NCT05633056 An Adaptive Randomized Controlled Trial
| NCT ID | NCT05633056 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Multi Drug Resistant Tuberculosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2023-03-07 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 360 participants in total. It began in 2023-03-07 with a primary completion date of 2027-04.
⚠ 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
This is a prospective, adaptive, randomized controlled trial comparing the effectiveness of 4 intervention arms on a combined endpoint in adults with confirmed MDR-TB HIV initiating Bedaquiline-containing MDR-TB treatment regimens and on ART (integrase strand transfer inhibitor (INSTI)-based fixed dose combination therapy) in KwaZulu-Natal, South Africa. Interventions arms include: enhanced standard of care; psychosocial support; mHealth using cellular-enabled electronic dose monitoring; combined mHealth psychosocial support. Level of support will be adjusted using a differentiated service delivery (DSD)- informed assessment of treatment support needs.
Eligibility Criteria
Inclusion Criteria: 1. Culture or molecular test positive for MTB 2. Molecular test positive for HIV or a documented HIV positive history 3. Drug-susceptibility testing by molecular (i.e. GeneXpert MTB/RIF) or conventional testing consistent with at least rifampicin-resistant TB, 4. Initiating treatment with a Bedaquiline -containing TB regimen within 4 weeks of enrollment and first-time being treated with BDQ 5. On treatment with Antiretroviral Therapy (ART) regimen, including dolutegravir-containing combination Antiretroviral Therapy regimen (i.e. Tenofovir-Lamivudine-Dolutergravir), or starting within 4 weeks of enrollment, 6. Capacity for informed consent in either isiZulu or English Exclusion Criteria: 1. Pregnancy 2. Prisoners 3. Discretion of IOR or clinician
Contact & Investigator
Max O'Donnell, MD, MPH
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT05633056 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multi 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 NCT05633056 currently recruiting?
Yes, NCT05633056 is actively recruiting participants. Contact the research team at Kogie.Naidoo@caprisa.org for enrollment information.
Where is the NCT05633056 trial being conducted?
This trial is being conducted at Durban, South Africa.
Who is sponsoring the NCT05633056 clinical trial?
NCT05633056 is sponsored by Columbia University. The principal investigator is Max O'Donnell, MD, MPH at Columbia University. The trial plans to enroll 360 participants.