Observational StudyAn Integrated Intervention Using a Pill Ingestible Sensor System

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.)