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

Studies

Study First Submitted Date 2022-06-21
Study First Posted Date 2022-06-24
Last Update Posted Date 2023-08-08
Start Month Year February 1, 2024
Primary Completion Month Year December 31, 2024
Verification Month Year August 2023
Verification Date 2023-08-31
Last Update Posted Date 2023-08-08

Detailed Descriptions

Sequence: 20712126
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.

Facilities

Sequence: 199990432 Sequence: 199990433 Sequence: 199990434
Name The University of Florida Name Florida State University Name The University of Michigan
City Gainesville City Tallahassee City Ann Arbor
State Florida State Florida State Michigan
Zip 32611 Zip 32310 Zip 48109
Country United States Country United States Country United States

Facility Contacts

Sequence: 28089626 Sequence: 28089627
Facility Id 199990433 Facility Id 199990433
Contact Type primary Contact Type backup
Name Sara Green, MSW Name Sylvie Naar, PhD
Email sara.green@med.fsu.edu Email sylvie.naar@med.fsu.edu
Phone 850-644-2334 Phone 850-644-2334

Conditions

Sequence: 52144708
Name HIV
Downcase Name hiv

Id Information

Sequence: 40139236
Id Source org_study_id
Id Value STUDY00002534

Countries

Sequence: 42547624
Name United States
Removed False

Design Groups

Sequence: 55565582
Group Type Experimental
Title Engagement in biosensor wearing
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.

Interventions

Sequence: 52460587
Intervention Type Behavioral
Name eWrapper-Engagement strategies to facilitate alcohol biosensor wearing
Description 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.

Design Outcomes

Sequence: 177287231
Outcome Type primary
Measure Engagement in biosensor wearing
Time Frame Within 12 hours after prompted engagement strategy
Description 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.

Sponsors

Sequence: 48295795 Sequence: 48295796 Sequence: 48295797
Agency Class OTHER Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name Florida State University Name University of Florida Name University of Michigan

Central Contacts

Sequence: 12002330 Sequence: 12002331
Contact Type primary Contact Type backup
Name Yan Wang, PhD Name Sylvie Naar, PhD
Phone 352-294-5942 Phone 850-644-2334
Email ywang48@ufl.edu Email sylvie.naar@med.fsu.edu
Role Contact Role Contact

Design Group Interventions

Sequence: 68115338
Design Group Id 55565582
Intervention Id 52460587

Eligibilities

Sequence: 30750914
Gender All
Minimum Age 18 Years
Maximum Age 29 Years
Healthy Volunteers Accepts Healthy Volunteers
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+ Incidental recruitment of pregnant women may occur, but pregnancy is not part of the study's exclusion criteria Prisoners Pregnant women
Adult True
Child False
Older Adult False

Calculated Values

Sequence: 254153671
Number Of Facilities 3
Registered In Calendar Year 2022
Were Results Reported False
Has Us Facility True
Has Single Facility False
Minimum Age Num 18
Maximum Age Num 29
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30497188
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Health Services Research
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28863460
Responsible Party Type Principal Investigator
Name Sylvie Naar
Title Distinguished Endowed Professor
Affiliation Florida State University