[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100437703":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":40,"centralContacts":44,"locations":50,"responsibleParty":67,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":10,"enrollmentInfo":83,"targetDuration":10,"studyType":86,"phases":10,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":53,"whyStopped":10,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral Antivirals",null,"Arm 1: People continuing oral (PO) antivirals for HIV treatment or prevention",[13],"Other: At Home Self-Collections",{"label":15,"type":10,"description":16,"interventionNames":17},"Q8W CAB±RPV Continuation","Arm 2: People continuing Q8W injections of CAB±RPV for HIV treatment or prevention",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Q8W CAB±RPV Initiation","Arm 3: People initiating Q8W injections of CAB±RPV for HIV treatment or prevention",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Q4W CAB±RPV Continuation\u002FInitiation","Arm 4: People continuing or initiating Q4W injections of CAB±RPV for HIV treatment or prevention",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Q26W LEN Continuation\u002FInitiation","Arm 5: People continuing or initiating Q26W injections of LEN for HIV treatment or prevention",[13],[31],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"At Home Self-Collections","Directly observed at home self-collection of blood samples",[9,27,23,15,19],[36,37,38,39],"Tasso-M20","Tasso+","Mitra","DBS by fingerstick",[41],{"name":42,"affiliation":5,"role":43},"Peter Anderson, PharmD","PRINCIPAL_INVESTIGATOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":10,"email":49},"Ryan Coyle, MPH","CONTACT","720-695-8020","ryan.coyle@cuanschutz.edu",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"University of Colorado Hospital (UCHealth)","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-104.83192,39.72943,{"lat":63,"lon":62},[66],{"name":46,"role":47,"phone":48,"phoneExt":10,"email":49},{"type":68,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[70],{"name":71,"class":72},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH","100437703","hiv-outpatient-monitoring-evaluation-through-self-collection-of-dried-blood-spots-100437703",false,"NCT04979728","HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots","HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots (HOME-1)","HOME-1","Inclusion criteria:\n\n* ≥18 years old\n* Receiving one or more antivirals for HIV treatment or prevention. This may include TFV (as TDF or TAF) and FTC (or 3TC)-based, LA (e.g., LA IM CAB±RPV Q4W or Q8W), or other antivirals (those who are transitioning to LA antivirals \\[e.g., LA IM CAB±RPV Q4W or Q8W\\] will also be eligible)\n* Current patient at the UCH-IDGP clinic\n* Able to comply with study procedures, including directly observed self-collection of DBS by fingerstick, Tasso-M20\u002FTasso+, Mitra, and\u002For other self-collection methods\u002Fdevices, and completion of survey\n\nExclusion criteria:\n\n* Inability to provide informed consent\n* Unable or unwilling to comply with directly observed self-collection of DBS (e.g., unavailable or unable to use live video-streaming or time-stamped video recording technology)\n* Any uncontrolled medical, social, or mental health issue(s) that, in the opinion of the investigators, could interfere with the study participation or study outcomes (e.g., current incarceration)\n* Any medical condition that, in the opinion of the study team, acutely and\u002For transiently influences the PK of CAB±RPV, including acute kidney injury, hepatic insufficiency, significant drug-drug interactions, active hemolysis or symptomatic hemoglobinopathies, etc. (Note: Given the need for PK data in pregnancy, women who become pregnant while on LA IM CAB±RPV Q4W or Q8W will be allowed to participate in this study, if their clinical provider decides to continue this regimen.)","ALL","18 Years",{"count":84,"type":85},150,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to establish an operational framework for home self-collections of blood samples to be used for antiviral drug concentration measurements.\n\nParticipants will continue on their prescribed antiviral(s) for HIV treatment or prevention and followed for up to approximately 1 year. The investigators will compare drug concentrations of antivirals and relevant metabolites\u002Fanabolites in clinic-collected and self-collected blood samples.",[89,90],"HIV Treatment","HIV Prevention",[92,93,94,95,96,97,98,99,100,101,102],"antivirals","ART","PrEP","long-acting","cabotegravir","rilpivirine","tenofovir","lenacapavir","self-collections","self-collected blood samples","drug concentrations","2026-02-27",{"date":105,"type":106},"2026-03-03","ACTUAL",{"date":108,"type":106},"2021-05-27",{"date":110,"type":85},"2027-06-30",{"name":5,"class":6},1]