Alcohol Monitor Validation

University of Florida

Status: Completed

Conditions: Human Immunodeficiency Virus (HIV)

Treatments: Device: Skyn Monitor Lab Session 1; Device: Skyn Monitor Lab Session 2; Device: Skyn Monitor Field Test with EMA App

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03617705

R21AA027191 (U.S. NIH Grant/Contract)

IRB201801188-N

Details and patient eligibility

About

This study will validate a wrist-worn alcohol monitor (BACtrack Skyn) in both laboratory and real-life settings.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 21 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

All participants (HIV+ and HIV- drinkers)

Other group

Description:

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.

Treatment:

Device: Skyn Monitor Lab Session 1

Device: Skyn Monitor Lab Session 2

Device: Skyn Monitor Field Test with EMA App