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

HIV/AIDS Clinical Trial

— TRAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03746600
• Other study ID #: FP00008294
• Secondary ID: 1K01AA025305-01A
• Status: Completed
• Phase: N/A
• Start date: June 5, 2019
• Est. completion date: June 7, 2023

Study information

• Verified date: July 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 7, 2023
• Est. primary completion date: June 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Alcohol Drinking
• HIV Infections
• HIV/AIDS
• Immunologic Deficiency Syndromes

Intervention

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.

Locations

Country	Name	City	State
United States	Atlanta Veterans Health Care System	Decatur	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Carolyn Lauckner	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Depressive Symptomology	Patient Health Questionnaire-9 (PHQ-9). For this 9-item scale, scores range from 0-27. Higher scores indicate greater depressive symptomology.	Baseline, 8-week post-test, 16-week follow-up
Other	Change in Anxiety Symptoms	Beck Anxiety Inventory. For this 21-item scale, scores range from 0-63. Higher score indicates greater anxiety symptoms.	Baseline, 8-week post-test, 16-week follow-up
Other	Change in Self-Reported Quality of Life	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.	Baseline, 8-week post-test, 16-week follow-up
Other	Change in Stress	Perceived Stress Scale-10. For this 10-item scale, scores range from 0-40. A higher score suggests higher perceived stress levels.	Baseline, 8-week post-test, 16-week follow-up
Other	Change in Social Support	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.	Baseline, 8-week post-test, 16-week follow-up
Other	Change in Coping Behaviors	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.	Baseline, 8-week post-test, 16-week follow-up
Primary	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
Primary	Change in daily alcohol consumption	Self-reported # of drinks consumed	Two times/day for 8 weeks
Primary	Change in Average Blood Alcohol Content	Reading obtained by BACTrack mobile breathalyzer	Two times/day for 8 weeks
Secondary	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
Secondary	Change in CD4 count	CD4 cell count as determined by medical chart	Baseline, 8-week post-test, 16-week follow-up
Secondary	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
Secondary	Change in Daily HIV/AIDS Medication adherence	Self-reported intake of HIV/AIDS medication	Daily for 8 weeks