Wrist Biosensor + mHealth App for HIV/AIDS

(SHARE Engage Trial)

No longer recruiting at 2 trial locations

Overseen By Yan Wang, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: Pregnant, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a wrist biosensor and mobile app designed to help people with HIV monitor their alcohol use. Participants will wear the sensor for 30 days and report their drinking habits using the app. The study also explores various methods to keep participants engaged, such as sending personalized feedback and messages (eWrapper-Engagement strategies to facilitate alcohol biosensor wearing). Individuals living in Florida, who have HIV, and have consumed alcohol in the past month may be suitable candidates. The goal is to identify effective strategies to encourage regular use of the alcohol biosensor. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance health monitoring for people with HIV.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on monitoring alcohol use with a wrist biosensor and app, so it's likely you can continue your medications, but you should confirm with the trial organizers.

What prior data suggests that this wrist biosensor and mHealth app are safe for use in this study?

Research has shown that wrist-worn alcohol biosensors, like those used in this trial, are generally safe for people. These devices continuously track alcohol use. Studies suggest that people usually find them comfortable, with no major side effects reported. However, removing the device can affect readings, so wearing it as instructed is important.

The eWrapper app enhances the biosensor experience by offering personalized feedback and messages. Although specific safety data for the app is not available, its purpose is to improve interaction with the biosensor, not to cause harm. It encourages consistent use of the biosensor and provides helpful feedback.

In summary, both the biosensor and the app are considered safe based on current research and are well-tolerated in similar studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to supporting individuals with HIV/AIDS who struggle with alcohol use. Unlike traditional treatments that focus on counseling or medication, this trial uses a wrist biosensor paired with a mobile health app to monitor alcohol consumption. This technology provides real-time data and personalized feedback, which can enhance engagement and compliance. By utilizing micro-randomization to deliver targeted messages, the approach aims to improve adherence to wearing the biosensor and ultimately support healthier lifestyle choices. This method represents a promising shift towards integrating technology with personalized healthcare strategies.

What evidence suggests that this wrist biosensor and mHealth app are effective for promoting engagement in alcohol monitoring for HIV/AIDS?

Research shows that technology can help people with HIV reduce alcohol consumption. One study found that participants who wore devices to track their alcohol use drank less over time. In this trial, the eWrapper app employs methods such as giving back and personalized feedback to maintain user engagement. Early results suggest these methods encourage regular use of the tracking device, aiding in monitoring and reducing alcohol intake. This approach could enhance health by promoting better tracking and reducing harmful drinking habits. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for young people living with HIV in Florida, aged 18-29, who have had a drink in the last month. They must understand English, be able to give informed consent, and have internet access. It's not for prisoners, those unable to consent or individuals without an HIV diagnosis.

Inclusion Criteria

I have been diagnosed with HIV.

Have internet access via smartphone, tablet or computer

Currently reside in Florida

Exclusion Criteria

You are pregnant.

I am unable to give consent for medical procedures.

Women who are pregnant may participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear a wrist alcohol biosensor and report alcohol use using an EMA app for 30 days. A subset is micro-randomized to test engagement strategies.

4 weeks

Follow-up

Participants are monitored for alcohol biomarker (PEth) at 1-month follow-up.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• eWrapper-Engagement strategies to facilitate alcohol biosensor wearing

Trial Overview Participants will wear a wrist alcohol biosensor for a month and use an app to report their drinking. The study tests if 'reciprocity' (exchanging things with others) and personalized feedback through the app can increase engagement with the biosensor.

How Is the Trial Designed?

Group I: Engagement in biosensor wearing Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11137611

Technology-based assessments and intervention to reduce alcohol ... The majority of persons with HIV (PWH) in the US consume alcohol, despite that alcohol use is associated with lower levels of HIV care engagement and HIV viral ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05431855/project-engage-a-wrist-biosensor-based-mhealth-suite-to-support-alcohol-intervention-in-young-people-living-with-hiv

A Wrist Biosensor-based mHealth Suite to Support Alcohol ... A subset of the sample will be micro-randomized to test two engagement strategies--reciprocity and personalized feedback via the eWrapper app to ...

3. researchgate.net researchgate.net/publication/319602484_ewrapper_Operationalizing_engagement_strategies_in_mHealth

(PDF) ewrapper: Operationalizing engagement strategies ... Although accumulating research has documented the effectiveness of couple-based interventions in reducing HIV/STIs, it remains unclear ...

4. humanfactors.jmir.org humanfactors.jmir.org/2025/1/e64664/

Use of Wearable Transdermal Alcohol Sensors for Monitoring ... There was a high TAS return rate (28/29, 97% of the participants returned the TAS). Secondary outcomes suggest that the BACtrack Skyn remains an ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11155371/

Integrating Alcohol Biosensors With Ecological Momentary ... The pilot trial (N = 41) they conducted showed promising effectiveness that participants showed decline in all alcohol use outcomes over the 4- ...

6. nature.com nature.com/articles/s41598-025-16640-y

Development of an alcohol biosensor non-wear algorithm Wrist-worn alcohol biosensors can continuously track alcohol consumption, but their measurements are disrupted when the device is removed.

7. reporter.nih.gov reporter.nih.gov/search/wItxCdfPr0mvoJud-kQx2g/project-details/11137611

Project Details - NIH RePORTER The EM group will wear a wrist alcohol biosensor, report alcohol and other risk factors (e.g., real-time anxiety, depression) and ART adherence through an ...