Comparing nurse-led and physician-led treatment for drug-resistant tuberculosis
Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment in Primary Care to Physician-Led, Hospital-Based Outpatient RR-TB Treatment: A Cluster Randomized, Non-Inferiority Trial
This study is testing whether treatment for drug-resistant tuberculosis led by nurses in local clinics works as well as treatment by doctors in hospitals, to see if it can help patients get better care at a lower cost.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2944 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 5 sites (Pietermaritzburg, KwaZulu-Natal and 4 other locations) |
| Trial ID | NCT05671718 on ClinicalTrials.gov |
What this trial studies
The Bring BPaL2Me Trial is a multi-site, cluster randomized trial aimed at comparing nurse-led treatment for rifampicin-resistant tuberculosis (RR-TB) in primary care clinics to standard physician-led treatment at district hospitals in South Africa. The study will evaluate treatment outcomes, safety, and the financial burden on patients over a five-year period. By integrating RR-TB care into primary care settings, the trial seeks to determine if this approach can maintain treatment efficacy while reducing costs and improving access to care for patients. The trial will include a blinded review process to ensure unbiased assessment of outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a new diagnosis of rifampicin-resistant tuberculosis, regardless of their HIV status.
Not a fit: Patients requiring hospital admission or those not suitable for outpatient treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide a more accessible and cost-effective treatment model for patients with drug-resistant tuberculosis.
How similar studies have performed: Other studies have shown success with nurse-led models for tuberculosis treatment, making this approach promising yet still innovative in the context of drug-resistant cases.
Eligibility criteria
Show full inclusion / exclusion 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 initiation (e.g., severe weakness, confusion, severe mental illness, symptomatic low blood pressure, severe shortness of breath, and temp \>39.0); 2. Hemoglobin \< 8mg/dL (from National Health Laboratory Service (NHLS) or point of care)) or liver disease (ALT \> 120 U/L); 3. prolonged QTc\>470ms, confirmed by 2 or more ecg; 4. rapid heartrate, tachycardia (HR \>140); confirmed after 5 minutes of rest; 5. pregnancy; 6. evidence of extrapulmonary disease; 7. enrolled in another clinical trial that changes BPaL-L regimen, duration or symptom management process.
Where this trial is running
Pietermaritzburg, KwaZulu-Natal and 4 other locations
- 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)
Study contacts
- Principal investigator: Jason Farley, PhD, MPH, ANP-BC — The Center for Infectious Disease and Nursing Innovation (CIDNI)
- Study coordinator: Kelly Lowensen, MSN, RN
- Email: klowens1@jhu.edu
- Phone: 4104091372
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.