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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV/AIDS, Acquired Immunodeficiency Syndrome, Alcohol Drinking

Intervention / Treatment
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* Behavioral: Project TRAC: Tracking and Reducing Alcohol Consumption


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized waitlist-controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Intervention Group<br>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<br>* 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.<br>|
| Other: Waitlist Control Group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Problematic Alcohol Use | (Alcohol Use Disorders Identification Test (AUDIT score). For this 10-item scale, scores range from 0-40. Higher values represent greater alcohol dependence. | Baseline, 8-week post-test, 16-week follow-up | 
| Change in daily alcohol consumption | Self-reported # of drinks consumed | Two times/day for 8 weeks | 
| Change in Average Blood Alcohol Content | Reading obtained by BACTrack mobile breathalyzer | Two times/day for 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HIV/AIDS Medication adherence | 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) | Baseline, 8-week post-test, 16-week follow up | 
| 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 | 
| Change in Daily HIV/AIDS Medication adherence | Self-reported intake of HIV/AIDS medication | Daily for 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV/AIDS, Alcohol Drinking, Medication Adherence