Smartwatch + App Monitoring for Medication Adherence in HIV

(USE-MI Trial)

Overseen By Jacob Karr

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Swedish Medical Center

Must be taking: ART, PrEP

Disqualifiers: Supervised setting, Non-English proficiency, others

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

Compensation: Varies

Number of Visits: 13

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartwatch and app system, the USE-MI System (Unobtrusive Sensing of Medication Intake System), to determine if it can help people with HIV remember to take their medications. The system monitors medication intake and sends reminders if someone forgets. People with HIV who manage their own medications, or those at risk and taking preventive meds, may be suitable if they can visit the research office monthly. The study examines whether this technology can support better medication habits. As an unphased trial, it offers a unique opportunity to contribute to innovative technology that could enhance medication adherence for many.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, since the study aims to monitor medication adherence, it seems likely that you will continue taking your current HIV-related medications.

What prior data suggests that the USE-MI system is safe for monitoring medication adherence?

Research shows that the USE-MI system helps people remember to take their HIV medications using a smartwatch and smartphone app. This system tracks when medications are taken and sends reminders if a dose is missed.

Although specific safety data for the USE-MI system is not available, similar technologies, like ingestible sensor systems, have been well received by participants in other studies. These systems have been linked to better medication adherence and improved health outcomes for people with HIV.

Since the USE-MI system is primarily a digital tool, it does not involve taking new medicines, suggesting a low risk for side effects. Participants in studies using similar technology reported positive experiences, indicating good safety and acceptance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The USE-MI System is unique because it integrates a smartwatch and smartphone app to monitor medication adherence for HIV patients. Unlike traditional methods that rely on self-reporting or pill counts, this system provides real-time data and reminders to ensure patients take their medication as prescribed. Researchers are excited about the potential of the USE-MI System to improve medication adherence, which is crucial for managing HIV effectively and preventing viral resistance. This innovative approach could lead to better health outcomes by empowering patients with a user-friendly and accessible tool.

What evidence suggests that the USE-MI system is effective for monitoring medication adherence in HIV?

Research has shown that the USE-MI system, which includes a smartwatch and smartphone app, can help people with HIV remember to take their medications. Studies highlight the importance of taking HIV medications regularly to control the virus. Many people struggle to take their medicine on time, which can cause the virus to become more active. Participants in this trial will use the USE-MI system, which sends reminders and tracks medication intake. Early evidence suggests that systems like this can improve adherence, increasing the likelihood of taking medicine as prescribed. This could lead to better health outcomes for those living with HIV. ^{1 2 3 6 7}

Who Is on the Research Team?

Barry Saver, MD

Principal Investigator

Swedish Medical Center

Jenna Marquard, PhD

Principal Investigator

University of Massachusetts, Amherst

Are You a Good Fit for This Trial?

This trial is for individuals with HIV on antiretroviral therapy (ART) or those at risk taking PrEP. Participants must manage their own medication, use pill bottles the USE-MI system can monitor, speak English reasonably well, and attend monthly follow-ups.

Inclusion Criteria

I am HIV positive and on ART, or at risk for HIV and taking PrEP.

Taking medications from pill bottles or other containers that the USE-MI system can monitor properly

Reasonable proficiency in English

Exclusion Criteria

Not responsible for taking their own HIV medications (e.g. residing in a supervised setting where their medications are administered to them)

Taking medications using a method that the USE-MI system cannot monitor properly

Lacking proficiency in English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Phase

Initial testing of the USE-MI system with 10 subjects for feedback

1 month

1 visit (in-person)

Main Evaluation Phase

Up to 50 subjects use the USE-MI system to assess accuracy, robustness, and acceptability

6 months

6 visits (monthly, in-person)

Follow-up

Participants are monitored for system acceptability and medication adherence

6 months

6 visits (monthly, in-person)

What Are the Treatments Tested in This Trial?

Interventions

• USE-MI System

Trial Overview The USE-MI study tests a new system combining a smartwatch and smartphone app designed to track when patients take their HIV medications and remind them if they forget, aiming to improve medication adherence in real-time.

How Is the Trial Designed?

Group I: USE-MI System Experimental Treatment 1 Intervention

Immediate use of the USE-MI smartwatch and smartphone app.

Who Is Running the Clinical Trial?

Swedish Medical Center

Lead Sponsor

Trials

55

Recruited

8,500+

University of Massachusetts, Amherst

Collaborator

Trials

83

Recruited

3,474,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A study involving 17 individuals with and at-risk for HIV revealed that most participants (67%) preferred a sensor-based system that provides real-time feedback on their medication adherence, indicating a strong interest in technology to support their health.

Participants expressed a desire to share adherence data with their physicians (69%), highlighting the potential for improved communication and monitoring in HIV treatment through user-friendly technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing a wrist-worn sensor to improve medication adherence: accommodating diverse user behaviors and technology preferences. Marquard, JL., Saver, B., Kandaswamy, S., et al.[2022]

A pilot study involving 15 people living with HIV (PLWH) and 6 healthcare providers (HCPs) explored their perceptions of a digital medicine program (DMP) that uses ingestible sensors to monitor medication adherence.

