Ingestible Sensor System for HIV/AIDS

(Sensor-SBDOH Trial)

Overseen By Yilan Huang, M.S.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, Los Angeles

Must be taking: Antiretrovirals

Disqualifiers: Mental confusion, Pregnancy, others

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

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

Compensation: Varies

Number of Visits: 28

Duration: 20 weeks

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people with HIV adhere to their medication routine. It employs a special sensor system that tracks pill intake and sends reminders, targeting those who frequently miss doses due to challenges like unstable housing or substance use. Participants will be divided into two groups: one using the Integrated Intervention with a Pill Ingestible Sensor System and extra support, and the other receiving regular care. The study seeks individuals with HIV who are on specific HIV medications and struggle with consistent medication adherence. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in HIV care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires participants to be on specific antiretroviral treatments (ART) like Truvada, Descovy, or Biktarvy, among others. If you are already on one of these, you may not need to change your medication.

What prior data suggests that this ingestible sensor system is safe for humans?

Research has shown that the FDA has already approved the ingestible sensor system as safe for use in other conditions, suggesting it is likely safe. Although it hasn't been tested specifically in people with HIV, other studies indicate that most people are satisfied with it and tolerate it well. One study found no major difference in treatment adherence, meaning the system didn't cause significant problems. This evidence suggests that the treatment is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Ingestible Sensor System for HIV/AIDS because it represents a novel way to monitor medication adherence using technology. Unlike current treatments that rely solely on patient reporting or periodic blood tests, this system uses an ingestible sensor to provide real-time data on when medication is taken. This innovative approach could lead to more accurate adherence tracking, which is crucial for the effective management of HIV. Additionally, by integrating social and behavioral determinants of health, this system aims to offer personalized insights that could improve overall treatment outcomes.

What evidence suggests that this ingestible sensor system is effective for improving HIV treatment outcomes?

In this trial, participants in the ISS-SBDOH arm will use the Ingestible Sensor System (ISS). Studies have shown that the ISS detects oral medication intake with 100% accuracy. Users have responded positively, with over 90% expressing satisfaction. Research indicates that the ISS helps people adhere more closely to their medication schedule, which is crucial for effective HIV management. Additionally, evidence suggests that using this system can lead to quicker decreases in viral activity. Overall, these findings suggest that the ISS could enhance HIV treatment by ensuring patients take their medication as prescribed. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with HIV from a Los Angeles County clinic, particularly those who struggle to stick to their treatment. Participants must be willing to use a pill sensor system that tracks medication intake and alerts for social and behavioral health issues.

Inclusion Criteria

Able to provide informed consent

Receiving ART with sub-optimal adherence estimated by patient (self-reports < 90% adherence over last 28 days) or treating clinician (e.g., based on gaps in treatment or viral load elevations within 6 months), or at high risk for sub-optimal adherence, or with known challenges with SBDOH (e.g., unstable housing, substance use disorder, and poverty)

I am HIV positive and currently receiving treatment for it.

Exclusion Criteria

Pregnancy (Evaluated during the screening visit through a pregnancy test)

I am mentally and physically able to follow the study's procedures without confusion or risky behavior.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the integrated intervention using the Ingestion Sensor System (ISS) and Social and Behavioral Determinants of Health (SBDOH) alerts to improve adherence to ART and virologic outcomes

20 weeks

Visits at weeks 4, 8, 12, 16, and 20

Sustainability Assessment

Assessment of the sustainability of the intervention's effects on adherence and virologic outcomes

10 weeks

Visits at weeks 24 and 28

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Integrated Intervention Using a Pill Ingestible Sensor System

Trial Overview

The study tests an integrated intervention using a pill ingestible sensor system (ISS) combined with support for social and behavioral determinants of health (SBDOH). It compares usual care against this new approach in terms of adherence, viral load control, and risky sexual behavior reduction.

How Is the Trial Designed?

Group I: ISS-SBDOH arm Experimental Treatment 1 Intervention

Ingestion Sensor System (ISS) - Social and Behavioral Determinants of Health (SBDOH) arm

Group II: Usual Care (UC) arm Active Control 1 Intervention

Usual Care (UC) arm UC is chosen as the control condition because it meets ethical and moral requirements to attempt treatment.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

EtectRX, Inc.

Industry Sponsor

Trials

3

Recruited

160+

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Collaborator

Trials

105

Recruited

46,600+

Published Research Related to This Trial

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]

The ingestible sensor (IS) system for monitoring adherence to antiretrovirals (ARVs) was highly accepted by participants, with over 90% satisfaction, and was associated with improved adherence compared to usual care.

Participants using the IS system showed a trend towards faster decay of HIV RNA viral load, suggesting that real-time monitoring may enhance treatment effectiveness and adherence in managing HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ingestible sensor system for measuring, monitoring and enhancing adherence to antiretroviral therapy: An open-label, usual care-controlled, randomised trial. Liu, H., Wang, Y., Huang, Y., et al.[2023]

Digital pill systems (DPS) have been approved by the FDA and have shown bioequivalence and stability for pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART), indicating they are safe and effective for measuring medication adherence.

