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ISO 27001 CertifiedActively Recruiting
Led by University of California, Los Angeles · Updated on 2026-02-13
110
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating an integrated approach to improve HIV treatment outcomes by combining a pill ingestible sensor system with alerts for social and behavioral factors that affect medication adherence. The study focuses on adults living with HIV who are at risk for poor adherence to antiretroviral therapy ART. This Phase 2 trial aims to assess how well this combined intervention works in enhancing adherence, achieving viral suppression, and reducing high-risk sexual behavior among people living with HIV PLWH. Participants will be randomly assigned to either an intervention group using the Ingestion Sensor System ISS combined with social and behavioral determinants of health SBDOH alerts or to a usual care group. The ISS system detects missed doses and automatically alerts a multidisciplinary care team to provide timely support tailored to each participants social and behavioral challenges. The integrated intervention lasts for 20 weeks, followed by a 10-week period to evaluate if improvements are sustained. Throughout the study, participants will be regularly monitored at multiple timepoints for adherence levels using sensor data and self-reports, viral load measurements, and reports of sexual behavior. The study will also track the acceptability of the intervention and the frequency and speed of social and behavioral support provided. Overall, the research evaluates the ability of real-time adherence technology combined with social support to improve HIV treatment and reduce transmission risks over approximately 30 weeks of participation.
CONDITIONS
An Integrated Intervention Using a Pill Ingestible Sensor System
J
Jie Shen, PhD
Y
Yilan Huang, M.S.
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University of California, Los Angeles
Lead Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Integrated ISS-SBDOH Sensor-Triggered Intervention | Usual Care (Standard SBDOH Support) |
|---|---|---|
| What is it? | A behavioral intervention combining ingestible sensors (ID-Cap ISS system) that monitor adherence to ART, automatically alerting a multidisciplinary care team to trigger immediate, coordinated SBDOH support for participants who miss doses. | Standard SBDOH interventions delivered by the HIV Care team, according to usual clinical practice, without ingestible sensor monitoring or automated alerts. |
| Role in trial | Active experimental arm receiving both ingestible sensor monitoring for ART adherence and immediate SBDOH support as needed. | Comparator arm; participants continue to receive usual SBDOH support from the HIV Care team without added sensor monitoring. |
| Primary use | To improve ART adherence and rapidly address SBDOH barriers using sensor-triggered multidisciplinary support. | To provide ongoing SBDOH support based on existing care-team-driven approaches for patients with HIV and adherence challenges. |
| How is it given or performed? | Participants take ART drugs co-encapsulated with ingestible sensors. The ISS system detects missed doses and triggers multidisciplinary outreach, including provider evaluation and tailored SBDOH interventions. All actions are coordinated and documented within the care process. | Participants continue ART and receive standard SBDOH interventions according to care-team assessment and clinical need. No sensor system or automated alerts are involved. |
| Evidence status | Currently under randomized investigation; published protocol exists, but no trial outcome results are available yet. Evidence for sensor-triggered SBDOH intervention is at the protocol stage only. | Usual care represents standard SBDOH intervention practice for PLWH with adherence challenges. Published evidence supports care-team-driven assessment and intervention as current practice, but this arm does not represent a novel treatment. |
| Important limitations | Potential limitations include the need for participants to consistently ingest sensor-equipped ART, reliance on real-time team response, possible adherence or technology barriers, and ongoing evaluation of intervention acceptability and clinical impact. Clinical effectiveness and patient outcomes remain unreported until study completion. | Usual care may not provide immediate detection of missed ART doses or targeted SBDOH outreach. Intervention frequency depends on provider assessment, potentially missing early challenges. No sensor-enabled feedback is available. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 20 weeks
Participants receive the integrated intervention using the ingestible sensor system to monitor adherence to antiretroviral therapy and to trigger timely social and behavioral interventions as needed.
Visits at Weeks 4, 8, 12, 16, and 20 for assessments
Duration - 10 weeks
Participants are assessed to evaluate the sustainability of adherence and social and behavioral health outcomes after the intervention ends.
Visits at Week 28 for assessments
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Honghu Liu, Jie Shen, Yan Wang...
https://pubmed.ncbi.nlm.nih.gov/41174603/University of California, Los Angeles
Lead Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborating Sponsor
