Alcohol Monitor Validation
Status: | Recruiting |
---|---|
Conditions: | HIV / AIDS, HIV / AIDS, HIV / AIDS |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 21 - 64 |
Updated: | 4/6/2019 |
Start Date: | April 1, 2019 |
End Date: | June 30, 2020 |
Contact: | Yan Wang, PhD |
Email: | ywang48@ufl.edu |
Phone: | 352-294-5942 |
Laboratory and Field Validation of a Wrist-Worn Alcohol Monitor
This study will validate a wrist-worn alcohol monitor (BACtrack Skyn) in both laboratory and
real-life settings.
real-life settings.
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). Up to 30 HIV+ and 30 HIV- drinkers will be recruited to validate the Skyn
biosensor in both laboratory and real life settings. 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) and BACtrack Mobile Pro
breathalyzer, and evaluate its usability and acceptability for daily alcohol monitoring. Also
explored will be factors (e.g., gender, viral load) that may be associated with individual
differences in biosensor readings (e.g., peak, time-to-peak).
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). Up to 30 HIV+ and 30 HIV- drinkers will be recruited to validate the Skyn
biosensor in both laboratory and real life settings. 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) and BACtrack Mobile Pro
breathalyzer, and evaluate its usability and acceptability for daily alcohol monitoring. Also
explored will be factors (e.g., gender, viral load) that may be associated with individual
differences in biosensor readings (e.g., peak, time-to-peak).
Inclusion Criteria:
- HIV+ consumers of alcohol; self-reported ≥10 days with at least 1 alcoholic drink, and
≥1days with at least 3 drinks
- HIV- consumers of alcohol; self-reported ≥10 days with at least 1 alcoholic drink, and
≥1days with at least 3 drinks
- participant has a smartphone
Exclusion Criteria:
- non-drinkers
- recent addiction treatment or treatment seeking
- urine positive for illegal drugs except THC
- past & current alcohol withdrawal
- severe alcohol use disorder (DSM-5)
- medical conditions (other than HIV) contraindicating alcohol
- pregnancy/breastfeeding in women
- psychosis or other severe psychiatric conditions.
We found this trial at
2
sites
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
Click here to add this to my saved trials
Click here to add this to my saved trials