RECRUITINGINTERVENTIONAL

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

About This Trial

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 \[H3\].

Who May Be Eligible (Plain English)

Who May Qualify: Cluster Who May Qualify: 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 Who May Qualify: 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 willing to sign a consent form in one of the four most common SA languages \[Zulu, Xhosa, Afrikaans, and English\] will be eligible. Participant Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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