Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment to Physician-Led RR-TB Treatment
Drug Resistant Tuberculosis
About this trial
This is an interventional health services research trial for Drug Resistant Tuberculosis focused on measuring nurse-led, non-inferiority cluster randomized trial, primary care, drug resistant tuberculosis, rifampicin resistant tuberculosis, human immunodeficiency virus, task sharing, South Africa
Eligibility Criteria
Inclusion Criteria: Cluster Inclusion Criteria: Primary Care Clinics (PCCs) (i.e., clusters) are eligible if they meet the following: within one of the selected hospital treatment catchment areas in Kwazulu-Natal, Gauteng and Eastern Cape Provinces; willingness of provincial TB program managers and hospital leadership to participate; willingness of PCC nurse manager to participate; diagnosis of 15 or more RR-TB patients per year; and have access to necessary labs, X-ray and electrocardiogram (ECG) equipment. Participant Inclusion Criteria: Adult 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. Participant Exclusion Criteria: any clinical presentation requiring hospital referral (e.g., severe weakness, confusion, severe mental illness); laboratory or clinical evidence of myelosuppression (hemoglobin < 8mg/dL; absolute neutrophil count <1800/microL; platelet count < 150,000/microL), renal (eGFR<60mL/min) or liver disease (ALT > 2 times upper limit of normal); prolonged QTc>500ms; pregnancy; evidence of extrapulmonary disease; any condition (social or medical), which in the opinion of the investigators, would make participation unsafe.
Sites / Locations
- Jose Pearson HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Nurse-Led Treatment in Primary Care
Physician-Led Treatment Hospital Based
At a primary care clinic intervention site, a nurse will be available once or twice weekly. The days/times 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/availability 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.
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/time for the patient prior to referral (generally < 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.