Recruitment and Randomization
confusion, UC
MAY
All participants were recruited from the Lundquist Institute at the Harbor-UCLA Medical Center (HUMC), and Long Beach Comprehensive Care HIV clinics from May 2018 to February 2020 (ClinicalTrials.gov Identifier: NCT02797262). The last follow-up study visit happened in October 2020. The inclusion criteria were (1) HIV-infected individuals in care; (2) at least 18 years old; (3) demonstrated ability to take co-encapsulated medication at the time of screening; (4) on ART with evidence of suboptimal adherence as defined by < 90% adherence over the last 28 days by self-report, or over the last 6 months as perceived by the treating clinician based on missed appointments, reported missed doses, or viral load elevations. The exclusion criteria were (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. Enrolled individuals were assigned to either the ingestible sensor (IS) group or the usual care (UC) group by a stratified randomization procedure on (1) whether HIV RNA viral load was detectable and (2) whether the participants were on single or multiple pill regimen. This study was approved by UCLA and Lundquist Institute Institutional Review Board. Written consent forms were acquired from all study participants.