Actively Recruiting
Led by University of California, Los Angeles · Updated on 2026-02-13
110
Participants Needed
1
Research Sites
N/A
Total Duration
U
University of California, Los Angeles
Lead Sponsor
L
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborating Sponsor
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 participant's 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
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
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
Total: 1 location
1
Lundquist
Los Angeles, California, United States, 90502
Actively Recruiting
J
Jie Shen, PhD
Y
Yilan Huang, M.S.
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