Port Shepstone

Researchers are evaluating a nurse-led treatment approach for rifampicin-resistant tuberculosis (RR-TB) in primary care clinics compared to the standard physician-led treatment at district hospitals in South Africa. This multi-site, cluster randomized, non-inferiority trial spans five years and aims to assess treatment outcomes, safety, and patient costs. The study includes participants from KwaZulu-Natal, Gauteng, and Eastern Cape provinces and considers patients regardless of HIV status. The trial compares nurse-led RR-TB care delivered in primary care clinics, where nurses visit once or twice weekly on a rotating schedule, to physician-led outpatient care in hospitals. This approach aims to create equal access and management responsibilities between the two models. The nurse-led care model is designed to be patient-centered and closer to patients' homes, following World Health Organization recommendations for decentralized treatment of RR-TB with six-month regimens. Participants will be closely monitored throughout the study, with assessments covering treatment outcomes at six months, safety through severe adverse events over twelve months, and evaluation of patient-related catastrophic costs within a year. Researchers will also examine treatment initiation times, microbiological conversion, HIV treatment progress, adherence to dosing guidelines, and cost-effectiveness. The study involves thorough clinical and laboratory evaluations, including access to necessary labs, X-rays, and ECGs, with ongoing safety and effectiveness monitoring over the trial duration.