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

• Sponsor: Florida State University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05431855
• Collaborator: University of Florida (Other), University of Michigan (Other)
• Enrollment: 222
• Arm: 1
• Anticipated Duration (Months): 19

Study Details

Study Description

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. They will also be micro-randomized to test two engagement strategies--reciprocity and personalized feedback via the eWrapper app to promote their engagement with the biosensor.

Condition or Disease	Intervention/Treatment	Phase
Hiv	Behavioral: eWrapper-Engagement strategies to facilitate alcohol biosensor wearing	N/A

Detailed Description

YPLWH (N = 222, 189 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). They 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. The will also allow us to investigate the relationship between engagement with the Skyn and alcohol use at different time scales (e.g., the relationship between engagement in a 12-hour time window and self-reported alcohol use in the subsequent 24 hours; the relationship between engagement patterns over the 30 days and PEth value at 1 month).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 222 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Self-management of HIV and Alcohol Reaching Emerging Adults: Project Engage
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Engagement in biosensor wearing All 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.

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. 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.

Outcome Measures

Primary Outcome Measures

1. Engagement in biosensor wearing [Within 12 months after prompted engagement strategy]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 29 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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+

• Incidental recruitment of pregnant women may occur, but pregnancy is not part of the study's exclusion criteria

• Prisoners

• Pregnant women

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Florida State University
• University of Florida
• University of Michigan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sylvie Naar, Distinguished Endowed Professor, Florida State University
• ClinicalTrials.gov Identifier: NCT05431855
• Other Study ID Numbers: STUDY00002534
• First Posted: Jun 24, 2022
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 3, 2022