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Completed

NCT Number: NCT03746600

Technological Intervention for Reducing Alcohol Use 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.

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Key information

Conditions

Acquired Immunodeficiency Syndrome Alcohol Drinking Behavior Blood-Borne Infections Communicable Diseases Drinking Behavior Genital Diseases HIV Infections HIV/AIDS Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Medication Adherence Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlanta Veterans Health Care System

Decatur, Georgia, 30033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Project TRAC: Tracking and Reducing Alcohol Consumption

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.

Primary outcomes

  1. Change in Problematic Alcohol Use

    Time frame: Baseline, 8-week post-test

    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

  2. Change in Daily Alcohol Consumption

    Time frame: Baseline (T1), Immediate follow-up at 8 weeks (T2)

    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

  3. Average Percent Change in Positive Breathalyzer Readings

    Time frame: Week 1 and Week 8 of the active intervention period

    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).

Secondary outcomes

  1. Percent Change in HIV/AIDS Medication Adherence

    Time frame: Baseline, 8-week post-test

    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.

  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. Percent Change in Daily HIV/AIDS Medication Adherence

    Time frame: Week 1 and Week 8 of the active intervention period

    % 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).

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Carolyn Lauckner

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Acronym: TRAC

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 19, 2018
Registry last updated
Aug 9, 2024

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.

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