Port Shepstone

Researchers are evaluating the treatment of rifampicin-resistant tuberculosis RR-TB by comparing nurse-led care in primary care clinics to the standard physician-led care at district hospitals in South Africa. This multi-site, cluster randomized, non-inferiority trial aims to assess treatment outcomes, safety, and patient-related costs over a five-year period, including patients with or without HIV co-infection. The study addresses the high costs and access barriers associated with hospital-based RR-TB care and explores the potential benefits of decentralized, patient-centered models closer to patients homes. The trial includes two groups one receiving nurse-led RR-TB treatment at primary care clinics with nurses available once or twice weekly on a rotating schedule, and the other receiving standard physician-led outpatient treatment at district hospitals. Nurses manage RR-TB treatment while physicians typically cover multiple clinics with limited availability. The trial assesses whether nurse-led treatment in primary care clinics is not inferior to physician-led hospital outpatient treatment regarding treatment success and safety. Participants aged 18 and older with new RR-TB diagnoses are involved in regular assessments including laboratory tests, ECGs, and monitoring for adverse events over 12 months. Researchers evaluate treatment outcomes at 6 months, severe adverse events, and patient costs at 12 months, along with secondary measures like time to treatment initiation, culture conversion, HIV treatment milestones, and provider adherence to guidelines. The study includes safety monitoring and cost-effectiveness evaluations, with a total participation duration varying based on individual treatment timelines.