An Adaptive Randomized Controlled Trial
Recruiting now · Not applicable
Conditions studied: Multi Drug Resistant Tuberculosis, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT05633056
- Run by
- Columbia University
- People needed
- 360
- Starts
- 2023-03-07
- Expected to finish
- 2029-04-01
- Last updated by the study team
- 2026-05-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Culture or molecular test positive for MTB
- Molecular test positive for HIV or a documented HIV positive history
- Drug-susceptibility testing by molecular (i.e. GeneXpert MTB/RIF) or conventional testing consistent with at least rifampicin-resistant TB,
- Initiating treatment with a Bedaquiline -containing TB regimen within 4 weeks of enrollment and first-time being treated with BDQ
- 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,
- Capacity for informed consent in either isiZulu or English
You may not qualify if…
- Pregnancy
- Prisoners
- Discretion of IOR or clinician
Where it is running
- King DinuZulu Hospital — Durban, KwaZulu-Natal, South Africa (enrolling)
Full record on ClinicalTrials.gov
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