Clinical trial NCT03746600: Technological Intervention for Reducing Alcohol Use Among People Living With HIV/AIDS
Official title: A Telemedicine and mHealth Intervention for Reducing Alcohol Consumption Among People Living With HIV/AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Immunodeficiency Syndrome
HIV/AIDS
Alcohol Drinking
Keywords: HIV/AIDS
Alcohol Drinking
Medication Adherence
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-11-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized waitlist-controlled trial
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Problematic Alcohol Use
timeFrame: Baseline, 8-week post-test
measure: Change in Daily Alcohol Consumption
timeFrame: Baseline (T1), Immediate follow-up at 8 weeks (T2)
measure: Average Percent Change in Positive Breathalyzer Readings
timeFrame: Week 1 and Week 8 of the active intervention period
Secondary outcomes:
measure: Percent Change in HIV/AIDS Medication Adherence
timeFrame: Baseline, 8-week post-test
measure: Change in CD4 Count
timeFrame: Baseline, 8-week post-test, 16-week follow-up
measure: Change in Viral Load
timeFrame: Baseline, 8-week post-test, 16-week follow-up
measure: Percent Change in Daily HIV/AIDS Medication Adherence
timeFrame: Week 1 and Week 8 of the active intervention period
Other outcomes:
measure: Change in Depressive Symptomology
timeFrame: Baseline, 8-week post-test, 16-week follow-up
measure: Change in Anxiety Symptoms
timeFrame: Baseline, 8-week post-test, 16-week follow-up
measure: Change in Self-Reported Quality of Life
timeFrame: Baseline, 8-week post-test, 16-week follow-up
measure: Change in Stress
timeFrame: Baseline, 8-week post-test, 16-week follow-up
measure: Change in Social Support
timeFrame: Baseline, 8-week post-test, 16-week follow-up
measure: Change in Coping Behaviors
timeFrame: Baseline, 8-week post-test, 16-week follow-up
Locations:
city: Decatur
country: United States
facility: Atlanta Veterans Health Care System
state: Georgia
Study officials:
affiliation: University of Kentucky
name: Carolyn Lauckner, PhD
role: PRINCIPAL_INVESTIGATOR
References: