HIVSHARE EngageNCT05431855
Project Engage: A Wrist Biosensor-based mHealth Suite to Support Alcohol Intervention in Young People Living With HIV
A study testing eWrapper-Engagement strategies to facilitate alcohol biosensor wearing in people with HIV, run by Florida State University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- HIV
- What is being tested?
- eWrapper-Engagement strategies to facilitate alcohol biosensor wearing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 2023to 12 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Adults unable to consent
- Individuals who are not yet adults
- Individuals who are not diagnosed as HIV+
- Prisoners
- Pregnant women
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The University of Michigan
Ann Arbor, Michigan, 48109
The University of Florida
Gainesville, Florida, 32611
Florida State University
Tallahassee, Florida, 32310
About this study
Official title: Self-management of HIV and Alcohol Reaching Emerging Adults: Project Engage
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.
Read the 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.
- Conditions
- HIV
- Being tested
- eWrapper-Engagement strategies to facilitate alcohol biosensor wearing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eWrapper-Engagement strategies to facilitate alcohol biosensor wearingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Assigned to eWrapper App | Experimental | Participants will have access to the eWrapper app while wearing the Skyn sensor for 30 days. Receives: Behavioral: eWrapper-Engagement strategies to facilitate alcohol biosensor wearing |
| Not Assigned to eWrapper App | No intervention | Participants will not have access to eWrapper app while wearing the Skyn sensor for 30 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (2)
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.
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Feb 2023
- Primary completion12 Feb 2025
- Study completion12 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida, University of Michigan, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Sylvie Naar, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431855
- Sponsor's protocol ID
- STUDY00002534
- Other IDs
- 1P01AA029547-01
- Acronym
- SHARE Engage
- Status last verified
- Mar 2026
- First submitted
- 21 Jun 2022
- Last updated
- 5 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41223419
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-management of HIV and Alcohol Reaching Emerging Adults: Project Engage
- ClinicalTrials.gov ID
- NCT05431855
- Acronym / sponsor ID
- SHARE Engage / STUDY00002534
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- University of Florida, University of Michigan, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 24 Jun 2022 (actual)
- Results
- Posted 5 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Assigned to eWrapper App | Experimental | Behavioral: eWrapper-Engagement strategies to facilitate alcohol biosensor wearingParticipants will have access to the eWrapper app while wearing the Skyn sensor for 30 days. |
| Not Assigned to eWrapper App | No intervention | –Participants will not have access to eWrapper app while wearing the Skyn sensor for 30 days. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- Adults unable to consent
- Individuals who are not yet adults
- Individuals who are not diagnosed as HIV+
- Prisoners
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eWrapper-Engagement strategies to facilitate alcohol biosensor wearingThe eWrapper app includes two engagement strategies (reciprocity and personalized feedback) and implements a micro-randomized trial (MRT) design to test whether the strategies work. | Behavioural | Assigned to eWrapper App |
Primary outcome
Engagement in Biosensor Wearing
Time frame: 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.
2 secondary outcomes
Feasibility/Acceptability of Biosensor Wearing
Time frame: 30 days
Feasibility/Accessibility of eWrapper
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41223419Carpenter 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eWrapper-Engagement strategies to facilitate alcohol biosensor wearing in people with HIV, run by Florida State University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement in Biosensor Wearing (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05431855, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.