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RECRUITING
NCT05671718
NA

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

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

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 \[H3\].

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2944

Start Date

2023-09-04

Completion Date

2030-12-31

Last Updated

2025-10-20

Healthy Volunteers

No

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.

Locations (5)

Doris Goodwin Hospital

Pietermaritzburg, KwaZulu-Natal, South Africa

Murchison Hospital

Port Shepstone, KwaZulu-Natal, South Africa

King Dinuzulu TB Hospital

East London, South Africa

Nkquebela TB Hospital

East London, South Africa

Jose Pearson Hospital

Port Elizabeth, South Africa