NCT05431855

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 24, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2025

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 5, 2026

Completed
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

June 21, 2022

Results QC Date

February 4, 2026

Last Update Submit

March 4, 2026

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Feasibility/Acceptability of Biosensor Wearing

    30 days

  • Feasibility/Accessibility of eWrapper

    30 days

Study Arms (2)

Assigned to eWrapper App

EXPERIMENTAL

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

Not Assigned to eWrapper App

NO INTERVENTION

Participants will not have access to eWrapper app while wearing the Skyn sensor for 30 days.

Interventions

eWrapper-Engagement strategies to facilitate alcohol biosensor wearingBEHAVIORAL

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.

Assigned to eWrapper App

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The University of Florida

Gainesville, Florida, 32611, United States

Location

Florida State University

Tallahassee, Florida, 32310, United States

Location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • 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.

    PMID: 41223419DERIVED

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Results Point of Contact

Title
Sylvie Naar, PhD; Contact MPI
Organization
Florida State University
sylvie.naar@med.fsu.edu
850-644-2334

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Participants at the beginning of the trial were not given the eWrapper engagement strategy. Once the eWrapper was fully developed, all participants were then assigned to the eWrapper arm to assess feasibility and acceptability of the eWrapper component.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Endowed Professor

Study Record Dates

First Submitted

June 21, 2022

First Posted

June 24, 2022

Study Start

February 1, 2023

Primary Completion

February 12, 2025

Study Completion

February 12, 2025

Last Updated

March 5, 2026

Results First Posted

March 5, 2026

Record last verified: 2026-03

Locations

US(3)