mHealth + Counseling for Alcoholism

Recruiting at 1 trial location

Overseen By Emmely Pavila

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Psychiatric conditions, Alcohol withdrawal, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to help people with HIV reduce alcohol consumption using mobile health tools (mHealth Tools). Participants will use devices like a smartphone breathalyzer and a wrist biosensor to monitor alcohol use. The study aims to determine if these tools, combined with support and incentives, can effectively reduce alcohol intake. Individuals with HIV who frequently use alcohol, speak English, and are willing to try these devices for at least 30 days may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance health outcomes 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 focuses on alcohol use reduction and does not mention any medication restrictions.

What prior data suggests that these mHealth tools are safe for use in alcohol reduction among people living with HIV?

Research has shown that mobile health (mHealth) tools, such as smartphone apps and wearable devices, are generally safe for tracking alcohol use. These tools include small breathalyzers and wristbands that monitor alcohol levels without causing harm.

Studies have found that these devices provide accurate and clear information about alcohol consumption. The portable breathalyzer is a small gadget that quickly and reliably measures alcohol levels. Wristbands, worn like a watch, collect alcohol data throughout the day. Although wristband data might be slightly delayed compared to other methods, they remain useful for monitoring.

Overall, users widely accept these mHealth tools, and they have not been linked to any major side effects. They are primarily used for monitoring, with no evidence suggesting they pose risks to users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for alcoholism because they harness the power of technology in a unique way. Unlike traditional treatments like counseling or medication, these methods use mHealth tools, such as wrist biosensors and smartphone breathalyzer readings, to provide real-time feedback and motivation. This tech-driven approach allows for immediate behavior tracking and personalized encouragement, which could lead to more engaged and consistent efforts to reduce drinking. By integrating technology with behavioral support, this trial aims to find out if a more interactive and responsive approach can boost treatment success rates.

What evidence suggests that mHealth tools and counseling could be effective for reducing alcohol use in people living with HIV?

Research shows that mobile health tools, such as smartphone breathalyzers and wrist-worn alcohol sensors, can help reduce drinking. In this trial, participants in various treatment arms will use these devices to regularly and accurately monitor their alcohol use, supporting efforts to drink less. Studies suggest that these wearable devices are practical for tracking alcohol use and encouraging habit changes. Although not every mobile health tool shows strong results, many have helped lower alcohol intake. These tools are especially promising for people with HIV, as they can help manage health risks related to alcohol. ^{1 6 7 8 9}

Who Is on the Research Team?

Robert Leeman, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for people living with HIV who frequently drink heavily, are willing to try not drinking for at least 30 days, and then reduce their alcohol use. They must be comfortable using smartphone apps and a wrist sensor to monitor their drinking. Those with severe psychiatric conditions, current alcohol withdrawal symptoms, or recent intensive addiction treatment are excluded.

Inclusion Criteria

Willingness to use smartphone applications and biosensor devices (i.e., breathalyzer device and wrist sensor) for alcohol use reduction purposes in the study. If participants do not have a compatible smartphone to use, they will be loaned one by the study

HIV positive

Fluency in English

Exclusion Criteria

Currently seeking or past-12-month history of inpatient or intensive treatment for addictive behaviors

I am not pregnant, nursing, and I use reliable birth control.

Psychiatric conditions that would interfere with participation in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants engage in daily Contingency Management using a smartphone breathalyzer for 30 days

4 weeks

Daily virtual interactions

Treatment Phase 2

Participants engage in weekly Contingency Management using a wrist biosensor for an additional 30 days

4 weeks

Weekly virtual interactions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Periodic virtual check-ins

What Are the Treatments Tested in This Trial?

Interventions

• Counseling
• mHealth Tools

Trial Overview The study tests mobile health tools—a smartphone breathalyzer app and a wrist-worn alcohol biosensor—to encourage less drinking among participants over a period of up to six months. The goal is to see if these mHealth innovations can help reduce alcohol consumption in individuals living with HIV.

How Is the Trial Designed?

Group I: mHealth and CM Experimental Treatment 2 Interventions

Participants will wear a wrist biosensor with daily CM based on smartphone breathalyzer readings for 30 days; then for a second 30 days, weekly CM based on wrist biosensor readings. Participants will also interact with a mobile health application to facilitate drinking reduction.

Group II: Non-Contingent Condition Experimental Treatment 1 Intervention

Participants will wear a wrist biosensor with daily CM based on smartphone breathalyzer readings for 30 days; then for a second 30 days, encouragement to reduce drinking but payment not based on drinking.

Group III: CM Experimental Treatment 1 Intervention

Participants will wear a wrist biosensor with daily CM based on smartphone breathalyzer readings for 30 days; then for a second 30 days, weekly CM based on wrist biosensor readings

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Florida State University

Collaborator

Trials

234

Recruited

41,100+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

University of Louisville

Collaborator

Trials

353

Recruited

76,400+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

This study evaluates the effectiveness of a wireless breathalyzer in conjunction with long-term treatment for alcohol use disorder, focusing on its impact on dropout rates, psychological distress, treatment motivation, and quality of life over a 3-month period with follow-up.

The randomized clinical trial will compare outcomes between participants with access to the wireless breathalyzer and those without, aiming to determine if ongoing monitoring can improve treatment adherence and reduce the need for higher levels of follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Effectiveness of a Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality: Protocol for a Randomized Controlled Trial. Buono, FD., Gleed, C., Boldin, M., et al.[2022]

In a pilot study with six participants over 9 weeks, the use of a smartphone app and breathalyzer significantly increased the submission of alcohol-negative breathalyzer samples during the contingency management phase (49%) compared to the noncontingent phases (27%), indicating the potential efficacy of this intervention.

