Comparing nurse-led and physician-led treatment for drug-resistant tuberculosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• New six-month regimen for MDR-TB in France using BPaLM or BPaLC/BPaLM+Clofazimine

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  Recruiting at 4 sites Phase 3 Assistance Publique - Hôpitaux de Paris · Amiens and 4 other locations · NCT07486024

• Personalized linezolid dosing with therapeutic drug monitoring during the BPaL regimen for MDR-TB

  This project will see if adjusting linezolid doses using therapeutic drug monitoring helps people aged 15 and older in Guinea with multidrug-resistant tuberculosis tolerate the 6-month BPaL regimen with fewer serious side effects.

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• Comparing different support methods for treating drug-resistant tuberculosis and HIV in South Africa

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  Recruiting Columbia University · Durban, KwaZulu-Natal · NCT05633056

• Understanding the natural history of tuberculosis

  This study is trying to learn more about tuberculosis by collecting samples and monitoring treatment in people with active or latent TB to improve how we understand and treat the disease.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT01212003

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.