[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100490868":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":22,"centralContacts":33,"locations":39,"responsibleParty":95,"collaborators":97,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":18,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":18,"enrollmentInfo":112,"targetDuration":18,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nurse-Led Treatment in Primary Care","EXPERIMENTAL","At a primary care clinic intervention site, a nurse will be available once or twice weekly. The days\u002Ftimes will be dependent on clinic volume (i.e., cluster size), with scheduled rotations between PCCs. This rotation between PCC sites will mimic the physician's responsibilities\u002Favailability at a district hospital and creates parity between the trial arms. In this trial, we will have nurses dedicated to the management of RR-TB treatment, yet the volume at each site will not require the presence of a full-time nurse.",[13],"Other: Nurse-Led Treatment in Primary Care",{"label":15,"type":16,"description":17,"interventionNames":18},"Physician-Led Treatment Hospital Based","NO_INTERVENTION","Representing standard of care, primary care clinics will refer to hospital-based, physician-led care who will provide outpatient treatment. The typical clinical operations involve initiation of new patients once or twice weekly and PCCs are required to schedule a clinic day\u002Ftime for the patient prior to referral (generally \\\u003C 72 hours from the time of referral). All individuals receiving care at this site will receive care at the district RR-TB treatment program for the catchment area. For HIV co-infected persons, their HIV treatment is also transferred to the RR-TB physician with details about the HIV treatment communicated in the transfer of care letter. Physicians often cover multiple clinics and routinely take on call sessions on the weekend, due to staffing limitations, thus preventing their sole focus on the RR-TB program and limiting the number of days the RR-TB clinic offers new patient visits and, in most cases, days for follow-up visits.",null,[20],{"type":6,"name":9,"description":11,"armGroupLabels":21,"otherNames":18},[9],[23,27,30],{"name":24,"affiliation":25,"role":26},"Jason Farley, PhD, MPH, ANP-BC","The Center for Infectious Disease and Nursing Innovation (CIDNI)","PRINCIPAL_INVESTIGATOR",{"name":28,"affiliation":29,"role":26},"Denise Evans, PhD","University of Witwatersrand, South Africa",{"name":31,"affiliation":32,"role":26},"Norbert Ndjeka, MBChB","University of Cape Town",[34],{"name":35,"role":36,"phone":37,"phoneExt":18,"email":38},"Kelly Lowensen, MSN, RN","CONTACT","4104091372","klowens1@jhu.edu",[40,57,68,78,85],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Doris Goodwin Hospital","RECRUITING","Pietermaritzburg","KwaZulu-Natal","3201","South Africa","ZA",{"type":49,"coordinates":50},"Point",[51,52],30.39278,-29.61679,{"lat":52,"lon":51},[55],{"name":56,"role":36,"phone":18,"phoneExt":18,"email":18},"Jason Farley, PhD",{"facility":58,"status":42,"city":59,"state":44,"zip":60,"country":46,"countryCode":47,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Murchison Hospital","Port Shepstone","7007",{"type":49,"coordinates":62},[63,64],30.45499,-30.74137,{"lat":64,"lon":63},[67],{"name":56,"role":36,"phone":18,"phoneExt":18,"email":18},{"facility":69,"status":42,"city":70,"state":18,"zip":18,"country":46,"countryCode":47,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"King Dinuzulu TB Hospital","East London",{"type":49,"coordinates":72},[73,74],27.91162,-33.01529,{"lat":74,"lon":73},[77],{"name":56,"role":36,"phone":18,"phoneExt":18,"email":18},{"facility":79,"status":42,"city":70,"state":18,"zip":18,"country":46,"countryCode":47,"cosmosGeoPoint":80,"geoPoint":82,"contacts":83},"Nkquebela TB Hospital",{"type":49,"coordinates":81},[73,74],{"lat":74,"lon":73},[84],{"name":56,"role":36,"phone":18,"phoneExt":18,"email":18},{"facility":86,"status":42,"city":87,"state":18,"zip":18,"country":46,"countryCode":47,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Jose