Participants reported mixed usability experiences with the app, highlighting some technical issues, which suggests that while the technology shows promise for managing alcohol use, improvements in usability are needed for better user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study of an Integrated Smartphone and Breathalyzer Contingency Management Intervention for Alcohol Use. Oluwoye, O., Reneau, H., Herron, J., et al.[2022]

A smartphone application designed to help reduce unhealthy alcohol use was found to be acceptable and useful among 130 adults, with significant reductions in weekly drinking (from 15.0 to 10.9 drinks/week) and binge drinking (from 95.4% to 64.3%) after 3 months.

Participants who used the application more than once reported a 30% reduction in weekly alcohol consumption, indicating that increased engagement with the app may lead to better drinking outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone application for unhealthy alcohol use: A pilot study. Bertholet, N., Daeppen, JB., McNeely, J., et al.[2022]

A survey of 139 participants showed strong interest in using a mobile health application that monitors blood alcohol concentration (BAC) through gait analysis, indicating potential for reducing risky drinking behaviors.

Participants expressed a desire for control over app features, with adults preferring the option to disable BAC monitoring, while females favored mandatory notifications and safety features, highlighting the importance of user preferences in app design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User-centered preferences for a gait-informed alcohol intoxication app. Borges, A., Caviness, C., Abrantes, AM., et al.[2023]

The study involving 379 college students showed that a smartphone app combined with Brief Motivational Interviewing (BMI) effectively reduced alcohol consumption and related consequences, particularly in voluntary participants.

In a controlled trial, participants using the app had a decrease in peak Blood Alcohol Concentration (BAC) compared to those receiving only in-person BMI, highlighting the app's potential as a beneficial tool for alcohol intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Theory-Based mHealth Intervention for High-Risk Drinking in College Students. Kazemi, DM., Borsari, B., Levine, MJ., et al.[2021]

The study demonstrated that BACtrack Skyn wearable alcohol monitors are feasible and acceptable for use among college students, with all participants successfully using the devices over a 5 to 7-day period, generating a total of 11,504 hours of transdermal alcohol content (TAC) data.

Participants reported high levels of satisfaction with the monitors, achieving a mean score of 4.3 out of 5 on both the Feasibility of Intervention Measure and the Acceptability of Intervention Measure, indicating strong potential for these devices in alcohol research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable alcohol monitors for alcohol use data collection among college students: Feasibility and acceptability. Rosenberg, M., Kianersi, S., Luetke, M., et al.[2023]

A review identified six smartphone apps aimed at reducing alcohol consumption or treating alcohol use disorder (AUD), with only two apps (A-CHESS and LBMI-A) showing self-reported reductions in alcohol use.

The study highlights a significant gap in the evaluation of these apps, indicating that while smartphone technology has potential for aiding individuals with AUD, more rigorous testing is needed to confirm their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone applications to reduce alcohol consumption and help patients with alcohol use disorder: a state-of-the-art review. Meredith, SE., Alessi, SM., Petry, NM.[2022]

A study involving 99 young adults showed that using mobile health technologies, like a smartphone breathalyzer and a BAC estimator app, was feasible and well-accepted for moderating drinking habits.

Participants reported a significant reduction in alcohol consumption during a 2-week field test, using the technologies on 67% of drinking days, suggesting these tools may help reduce heavy drinking among young adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A combined laboratory and field test of a smartphone breath alcohol device and blood alcohol concentration estimator to facilitate moderate drinking among young adults. Leeman, RF., Berey, BL., Frohe, T., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9498895/

Leveraging mHealth and Wearable Sensors to Manage ... Conclusion: While not all mHealth interventions demonstrated statistically significant reduction in alcohol consumption, most are still ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12159286/

Current approaches using remote monitoring technology in ... Portable breathalyzers are compact devices that allow frequent alcohol monitoring by providing objective measures of alcohol consumption at ...

3. papers.ssrn.com papers.ssrn.com/sol3/Delivery.cfm/5267566.pdf?abstractid=5267566&mirid=1

Data-Driven Detection of Alcohol Abuse ... Our systematic review highlights the strong feasibility of using wearable devices and biosensors to monitor alcohol consumption and support intervention efforts ...

4. research.bactrack.com research.bactrack.com/wp-content/uploads/2022/04/Yan-Wang-et-al-Wrist-worn-alcohol-biosensors-Applications-and-usability-in-behavioral-research.pdf

Wrist-worn alcohol biosensors Wrist-worn alcohol biosensor technology has developed rapidly in recent years. These devices are light, easy to wear, relatively inexpensive, and resemble ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2021.642813/pdf

A Review of Wearable Biosensors in Alcohol Use Disorder ... Broadly known as digital health, this area of research explores the use of mobile and computer software applications and wearable biosensor.

6. withpower.com withpower.com/trial/phase-alcohol-drinking-2022-4061d

mHealth + Counseling for Alcoholism The mHealth + Counseling treatment for alcoholism is unique because it uses mobile health tools like smartphone apps and wearable devices to monitor alcohol use ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9362858/

Wrist-worn alcohol biosensors: Applications and usability ... Data from alcohol biosensors can be used to provide objective data on alcohol use in near real-time, although TAC often lags behind the blood or breath alcohol ...

8. academic.oup.com academic.oup.com/alcalc/article-pdf/60/4/agaf032/63473591/agaf032.pdf

Current approaches using remote monitoring technology in ... Included studies focused on the implementation of digital health tools for remote alcohol consumption monitoring or related outcomes in real-world settings, ...

9. humanfactors.jmir.org humanfactors.jmir.org/2025/1/e64664/PDF

Use of Wearable Transdermal Alcohol Sensors for ... Secondary outcomes suggest that the BACtrack Skyn remains an accurate tool to monitor alcohol consumption compared to self-report data and that ...