An Integrated Intervention Using a Pill Ingestible Sensor System

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT06480578
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ISS-SBDOH arm — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Dec 19, 2024
Status verified
Feb 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ISS-SBDOH arm
    Ingestion Sensor System (ISS) - Social and Behavioral Determinants of Health (SBDOH) arm
  • No Intervention: Usual Care (UC) arm
    Usual Care (UC) arm UC is chosen as the control condition because it meets ethical and moral requirements to attempt treatment.

Primary Outcome Measure

Acceptability to the integrated intervention [ Time Frame: week 4, 8, 12, and 16 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
LundquistLos AngelesCalifornia90502
Mario Guerrero
[email protected]
Eric Daar, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
HIV
By specialty
Infectious disease
By research site
Lundquist· Los Angeles, CA

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