Alcohol Monitor Validation

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

Detailed Description
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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.

Official Title
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Laboratory and Field Validation of a Wrist-Worn Alcohol Monitor

Conditions
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Human Immunodeficiency Virus (HIV)

Intervention / Treatment
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* Device: Skyn Monitor Lab Session 1
* Device: Skyn Monitor Field Test with EMA App
* Device: Skyn Monitor Lab Session 2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All participants (HIV+ and HIV- drinkers)<br>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. | Device: Skyn Monitor Lab Session 1<br>* 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.<br>* Other names: Skyn Alcohol Monitoring Device;Device: Skyn Monitor Field Test with EMA App<br>* 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.<br>* Other names: Skyn Alcohol Monitoring Device;Device: Skyn Monitor Lab Session 2<br>* 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.<br>* Other names: Skyn Alcohol Monitoring Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transdermal Alcohol Concentration (TAC) | Here we reported mean and SD of peak TAC in the laboratory sessions and in the field test. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol consumption