[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564918":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":26,"centralContacts":31,"locations":10,"responsibleParty":39,"collaborators":42,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":10,"enrollmentInfo":55,"targetDuration":10,"studyType":58,"phases":10,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":68,"whyStopped":10,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":10},{"fullName":5,"class":6},"MetroHealth Medical Center","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Patient participants receiving in clinic nurse administered long-acting injectable ART",null,"People with HIV on long acting cabotegravir + rilpivirine who elect to continue to receive their injections in clinic by a nurse",[13],"Other: Model of care delivery for long-acting injectable ART",{"label":15,"type":10,"description":16,"interventionNames":17},"Patient participants receiving pharmacist administered long-acting injectable ART in pharmacy","People with HIV on long acting cabotegravir + rilpivirine who elect to continue to receive their injections in a satellite pharmacy by a pharmacist",[13],{"label":19,"type":10,"description":20,"interventionNames":10},"Staff participants","Staff involved in the long-acting injectable ART workflow",[22],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"Model of care delivery for long-acting injectable ART","This study is assessing a novel model of care delivery, i.e. pharmacist administered long-acting cabotegravir + rilpivirine (CAB+RPV LA). In phase 2 and 3, no medication will be provided by the study. The decision to initiate CAB+RPV LA will be at the discretion of the patient and their provider in accordance with both standard of care and local prescribing practices. This will occur independent of study participation. The study intervention is the model of care for CAB+RPV LA administration. The models of care being studied include (1) pharmacist administered CAB+RPV LA in MetroHealth satellite pharmacy setting (novel model of care); (2) nurse administered CAB+RPV LA in the Infectious Diseases clinic at MetroHealth main campus (current standard of care).",[9,15],[27],{"name":28,"affiliation":29,"role":30},"Corrilynn O Hileman, MD","MetroHealth System, Ohio","PRINCIPAL_INVESTIGATOR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":10,"email":35},"CONTACT","216-778-7827","chileman@metrohealth.org",{"name":37,"role":33,"phone":34,"phoneExt":10,"email":38},"Demetria Web","dwebb@metrohealth.org",{"type":30,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Corrilynn Hileman","Medical Director of the Infectious Disease Clinic, Associate Professor of Medicine",[43],{"name":44,"class":45},"ViiV Healthcare","INDUSTRY","100564918","the-expand-study-pharmacist-administered-long-acting-cabotegravir--rilpivirine-to-expand-access-for-people-with-hiv-100564918",false,"NCT06635421","The Expand Study-Pharmacist Administered Long Acting Cabotegravir + Rilpivirine to Expand Access for People With HIV","EXPAND","Patient Participant Inclusion Criteria:\n\n* 18 years of age and older\n* diagnosed with HIV by approved HIV screen and confirmation test\n* currently on CAB+RPV LA every 4 or 8 weeks\n* has received at least two doses of CAB+PRV LA\n* last HIV-1 RNA \\\u003C50 copies\u002Fml\n* no known or suspected resistance to either cabotegravir or rilpivirine\n* no plans to change medication in the next 48 weeks\n* no plans to move out of state\n* has plans to avoid pregnancy if of reproductive potential\n\nPatient Participant Exclusion Criteria:\n\n* individuals who are unable or unwilling to adhere to the study protocol\n* unable to speak\u002Fcomprehend English\n* insurance coverage for medication through medical benefit\n\nStaff Participant Inclusion\u002FExclusion Criteria:\n\n-all available staff involved in the CAB+RPV LA workflow will be approached for inclusion","ALL","18 Years",{"count":56,"type":57},164,"ESTIMATED","OBSERVATIONAL","The purpose of The EXPAND study is to develop and pilot a pharmacist led model of medication delivery. Following a co-design phase, patients may receive injections at satellite pharmacies by a licensed pharmacist. The acceptability, appropriateness, and feasibility of this approach and standard in clinic administration by a nurse will be assessed.",[61],"HIV I Infection",[63,64,65,66,67],"long acting injectable antiretroviral therapy","cabotegravir","rilpivirine","HIV","pharmacist administered medication","NOT_YET_RECRUITING","2024-10-08",{"date":71,"type":72},"2024-10-10","ACTUAL",{"date":74,"type":57},"2024-11-01",{"date":76,"type":57},"2026-12-31",{"name":5,"class":6}]