Trial Outcomes & Findings for Technological Intervention for Reducing Alcohol Use Among People Living With HIV/AIDS (NCT NCT03746600)
NCT ID: NCT03746600
Last Updated: 2024-08-09
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Baseline, 8-week post-test
Results posted on
2024-08-09
Participant Flow
Participants for this study were recruited from the Infectious Diseases Clinic of the Atlanta Veterans Affairs Medical Center between 05/2020 and 01/2023. The first participant was enrolled in 05/2020 and the last participant was enrolled in 01/2023.
50 participants were enrolled and completed the baseline assessment; 3 participants dropped out before completing any intervention sessions.
Participant milestones
| Measure |
Immediate Intervention Group
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.
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.
|
Waitlist Control Group
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
24
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Immediate Intervention Group
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.
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.
|
Waitlist Control Group
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.
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
dismissed from study
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Technological Intervention for Reducing Alcohol Use Among People Living With HIV/AIDS
Baseline characteristics by cohort
| Measure |
Immediate Intervention Group
n=26 Participants
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.
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.
|
Waitlist Control Group
n=24 Participants
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.
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.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
51.08 years
STANDARD_DEVIATION 11.48 • n=5 Participants
|
55.79 years
STANDARD_DEVIATION 10.00 • n=7 Participants
|
53.34 years
STANDARD_DEVIATION 10.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8-week post-testPopulation: Participants who had complete data for T1 (baseline) and T2 (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
Outcome measures
| Measure |
Immediate Intervention Group
n=21 Participants
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.
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.
|
Waitlist Control Group
n=20 Participants
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.
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.
|
|---|---|---|
|
Change in Problematic Alcohol Use
|
-0.95 score on a scale
Standard Deviation 1.50
|
-1.00 score on a scale
Standard Deviation 3.32
|
PRIMARY outcome
Timeframe: Baseline (T1), Immediate follow-up at 8 weeks (T2)Population: Participants who had complete data for T1 (baseline) and T2 (8-week post-test)
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
Outcome measures
| Measure |
Immediate Intervention Group
n=20 Participants
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.
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.
|
Waitlist Control Group
n=20 Participants
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.
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.
|
|---|---|---|
|
Change in Daily Alcohol Consumption
|
-2.95 days
Standard Deviation 7.78
|
-2.10 days
Standard Deviation 12.48
|
PRIMARY outcome
Timeframe: Week 1 and Week 8 of the active intervention periodPopulation: Participants who completed at least one breathalyzer reading in both Week 1 and Week 8
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).
Outcome measures
| Measure |
Immediate Intervention Group
n=19 Participants
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.
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.
|
Waitlist Control Group
n=20 Participants
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.
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.
|
|---|---|---|
|
Average Percent Change in Positive Breathalyzer Readings
|
-0.10 Average percent change
Standard Deviation 0.25
|
-0.07 Average percent change
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: Baseline, 8-week post-testPopulation: participants who completed at least one follow up questionnaire and had complete data
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.
Outcome measures
| Measure |
Immediate Intervention Group
n=21 Participants
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.
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.
|
Waitlist Control Group
n=20 Participants
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.
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.
|
|---|---|---|
|
Percent Change in HIV/AIDS Medication Adherence
|
0 percent change in medication adherence
Standard Deviation 27.71
|
1.95 percent change in medication adherence
Standard Deviation 6.44
|
SECONDARY outcome
Timeframe: Baseline, 8-week post-test, 16-week follow-upPopulation: Data were not collected
CD4 cell count as determined by medical chart
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 8-week post-test, 16-week follow-upPopulation: data were not collected
Level of HIV virus in the month as determined by medical chart
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 1 and Week 8 of the active intervention periodPopulation: Participants who completed at least 1 daily survey during Week 1 AND during Week 8
% 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).
Outcome measures
| Measure |
Immediate Intervention Group
n=17 Participants
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.
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.
|
Waitlist Control Group
n=19 Participants
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.
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.
|
|---|---|---|
|
Percent Change in Daily HIV/AIDS Medication Adherence
|
0.01 average percent change
Standard Deviation 0.03
|
-0.02 average percent change
Standard Deviation 0.06
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 8-week post-test, 16-week follow-upPatient Health Questionnaire-9 (PHQ-9). For this 9-item scale, scores range from 0-27. Higher scores indicate greater depressive symptomology.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 8-week post-test, 16-week follow-upBeck Anxiety Inventory. For this 21-item scale, scores range from 0-63. Higher score indicates greater anxiety symptoms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 8-week post-test, 16-week follow-upQuality 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 8-week post-test, 16-week follow-upPerceived Stress Scale-10. For this 10-item scale, scores range from 0-40. A higher score suggests higher perceived stress levels.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 8-week post-test, 16-week follow-upMedical 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 8-week post-test, 16-week follow-upBrief 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.
Outcome measures
Outcome data not reported
Adverse Events
Immediate Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Carolyn Lauckner, PhD
University of Kentucky College of Medicine
Phone: 989-928-2359
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place