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Completed

NCT Number: NCT05431855

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

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.

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Key information

Conditions

HIV

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Florida, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eWrapper-Engagement strategies to facilitate alcohol biosensor wearing

Behavioral

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.

Primary outcomes

  1. Engagement in Biosensor Wearing

    Time frame: 30 days

    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.

Secondary outcomes

  1. Feasibility/Acceptability of Biosensor Wearing

    Time frame: 30 days

    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.

  2. Feasibility/Accessibility of eWrapper

    Time frame: 30 days

    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.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • University of Florida
  • University of Michigan

Registry information

Official study title

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

Acronym: SHARE Engage

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2022
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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