Pearson Hospital","Port Elizabeth",{"type":49,"coordinates":89},[90,91],25.61494,-33.96109,{"lat":91,"lon":90},[94],{"name":56,"role":36,"phone":18,"phoneExt":18,"email":18},{"type":96,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[98,99,100],{"name":29,"class":6},{"name":32,"class":6},{"name":101,"class":102},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH","100490868","bring-bpal2me-trial-comparing-nurse-led-rr-tb-treatment-to-physician-led-rr-tb-treatment-100490868",false,"NCT05671718","Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment to Physician-Led RR-TB Treatment","Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment in Primary Care to Physician-Led, Hospital-Based Outpatient RR-TB Treatment: A Cluster Randomized, Non-Inferiority Trial","Inclusion Criteria:\n\nCluster Inclusion Criteria:\n\nPrimary Care Clinics (PCCs) (i.e., clusters) are eligible if they meet the following:\n\n1. within one of the selected hospital treatment catchment areas in Kwazulu-Natal, Gauteng and Eastern Cape Provinces;\n2. willingness of provincial TB program managers and hospital leadership to participate;\n3. willingness of PCC nurse manager to participate;\n4. diagnosis of 10 or more RR-TB patients per year; and\n5. have access to necessary labs, X-ray and electrocardiogram (ECG) equipment.\n\nParticipant Inclusion Criteria:\n\nAdult participants aged 18 years of age and older, regardless of HIV status, who have a new RR-TB diagnosis, deemed willing and able to provide informed consent in one of the four most common SA languages \\[Zulu, Xhosa, Afrikaans, and English\\] will be eligible.\n\nParticipant Exclusion Criteria:\n\n1. any clinical presentation requiring hospital admission or, in other words, the participant is not a candidate for outpatient primary care initiation (e.g., severe weakness, confusion, severe mental illness, symptomatic low blood pressure, severe shortness of breath, and temp \\>39.0);\n2. Hemoglobin \\\u003C 8mg\u002FdL (from National Health Laboratory Service (NHLS) or point of care)) or liver disease (ALT \\> 120 U\u002FL);\n3. prolonged QTc\\>470ms, confirmed by 2 or more ecg;\n4. rapid heartrate, tachycardia (HR \\>140); confirmed after 5 minutes of rest;\n5. pregnancy;\n6. evidence of extrapulmonary disease;\n7. enrolled in another clinical trial that changes BPaL-L regimen, duration or symptom management process.","ALL","18 Years",{"count":113,"type":114},2944,"ESTIMATED","INTERVENTIONAL",[117],"NA","The goal of the BringBPaL2Me Trial, a multi-principal investigator, multi-site, cluster randomized, non-inferiority trial is to compare nurse-led RR-TB treatment in primary care clinics to standard of care physician-led RR-TB treatment at district hospitals in the provinces of KwaZulu-Natal, Gauteng, and Eastern Cape.\n\nThe main aim is to conduct a 5-year, analyst and clinical safety review committee blinded, multi-site, cluster randomized trial to evaluate 1) treatment outcome; 2) safety; 3) patient associated catastrophic costs with the following hypotheses:\n\n1. Outpatient nurse-led treatment in PCCs will be non-inferior to outpatient physician-led treatment at hospital-based outpatient sites among RR-TB patients, regardless of HIV co-infection, as determined by a successful treatment outcome \\[H1\\].\n2. The proportion of SAEs identified will not significantly differ by blinded, independent review \\[H2\\].\n3. Patient associated catastrophic costs (i.e., costs 20% or more of household income) will be lower in nurse-led treatment \\[H3\\].",[120],"Drug Resistant Tuberculosis",[122,123,124,125,126,127,128,46],"nurse-led","non-inferiority cluster randomized trial","primary care","drug resistant tuberculosis","rifampicin resistant tuberculosis","human immunodeficiency virus","task sharing","2025-10-15",{"date":131,"type":132},"2025-10-20","ACTUAL",{"date":134,"type":132},"2023-09-04",{"date":136,"type":114},"2030-12-31",{"name":5,"class":6},5]