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

Florida State University

Status: Enrolling

Conditions: HIV

Treatments: Behavioral: eWrapper-Engagement strategies to facilitate alcohol biosensor wearing

Study type: Interventional

Funder types: Other

Identifiers

NCT05431855

STUDY00002534

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 29 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

Engagement in biosensor wearing

Experimental group

Description:

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.

Treatment:

Behavioral: eWrapper-Engagement strategies to facilitate alcohol biosensor wearing