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

HIV Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05431855
• Other study ID #: STUDY00002534
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Florida State University
• Contact: Yan Wang, PhD
• Phone: 352-294-5942
• Email: ywang48[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan
United States	The University of Florida	Gainesville	Florida
United States	Florida State University	Tallahassee	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Florida State University	University of Florida, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engagement in biosensor wearing	For the whole sample, it is an observational study, so the outcome is just percentage of biosensor wearing during the 30 day period.; For the subset who also go through MRT for engagement strategies, we will test the effect of each strategy using % time wearing the sensor in the next 12 hours as the proximal outcome. We hypothesize that the engagement strategies will be better than no prompt and that reciprocity will have an advantage over personalized feedback as it requires less cognitive processing.	Within 12 hours after prompted engagement strategy