Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified July 2019 by Carolyn Lauckner, University of Georgia

Sponsor
University of Georgia

Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Information provided by (Responsible Party)
Carolyn Lauckner, University of Georgia

ClinicalTrials.gov Identifier
NCT03746600

First received: September 24, 2018
Last updated: July 15, 2019
Last Verified: July 2019
History of Changes
Purpose

Purpose

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.

Condition Intervention
Acquired Immunodeficiency Syndrome
HIV/AIDS
Alcohol Drinking

Behavioral : Project TRAC: Tracking and Reducing Alcohol Consumption

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized waitlist-controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Telemedicine and mHealth Intervention for Reducing Alcohol Consumption Among People Living With HIV/AIDS

Further study details as provided by Carolyn Lauckner, University of Georgia:

Primary Outcome Measures

  • Change in Problematic Alcohol Use [ Time Frame: Baseline, 8-week post-test, 16-week follow-up ]
    (Alcohol Use Disorders Identification Test (AUDIT score). For this 10-item scale, scores range from 0-40. Higher values represent greater alcohol dependence.
  • Change in daily alcohol consumption [ Time Frame: Two times/day for 8 weeks ]
    Self-reported # of drinks consumed
  • Change in Average Blood Alcohol Content [ Time Frame: Two times/day for 8 weeks ]
    Reading obtained by BACTrack mobile breathalyzer
Secondary Outcome Measures:
  • Change in HIV/AIDS Medication adherence [ Time Frame: Baseline, 8-week post-test, 16-week follow up ]
    Reported % adherence over previous month (participants self-report on a single item scale of 0-100% how much of their medication they have taken in the previous month)
  • Change in CD4 count [ Time Frame: Baseline, 8-week post-test, 16-week follow-up ]
    CD4 cell count as determined by medical chart
  • Change in Viral load [ Time Frame: Baseline, 8-week post-test, 16-week follow-up ]
    Level of HIV virus in the month as determined by medical chart
  • Change in Daily HIV/AIDS Medication adherence [ Time Frame: Daily for 8 weeks ]
    Self-reported intake of HIV/AIDS medication
Other Outcome Measures:
  • Change in Depressive Symptomology [ Time Frame: Baseline, 8-week post-test, 16-week follow-up ]
    Patient Health Questionnaire-9 (PHQ-9). For this 9-item scale, scores range from 0-27. Higher scores indicate greater depressive symptomology.
  • Change in Anxiety Symptoms [ Time Frame: Baseline, 8-week post-test, 16-week follow-up ]
    Beck Anxiety Inventory. For this 21-item scale, scores range from 0-63. Higher score indicates greater anxiety symptoms.
  • Change in Self-Reported Quality of Life [ Time Frame: Baseline, 8-week post-test, 16-week follow-up ]
    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.
  • Change in Stress [ Time Frame: Baseline, 8-week post-test, 16-week follow-up ]
    Perceived Stress Scale-10. For this 10-item scale, scores range from 0-40. A higher score suggests higher perceived stress levels.
  • Change in Social Support [ Time Frame: Baseline, 8-week post-test, 16-week follow-up ]
    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.
  • Change in Coping Behaviors [ Time Frame: Baseline, 8-week post-test, 16-week follow-up ]
    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.

Estimated Enrollment: 60
Study Start Date: June 5, 2019
Estimated Study Completion Date: July 2022
Estimated Primary Completion Date: July 2022 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03746600

Contacts

Contact:   Carolyn K Lauckner, PhD 7065424447 clauck@uga.edu

Locations

United States, Georgia
Atlanta Veterans Health Care System Recruiting
Decatur, Georgia, United States, 30033
Contact: Vincent Marconi, MD    404-321-6111 ext 207592    vcmarco@emory.edu
Sub-Investigator: Carolyn Lauckner, PhD

Sponsors and Collaborators

University of Georgia
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator: Carolyn Lauckner, PhD University of Georgia
More Information

More Information


Responsible Party: Carolyn Lauckner, Assistant Professor, University of Georgia  
ClinicalTrials.gov Identifier: NCT03746600   History of Changes  
Other Study ID Numbers: FP00008294  
  1K01AA025305-01A1  
Study First Received: September 24, 2018  
Last Updated: July 15, 2019  
Individual Participant Data    
Plan to Share IPD: Undecided  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Carolyn Lauckner, University of Georgia:

HIV/AIDS
Alcohol Drinking
Medication Adherence

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Alcohol Drinking

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.