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

Trial Summary

What is the purpose of this trial?

The investigators propose using an electronic adherence device that is basically a pill container that can alert when it is not opened at a scheduled time. The investigators will use this device to alert the medication user at the time when medication is supposed to be taken if the device did not get opened and a pre-identified social support person or case manager when 2 or 7 consecutive days of nonadherence are detected, respectively. The investigators call our approach "A-Team" (Antiretroviral Therapy Electronic Adherence Monitoring). The aims of this application are to determine the acceptability and feasibility of real-time adherence monitoring in support persons and case managers of African American Men who have sex with Men and to test this approach for these men in a 6-month randomized controlled trial among 54 of these men living with HIV and measure ART adherence and viral suppression (the primary outcome).

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 data supports the effectiveness of the A-TEAM treatment for HIV?

Research shows that using electronic monitoring devices can improve adherence to antiretroviral therapy, with one study noting an increase in adherence from 84% to 93% when real-time monitoring and follow-up were used. Additionally, technology-driven interventions, like electronic reminder devices, have been shown to significantly improve adherence in several studies, although more rigorous research is needed to confirm these findings. ^{1 2 3 4 5}

Is the Electronic Monitoring Device for HIV safe for humans?

The research does not provide specific safety data for the Electronic Monitoring Device itself, but it does not report any safety concerns related to its use in monitoring medication adherence among HIV patients. ^{2 6 7 8 9}

What makes the A-TEAM treatment unique for HIV?

The A-TEAM treatment is unique because it uses electronic monitoring devices to track when patients take their HIV medication, allowing for real-time interventions if doses are missed. This approach aims to improve adherence to antiretroviral therapy, which is crucial for controlling the virus and preventing progression to AIDS. ^{3 5 7 10 11}

Research Team

Mark Dworkin, MD

Principal Investigator

University of Illinois Chicago

Eligibility Criteria

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 am over 18 years old and have self-reported as HIV positive.

I own a working cell phone.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Real-time electronic adherence monitoring plus follow-up improves adherence compared with standard electronic adherence monitoring. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Use of electronic reminder devices to improve adherence to antiretroviral therapy: a systematic review. [2022]

4. Switzerland 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. [2020]

5. Canada pubmed.ncbi.nlm.nih.gov

Acceptability and Feasibility of Real-Time Antiretroviral Therapy Adherence Interventions in Rural Uganda: Mixed-Method Pilot Randomized Controlled Trial. [2023]

6. England 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. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Use of electronic monitoring devices to measure antiretroviral adherence: practical considerations. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

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

10. Canada 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. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Computer-assisted self-interviewing (CASI) to improve provider assessment of adherence in routine clinical practice. [2020]