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| ID | Type | Description | Link |
|---|---|---|---|
| 1P01AA029547-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Florida | OTHER |
| University of Michigan | OTHER |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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 assigned to use an app called the eWrapper app that is a game app designed to promote engagement with the Skyn sensor via reciprocity and personalized feedback.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assigned to eWrapper App | Experimental | Participants will have access to the eWrapper app while wearing the Skyn sensor for 30 days. |
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| Not Assigned to eWrapper App | No Intervention | Participants will not have access to eWrapper app while wearing the Skyn sensor for 30 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eWrapper-Engagement strategies to facilitate alcohol biosensor wearing | Behavioral | The eWrapper app includes two engagement strategies (reciprocity and personalized feedback) and implements a micro-randomized trial (MRT) design to test whether the strategies work. |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement in Biosensor Wearing | The percentage of Skyn sensor wearing will be the primary outcome. We will calculate the percentage of time participants wear the sensor during the 30 days, and compare whether this differs between those who have access to the eWrapper vs. those who do not. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility/Acceptability of Biosensor Wearing | Survey adapted from the System Usability Scale (Brooke, 1986) will be used to assess participant perception of feasibility of wearing the alcohol biosensor. This survey was administered at the conclusion of the 30 day trial. Items in the System Usability Scale were measured on a five-point Likert scale from 1-strongly disagree to 5-strongly agree. The Mean score was calculated to form a total scale score, with a higher number indicating higher overall usability/acceptability. No subscale scores were calculated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Florida | Gainesville | Florida | 32611 | United States | ||
| Florida State University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41223419 | Derived | Carpenter SM, Case S, Lustria MLA, Marks LR, Yu Q, MacDonell K, Naar S, Wang Y. Feasibility of mHealth Strategies to Promote Use of Wrist-Worn Alcohol Biosensors Among Young Adults With HIV: Protocol for the Engage Microrandomized Trial. JMIR Res Protoc. 2025 Nov 12;14:e69966. doi: 10.2196/69966. |
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Of the 66 participants who consented and enrolled, only 39 completed the post baseline survey assessment onboarding session for the 30-day Skyn sensor use period, resulting in no group assignment for 27 consented participants.
Participants were recruited in Florida both virtually and through clinic partner sites. Recruitment began on February 1, 2023 and concluded on November 30, 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Assigned to eWrapper App | Participants in the eWrapper App intervention arm will have access to the eWrapper app while wearing the Skyn sensor 30 days. |
| FG001 | Not Assigned to eWrapper App |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 28, 2024 | Aug 30, 2025 |
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Participants at the beginning of the trial were not given the eWrapper engagement strategy. Once the eWrapper was fully developed, all participants were then assigned to the eWrapper arm to assess feasibility and acceptability of the eWrapper component.
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| 30 days |
| Feasibility/Accessibility of eWrapper | Survey adapted from the System Usability Scale (Brooke, 1986) will be used to assess participant perception of the eWrapper app. Survey is administered upon conclusion of 30 day trial. Items in the System Usability Scale were measured on a five-point Likert scale from 1-strongly disagree to 5-strongly agree. The Mean score was calculated to form a total scale score, with a higher number indicating higher overall usability/acceptability. No subscale scores were calculated. | 30 days |
| Tallahassee |
| Florida |
| 32310 |
| United States |
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
Participants in the non-intervention arm will not be assigned to have access to the eWrapper app while wearing the Skyn sensor for 30 days.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Assigned to eWrapper App | Participants in the eWrapper App intervention arm will have access to the eWrapper app while wearing the Skyn sensor 30 days. |
| BG001 | Not Assigned to eWrapper App | Participants in the non-intervention arm will not be assigned to have access to the eWrapper app while wearing the Skyn sensor for 30 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Engagement in Biosensor Wearing | The percentage of Skyn sensor wearing will be the primary outcome. We will calculate the percentage of time participants wear the sensor during the 30 days, and compare whether this differs between those who have access to the eWrapper vs. those who do not. | Of the 66 participants consented, Skyn sensor wearing data was only available for 39 participants. Total time deemed by the algorithm as wearing divided by maximum possible wearing time which is 24hours*30days. | Posted | Mean | Standard Deviation | percentage of time worn | 30 days |
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| Secondary | Feasibility/Acceptability of Biosensor Wearing | Survey adapted from the System Usability Scale (Brooke, 1986) will be used to assess participant perception of feasibility of wearing the alcohol biosensor. This survey was administered at the conclusion of the 30 day trial. Items in the System Usability Scale were measured on a five-point Likert scale from 1-strongly disagree to 5-strongly agree. The Mean score was calculated to form a total scale score, with a higher number indicating higher overall usability/acceptability. No subscale scores were calculated. | Of the 66 participants who consented, only 27 completed study activities and follow-up surveys. | Posted | Mean | Standard Deviation | score on a scale | 30 days |
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| Secondary | Feasibility/Accessibility of eWrapper | Survey adapted from the System Usability Scale (Brooke, 1986) will be used to assess participant perception of the eWrapper app. Survey is administered upon conclusion of 30 day trial. Items in the System Usability Scale were measured on a five-point Likert scale from 1-strongly disagree to 5-strongly agree. The Mean score was calculated to form a total scale score, with a higher number indicating higher overall usability/acceptability. No subscale scores were calculated. | Of the 66 participants, only 27 participants completed study activities. Of these 27, only 8 participants completed the SUS survey measure for this outcome. | Posted | Mean | Standard Deviation | score on a scale | 30 days |
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Adverse events were collected from the time of study enrollment through Day 30 (end of participant involvement). Participants were enrolled for 30 days; therefore, the adverse event reporting timeframe is 30 days.
No adverse events occurred
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Assigned to eWrapper App | Participants in the eWrapper App intervention arm will have access to the eWrapper app while wearing the Skyn sensor 30 days. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG001 | Not Assigned to eWrapper App | Participants in the non-intervention arm will not be assigned to have access to the eWrapper app while wearing the Skyn sensor for 30 days. | 0 | 27 | 0 | 27 | 0 | 27 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sylvie Naar, PhD; Contact MPI | Florida State University | 850-644-2334 | sylvie.naar@med.fsu.edu |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 23, 2026 | Feb 4, 2026 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 4, 2024 | Jul 3, 2025 | ICF_000.pdf |
| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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