Acquired Immunodeficiency Syndrome, Alcohol Drinking, HIV/AIDS
Conditions
Keywords
HIV/AIDS, Alcohol Drinking, Medication Adherence
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.
Interventions
BEHAVIORALProject 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.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Carolyn Lauckner
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized waitlist-controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Stress | Baseline, 8-week post-test, 16-week follow-up | Perceived Stress Scale-10. For this 10-item scale, scores range from 0-40. A higher score suggests higher perceived stress levels. |
| Change in Self-Reported Quality of Life | Baseline, 8-week post-test, 16-week follow-up | 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. |
| Change in Anxiety Symptoms | Baseline, 8-week post-test, 16-week follow-up | Beck Anxiety Inventory. For this 21-item scale, scores range from 0-63. Higher score indicates greater anxiety symptoms. |
| Change in Social Support | Baseline, 8-week post-test, 16-week follow-up | 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. |
| Change in Coping Behaviors | Baseline, 8-week post-test, 16-week follow-up | 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. |
| Change in Depressive Symptomology | Baseline, 8-week post-test, 16-week follow-up | Patient Health Questionnaire-9 (PHQ-9). For this 9-item scale, scores range from 0-27. Higher scores indicate greater depressive symptomology. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
50 participants were enrolled and completed the baseline assessment; 3 participants dropped out before completing any intervention sessions.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 26 |
| 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. | 24 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | dismissed from study | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | Immediate Intervention Group | Waitlist Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 22 Participants | 46 Participants |
| Age, Continuous | 51.08 years STANDARD_DEVIATION 11.48 | 55.79 years STANDARD_DEVIATION 10 | 53.34 years STANDARD_DEVIATION 10.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 23 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 21 Participants | 46 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 26 Participants | 24 Participants | 50 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 26 Participants | 23 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 24 |
| other Total, other adverse events | 0 / 26 | 0 / 24 |
| serious Total, serious adverse events | 0 / 26 | 0 / 24 |
Outcome results
Primary
Average Percent Change in Positive Breathalyzer Readings
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).
Time frame: Week 1 and Week 8 of the active intervention period
Population: Participants who completed at least one breathalyzer reading in both Week 1 and Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention Group | Average Percent Change in Positive Breathalyzer Readings | -0.10 Average percent change | Standard Deviation 0.25 |
| Waitlist Control Group | Average Percent Change in Positive Breathalyzer Readings | -0.07 Average percent change | Standard Deviation 0.3 |
Primary
Change in Daily Alcohol Consumption
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
Time frame: Baseline (T1), Immediate follow-up at 8 weeks (T2)
Population: Participants who had complete data for T1 (baseline) and T2 (8-week post-test)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention Group | Change in Daily Alcohol Consumption | -2.95 days | Standard Deviation 7.78 |
| Waitlist Control Group | Change in Daily Alcohol Consumption | -2.10 days | Standard Deviation 12.48 |
Primary
Change in Problematic Alcohol Use
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
Time frame: Baseline, 8-week post-test
Population: Participants who had complete data for T1 (baseline) and T2 (8-week post-test).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention Group | Change in Problematic Alcohol Use | -0.95 score on a scale | Standard Deviation 1.5 |
| Waitlist Control Group | Change in Problematic Alcohol Use | -1.00 score on a scale | Standard Deviation 3.32 |
Secondary
Change in CD4 Count
CD4 cell count as determined by medical chart
Time frame: Baseline, 8-week post-test, 16-week follow-up
Population: Data were not collected
Secondary
Change in Viral Load
Level of HIV virus in the month as determined by medical chart
Time frame: Baseline, 8-week post-test, 16-week follow-up
Population: data were not collected
Secondary
Percent Change in Daily HIV/AIDS Medication Adherence
% 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).
Time frame: Week 1 and Week 8 of the active intervention period
Population: Participants who completed at least 1 daily survey during Week 1 AND during Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention Group | Percent Change in Daily HIV/AIDS Medication Adherence | 0.01 average percent change | Standard Deviation 0.03 |
| Waitlist Control Group | Percent Change in Daily HIV/AIDS Medication Adherence | -0.02 average percent change | Standard Deviation 0.06 |
Secondary
Percent Change in HIV/AIDS Medication Adherence
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.
Time frame: Baseline, 8-week post-test
Population: participants who completed at least one follow up questionnaire and had complete data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention Group | Percent Change in HIV/AIDS Medication Adherence | 0 percent change in medication adherence | Standard Deviation 27.71 |
| Waitlist Control Group | Percent Change in HIV/AIDS Medication Adherence | 1.95 percent change in medication adherence | Standard Deviation 6.44 |
Other Pre-specified
Change in Anxiety Symptoms
Beck Anxiety Inventory. For this 21-item scale, scores range from 0-63. Higher score indicates greater anxiety symptoms.
Time frame: Baseline, 8-week post-test, 16-week follow-up
Other Pre-specified
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.
Time frame: Baseline, 8-week post-test, 16-week follow-up
Other Pre-specified
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.
Time frame: Baseline, 8-week post-test, 16-week follow-up
Other Pre-specified
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.
Time frame: Baseline, 8-week post-test, 16-week follow-up
Other Pre-specified
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.
Time frame: Baseline, 8-week post-test, 16-week follow-up
Other Pre-specified
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.
Time frame: Baseline, 8-week post-test, 16-week follow-up