An Integrated Intervention Using a Pill Ingestible Sensor System

Recruiting now · Phase 2

Conditions studied: HIV/AIDS, Medication Adherence, Social Determinants of Health (SDOH)

In brief

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 facts

Study ID

NCT06480578

Run by

University of California, Los Angeles

People needed

110

Starts

2024-12-19

Expected to finish

2027-07-01

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Receiving ART with sub-optimal adherence estimated by patient (self-reports < 90% adherence over last 28 days) or treating clinician [e.g., based on gaps in treatment (e.g. missed appointments) or viral load elevations within 6 months], or at high risk for sub-optimal adherence, or with known challenges with SBDOH (e.g. unstable housing, substance use disorder, and poverty
• Currently receiving antiretroviral treatment that includes one of the following:
• TDF/FTC (Truvada)
• TAF/FTC (Descovy)
• EFV/FTC/TDF (Atripla)
• ABC/3TC (Epzicom)
• DTG/ABC/3TC (Triumeq)
• RPV/TAF/FTC (Odefsey)
• EVG/c/FTC/TAF (Genvoya)
• BIC/FTC/TAF (Biktarvy)
• For participants of reproductive potential, negative serum or urine pregnancy test with a sensitivity of ≤25 mIU/mL at screening. This will be repeated again at study entry.
• NOTE: Participants are considered to be NOT of reproductive potential if:
• participants have had amenorrhea for at least 12 consecutive months prior to study entry (i.e., who have had no menses within 12 months prior to study entry), and have a documented FSH >40 IU/mL; OR
• an FSH level is not available, but participants have had 24 consecutive months of amenorrhea (in the absence of medications known to induce amenorrhea); OR
• participants report having undergone surgical sterilization (e.g., hysterectomy, or bilateral oophorectomy, or bilateral tubal ligation/hysteroscopic tubal occlusion).

You may not qualify if…

• 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.)

Where it is running

• Lundquist — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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