Alcohol Monitor Validation

NCT03617705 | Completed Results FDA Device

• 2 other identifiers: IRB201801188-NR21AA027191
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Human Immunodeficiency Virus (HIV)

Keywords

alcohol consumption

Outcome Measures

Primary Outcomes (1)

• Transdermal Alcohol Concentration (TAC)

  Here we reported mean and SD of peak TAC in the laboratory sessions and in the field test.

  2 weeks

Study Arms (1)

All participants (HIV+ and HIV- drinkers)

OTHER

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

Interventions

Skyn Monitor Lab Session 1 DEVICE

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.

Also known as: BACtrack Skyn, Skyn Alcohol Monitoring Device

All participants (HIV+ and HIV- drinkers)

Skyn Monitor Field Test with EMA App DEVICE

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.

Also known as: BACtrack Skyn, Skyn Alcohol Monitoring Device

All participants (HIV+ and HIV- drinkers)

Skyn Monitor Lab Session 2 DEVICE

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.

Also known as: BACtrack Skyn, Skyn Alcohol Monitoring Device

All participants (HIV+ and HIV- drinkers)

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

HealthStreet

Gainesville, Florida, 32608, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Alcohol Drinking

Interventions

Monitoring, Physiologic

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Dr. Yan Wang
• Organization: University of Florida

ywang48@ufl.edu

3522945942

Study Officials

• Yan Wang, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 6, 2018
• Study Start: April 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: June 28, 2023
• Results First Posted: June 28, 2023

Record last verified: 2023-06

Locations

US (2)