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Clinical Trials/NCT03746600
NCT03746600
Completed
Not Applicable

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

Carolyn Lauckner1 site in 1 country50 target enrollmentMay 23, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acquired Immunodeficiency Syndrome
Sponsor
Carolyn Lauckner
Enrollment
50
Locations
1
Primary Endpoint
Change in Daily Alcohol Consumption
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 23, 2020
End Date
June 7, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Carolyn Lauckner
Responsible Party
Sponsor Investigator
Principal Investigator

Carolyn Lauckner

Assistant Professor

University of Kentucky

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

Outcomes

Primary Outcomes

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

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).

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

Secondary Outcomes

  • Percent Change in HIV/AIDS Medication Adherence(Baseline, 8-week post-test)
  • Change in CD4 Count(Baseline, 8-week post-test, 16-week follow-up)
  • Percent Change in Daily HIV/AIDS Medication Adherence(Week 1 and Week 8 of the active intervention period)
  • Change in Viral Load(Baseline, 8-week post-test, 16-week follow-up)

Study Sites (1)

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