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An Integrated Intervention Using a Pill Ingestible Sensor System

NCT06480578 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-02-13

No results posted yet for this study

Summary

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

  • HIV/AIDS
  • Medication Adherence
  • Social Determinants of Health (SDOH)

Interventions

BEHAVIORAL

ISS-SBDOH arm

Once the ID-Cap ISS system has identified a participant who has missed his/her prescribed ARVs for five (5) consecutive days, a member of the multidisciplinary team will be informed automatically by the system and reach out to the participant immediately. The team will work with the primary provider and the participant to evaluate and understand the patient's SBDOH profile and status and develop a coordinated plan that fits the patient's specific need to address the patient's particular challenges in SBDOH. This plan (all SBDOH interventions) is considered standard of care and would be initiated in the same manner regardless of participation. Participation in this study will not alter the planned interventions determined by the HIV Care team.

Sponsors & Collaborators

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    collaborator OTHER

  • EtectRX, Inc.

    collaborator INDUSTRY

  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH

  • University of California, Los Angeles

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-19
Primary Completion
2027-07-01
Completion
2027-07-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06480578 on ClinicalTrials.gov