Trial Outcomes & Findings for Project Engage: A Wrist Biosensor-based mHealth Suite to Support Alcohol Intervention in Young People Living With HIV (NCT NCT05431855)
NCT ID: NCT05431855
Last Updated: 2026-03-05
Results Overview
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.
COMPLETED
NA
66 participants
30 days
2026-03-05
Participant Flow
Participants were recruited in Florida both virtually and through clinic partner sites. Recruitment began on February 1, 2023 and concluded on November 30, 2024.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
27
|
|
Overall Study
COMPLETED
|
10
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Project Engage: A Wrist Biosensor-based mHealth Suite to Support Alcohol Intervention in Young People Living With HIV
Baseline characteristics by cohort
| Measure |
Not Assigned to eWrapper App
n=27 Participants
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.
|
Total
n=39 Participants
Total of all reporting groups
|
Assigned to eWrapper App
n=12 Participants
Participants in the eWrapper App intervention arm will have access to the eWrapper app while wearing the Skyn sensor 30 days.
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=35 Participants
|
39 Participants
n=76 Participants
|
12 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=41 Participants
|
|
Age, Continuous
|
26.8 Years
STANDARD_DEVIATION 2.7 • n=35 Participants
|
26.7 Years
STANDARD_DEVIATION 2.5 • n=76 Participants
|
26.6 Years
STANDARD_DEVIATION 2.3 • n=41 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=35 Participants
|
3 Participants
n=76 Participants
|
1 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=35 Participants
|
36 Participants
n=76 Participants
|
11 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=35 Participants
|
15 Participants
n=76 Participants
|
4 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=35 Participants
|
24 Participants
n=76 Participants
|
8 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=35 Participants
|
13 Participants
n=76 Participants
|
5 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=35 Participants
|
17 Participants
n=76 Participants
|
5 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=35 Participants
|
5 Participants
n=76 Participants
|
2 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=35 Participants
|
4 Participants
n=76 Participants
|
0 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=35 Participants
|
39 participants
n=76 Participants
|
12 participants
n=41 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: 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.
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.
Outcome measures
| Measure |
Assigned to eWrapper App
n=12 Participants
Participants in the eWrapper App intervention arm will have access to the eWrapper app while wearing the Skyn sensor 30 days.
|
Not Assigned to eWrapper App
n=27 Participants
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.
|
|---|---|---|
|
Engagement in Biosensor Wearing
|
20.6 percentage of time worn
Standard Deviation 25.5
|
25.0 percentage of time worn
Standard Deviation 33.4
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Of the 66 participants who consented, only 27 completed study activities and follow-up surveys.
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.
Outcome measures
| Measure |
Assigned to eWrapper App
n=10 Participants
Participants in the eWrapper App intervention arm will have access to the eWrapper app while wearing the Skyn sensor 30 days.
|
Not Assigned to eWrapper App
n=17 Participants
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.
|
|---|---|---|
|
Feasibility/Acceptability of Biosensor Wearing
|
3.3 score on a scale
Standard Deviation 0.70
|
3.1 score on a scale
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Of the 66 participants, only 27 participants completed study activities. Of these 27, only 8 participants completed the SUS survey measure for this outcome.
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.
Outcome measures
| Measure |
Assigned to eWrapper App
n=8 Participants
Participants in the eWrapper App intervention arm will have access to the eWrapper app while wearing the Skyn sensor 30 days.
|
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.
|
|---|---|---|
|
Feasibility/Accessibility of eWrapper
|
3.4 score on a scale
Standard Deviation 0.60
|
—
|
Adverse Events
Assigned to eWrapper App
Not Assigned to eWrapper App
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place