Ingestible Sensor System for HIV/AIDS (Sensor-SBDOH Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of California, Los Angeles

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of 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

This trial is for adults with HIV from a Los Angeles County clinic, particularly those who struggle to stick to their treatment. Participants must be willing to use a pill sensor system that tracks medication intake and alerts for social and behavioral health issues.

Inclusion Criteria

I am HIV positive and currently receiving treatment for it.

I am older than 17 years.

I can take ARV medication as prescribed.

I am on antiretroviral therapy with specific medications.

Exclusion Criteria

I am mentally and physically able to follow the study's procedures without confusion or risky behavior.

Treatment Details

The study tests an integrated intervention using a pill ingestible sensor system (ISS) combined with support for social and behavioral determinants of health (SBDOH). It compares usual care against this new approach in terms of adherence, viral load control, and risky sexual behavior reduction.

2Treatment groups

Experimental Treatment

Active Control

Group I: ISS-SBDOH armExperimental Treatment1 Intervention

Ingestion Sensor System (ISS) - Social and Behavioral Determinants of Health (SBDOH) arm

Group II: Usual Care (UC) armActive Control1 Intervention

Usual Care (UC) arm UC is chosen as the control condition because it meets ethical and moral requirements to attempt treatment.