[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100445802":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":34,"responsibleParty":50,"collaborators":52,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":18,"enrollmentInfo":65,"targetDuration":18,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":18,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Makerere University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"intervention(Enhanced package of care) Arm","EXPERIMENTAL","The patients with advanced HIV disease that receive HIV care at the intervention clinics will receive the enhanced intervention package which will include: point of care CD4 testing with visitect, screening for TB and cryptococcal meningitis using Fujifilm LAM and semiquantitative crAg LFA respectively and pre-emptive treatment with isoniazid and rifapentine for one month. Those with a high crAg titers will receive treatment for CNS cryptococcal disease.",[13],"Other: Enhanced care package",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care Arm","NO_INTERVENTION","The patients with advanced HIV disease that receive HIV care at the standard of care clinics will receive the usual routine HIV care as per the Uganda national guidelines. That is CD4 testing with flowcytometry or other CD4 testing modalities available, screening for TB and cryptococcal meningitis using Alere LAM and crAg LFA respectively and pre-emptive treatment with isoniazid and rifapentine for 3-6 month. Treatment of all asymptomatic crAG positives with fluconazole as per guidelines.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Enhanced care package","The intervention is an improved package of care for patients with advanced HIV disease with point of care CD4 testing, more sensitive screening tests for opportunistic infections and more intensive pre-emptive treatment for opportunistic infections",[9],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Radha Rajasingham, MD","CONTACT","612 626-8171","radha@umn.edu",{"name":31,"role":27,"phone":32,"phoneExt":18,"email":33},"Elizabeth Nalintya, MBChB,MPH","0414307000","nalintyaelizabeth@gmail.com",[35],{"facility":36,"status":37,"city":38,"state":18,"zip":18,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"kisugu health center IV","RECRUITING","Kampala","Uganda","UG",{"type":42,"coordinates":43},"Point",[44,45],32.58219,0.31628,{"lat":45,"lon":44},[48],{"name":49,"role":27,"phone":18,"phoneExt":18,"email":18},"Teopista Namuli",{"type":51,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[53],{"name":54,"class":6},"University of Minnesota","100445802","phase-3-an-enhanced-package-of-care-to-reduce-reduce-mortality-in-advanced-hiv-disease-100445802",false,"NCT05085171","An Enhanced Package of Care to Reduce Reduce Mortality in Advanced HIV Disease","A Community-based Phase III, Cluster Randomized Trial of Point-of-care CD4 Testing and Enhanced Screening and Prophylaxis in Advanced HIV Disease","ENCORE","Inclusion Criteria:\n\n* Age \\>18 years\n* CD4\\\u003C200 cells\u002FµL\n* Ability and willingness to give informed consent for the enhanced package of care arm.\n\nExclusion Criteria:\n\n* Known virologic suppression (viral load \\\u003C1000 copies\u002FmL) within prior 3 months\n* Cannot or unlikely to attend regular clinic visits","ALL","18 Years",{"count":66,"type":67},2400,"ESTIMATED","INTERVENTIONAL",[70],"PHASE3","A community-based Phase III, cluster randomized trial that seeks to determine the 24 week survival with retention in care of point of care CD4 testing with visitect and an enhanced package of screening and prophylaxis for opportunistic infections among patients with advanced HIV disease.",[73],"The Study Will Focus on Assessing the Survival Benefit on an Enhanced Package of Care for Patients With Advanced HIV Disease","2022-07-09",{"date":76,"type":77},"2022-07-12","ACTUAL",{"date":79,"type":77},"2022-05-04",{"date":81,"type":67},"2027-09-01",{"name":5,"class":6},1]