HIV
Conditions
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. 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.
Detailed 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 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.
Interventions
BEHAVIORALeWrapper-Engagement strategies to facilitate alcohol biosensor wearing
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.
Sponsors
Florida State University
University of Florida
University of Michigan
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Engagement in Biosensor Wearing | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility/Acceptability of Biosensor Wearing | 30 days | 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. |
| Feasibility/Accessibility of eWrapper | 30 days | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited in Florida both virtually and through clinic partner sites. Recruitment began on February 1, 2023 and concluded on November 30, 2024.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants |
| Age, Continuous | 26.7 Years STANDARD_DEVIATION 2.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 27 |
| other Total, other adverse events | 0 / 12 | 0 / 27 |
| serious Total, serious adverse events | 0 / 12 | 0 / 27 |
Outcome results
None listed