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

Self-management of HIV and Alcohol Reaching Emerging Adults: Project Engage

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: eWrapper-Engagement strategies to facilitate alcohol biosensor wearing

Detailed 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 assigned to use an app called the eWrapper app that is a game app designed to promote engagement with the Skyn sensor via reciprocity and personalized feedback.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • The University of Florida
    • Tallahassee, Florida, United States, 32310
      • Florida State University
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • The University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Criteria:

• Adults unable to consent
• Individuals who are not yet adults
• Individuals who are not diagnosed as HIV+
• Prisoners
• Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Assigned to eWrapper App; Participants will have access to the eWrapper app while wearing the Skyn sensor for 30 days.	Behavioral: eWrapper-Engagement strategies to facilitate alcohol biosensor wearing; The eWrapper app includes two engagement strategies (reciprocity and personalized feedback) and implements a micro-randomized trial (MRT) design to test whether the strategies work.
No Intervention: Not Assigned to eWrapper App; Participants will not have access to eWrapper app while wearing the Skyn sensor for 30 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement in Biosensor Wearing	The percentage of Skyn sensor wearing will be the primary outcome. We will calculate the percentage of time participants wear the sensor during the 30 days, and compare whether this differs between those who have access to the eWrapper vs. those who do not.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility/Acceptability of Biosensor Wearing	Survey adapted from the System Usability Scale (Brooke, 1986) will be used to assess participant perception of feasibility of wearing the alcohol biosensor. This survey was administered at the conclusion of the 30 day trial. Items in the System Usability Scale were measured on a five-point Likert scale from 1-strongly disagree to 5-strongly agree. The Mean score was calculated to form a total scale score, with a higher number indicating higher overall usability/acceptability. No subscale scores were calculated.	30 days
Feasibility/Accessibility of eWrapper	Survey adapted from the System Usability Scale (Brooke, 1986) will be used to assess participant perception of the eWrapper app. Survey is administered upon conclusion of 30 day trial. Items in the System Usability Scale were measured on a five-point Likert scale from 1-strongly disagree to 5-strongly agree. The Mean score was calculated to form a total scale score, with a higher number indicating higher overall usability/acceptability. No subscale scores were calculated.	30 days

Collaborators and Investigators

• Sponsor: Florida State University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); University of Michigan; University of Florida

Publications and helpful links

General Publications

• Carpenter SM, Case S, Lustria MLA, Marks LR, Yu Q, MacDonell K, Naar S, Wang Y. Feasibility of mHealth Strategies to Promote Use of Wrist-Worn Alcohol Biosensors Among Young Adults With HIV: Protocol for the Engage Microrandomized Trial. JMIR Res Protoc. 2025 Nov 12;14:e69966. doi: 10.2196/69966.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): February 12, 2025
• Study Completion (Actual): February 12, 2025

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Alcohols; Ethanol
• Other Study ID Numbers: STUDY00002534; 1P01AA029547-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No