Actively Recruiting
Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment to Physician-Led RR-TB Treatment
Led by Johns Hopkins University · Updated on 2025-10-20
2944
Participants Needed
5
Research Sites
382 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
U
University of Witwatersrand, South Africa
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 \[H3\].
CONDITIONS
Official Title
Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment to Physician-Led RR-TB Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary Care Clinics within selected hospital catchment areas in KwaZulu-Natal, Gauteng, and Eastern Cape Provinces
- Willingness of provincial TB program managers, hospital leadership, and PCC nurse managers to participate
- Diagnosis of 10 or more RR-TB patients per year at the clinic
- Access to necessary labs, X-ray, and electrocardiogram (ECG) equipment at the clinic
- Adult participants aged 18 years and older with a new RR-TB diagnosis
- Willing and able to provide informed consent in Zulu, Xhosa, Afrikaans, or English
You will not qualify if you...
- Clinical presentation requiring hospital admission (e.g., severe weakness, confusion, severe mental illness, symptomatic low blood pressure, severe shortness of breath, temperature above 39.0°C)
- Hemoglobin level below 8 mg/dL or liver disease (ALT above 120 U/L)
- Prolonged QTc interval above 470 ms confirmed by two or more ECGs
- Rapid heart rate (tachycardia) above 140 beats per minute confirmed after 5 minutes of rest
- Pregnancy
- Evidence of extrapulmonary tuberculosis
- Enrollment in another clinical trial that changes the BPaL-L regimen, duration, or symptom management process
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Doris Goodwin Hospital
Pietermaritzburg, KwaZulu-Natal, South Africa, 3201
Actively Recruiting
2
Murchison Hospital
Port Shepstone, KwaZulu-Natal, South Africa, 7007
Actively Recruiting
3
King Dinuzulu TB Hospital
East London, South Africa
Actively Recruiting
4
Nkquebela TB Hospital
East London, South Africa
Actively Recruiting
5
Jose Pearson Hospital
Port Elizabeth, South Africa
Actively Recruiting
Research Team
K
Kelly Lowensen, MSN, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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