NCT03617705

Alcohol Monitor Validation

Completed NA Results posted Last updated 28 June 2023

What this trial tests

NA trial testing Skyn Monitor Lab Session 1 in Human Immunodeficiency Virus (HIV) in 49 participants. Completed in 30 June 2022.

Timeline

1 April 2019

Primary endpoint
30 June 2022

30 June 2022

Quick facts

Lead sponsor	University of Florida
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	49
Start date	1 April 2019
Primary completion	30 June 2022
Estimated completion	30 June 2022
Sites	2 locations across United States

Drugs / interventions tested

• Skyn Monitor Lab Session 1
• Skyn Monitor Field Test with EMA App
• Skyn Monitor Lab Session 2

Conditions studied

• Human Immunodeficiency Virus (HIV) — all drugs for Human Immunodeficiency Virus (HIV) →

Sponsor

University of Florida

Who can join

Adults 21 to 64, any sex, with Human Immunodeficiency Virus (HIV). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Transdermal Alcohol Concentration (TAC) Primary · 2 weeks

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

Lab session

Group	Value	95% CI
All Participants (HIV+ and HIV- Drinkers)	38.3	± 28.4

Field test

Group	Value	95% CI
All Participants (HIV+ and HIV- Drinkers)	95.8	± 113.7

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.