[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553014":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":34,"responsibleParty":56,"collaborators":59,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":18,"enrollmentInfo":78,"targetDuration":18,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ISS-SBDOH arm","EXPERIMENTAL","Ingestion Sensor System (ISS) - Social and Behavioral Determinants of Health (SBDOH) arm",[13],"Behavioral: ISS-SBDOH arm",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care (UC) arm","NO_INTERVENTION","Usual Care (UC) arm\n\nUC is chosen as the control condition because it meets ethical and moral requirements to attempt treatment.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","Once the ID-Cap ISS system has identified a participant who has missed his\u002Fher 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.",[9],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Jie Shen, PhD","CONTACT","3105917541","shenjie@ucla.edu",{"name":31,"role":27,"phone":32,"phoneExt":18,"email":33},"Yilan Huang, M.S.","4244404370","yilanh19@g.ucla.edu",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Lundquist","RECRUITING","Los Angeles","California","90502","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-118.24368,34.05223,{"lat":47,"lon":46},[50,53],{"name":51,"role":27,"phone":18,"phoneExt":18,"email":52},"Mario Guerrero","mguerrero@lundquist.org",{"name":54,"role":55,"phone":18,"phoneExt":18,"email":18},"Eric Daar, MD","PRINCIPAL_INVESTIGATOR",{"type":55,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Honghu Liu","Professor",[60,62,65],{"name":61,"class":6},"Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center",{"name":63,"class":64},"EtectRX, Inc.","INDUSTRY",{"name":66,"class":67},"National Institute on Minority Health and Health Disparities (NIMHD)","NIH","100553014","phase-2-an-integrated-intervention-using-a-pill-ingestible-sensor-system-100553014",false,"NCT06480578","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","Sensor-SBDOH","Inclusion Criteria:\n\n1. HIV-infected individuals in HIV care\n2. Greater than 17 years of age\n3. Demonstrated ability to take co-encapsulated ARVs at the time of screening\n4. Able to provide informed consent\n5. Receiving ART with sub-optimal adherence estimated by patient (self-reports \\\u003C 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\n6. Currently receiving antiretroviral treatment that includes one of the following:\n\n   * TDF\u002FFTC (Truvada)\n   * TAF\u002FFTC (Descovy)\n   * EFV\u002FFTC\u002FTDF (Atripla)\n   * ABC\u002F3TC (Epzicom)\n   * DTG\u002FABC\u002F3TC (Triumeq)\n   * RPV\u002FTAF\u002FFTC (Odefsey)\n   * EVG\u002Fc\u002FFTC\u002FTAF (Genvoya)\n   * BIC\u002FFTC\u002FTAF (Biktarvy)\n7. For participants of reproductive potential, negative serum or urine pregnancy test with a sensitivity of ≤25 mIU\u002FmL at screening. This will be repeated again at study entry.\n\nNOTE: Participants are considered to be NOT of reproductive potential if:\n\n1. 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\u002FmL; OR\n2. 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\n3. participants report having undergone surgical sterilization (e.g., hysterectomy, or bilateral oophorectomy, or bilateral tubal ligation\u002Fhysteroscopic tubal occlusion).\n\nExclusion Criteria:\n\n1. Inability to follow the study procedures manifested during the intake, as evidenced by mental confusion, disorganization, intoxication, withdrawal, risky or threatening behavior\n2. Pregnancy (Evaluated during the screening visit through a pregnancy test.)","ALL","18 Years",{"count":79,"type":80},110,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","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.",[86,87,88],"HIV\u002FAIDS","Medication Adherence","Social Determinants of Health (SDOH)",[86,87,90],"SDOH","2026-02-11",{"date":93,"type":94},"2026-02-13","ACTUAL",{"date":96,"type":94},"2024-12-19",{"date":98,"type":80},"2027-07-01",{"name":5,"class":6},1]