Project Engage: A Wrist Biosensor-based mHealth Suite to Support Alcohol Intervention in Young People Living With HIV

Last updated: July 3, 2025
Sponsor: Florida State University
Overall Status: Completed

Phase

N/A

Condition

Hiv

Treatment

eWrapper-Engagement strategies to facilitate alcohol biosensor wearing

Clinical Study ID

NCT05431855
STUDY00002534
1P01AA029547-01
  • Ages 18-29
  • All Genders

Study Summary

In this study, participants will be asked to wear a wrist alcohol biosensor for 30 days and report alcohol use using a ecological momentary assessment (EMA) app. A subset of the sample will be micro-randomized to test two engagement strategies--reciprocity and personalized feedback via the eWrapper app to promote their engagement with the biosensor.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years and 0 months to 29 years and 11 months

  • Currently reside in Florida

  • Report having had at least 1 alcoholic drink in the last 30 days

  • Able to read and understand English

  • Have internet access via smartphone, tablet or computer

  • Be diagnosed as HIV positive and;

  • Willing to provide informed consent.

Exclusion

Exclusion Criteria:

  • Adults unable to consent

  • Individuals who are not yet adults

  • Individuals who are not diagnosed as HIV+

  • Prisoners

  • Pregnant women

Study Design

Total Participants: 66
Treatment Group(s): 1
Primary Treatment: eWrapper-Engagement strategies to facilitate alcohol biosensor wearing
Phase:
Study Start date:
February 01, 2023
Estimated Completion Date:
February 12, 2025

Study Description

YPLWH (N = 160, 136 after 15% attrition, 18-29 years of age, estimated to include 73% male, 26% female, 1% transgender, 70% racial and ethnic minorities) will be asked to wear a wrist alcohol biosensor (BACtrack Skyn) for 30 days and report their alcohol use using daily ecological momentary assessment (EMA). A subset of the sample will also be micro-randomized twice daily to test two empirically-based engagement strategies - reciprocity and personalized feedback. Data from the 30-day MRT will be used to (a) develop and validate the algorithm for alcohol detection based on Skyn data; and (b) address scientific questions concerning which engagement strategy works best, for whom and under what conditions in terms of facilitating proximal engagement in biosensor wearing. We will also collect alcohol biomarker (i.e., PEth) at 1-month follow up.

Connect with a study center

  • The University of Florida

    Gainesville, Florida 32611
    United States

    Site Not Available

  • Florida State University

    Tallahassee, Florida 32310
    United States

    Site Not Available

  • The University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.