# The Bring BPaL2Me Trial - Comparing Nurse-Led RR-TB Treatment in Primary Care to Physician-Led, Hospital-Based RR-TB Treatment: A Cluster Randomized, Non-Inferiority Trial

> **NIH NIH R01** · JOHNS HOPKINS UNIVERSITY · 2024 · $681,271

## Abstract

This administrative supplement supports the BringBPaL2Me Trial in order to fully meet trial aims. In South
Africa (SA), Mycobacterium tuberculosis (TB) is managed within primary care clinics (PCCs), where nurses treat
drug-susceptible TB and TB/HIV coinfection with treatment outcomes rivaling the best in the world. A PCC
management strategy offers a more convenient, patient-centered, differentiated model of care that integrates TB
and HIV treatment within the same setting. A diagnosis of rifampicin-resistant TB (RR-TB), however, upends
this model, requiring referral to a hospital-based, physician-led outpatient treatment center. Hospital-based,
physician-led models add significant patient-associated costs, with estimates suggesting 81% of RR-TB patients
experience catastrophic costs even in a decentralized outpatient model. There is hope, however, to move RR-TB
care into PCCs and in many settings this involves nurse-led management. The BringBPaL2Me Trial is a multi-
principal investigator, multi-site, cluster randomized, non-inferiority trial (CR-NIT), to compare nurse-led RR-
TB treatment in PCCs to standard of care physician-led RR-TB treatment at district hospitals in the provinces of
KwaZulu-Natal (KZN), Gauteng (GP) and Eastern Cape (EC), SA. Clusters include 10 PCCs affiliated with 5
decentralized outpatient programs at RR-TB district hospitals (n=70 clusters). We estimate the need to screen
3,800 RR-TB positive patients to enroll 2,800, or 49 RR-TB participants per PCC cluster. We estimate 60-70%
will be HIV co-infected. The interclass correlation is 0.024 based on our prior CRT enrolling 3,000 patients in
KZN and EC. The non-inferiority margin is set at 5% with the assumption of 90% treatment success in the
physician-led arm. Treatment will include either a 6-month RR-TB regimen (i.e., bedaquiline, pretomanid,
linezolid and levofloxacin, or BPaL-L) or fluroquinolone-resistant TB (i.e., BPaL) regimen. The BringBPaL2Me
primary aim is to conduct a 5-year, analyst and clinical safety review committee blinded, multi-site, CR-NIT to
evaluate 1) treatment outcome; 2) safety; and 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 severe adverse events (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]. Our secondary aims include: 1) time to
event analysis for a) RR-TB treatment initiation; b) smear/culture conversion; and, as applicable, c) HIV
treatment initiation; d) HIV viral suppression; and e) AE and SAE symptom resolution; 2) characterization of
provider adherence to guidelines for: a) dosing require...

## Key facts

- **NIH application ID:** 11071583
- **Project number:** 3R01AI177135-02S1
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Denise Evans
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $681,271
- **Award type:** 3
- **Project period:** 2023-03-10 → 2028-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11071583

## Citation

> US National Institutes of Health, RePORTER application 11071583, The Bring BPaL2Me Trial - Comparing Nurse-Led RR-TB Treatment in Primary Care to Physician-Led, Hospital-Based RR-TB Treatment: A Cluster Randomized, Non-Inferiority Trial (3R01AI177135-02S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/11071583. Licensed CC0.

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