An Integrated Intervention Using a Pill Ingestible Sensor System
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Los Angeles
About this trial
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.
Eligibility criteria
Qualifiers
HIV-infected individuals in HIV care
Greater than 17 years of age
Demonstrated ability to take co-encapsulated ARVs at the time of screening
Able to provide informed consent
Disqualifiers
Inability to follow the study procedures manifested during the intake, as evidenced by mental confusion, disorganization, intoxication, withdrawal, risky or threatening behavior
Pregnancy (Evaluated during the screening visit through a pregnancy test.)
Trial design
Treatments tested in this trial
- ISS-SBDOH arm
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of California, Los Angeles
Lead sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborator
EtectRX, Inc.
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov