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An Integrated Intervention Using a Pill Ingestible Sensor System

Study acronym: Sensor-SBDOH
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Dec 2027 to Jul 1, 2027v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2024 to Dec 19, 2024
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06480578
Lead Sponsor University of California, Los Angeles
Collaborators: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, EtectRX, Inc., National Institute on Minority Health and Health Disparities (NIMHD)
Conditions
(from sponsor)		 HIV/AIDS, Medication Adherence, Social Determinants of Health (SDOH)
Related terms Acquired Immunodeficiency Syndrome, Medication Adherence
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov