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Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment to Physician-Led RR-TB Treatment

NCT05671718 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2944

Last updated 2025-10-17

No results posted yet for this study

Summary

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

  • Drug Resistant Tuberculosis

Interventions

OTHER

Nurse-Led Treatment in Primary Care

At a primary care clinic intervention site, a nurse will be available once or twice weekly. The days/times will be dependent on clinic volume (i.e., cluster size), with scheduled rotations between PCCs. This rotation between PCC sites will mimic the physician's responsibilities/availability at a district hospital and creates parity between the trial arms. In this trial, we will have nurses dedicated to the management of RR-TB treatment, yet the volume at each site will not require the presence of a full-time nurse.

Sponsors & Collaborators

  • University of Witwatersrand, South Africa

    collaborator OTHER

  • University of Cape Town

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Jason Farley, PhD, MPH, ANP-BC · The Center for Infectious Disease and Nursing Innovation (CIDNI)

  • Denise Evans, PhD · University of Witwatersrand, South Africa

  • Norbert Ndjeka, MBChB · University of Cape Town

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-04
Primary Completion
2028-06-30
Completion
2030-12-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05671718 on ClinicalTrials.gov