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

A Telemedicine and mHealth Intervention for Reducing Alcohol Consumption Among People Living With HIV/AIDS

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.

Study Overview

• Status: Completed
• Conditions: Acquired Immunodeficiency Syndrome; Alcohol Drinking; HIV/AIDS
• Intervention / Treatment: Behavioral: Project TRAC: Tracking and Reducing Alcohol Consumption

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Atlanta Veterans Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Other: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Problematic Alcohol Use	Alcohol Use Disorders Identification Test-C (AUDIT-C): A validated, self-report instrument assessing problematic alcohol use. For this 3-item scale, scores range from 0-12. Higher values represent greater problematic alcohol use. Change= Week 8 score - Baseline score	Baseline, 8-week post-test
Change in Daily Alcohol Consumption	Single item asking how many days in the past month participants consumed alcohol. Responses range from 0-31. Change= Days reported at 8 weeks - Days reported at baseline	Baseline (T1), Immediate follow-up at 8 weeks (T2)
Average Percent Change in Positive Breathalyzer Readings	Participants completed up to 14 breathalyzer readings/week obtained by BACTrack mobile breathalyzer. This outcome compares average % of positive breathalyzer readings (breathalyzer values > 0.00) per participant at Week 1 to Week 8. Numbers should be converted to percentages to aid in interpretation (e.g., -0.10 corresponds to a 10% decrease).	Week 1 and Week 8 of the active intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in HIV/AIDS Medication Adherence	Single item: Participants self-report on a scale of 0-100% how much of their HIV/AIDS medication they have taken in the previous month. Scores range from 0-100. Change = Week 8 score - Baseline score.	Baseline, 8-week post-test
Change in CD4 Count	CD4 cell count as determined by medical chart	Baseline, 8-week post-test, 16-week follow-up
Change in Viral Load	Level of HIV virus in the month as determined by medical chart	Baseline, 8-week post-test, 16-week follow-up
Percent Change in Daily HIV/AIDS Medication Adherence	% change in self-reported HIV/AIDS medication as measured via daily surveys, comparing percent of days HIV/AIDS medication was taken in Week 1 to Week 8. Numbers should be converted to percentages (i.e., a decrease of -0.01 is equivalent to a 1% decrease).	Week 1 and Week 8 of the active intervention period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Depressive Symptomology	Patient Health Questionnaire-9 (PHQ-9). For this 9-item scale, scores range from 0-27. Higher scores indicate greater depressive symptomology.	Baseline, 8-week post-test, 16-week follow-up
Change in Anxiety Symptoms	Beck Anxiety Inventory. For this 21-item scale, scores range from 0-63. Higher score indicates greater anxiety symptoms.	Baseline, 8-week post-test, 16-week follow-up
Change in Self-Reported Quality of Life	Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). For this 16-item scale, raw scores range from 14-70. Scores are then converted to percentages, with higher percentages equaling greater quality of life.	Baseline, 8-week post-test, 16-week follow-up
Change in Stress	Perceived Stress Scale-10. For this 10-item scale, scores range from 0-40. A higher score suggests higher perceived stress levels.	Baseline, 8-week post-test, 16-week follow-up
Change in Social Support	Medical Outcomes Study Social Support Survey-12 (MOS-SSS-12). For this 12-item scale, scores range from 12-60. Higher scores suggest greater levels of social support.	Baseline, 8-week post-test, 16-week follow-up
Change in Coping Behaviors	Brief COPE. This 28-item scale measures use of multiple forms of coping strategies, reflected in several subscales: Self-distraction, Active coping, Denial, Substance use, Use of emotional support, Use of instrumental support, Behavioral disengagement, Venting, Positive reframing, Planning, Humor, Acceptance, Religion, and Self-blame. Scores for each subscale range from 2-8, with higher values indicating greater use of that coping strategy.	Baseline, 8-week post-test, 16-week follow-up

Collaborators and Investigators

• Sponsor: Carolyn Lauckner
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Carolyn Lauckner, PhD, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2020
• Primary Completion (Actual): June 7, 2023
• Study Completion (Actual): June 7, 2023

Study Registration Dates

• First Submitted: September 24, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Alcohol Drinking; HIV/AIDS; Medication Adherence
• Additional Relevant MeSH Terms: Drinking Behavior; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; Alcohol Drinking; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
• Other Study ID Numbers: FP00008294; 1K01AA025305-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will not share data due to: 1) the sensitive nature of the data (small sample size and information about HIV status of participants) and 2) the fact that these preliminary data will be used to inform a larger randomized controlled trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No