Responses to the DMP were mixed, revealing both benefits and challenges, which suggests that understanding the experiences of PLWH is crucial for improving adherence technologies and patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of People Living with HIV and HIV Healthcare Providers on Real-Time Measuring and Monitoring of Antiretroviral Adherence Using Ingestible Sensors: A Qualitative Study. Kamal, S., Rosen, MI., Lazar, C., et al.[2022]

A study involving 26 people living with HIV showed that using a smartphone app to report on antiretroviral therapy (ART) adherence and substance use was highly feasible, with participants completing 95.3% of daily reports over 14 days.

Participants expressed high satisfaction with the app and a willingness to use smartphones for future health behavior reporting, indicating that mobile technology could be a valuable tool for monitoring ART adherence and substance use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of a Smartphone App for Daily Reports of Substance Use and Antiretroviral Therapy Adherence among HIV-Infected Adults. Przybyla, SM., Eliseo-Arras, RK., Krawiec, G., et al.[2022]

In a study of 120 HIV-infected patients in China, real-time reminders and counseling based on electronic adherence data significantly improved antiretroviral therapy (ART) adherence, with 87.3% of intervention participants achieving optimal adherence compared to 51.8% in the control group.

Among those who were initially suboptimal adherers, 78.3% in the intervention group reached optimal adherence, demonstrating that targeted reminders can effectively enhance medication compliance in chronic disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Adherence to Antiretroviral Therapy With Triggered Real-time Text Message Reminders: The China Adherence Through Technology Study. Sabin, LL., Bachman DeSilva, M., Gill, CJ., et al.[2022]

The WiseApp trial is testing a mobile health technology designed to improve adherence to antiretroviral therapy (ART) among underserved individuals living with HIV in New York City, with 200 participants followed for 6 months.

The app features real-time medication monitoring and personalized support, which may help patients manage their treatment better and prevent drug resistance, making it a promising tool for enhancing HIV self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol of the randomized control trial: the WiseApp trial for improving health outcomes in PLWH (WiseApp). Flynn, G., Jia, H., Reynolds, NR., et al.[2021]

The study found that daily self-reports via smartphone app showed good reliability and validity when compared to 14-day recall web-surveys in people living with HIV, particularly for physical and mental health quality-of-life and antiretroviral adherence.

However, the reliability for detailed sexual encounter surveys was lower, indicating potential biases in reporting sensitive behaviors like unprotected sex and alcohol use, suggesting that event-based reporting may help improve accuracy in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability and validity of daily self-monitoring by smartphone application for health-related quality-of-life, antiretroviral adherence, substance use, and sexual behaviors among people living with HIV. Swendeman, D., Comulada, WS., Ramanathan, N., et al.[2021]

In a study of 225 participants taking antiretroviral therapy and HIV pre-exposure prophylaxis, 13% reported adherence rates below 90%, with younger age and clinic sample being associated factors.

Participants using mediset devices had significantly better adherence rates compared to those using pill bottles, while those using blister packs and pill rolls had worse adherence, indicating that the type of medication management system can impact adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Art and PrEP Adherence and Medication-Taking Practices and Preferences to Inform Development of a Wrist-Worn Adherence System. Stekler, JD., Scanlan, JM., Simoni, JM., et al.[2020]

A 16-week pilot study involving 15 HIV-infected individuals demonstrated that a co-encapsulated pill sensor system effectively monitored pill ingestion in real-time, with 80% of participants completing follow-up through 8 weeks.

The majority of participants found the system comfortable and helpful, with 75% reporting the patch was comfortable and only 10-15% not finding the text message reminders useful, indicating good acceptability of the monitoring system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Time and Wireless Assessment of Adherence to Antiretroviral Therapy With Co-Encapsulated Ingestion Sensor in HIV-Infected Patients: A Pilot Study. Daar, ES., Rosen, MI., Wang, Y., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03571022?tab=history&a=3

Record History | ver. 3: 2018-11-08 | NCT03571022 The purpose of this study is to test the USE-MI system hardware and software to see if it can accurately measure when subjects take their HIV-related ...

2. providence.elsevierpure.com providence.elsevierpure.com/en/projects/unobtrusive-sensing-of-medication-intake-use-mi

Unobtrusive Sensing of Medication Intake (USE-MI) HIV treatment and PrEP require high levels of medication adherence sustained over many years to achieve optimal outcomes. Research on interventions to improve ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6241509/

Designing a wrist-worn sensor to improve medication ... In this study of persons taking HIV-related medications, many reported taking fewer than 90% of their pills in the previous 4 weeks (>90% is considered good) ...

4. thelancet.com thelancet.com/journals/ebiom/article/PIIS2352-3964(22)00512-6/fulltext

Ingestible sensor system for measuring, monitoring and ... The IS system was well accepted by participants and its use was associated with improved adherence and lower HIV RNA VL. The findings provide a ...

5. clinconnect.io clinconnect.io/trials/NCT03571022

Unobtrusive Sensing of Medication Intake ("USE-MI") The purpose of this study is to test the USE-MI system hardware and software to see if it can accurately measure when subjects take their HIV-related ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9782816/

Ingestible sensor system for measuring, monitoring and ... The IS system was well accepted by participants and its use was associated with improved adherence and lower HIV RNA VL.

7. thieme-connect.com thieme-connect.com/products/ejournals/abstract/10.1055/a-2148-8036?device=mobile&id=&lang=en

Thieme E-Books & E-Journals - ... use patient-generated health data to: (1) improve hypertension control and (2) measure and improve adherence to HIV-related medications. Methods CONDUIT-HID ...