Human Immunodeficiency Virus (HIV)
Conditions
Keywords
alcohol consumption
Brief summary
This study will validate a wrist-worn alcohol monitor (BACtrack Skyn) in both laboratory and real-life settings.
Detailed description
The overarching goal of this research program is to improve alcohol intervention and eventually related clinical outcomes (e.g., liver function) among HIV+ drinkers through biosensor-assisted intervention. Research shows HIV infection can influence alcohol metabolism (i.e., higher blood alcohol levels), so it's necessary to validate the new alcohol biosensor in HIV+ drinkers rather than in general population. The primary goal of this project, as a step toward the development and evaluation of a biosensor-assisted alcohol intervention, is to validate the newly available wrist worn transdermal alcohol biosensor (BACtrack Skyn). The two specific aims are: (1) To assess validity and reliability of the Skyn biosensor using fixed-dose lab administration of alcohol through comparison with laboratory grade breathalyzer, and (2) To validate Skyn biosensor in daily life using a 2-week ecological momentary assessment (EMA) to compare self-reported drinking and the Skyn derived transdermal alcohol concentration (TAC) readings.
Interventions
DEVICESkyn Monitor Lab Session 1
Participants will be instructed to wear the Skyn wrist-worn alcohol monitor and drink 3 beers over the course of an hour and a half. BrAC will be measured every 15 minutes throughout the session.
DEVICESkyn Monitor Field Test with EMA App
After Skyn Monitor Lab Session 1, participants will be instructed to wear Skyn monitor for the rest of the day and the following two weeks. Participants will also enter information on each drinking session during the two week time using a mobile-based ecological momentary assessment (EMA) to collect real-time data in daily life.
DEVICESkyn Monitor Lab Session 2
Participants will be instructed to wear the Skyn wrist-worn alcohol monitor and drink 3 beers over the course of an hour and a half. BrAC will be measured every 15 minutes throughout the session. Participant will also complete device acceptability and usability survey.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* HIV+ consumers of alcohol; self-reported ≥ 5 days with at least 1 alcoholic drink, and ≥1days with at least 3 drinks * HIV- consumers of alcohol; self-reported ≥ 5 days with at least 1 alcoholic drink, and ≥1days with at least 3 drinks
Exclusion criteria
* non-drinkers * recent addiction treatment or treatment seeking * urine positive for illegal drugs except THC (not applicable to those who are only invited to do field test); * past & current alcohol withdrawal * severe alcohol use disorder (DSM-5) * meeting criteria for current nicotine dependence (not applicable to field only participants) or current substance use disorder (excluding mild cannabis use disorder and mild/moderate alcohol use disorder) * medical conditions (other than HIV) contraindicating alcohol * pregnancy/breastfeeding in women * psychosis or other severe psychiatric conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transdermal Alcohol Concentration (TAC) | 2 weeks | Here we reported mean and SD of peak TAC in the laboratory sessions and in the field test. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants (HIV+ and HIV- Drinkers) All participants were planned to complete the BACtrack Skyn biosensor in two lab sessions, and wear the Skyn biosensor for two weeks in the field. However, due to COVID, not all participants were able to complete the lab sessions.
Skyn Monitor Lab Session 1: Participants will be instructed to wear the Skyn wrist-worn alcohol monitor and drink 3 beers over the course of an hour and a half. BrAC will be measured every 15 minutes throughout the session.
Skyn Monitor Field Test with EMA App: After Skyn Monitor Lab Session 1, participants will be instructed to wear Skyn monitor for the rest of the day and the following two weeks. Participants will also enter information on each drinking session during the two week time using a mobile-based ecological momentary assessment (EMA) to collect real-time data in daily life.
Skyn Monitor Lab Session 2: Participants will be instructed to wear the Skyn wrist-worn alcohol monitor and drink 3 beers over the course of an hour and a half. BrAC will be measured every 15 minutes throughout the session. Participant will also complete device acceptability and usability survey. | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | lost contact after screening due to covid pandemic | 6 |
| Overall Study | withdrawal by study team due to non-compliance | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | All Participants (HIV+ and HIV- Drinkers) |
|---|---|
| Age, Continuous | 34.5 years STANDARD_DEVIATION 15.4 |
| HIV status HIV- | 33 Participants |
| HIV status HIV+ | 16 Participants |
| Race/Ethnicity, Customized Race Asian | 4 Participants |
| Race/Ethnicity, Customized Race Black | 10 Participants |
| Race/Ethnicity, Customized Race Choose not to response or no data | 2 Participants |
| Race/Ethnicity, Customized Race Multi-racial | 2 Participants |
| Race/Ethnicity, Customized Race Native American | 0 Participants |
| Race/Ethnicity, Customized Race White | 31 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 49 |
| other Total, other adverse events | 0 / 49 |
| serious Total, serious adverse events | 0 / 49 |
Outcome results
Primary
Transdermal Alcohol Concentration (TAC)
Here we reported mean and SD of peak TAC in the laboratory sessions and in the field test.
Time frame: 2 weeks
Population: There were nine participants were enrolled but did not complete any study procedures due to various of reasons such as self withdrawal or administrative withdrawal, so only 40 participants had usable data for the outcome measure. Also, not all participants completed all study procedures outlined in the description due to COVID pandemic, n for lab and field data analyses varied according to how many participants completed respective study procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants (HIV+ and HIV- Drinkers) | Transdermal Alcohol Concentration (TAC) | Lab session | 38.3 ug/L | Standard Deviation 28.4 |
| All Participants (HIV+ and HIV- Drinkers) | Transdermal Alcohol Concentration (TAC) | Field test | 95.8 ug/L | Standard Deviation 113.7 |