An Integrated Intervention Using a Pill Ingestible Sensor System

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Jun 24, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help people living with HIV stay on their medication, which is crucial for their health. The study involves using a special sensor in a pill that helps track if patients are taking their HIV medications as prescribed. It also provides alerts related to social and personal challenges that might affect their treatment, such as housing stability or substance use. The trial will include 110 adults from an HIV clinic in Los Angeles, focusing on those who have had trouble sticking to their medication routines. Participants will be randomly assigned to either receive this new support system or the usual care they currently get.

To join the study, participants need to be at least 18 years old, currently receiving HIV treatment, and have shown difficulty in taking their medications consistently. This could be due to missed doses, scheduling issues, or challenges related to their living situations. During the trial, participants will be monitored for how well they adhere to their treatment, changes in their viral load (which measures the amount of HIV in the blood), and any high-risk behaviors. Overall, the goal is to find out if this integrated approach can lead to better health outcomes for people living with HIV.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. HIV-infected individuals in HIV care
• • 2. Greater than 17 years of age
• • 3. Demonstrated ability to take co-encapsulated ARVs at the time of screening
• • 4. Able to provide informed consent
• • 5. 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
• 6. 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)
• • 7. 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:
• • 1. 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
• • 2. 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
• • 3. participants report having undergone surgical sterilization (e.g., hysterectomy, or bilateral oophorectomy, or bilateral tubal ligation/hysteroscopic tubal occlusion).
• Exclusion Criteria:
• • 1. Inability to follow the study procedures manifested during the intake, as evidenced by mental confusion, disorganization, intoxication, withdrawal, risky or threatening behavior
• • 2. Pregnancy (Evaluated during the screening visit through a pregnancy test.)