Condition: Drug Resistant Tuberculosis · Sponsor: Johns Hopkins University
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 \[H3\].
This description comes directly from the study's public registry record.
Kelly Lowensen, MSN, RN · 4104091372 · klowens1@jhu.edu
Always discuss trial participation with your own doctor first.
| Doris Goodwin Hospital | Pietermaritzburg, KwaZulu-Natal, South Africa | Recruiting |
| Murchison Hospital | Port Shepstone, KwaZulu-Natal, South Africa | Recruiting |
| King Dinuzulu TB Hospital | East London, South Africa | Recruiting |
| Nkquebela TB Hospital | East London, South Africa | Recruiting |
| Jose Pearson Hospital | Port Elizabeth, South Africa | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05671718