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 \[H3\].
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 10 or more RR-TB patients per year; and
✓. have access to necessary labs, X-ray and electrocardiogram (ECG) equipment.
Exclusion criteria
✕. any clinical presentation requiring hospital admission or, in other words, the participant is not a candidate for outpatient primary care initiation (e.g., severe weakness, confusion, severe mental illness, symptomatic low blood pressure, severe shortness of breath, and temp \>39.0);
✕. Hemoglobin \< 8mg/dL (from National Health Laboratory Service (NHLS) or point of care)) or liver disease (ALT \> 120 U/L);
✕. prolonged QTc\>470ms, confirmed by 2 or more ecg;
✕
What they're measuring
1
RR-TB treatment outcome
Timeframe: 6 months
2
Severe Adverse Events as assessed by the Division of AIDS (DAIDS) AE grading table