are adherent enough to their medication to achieve viral suppression. Alcohol consumption has been shown to have a significant effect on HIV medication adherence, so the proposed research will aim to reduce alcohol use among people living with HIV/AIDS through a technology-driven intervention. This eight-session intervention will be delivered using a combination of videoconferencing, smart phones, and Bluetooth-enabled breathalyzers for monitoring of alcohol consumption, with an overall goal of reducing alcohol use, mitigating adherence issues, and achieving optimal prevention and treatment responses for people living with HIV/AIDS.

Detailed Description

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The TRAC intervention focuses on increasing motivation and building skills for avoiding triggers and managing situations that encourage drinking. It requires eight 30-minute sessions with a counselor using videoconferencing and mobile phones. In addition to receiving the eight sessions of intervention content, participants will complete smartphone-based self-monitoring of medication adherence and alcohol consumption, which will be discussed during intervention sessions. Each day, they will be texted at two random times to complete a breathalyzer reading using a BACtrack Mobile Pro, which is sold by a company with FDA clearance and utilizes law enforcement-grade sensors for determining blood alcohol level. It connects wirelessly to phones via Bluetooth, automatically uploads readings, allows the user to view their current and past readings with a mobile app, and allows them to share their readings with counselors. At the time of the breathalyzer reading, participants will also be asked to indicate via survey how many drinks they have consumed and their medication use for the day. The surveys will be programmed using Qualtrics and accessible via a link in the reminder text message. Data analytic methods will be focused on examining effects on alcohol intake, HAART adherence, and HIV-related medical outcomes (CD4 count and viral load).If shown to be feasible, acceptable, and potentially efficacious, this intervention could have a significant impact on improving the accessibility of alcohol reduction counseling among PLWHA.

Conditions

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Acquired Immunodeficiency Syndrome HIV/AIDS Alcohol Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized waitlist-controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate Intervention Group

Receives the eight-week intervention, "Project TRAC: Tracking and Reducing Alcohol Consumption," immediately upon enrollment. This intervention focuses on skill building and motivational enhancement for reducing alcohol consumption.

Group Type EXPERIMENTAL

Project TRAC: Tracking and Reducing Alcohol Consumption

Intervention Type BEHAVIORAL

The TRAC intervention for people living with HIV/AIDS focuses on increasing motivation and building skills for avoiding triggers and managing situations that encourage alcohol consumption. It requires eight 30-minute sessions with a counselor using videoconferencing and mobile phones. In addition to receiving the eight sessions of intervention content, participants will complete smart phone-based self-monitoring of medication adherence and alcohol consumption, which will be discussed during intervention sessions.

Waitlist Control Group

Receives the "Project TRAC: Tracking and Reducing Alcohol Consumption" alcohol reduction intervention after an 8-week, assessment-only period. This 8-wek intervention focuses on skill building and motivational enhancement for reducing alcohol consumption.

Group Type OTHER

Project TRAC: Tracking and Reducing Alcohol Consumption

Intervention Type BEHAVIORAL

The TRAC intervention for people living with HIV/AIDS focuses on increasing motivation and building skills for avoiding triggers and managing situations that encourage alcohol consumption. It requires eight 30-minute sessions with a counselor using videoconferencing and mobile phones. In addition to receiving the eight sessions of intervention content, participants will complete smart phone-based self-monitoring of medication adherence and alcohol consumption, which will be discussed during intervention sessions.

Interventions

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Project TRAC: Tracking and Reducing Alcohol Consumption

The TRAC intervention for people living with HIV/AIDS focuses on increasing motivation and building skills for avoiding triggers and managing situations that encourage alcohol consumption. It requires eight 30-minute sessions with a counselor using videoconferencing and mobile phones. In addition to receiving the eight sessions of intervention content, participants will complete smart phone-based self-monitoring of medication adherence and alcohol consumption, which will be discussed during intervention sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* HIV-positive
* 18 years or older
* At-risk drinker
* Currently prescribed HIV medication
* Current patient at the study recruitment site(s)

Exclusion Criteria

* Less than 18 years old
* Non-English Speaking
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Carolyn Lauckner

OTHER

Sponsor Role lead

Responsible Party

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Carolyn Lauckner

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Carolyn Lauckner, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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Atlanta Veterans Health Care System

Decatur, Georgia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1K01AA025305-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FP00008294

Identifier Type: -

Identifier Source: org_study_id

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