Alcohol Monitor Validation
- Conditions
- Human Immunodeficiency Virus (HIV)
- Registration Number
- NCT03617705
- Lead Sponsor
- University of Florida
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Transdermal Alcohol Concentration (TAC) 2 weeks Here we reported mean and SD of peak TAC in the laboratory sessions and in the field test.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
HealthStreet
🇺🇸Gainesville, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, United States
HealthStreet🇺🇸Gainesville, Florida, United States