Pilot studies suggest that DPS are feasible and acceptable for tracking adherence to PrEP and ART, and future advancements may enhance their integration into behavioral interventions to improve adherence rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ingestible Electronic Sensors for Monitoring Real-time Adherence to HIV Pre-exposure Prophylaxis and Antiretroviral Therapy. Goodman, GR., Vaz, C., Albrechta, H., et al.[2023]

Ingestible sensor systems can provide valuable physiological data from the gastrointestinal tract, helping researchers understand how oral medications behave as they pass through the body.

These sensors can measure important factors like transit times, pH, temperature, and pressure, which enhance our understanding of oral drug delivery mechanisms, particularly in animal models like dogs and pigs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ingestible devices for studying the gastrointestinal physiology and their application in oral biopharmaceutics. Weitschies, W., Müller, L., Grimm, M., et al.[2022]

A new method called co-encapsulation (CoE) combines oral medications with an edible ingestion sensor (IS) to create 'digitized' medications that accurately track when patients take their medicine, enhancing medication adherence.

In a study involving 12 patients with active tuberculosis, the CoE-IS-Rifamate showed bioequivalence to the standard Rifamate formulation, meaning it works just as effectively without compromising the quality of the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digitizing Medicines for Remote Capture of Oral Medication Adherence Using Co-encapsulation. Browne, SH., Peloquin, C., Santillo, F., et al.[2019]

A miniaturized lab-in-a-pill device has been developed to measure temperature and pH in the gastrointestinal tract, providing real-time data that can help identify potential diseases.

Initial testing in pigs showed that the device's measurements were accurate, aligning with 90% of established literature values, and its battery life was extended by 70% through a power-saving data compression algorithm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of radiotelemetry in a lab-in-a-pill format. Johannessen, EA., Wang, L., Reid, SW., et al.[2006]

The Ingestible Sensor System (ISS) demonstrated 100% accuracy in detecting the ingestion of oral medications in a study of 20 kidney transplant patients over an average of 9.2 weeks, indicating its potential for improving treatment adherence.

While the ISS showed high adherence rates (99.4%) and no serious adverse events, some patients experienced gastrointestinal symptoms and skin irritation from the monitoring device, highlighting the need for careful patient management during use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication adherence assessment: high accuracy of the new Ingestible Sensor System in kidney transplants. Eisenberger, U., Wüthrich, RP., Bock, A., et al.[2022]

A new ingestible smart biosensing pill has been developed that can autonomously measure pH levels in the gastrointestinal tract, providing a non-invasive alternative to traditional diagnostic methods like colonoscopy.

The pill is equipped with advanced pH sensors and electronics, allowing for easy data collection after the pill is excreted, which could lead to more efficient and cost-effective monitoring of gastrointestinal diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ingestible pH sensing device for gastrointestinal health monitoring based on thread-based electrochemical sensors. Asci, C., Sharma, A., Del-Rio-Ruiz, R., et al.[2023]

A new microelectronic 'pill' has been created to study the gastrointestinal tract, featuring microsensors that can measure temperature, pH, conductivity, and dissolved oxygen in real-time.

This pill is designed with a biocompatible outer capsule and can operate for up to 40 hours, making it suitable for various biomedical and industrial applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of multichannel sensors for remote biomedical measurements in a microsystems format. Johannessen, EA., Wang, L., Cui, L., et al.[2019]

Citations

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Study protocol to evaluate an integrated intervention using ...

The overarching goals of this study are to develop and test a targeted program that integrates the cutting-edge ingestible sensor system that ...

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Ingestible sensor system for measuring, monitoring and ...

Overall satisfaction rate for the IS system was >90%. The IPAM score was higher (0.018, 95% CI: −0.098–0.134, p = 0.75) and VL decayed faster (− ...

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An Integrated Intervention Using a Pill Ingestible Sensor ...

The study aims to assess the effectiveness of the integrated intervention in improving adherence, virologic outcomes, and reducing high-risk ...

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Ingestible Sensor System for HIV/AIDS (Sensor-SBDOH Trial)

The Ingestible Sensor System (ISS) demonstrated 100% accuracy in detecting the ingestion of oral medications in a study of 20 kidney transplant patients over ...

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The primary outcomes are acceptability of the integrated intervention, frequency and timeliness of SBDOH intervention, level of challenges of ...

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This study integrates technology-based adherence measures with alerts for social and behavioral determinants of health (SBDOH) to improve HIV ...

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clinicaltrials.gov/study/NCT02797262

Measuring and Monitoring Adherence to ART With Pill ...

The ingestible sensor and patch monitor system is already FDA-approved as safe, but has yet to be tested in HIV-infected patients in clinical setting.

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taggs.hhs.gov/Detail/AwardDetail?arg_AwardNum=R01MD019188&arg_ProgOfficeCode=56

Award Information | HHS TAGGS

An integrated intervention using a pill ingestible sensor system to trigger actions on multifaceted social and behavioral determinants of health among PLWH ...