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 |
Trial Parameters
Eligibility Fast-Check
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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