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

NCT ID: NCT05431855

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2025-02-12

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.

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 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.

Conditions

HIV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Engagement in biosensor wearing

A subset of the participants will receive the same interventions, namely the reciprocity messages, personalized feedback, or no prompt (as control condition), using micro-randomization procedure that randomly assign one of the condition in the morning and one of the condition in the evening.

Group Type: EXPERIMENTAL

eWrapper-Engagement strategies to facilitate alcohol biosensor wearing

Intervention Type: BEHAVIORAL

We will conduct a 30-day micro-randomized trial (MRT)--a clinical trial design for developing and optimizing mHealth interventions to test which engagement strategy works better, for who, and under what condition. A subset of the participants will be micro-randomized in the morning and in the evening, to either a prompt delivering non-contingent small reward (reciprocity); or a prompt containing feedback on self-monitoring progress based on dynamic self-regulation theories (personalized feedback); or no prompt.

Interventions

eWrapper-Engagement strategies to facilitate alcohol biosensor wearing

We will conduct a 30-day micro-randomized trial (MRT)--a clinical trial design for developing and optimizing mHealth interventions to test which engagement strategy works better, for who, and under what condition. A subset of the participants will be micro-randomized in the morning and in the evening, to either a prompt delivering non-contingent small reward (reciprocity); or a prompt containing feedback on self-monitoring progress based on dynamic self-regulation theories (personalized feedback); or no prompt.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Sylvie Naar

Distinguished Endowed Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The University of Florida

Gainesville, Florida, United States

Florida State University

Tallahassee, Florida, United States

The University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1P01AA029547-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00002534

Identifier Type: -

Identifier Source: org_study_id