Trial Outcomes & Findings for Alcohol Monitor Validation (NCT NCT03617705)
NCT ID: NCT03617705
Last Updated: 2023-06-28
Results Overview
Here we reported mean and SD of peak TAC in the laboratory sessions and in the field test.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
2 weeks
Results posted on
2023-06-28
Participant Flow
Participant milestones
| Measure |
All Participants (HIV+ and HIV- Drinkers)
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.
Skyn Monitor Lab Session 1: 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.
Skyn Monitor Field Test with EMA App: 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.
Skyn Monitor Lab Session 2: 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.
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
All Participants (HIV+ and HIV- Drinkers)
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.
Skyn Monitor Lab Session 1: 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.
Skyn Monitor Field Test with EMA App: 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.
Skyn Monitor Lab Session 2: 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.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
lost contact after screening due to covid pandemic
|
6
|
|
Overall Study
withdrawal by study team due to non-compliance
|
1
|
Baseline Characteristics
Alcohol Monitor Validation
Baseline characteristics by cohort
| Measure |
All Participants (HIV+ and HIV- Drinkers)
n=49 Participants
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.
Skyn Monitor Lab Session 1: 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.
Skyn Monitor Field Test with EMA App: 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.
Skyn Monitor Lab Session 2: 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.
|
|---|---|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 15.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
31 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
10 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Native American
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
4 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Multi-racial
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Choose not to response or no data
|
2 Participants
n=99 Participants
|
|
HIV status
HIV+
|
16 Participants
n=99 Participants
|
|
HIV status
HIV-
|
33 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: There were nine participants were enrolled but did not complete any study procedures due to various of reasons such as self withdrawal or administrative withdrawal, so only 40 participants had usable data for the outcome measure. Also, not all participants completed all study procedures outlined in the description due to COVID pandemic, n for lab and field data analyses varied according to how many participants completed respective study procedure.
Here we reported mean and SD of peak TAC in the laboratory sessions and in the field test.
Outcome measures
| Measure |
All Participants (HIV+ and HIV- Drinkers)
n=40 Participants
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.
Skyn Monitor Lab Session 1: 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.
Skyn Monitor Field Test with EMA App: 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.
Skyn Monitor Lab Session 2: 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.
|
|---|---|
|
Transdermal Alcohol Concentration (TAC)
Lab session
|
38.3 ug/L
Standard Deviation 28.4
|
|
Transdermal Alcohol Concentration (TAC)
Field test
|
95.8 ug/L
Standard Deviation 113.7
|
Adverse Events
All Participants (HIV+ and HIV- Drinkers)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place