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NCT05633056
An Adaptive Randomized Controlled Trial
Conditions: Multi Drug Resistant Tuberculosis, HIV Infections
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 360
Sponsor: Columbia University
Location: South Africa
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:Culture or molecular test positive for MTBMolecular test positive for HIV or a documented HIV positive historyDrug-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 BDQOn 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 EnglishExclusion Criteria:PregnancyPrisonersDiscretion of IOR or clinician
Source: ClinicalTrials.gov (NCT05633056). StuddyBuddy aggregates publicly available trial information.