NCT05671718 Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment to Physician-Led RR-TB Treatment
| NCT ID | NCT05671718 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Drug Resistant Tuberculosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,944 participants |
| Start Date | 2023-09-04 |
| Primary Completion | 2028-06-30 |
Trial Parameters
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Brief Summary
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. The 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: 1. 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 \[H1\]. 2. The proportion of SAEs identified will not significantly differ by blinded, independent review \[H2\]. 3. Patient associated catastrophic costs (i.e., costs 20% or more of household income) will be lower in nurse-led treatment \[H3\].
Eligibility Criteria
Inclusion Criteria: Cluster Inclusion Criteria: Primary Care Clinics (PCCs) (i.e., clusters) are eligible if they meet the following: 1. within one of the selected hospital treatment catchment areas in Kwazulu-Natal, Gauteng and Eastern Cape Provinces; 2. willingness of provincial TB program managers and hospital leadership to participate; 3. willingness of PCC nurse manager to participate; 4. diagnosis of 10 or more RR-TB patients per year; and 5. 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: 1. any clinical presentation requiring hospital admission or, in other words, the participant is not a candidate for outpatient primary care ini