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Trial record 27 of 126 for:    "Viral Infectious Disease" | "Ethanol"

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

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ClinicalTrials.gov Identifier: NCT03746600
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Carolyn Lauckner, University of Georgia

Brief Summary:
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 or disease Intervention/treatment Phase
Acquired Immunodeficiency Syndrome HIV/AIDS Alcohol Drinking Behavioral: Project TRAC: Tracking and Reducing Alcohol Consumption Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Actual Study Start Date : June 5, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol HIV/AIDS

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.

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.




Primary Outcome Measures :
  1. 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.

  2. Change in daily alcohol consumption [ Time Frame: Two times/day for 8 weeks ]
    Self-reported # of drinks consumed

  3. Change in Average Blood Alcohol Content [ Time Frame: Two times/day for 8 weeks ]
    Reading obtained by BACTrack mobile breathalyzer


Secondary Outcome Measures :
  1. 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)

  2. Change in CD4 count [ Time Frame: Baseline, 8-week post-test, 16-week follow-up ]
    CD4 cell count as determined by medical chart

  3. 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

  4. Change in Daily HIV/AIDS Medication adherence [ Time Frame: Daily for 8 weeks ]
    Self-reported intake of HIV/AIDS medication


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746600


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

Locations
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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
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Principal Investigator: Carolyn Lauckner, PhD University of Georgia

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Responsible Party: Carolyn Lauckner, Assistant Professor, University of Georgia
ClinicalTrials.gov Identifier: NCT03746600     History of Changes
Other Study ID Numbers: FP00008294
1K01AA025305-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Plan for sharing is undecided 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.

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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:
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RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Ethanol
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Alcohol Drinking
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Drinking Behavior
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs