Electronic Monitoring Device for HIV

(A-TEAM Trial)

Overseen By Anita Shaperd, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Illinois at Chicago

Must be taking: Antiretrovirals

Disqualifiers: Not meeting inclusion criteria, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

126 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new pill container designed to remind people with HIV to take their medicine on time. If the container remains unopened when expected, it sends alerts to the user and their support team, such as a friend or case manager. The goal is to determine if this reminder system, known as the A-TEAM (Antiretroviral Therapy Electronic Adherence Monitoring), helps individuals adhere to their medication schedule and maintain viral control. It is particularly suited for African American men who have sex with men, have been on HIV medication for at least six months, and have experienced challenges with medication adherence. Participants must have a working cell phone and a case manager who can join the study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking adherence tool.

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 it involves monitoring adherence to your existing HIV medication, it seems likely that you will continue your current treatment.

What prior data suggests that this electronic monitoring device is safe for use in HIV treatment adherence?

In a previous study, electronic monitors revealed that participants took their medication correctly 94% of the time, indicating adherence to their medication schedule. Only a few missed their medication for more than a week. Most participants found the monitors helpful and easy to use. No major safety issues were reported with these devices, confirming their safety and lack of harm. This trial aims to use the device to help individuals remember to take their HIV medication, which is crucial for controlling the virus. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the A-TEAM approach for HIV treatment adherence because it incorporates a novel use of technology and social support. Unlike standard antiretroviral therapies that rely on patients remembering to take their medication, the A-TEAM method actively monitors adherence with an electronic device. If the device detects missed doses, it immediately sends alerts to the patient and, if necessary, their support network, ensuring timely intervention. This proactive approach could significantly improve medication adherence and overall health outcomes for individuals living with HIV.

What evidence suggests that this electronic monitoring device is effective for improving ART adherence in HIV patients?

Research has shown that electronic tools, such as the A-TEAM approach being tested in this trial, can assist individuals in maintaining their antiretroviral therapy (ART) schedules. One study found that these digital tools helped over 75% of patients adhere to their treatment plans. Another study reported an average adherence rate of 94% among those using electronic monitors, with many users finding the devices very helpful. Additionally, research found that these tools significantly improved adherence compared to not using them. Overall, these findings suggest that the A-TEAM approach, which participants in this trial may receive, could help people living with HIV manage their treatment more effectively and potentially improve their health. ^{1 2 3 4 6}

Who Is on the Research Team?

Mark Dworkin, MD

Principal Investigator

University of Illinois Chicago

Are You a Good Fit for This Trial?

This trial is for African American men who have sex with men, over 18 years old, living with HIV and struggling with medication adherence. They must be on antiretroviral therapy (ART) for at least six months, own a cell phone, and have either a detectable viral load or self-reported poor adherence. A supportive case manager or person from their social circle also needs to participate.

Inclusion Criteria

I am over 18 years old.

I own a working cell phone.

I have a case manager ready to join the study with me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the A-TEAM intervention with real-time electronic adherence monitoring for 6 months

6 months

Monthly check-ins (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• A-TEAM

Trial Overview The 'A-Team' intervention uses an electronic pill container that alerts the user when it's time to take their medication and notifies a support person if doses are missed. The study will test its effectiveness in improving ART adherence and achieving viral suppression over six months in a randomized controlled trial.

How Is the Trial Designed?

Group I: A-TEAM Experimental Treatment 1 Intervention

This arm receives the A-TEAM approach where the men, their social support (if they have one), and their case manager participate. If the adherence device identifies non-opening of the device, the men are alerted by text or email the same day. If the device identifies non-opening of the device two days in a row, the social support (or case manager) is notified, and if 7 days of non-opening is detected, the case manager is notified.

Group II: Control Active Control 1 Intervention

The men are monitored with the adherence device but there is no intervention on their adherence - they otherwise experience routine care and they don't receive alerts if they the device detects non-openings.

A-TEAM is already approved in United States for the following indications:

Approved in United States as A-Team for:

• HIV treatment adherence support

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

A pilot study involving 63 individuals living with HIV in rural Uganda found that real-time adherence monitoring linked to SMS reminders is generally acceptable and perceived as beneficial for motivating medication adherence.

The intervention was technically feasible, with most participants successfully using the monitoring devices, although challenges such as confidentiality concerns and shared phone ownership were noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and Feasibility of Real-Time Antiretroviral Therapy Adherence Interventions in Rural Uganda: Mixed-Method Pilot Randomized Controlled Trial. Musiimenta, A., Atukunda, EC., Tumuhimbise, W., et al.[2023]

Adherence to HIV antiretroviral therapy is crucial for achieving viral load suppression and preventing progression to AIDS or death, highlighting the importance of effective adherence assessment.

Using computer-assisted self-interview technology can significantly improve the identification of medication errors and adherence monitoring, which may enhance the overall effectiveness of HIV treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-assisted self-interviewing (CASI) to improve provider assessment of adherence in routine clinical practice. Bangsberg, DR., Bronstone, A., Chesney, MA., et al.[2020]

The review analyzed 15 studies on electronic reminder devices (ERDs) aimed at improving adherence to antiretroviral therapy (ART) among people living with HIV/AIDS, finding that while some studies reported improved adherence, the overall evidence was inconclusive due to methodological limitations.

Patient satisfaction with ERDs was generally positive, but the impact of these devices on virological and immunological outcomes was inconsistent, highlighting the need for more rigorous research to determine their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of electronic reminder devices to improve adherence to antiretroviral therapy: a systematic review. Wise, J., Operario, D.[2022]

Switching from standard electronic adherence monitoring to real-time electronic adherence monitoring significantly improved antiretroviral therapy adherence among 112 participants, increasing from 84% to 93%.

This elevated adherence level was sustained for 6 months after the switch, indicating that real-time monitoring could be an effective strategy for enhancing treatment compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time electronic adherence monitoring plus follow-up improves adherence compared with standard electronic adherence monitoring. Haberer, JE., Musinguzi, N., Tsai, AC., et al.[2022]

In a study of 128 HIV-infected adults using electronic monitoring devices (EMDs) for their antiretroviral therapy, 36% reported inconsistent use, indicating potential challenges in adherence monitoring.

The findings suggest that EMDs may not accurately reflect true medication adherence, as many participants reported taking multiple doses at once or opening the device without taking the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of electronic monitoring devices to measure antiretroviral adherence: practical considerations. Bova, CA., Fennie, KP., Knafl, GJ., et al.[2006]

Cell phone-based technologies for HIV prevention and treatment have been developed to improve education, care linkage, and adherence to therapy, particularly in resource-limited settings.

Recent advancements include real-time adherence monitors combined with SMS reminders, and new methods like ingestion monitoring and metabolite detection to confirm adherence, highlighting the ongoing evolution and potential of these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cell Phone-Based and Adherence Device Technologies for HIV Care and Treatment in Resource-Limited Settings: Recent Advances. Campbell, JI., Haberer, JE.[2018]

The Disease Management Assistance System, a pocket-sized device, has been shown to improve adherence to antiretroviral therapy in HIV patients more effectively than traditional monthly educational sessions.

This device provides electronic reminders for medication timing and side effect monitoring, enhancing patient engagement and potentially leading to better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV adherence strategies take a high-tech route. Andrade, A.[2016]

Electronic medication monitoring-informed counseling significantly improved medication adherence among HIV patients, with a standardized mean difference of 0.51 based on 13 studies.

Patients receiving this counseling were 35% more likely to achieve undetectable HIV RNA levels compared to those who did not receive such counseling, indicating a positive impact on virologic treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic medication monitoring-informed counseling to improve adherence to combination anti-retroviral therapy and virologic treatment outcomes: a meta-analysis. Langebeek, N., Nieuwkerk, P.[2020]

A study involving interviews with 49 participants (34 healthcare administrators/clinicians and 15 ART clients) in Uganda found that low-cost electronic adherence monitors, combined with supportive interventions, are viewed positively and could enhance adherence to HIV treatment and improve clinical outcomes.

Key factors for successful implementation include addressing stigma, ensuring proper training, and evaluating the cost-effectiveness of the technology, with a need for coordination across the healthcare system and support from the Ministry of Health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Affecting the Implementation of Electronic Antiretroviral Therapy Adherence Monitoring and Associated Interventions for Routine HIV Care in Uganda: Qualitative Study. Haberer, JE., Garrison, L., Tumuhairwe, JB., et al.[2021]

Technology-driven interventions, including mobile phones and internet-based approaches, have shown significant effectiveness in improving adherence to antiretroviral therapy (ART) among individuals living with HIV, based on a review of 13 studies conducted between 2013 and 2015.

These technology-enhanced strategies not only support ART adherence but also lead to better clinical outcomes, highlighting their potential as a low-cost solution to manage the increasing demand for HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence for Technology Interventions to Promote ART Adherence in Adult Populations: a Review of the Literature 2012-2015. Amico, KR.[2022]

A participant in a trial showed over 99% adherence to antiretroviral treatment (ART) through self-reports, pill counts, and real-time medication monitoring (RTMM), yet died from cryptococcal meningitis, highlighting potential discrepancies in adherence measurements.

Despite high adherence rates, the participant maintained consistently high HIV viral loads, suggesting that adherence assessments alone are insufficient and should be combined with viral load monitoring for effective HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Returning of antiretroviral medication dispensed over a period of 8 months suggests non-adherence despite full adherence according to real time medication monitoring. Ngowi, KM., Masika, L., Lyamuya, F., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11236270/

The Effect of Real-Time Medication Monitoring-Based ... Our meta-analyses found that RTMM-based DATs did not have a significant effect on ART adherence and viral suppression.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2949916X24000306

Digital tools for improving antiretroviral adherence among ... Tools already integrated in antiretroviral therapy care have recorded over 75% adherence and treatment retention rate. •. User-friendliness, privacy, stigma ...

3. frontiersin.org frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2022.899643/full

Implementation of Electronic Adherence Monitors and ... Average adherence was 94%; four clients had adherence gaps >1 week. Acceptability was high; all but one client found the monitor "very useful” ...

4. bmcmedinformdecismak.biomedcentral.com bmcmedinformdecismak.biomedcentral.com/articles/10.1186/s12911-025-03106-4

Predicting antiretroviral therapy adherence status of adult HIV ... Adherence with Anti-Retroviral Therapy (ART) reduces viral load, as well as HIV-related morbidity and mortality.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4436806/

Electronic Medication Monitoring-Informed Counseling to ... A total of 13 studies were included. Adherence was significantly higher in intervention groups than in control groups (SMD 0.51, 95% CI 0.31–0.71). Patients in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10771872/

Electronic Antiretroviral Therapy Adherence Monitors and ... Abstract. Many adolescents and young adults with HIV (AYWH) struggle with antiretroviral therapy (ART) adherence and experience poorer outcomes than adults.