RECRUITINGPhase 2INTERVENTIONAL

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

About 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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form 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). Who Should NOT Join This Trial: 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.) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.)

Treatments Being Tested

BEHAVIORAL

ISS-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.

Locations (1)

Lundquist

Los Angeles, California, United States