Alcohol Monitor Validation

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus (HIV)
• Interventions: Device: Skyn Monitor Lab Session 1; Device: Skyn Monitor Field Test with EMA App; Device: Skyn Monitor Lab Session 2

• 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-07-19
• Study First Submitted QC: 2018-07-31
• Study First Posted: 2018-08-06
• Study Start: 2019-04-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-06
• Results First Submitted: 2023-06-04
• Results First Submitted QC: 2023-06-27
• Last Update Submitted: 2023-06-27
• Results First Posted: 2023-06-28
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants (HIV+ and HIV- drinkers)	Skyn Monitor Lab Session 1	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.
All participants (HIV+ and HIV- drinkers)	Skyn Monitor Field Test with EMA App	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.
All participants (HIV+ and HIV- drinkers)	Skyn Monitor Lab Session 2	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.

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.

Trial Locations

Locations (2)

University of Florida; 🇺🇸 Gainesville, Florida, United States

HealthStreet; 🇺🇸 Gainesville, Florida, United States