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Compares treatment options for Drug Resistant Tuberculosis
Official title Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment to Physician-Led RR-TB Treatment
ClinicalTrials.gov ID: NCT05671718
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Cluster 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
You likely can't join if
- any clinical presentation requiring hospital admission or, in other words, the participant is not a candidate for outpatient primary care initiation...
- Hemoglobin \ 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;
See the full eligibility criteria
- Cluster 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 Adult participants aged 18 years of age and older, regardless of HIV status, who have a new RR-TB diagnosis, deemed willing and...
- 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...
- Hemoglobin \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Pietermaritzburg, KwaZulu-Natal, South Africa
- Port Shepstone, KwaZulu-Natal, South Africa
- East London, South Africa
- Port Elizabeth, South Africa
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pietermaritzburg, KwaZulu-Natal, South Africa; Port Shepstone, KwaZulu-Natal, South Africa; East London, South Africa; Port Elizabeth, South Africa. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.