Alcohol Monitor Validation

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    60
  • sponsor
    University of Florida
Updated on 22 August 2021
HIV Vaccine

Summary

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

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). Up to 30 HIV+ and 30 HIV- drinkers will be recruited to validate the Skyn biosensor in both laboratory and real life settings. 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) and BACtrack Mobile Pro breathalyzer, and evaluate its usability and acceptability for daily alcohol monitoring. Also explored will be factors (e.g., gender, viral load) that may be associated with individual differences in biosensor readings (e.g., peak, time-to-peak).

Details
Condition HIV, HIV infection, HIV (Pediatric), HIV Infections, human immunodeficiency virus, hiv disease
Treatment Skyn Monitor Lab Session 1, Skyn Monitor Field Test with EMA App, Skyn Monitor Lab Session 2
Clinical Study IdentifierNCT03617705
SponsorUniversity of Florida
Last Modified on22 August 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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