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

Not Applicable

Completed

Conditions: Alcohol Drinking
Acquired Immunodeficiency Syndrome
HIV/AIDS

Registration Number: NCT03746600

Lead Sponsor: Carolyn Lauckner

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Daily Alcohol Consumption	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
Average Percent Change in Positive Breathalyzer Readings	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).
Change in Problematic Alcohol Use	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

Secondary Outcome Measures

Name	Time	Method
Percent Change in HIV/AIDS Medication Adherence	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.
Change in CD4 Count	Baseline, 8-week post-test, 16-week follow-up	CD4 cell count as determined by medical chart
Percent Change in Daily HIV/AIDS Medication Adherence	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).
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