Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06480578

An Integrated Intervention Using a Pill Ingestible Sensor System

Led by University of California, Los Angeles · Updated on 2026-02-13

110

Participants Needed

1

Research Sites

132 weeks

Total Duration

On this page

Sponsors

U

University of California, Los Angeles

Lead Sponsor

L

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study integrates technology-based adherence measures with alerts for social and behavioral determinants of health (SBDOH) to improve HIV treatment outcomes. It involves 110 adult patients from a Los Angeles County HIV clinic, focusing on those at risk for poor adherence. Participants will be randomized into intervention or usual care groups, with endpoints including intervention acceptability, SBDOH interventions, adherence to ART, viral load, and high-risk sexual activity. The study aims to assess the effectiveness of the integrated intervention in improving adherence, virologic outcomes, and reducing high-risk behavior among PLWH.

CONDITIONS

Official Title

An Integrated Intervention Using a Pill Ingestible Sensor System

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • HIV-infected individuals in HIV care
  • Age greater than 17 years
  • Ability to take co-encapsulated antiretroviral medications at screening
  • Able to provide informed consent
  • Receiving ART with sub-optimal adherence (self-reported less than 90% adherence in last 28 days) or at high risk for sub-optimal adherence or with known social and behavioral challenges
  • Currently receiving antiretroviral treatment that includes one of the specified regimens: TDF/FTC (Truvada), TAF/FTC (Descovy), EFV/FTC/TDF (Atripla), ABC/3TC (Epzicom), DTG/ABC/3TC (Triumeq), RPV/TAF/FTC (Odefsey), EVG/c/FTC/TAF (Genvoya), or BIC/FTC/TAF (Biktarvy)
  • For participants of reproductive potential, negative serum or urine pregnancy test at screening and study entry
  • Participants not of reproductive potential defined by amenorrhea criteria or surgical sterilization
Not Eligible

You will not qualify if you...

  • Inability to follow study procedures due to mental confusion, disorganization, intoxication, withdrawal, or risky/threatening behavior
  • Pregnancy at screening or study entry

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Lundquist

Los Angeles, California, United States, 90502

Actively Recruiting

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Research Team

J

Jie Shen, PhD

CONTACT

Y

Yilan Huang, M.S.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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