RecruitingPhase 2NCT06480578

An Integrated Intervention Using a Pill Ingestible Sensor System

An Integrated Intervention Using a Pill Ingestible Sensor System to Trigger Actions on Multifaceted Social and Behavioral Determinants of Health Among PLWH

Sponsor

University of California, Los Angeles

Enrollment

110 participants

Start Date

Dec 19, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a "smart pill" technology — where your HIV medication is coated with a tiny ingestible sensor — can help people with HIV take their medications more consistently. The sensor confirms when you've taken your pill and sends that information to an app, potentially making it easier for both patients and doctors to track adherence. **You may be eligible if...** - You are over 17 years old and living with HIV - You are currently on antiretroviral therapy (ART) but having trouble taking it consistently - Your doctor or your own estimate suggests you're taking less than 90% of your doses - You are taking one of several specific ART combinations (such as Truvada, Descovy, Atripla, Epzicom, or Triumeq) - You are able to give informed consent **You may NOT be eligible if...** - You are not currently on one of the eligible ART combinations - You are unable to take pills in the required co-encapsulated format - You are under 18 years old Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALISS-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.