NCT05671718Recruiting
Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment to Physician-Led RR-TB Treatment
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
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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 \[H3\].
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2944 (estimated)
- First submitted
- 20 Dec 2022
- Start date
- 4 Sept 2023
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Johns Hopkins University
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT05671718
What you commit to
- Study type: Interventional
- Planned participants: 2944
- From 4 Sept 2023 to the primary completion date, 30 Jun 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Cluster Inclusion Criteria:
- Primary Care Clinics (PCCs) (i.e., clusters) are eligible if they meet the following:
- within one of the selected hospital treatment catchment areas in Kwazulu-Natal, Gauteng and Eastern Cape Provinces;
- willingness of provincial TB program managers and hospital leadership to participate;
- willingness of PCC nurse manager to participate;
- diagnosis of 10 or more RR-TB patients per year; and
- 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:
- 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);
- Hemoglobin \< 8mg/dL (from National Health Laboratory Service (NHLS) or point of care)) or liver disease (ALT \> 120 U/L);
- prolonged QTc\>470ms, confirmed by 2 or more ecg;
- rapid heartrate, tachycardia (HR \>140); confirmed after 5 minutes of rest;
- pregnancy;
- evidence of extrapulmonary disease;
- enrolled in another clinical trial that changes BPaL-L regimen, duration or symptom management process.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nkquebela TB Hospital Coordinator of this site? Confirm its status | East London | South Africa | Recruiting |
| King Dinuzulu TB Hospital Coordinator of this site? Confirm its status | East London | South Africa | Recruiting |
| Doris Goodwin Hospital Coordinator of this site? Confirm its status | Pietermaritzburg | South Africa | Recruiting |
| Jose Pearson Hospital Coordinator of this site? Confirm its status | Port Elizabeth | South Africa | Recruiting |
| Murchison Hospital Coordinator of this site? Confirm its status | Port Shepstone | South Africa | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.