NCT05671718 Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment to Physician-Led RR-TB Treatment
| NCT ID | NCT05671718 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Drug Resistant Tuberculosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,944 participants |
| Start Date | 2023-09-04 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,944 participants in total. It began in 2023-09-04 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 \[H3\].
Eligibility Criteria
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.
Contact & Investigator
Jason Farley, PhD, MPH, ANP-BC
PRINCIPAL INVESTIGATOR
The Center for Infectious Disease and Nursing Innovation (CIDNI)
Frequently Asked Questions
Who can join the NCT05671718 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Drug Resistant Tuberculosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05671718 currently recruiting?
Yes, NCT05671718 is actively recruiting participants. Contact the research team at klowens1@jhu.edu for enrollment information.
Where is the NCT05671718 trial being conducted?
This trial is being conducted at Pietermaritzburg, South Africa, Port Shepstone, South Africa, East London, South Africa, East London, South Africa and 1 additional location.
Who is sponsoring the NCT05671718 clinical trial?
NCT05671718 is sponsored by Johns Hopkins University. The principal investigator is Jason Farley, PhD, MPH, ANP-BC at The Center for Infectious Disease and Nursing Innovation (CIDNI). The trial plans to enroll 2,944 participants.