TRAC: Technological Intervention for Reducing Alcohol Use Among People Living With HIV/AIDS
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Change in Problematic Alcohol Use [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 [Two times/day for 8 weeks]
Self-reported # of drinks consumed
- Change in Average Blood Alcohol Content [Two times/day for 8 weeks]
Reading obtained by BACTrack mobile breathalyzer
Secondary Outcome Measures
- Change in HIV/AIDS Medication adherence [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 [Baseline, 8-week post-test, 16-week follow-up]
CD4 cell count as determined by medical chart
- Change in Viral load [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 [Daily for 8 weeks]
Self-reported intake of HIV/AIDS medication
Other Outcome Measures
- Change in Depressive Symptomology [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 [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 [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 [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 [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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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HIV-positive
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18 years or older
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At-risk drinker
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Currently prescribed HIV medication
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Current patient at the study recruitment site(s)
Exclusion Criteria:
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Less than 18 years old
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Non-English Speaking
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Atlanta Veterans Health Care System | Decatur | Georgia | United States | 30033 |
Sponsors and Collaborators
- Carolyn Lauckner
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
- Principal Investigator: Carolyn Lauckner, PhD, University of Kentucky
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FP00008294
- 1K01AA025305-01A1