Human Immunodeficiency Virus (HIV)NCT03617705
Alcohol Monitor Validation
A study testing Skyn Monitor Lab Session 1, Skyn Monitor Field Test with EMA App and Skyn Monitor Lab Session 2 in people with Human Immunodeficiency Virus (HIV), run by University of Florida at 2 sites in United States.
Trial summary
This study will validate a wrist-worn alcohol monitor (BACtrack Skyn) in both laboratory and real-life settings. Read more about this study
- Who is it for?
- Ages 21 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus (HIV)
- What is being tested?
- Skyn Monitor Lab Session 1, Skyn Monitor Field Test with EMA App and Skyn Monitor Lab Session 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- medical conditions (other than HIV) contraindicating alcohol
- pregnancy/breastfeeding in women
- psychosis or other severe psychiatric conditions.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
HealthStreet
Gainesville, Florida, 32608
University of Florida
Gainesville, Florida, 32611
About this study
Official title: Laboratory and Field Validation of a Wrist-Worn Alcohol Monitor
This study will validate a wrist-worn alcohol monitor (BACtrack Skyn) in both laboratory and real-life settings.
Read the 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.
- Conditions
- Human Immunodeficiency Virus (HIV)
- Being tested
- Skyn Monitor Lab Session 1, Skyn Monitor Field Test with EMA App, Skyn Monitor Lab Session 2
- Keywords
- alcohol consumption
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skyn Monitor Lab Session 1Device
Also called BACtrack Skyn, Skyn Alcohol Monitoring 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.
Skyn Monitor Field Test with EMA AppDevice
Also called BACtrack Skyn, Skyn Alcohol Monitoring 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.
Skyn Monitor Lab Session 2Device
Also called BACtrack Skyn, Skyn Alcohol Monitoring 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Skyn Monitor Lab Session 1; Device: Skyn Monitor Field Test with EMA App; Device: Skyn Monitor Lab Session 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transdermal Alcohol Concentration (TAC)
Here we reported mean and SD of peak TAC in the laboratory sessions and in the field test.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Apr 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Yan Wang, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617705
- Sponsor's protocol ID
- IRB201801188-N
- Other IDs
- R21AA027191
- Status last verified
- Jun 2023
- First submitted
- 19 Jul 2018
- Last updated
- 28 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laboratory and Field Validation of a Wrist-Worn Alcohol Monitor
- ClinicalTrials.gov ID
- NCT03617705
- Acronym / sponsor ID
- IRB201801188-N
- Conditions
- Human Immunodeficiency Virus (HIV)
- Keywords
- alcohol consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Posted 28 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants (HIV+ and HIV- drinkers) | Other | Device: Skyn Monitor Lab Session 1, Device: Skyn Monitor Field Test with EMA App, Device: Skyn Monitor Lab Session 2All 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. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skyn Monitor Lab Session 1Also: BACtrack Skyn, Skyn Alcohol Monitoring DeviceParticipants 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. | Device | All participants (HIV+ and HIV- drinkers) |
| Skyn Monitor Field Test with EMA AppAlso: BACtrack Skyn, Skyn Alcohol Monitoring DeviceAfter 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. | Device | All participants (HIV+ and HIV- drinkers) |
| Skyn Monitor Lab Session 2Also: BACtrack Skyn, Skyn Alcohol Monitoring DeviceParticipants 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. | Device | All participants (HIV+ and HIV- drinkers) |
Primary outcome
Transdermal Alcohol Concentration (TAC)
Time frame: 2 weeks
Here we reported mean and SD of peak TAC in the laboratory sessions and in the field test.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Wang, PhD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skyn Monitor Lab Session 1, Skyn Monitor Field Test with EMA App and Skyn Monitor Lab Session 2 in people with Human Immunodeficiency Virus (HIV), run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transdermal Alcohol Concentration (TAC) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.